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    <VOL>69</VOL>
    <NO>219</NO>
    <DATE>Monday, November 15, 2004</DATE>
    <UNITNAME>Contents</UNITNAME>
    <CNTNTS>
        <AGCY>
            <EAR>Administration</EAR>
            <PRTPAGE P="iii"/>
            <HD>Administration on Aging</HD>
            <SEE>
                <HD SOURCE="HED">See</HD>
                <P> Aging Administration</P>
            </SEE>
        </AGCY>
        <AGCY>
            <EAR>Aging</EAR>
            <HD>Aging Administration</HD>
            <CAT>
                <HD>NOTICES</HD>
                <DOCENT>
                    <DOC>Agency information collection activities; proposals, submissions, and approvals, </DOC>
                    <PGS>65601-65602</PGS>
                    <FRDOCBP T="15NON1.sgm" D="2">04-25241</FRDOCBP>
                </DOCENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Agriculture</EAR>
            <HD>Agriculture Department</HD>
            <SEE>
                <HD SOURCE="HED">See</HD>
                <P> Farm Service Agency</P>
            </SEE>
            <SEE>
                <HD SOURCE="HED">See</HD>
                <P> Forest Service</P>
            </SEE>
            <SEE>
                <HD SOURCE="HED">See</HD>
                <P> Natural Resources Conservation Service</P>
            </SEE>
            <SEE>
                <HD SOURCE="HED">See</HD>
                <P> Rural Business-Cooperative Service</P>
            </SEE>
            <SEE>
                <HD SOURCE="HED">See</HD>
                <P> Rural Housing Service</P>
            </SEE>
            <SEE>
                <HD SOURCE="HED">See</HD>
                <P> Rural Utilities Service</P>
            </SEE>
        </AGCY>
        <AGCY>
            <EAR>Antitrust</EAR>
            <HD>Antitrust Division</HD>
            <CAT>
                <HD>NOTICES</HD>
                <SJ>Competitive impact statements and proposed consent judgments:</SJ>
                <SJDENT>
                    <SJDOC>Cingular Wireless Corp. et al., </SJDOC>
                    <PGS>65633-65654</PGS>
                    <FRDOCBP T="15NON1.sgm" D="22">04-25323</FRDOCBP>
                </SJDENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Centers</EAR>
            <HD>Centers for Medicare &amp; Medicaid Services</HD>
            <SEE>
                <HD SOURCE="HED">See</HD>
                <P> Inspector General Office, Health and Human Services Department</P>
            </SEE>
            <CAT>
                <HD>RULES</HD>
                <SJ>Medicare:</SJ>
                <SJDENT>
                    <SJDOC>Hospital outpatient prospective payment system and 2005 CY payment rates, </SJDOC>
                    <PGS>65681-66233</PGS>
                    <FRDOCBP T="15NOR2.sgm" D="553">04-24759</FRDOCBP>
                </SJDENT>
                <SJDENT>
                    <SJDOC>Physician fee schedule (2005 CY); payment policies and relative value units adjustment, </SJDOC>
                    <PGS>66235-66915</PGS>
                    <FRDOCBP T="15NOR3.sgm" D="681">04-24758</FRDOCBP>
                </SJDENT>
                <SJDENT>
                    <SJDOC>Psychiatric facilities; hospital inpatient services prospective payment system, </SJDOC>
                    <PGS>66921-67015</PGS>
                    <FRDOCBP T="15NOR4.sgm" D="95">04-24787</FRDOCBP>
                </SJDENT>
            </CAT>
            <CAT>
                <HD>NOTICES</HD>
                <DOCENT>
                    <DOC>Agency information collection activities; proposals, submissions, and approvals, </DOC>
                    <PGS>65602-65603</PGS>
                    <FRDOCBP T="15NON1.sgm" D="2">04-25250</FRDOCBP>
                </DOCENT>
                <SJ>Medicare:</SJ>
                <SJDENT>
                    <SJDOC>Ambulance services; fee schedule; inflation update, </SJDOC>
                    <PGS>66917-66920</PGS>
                    <FRDOCBP T="15NON2.sgm" D="4">04-24757</FRDOCBP>
                </SJDENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Civil</EAR>
            <HD>Civil Rights Commission</HD>
            <CAT>
                <HD>NOTICES</HD>
                <SJ>Meetings; State advisory committees:</SJ>
                <SJDENT>
                    <SJDOC>Vermont, </SJDOC>
                    <PGS>65579-65580</PGS>
                    <FRDOCBP T="15NON1.sgm" D="2">04-25248</FRDOCBP>
                </SJDENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Coast Guard</EAR>
            <HD>Coast Guard</HD>
            <CAT>
                <HD>PROPOSED RULES</HD>
                <SJ>Pollution:</SJ>
                <SUBSJ>Marine liquefied natural gas spills; thermal and vapor dispersion exclusion zones; rulemaking petition</SUBSJ>
                <SSJDENT>
                    <SUBSJDOC>Correction, </SUBSJDOC>
                    <PGS>65555-65556</PGS>
                    <FRDOCBP T="15NOP1.sgm" D="2">04-25254</FRDOCBP>
                </SSJDENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Commerce</EAR>
            <HD>Commerce Department</HD>
            <SEE>
                <HD SOURCE="HED">See</HD>
                <P> Foreign-Trade Zones Board</P>
            </SEE>
            <SEE>
                <HD SOURCE="HED">See</HD>
                <P> Industry and Security Bureau</P>
            </SEE>
            <SEE>
                <HD SOURCE="HED">See</HD>
                <P> National Oceanic and Atmospheric Administration</P>
            </SEE>
        </AGCY>
        <AGCY>
            <EAR>Commodity</EAR>
            <HD>Commodity Futures Trading Commission</HD>
            <CAT>
                <HD>NOTICES</HD>
                <DOCENT>
                    <DOC>International Exchange, Inc.; brokers and traders treatment as eligible commercial entities, </DOC>
                    <PGS>65584-65591</PGS>
                    <FRDOCBP T="15NON1.sgm" D="8">04-25282</FRDOCBP>
                </DOCENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Comptroller</EAR>
            <HD>Comptroller of the Currency</HD>
            <CAT>
                <HD>NOTICES</HD>
                <SJ>Reports and guidance documents; availability, etc.:</SJ>
                <SJDENT>
                    <SJDOC>Retail credit risk for regulatory capital; internal ratings-based systems use; correction, </SJDOC>
                    <PGS>65679</PGS>
                    <FRDOCBP T="15NOCX.sgm" D="1">C4-23771</FRDOCBP>
                </SJDENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Defense</EAR>
            <HD>Defense Department</HD>
            <CAT>
                <HD>NOTICES</HD>
                <SJ>Federal Acquisition Regulation (FAR):</SJ>
                <SJDENT>
                    <SJDOC>Agency information collection activities; proposals, submissions, and approvals, </SJDOC>
                    <PGS>65591-65594</PGS>
                    <FRDOCBP T="15NON1.sgm" D="2">04-25291</FRDOCBP>
                    <FRDOCBP T="15NON1.sgm" D="2">04-25292</FRDOCBP>
                    <FRDOCBP T="15NON1.sgm" D="1">04-25293</FRDOCBP>
                    <FRDOCBP T="15NON1.sgm" D="2">04-25295</FRDOCBP>
                </SJDENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Education</EAR>
            <HD>Education Department</HD>
            <CAT>
                <HD>NOTICES</HD>
                <DOCENT>
                    <DOC>Agency information collection activities; proposals, submissions, and approvals, </DOC>
                    <PGS>65594</PGS>
                    <FRDOCBP T="15NON1.sgm" D="1">04-25256</FRDOCBP>
                </DOCENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Employment</EAR>
            <HD>Employment and Training Administration</HD>
            <CAT>
                <HD>NOTICES</HD>
                <SJ>Reports and guidance documents; availability, etc.:</SJ>
                <SJDENT>
                    <SJDOC>Workforce security programs; Unemployment Insurance Program Letters interpreting Federal law, </SJDOC>
                    <PGS>65654-65656</PGS>
                    <FRDOCBP T="15NON1.sgm" D="3">E4-3162</FRDOCBP>
                </SJDENT>
                <SJ>
                    Agency information collection activities; proposals, submissions, and approvals, [
                    <E T="04">Editiorial Note:</E>
                     The page number for this document was incorrectly listed in the Friday, November 12, 2004 
                    <E T="04">Federal Register</E>
                     Table of Contents.  The correct page number is  65508.]
                </SJ>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>EPA</EAR>
            <HD>Environmental Protection Agency</HD>
            <CAT>
                <HD>PROPOSED RULES</HD>
                <SJ>Toxic substances:</SJ>
                <SJDENT>
                    <SJDOC>Enzymes and proteins; nomenclature inventory, </SJDOC>
                    <PGS>65565-65570</PGS>
                    <FRDOCBP T="15NOP1.sgm" D="6">04-25307</FRDOCBP>
                </SJDENT>
            </CAT>
            <CAT>
                <HD>NOTICES</HD>
                <SJ>Air pollution control; new motor vehicles and engines:</SJ>
                <SUBSJ>California pollution control standards—</SUBSJ>
                <SSJDENT>
                    <SUBSJDOC>Heavy-duty diesel engines and vehicles; 2007 and subsequent model years; Federal preemption waiver request, </SUBSJDOC>
                    <PGS>65594-65596</PGS>
                    <FRDOCBP T="15NON1.sgm" D="3">04-25304</FRDOCBP>
                </SSJDENT>
                <DOCENT>
                    <DOC>Confidential business information and data transfer, </DOC>
                    <PGS>65596</PGS>
                    <FRDOCBP T="15NON1.sgm" D="1">04-25306</FRDOCBP>
                </DOCENT>
                <SJ>Reports and guidance documents; availability, etc.:</SJ>
                <SJDENT>
                    <SJDOC>CERCLA service station dealer exemption; model application/information request, </SJDOC>
                    <PGS>65596-65597</PGS>
                    <FRDOCBP T="15NON1.sgm" D="2">04-25305</FRDOCBP>
                </SJDENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Executive</EAR>
            <HD>Executive Office of the President</HD>
            <SEE>
                <HD SOURCE="HED">See</HD>
                <P> Presidential Documents</P>
            </SEE>
            <SEE>
                <HD SOURCE="HED">See</HD>
                <P> Trade Representative, Office of United States</P>
            </SEE>
        </AGCY>
        <AGCY>
            <EAR>Farm</EAR>
            <HD>Farm Service Agency</HD>
            <CAT>
                <HD>RULES</HD>
                <SJ>Program regulations:</SJ>
                <SUBSJ>Farm Security and Rural Investment Act—</SUBSJ>
                <SSJDENT>
                    <SUBSJDOC>General credit provisions; correction, </SUBSJDOC>
                    <PGS>65520</PGS>
                    <FRDOCBP T="15NOR1.sgm" D="1">04-25285</FRDOCBP>
                </SSJDENT>
                <DOCENT>
                    <DOC>State Nonmetropolitan Median Household Income; definition clarification, </DOC>
                    <PGS>65517-65519</PGS>
                    <FRDOCBP T="15NOR1.sgm" D="3">04-25245</FRDOCBP>
                </DOCENT>
            </CAT>
            <CAT>
                <HD>PROPOSED RULES</HD>
                <SJ>Program regulations:</SJ>
                <SJDENT>
                    <SJDOC>Servicing of water and waste loan and grant programs, </SJDOC>
                    <PGS>65546-65554</PGS>
                    <FRDOCBP T="15NOP1.sgm" D="9">04-25247</FRDOCBP>
                </SJDENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>FAA</EAR>
            <PRTPAGE P="iv"/>
            <HD>Federal Aviation Administration</HD>
            <CAT>
                <HD>RULES</HD>
                <SJ>Airworthiness directives:</SJ>
                <SJDENT>
                    <SJDOC>Airbus, </SJDOC>
                    <PGS>65523-65531</PGS>
                    <FRDOCBP T="15NOR1.sgm" D="4">04-24930</FRDOCBP>
                    <FRDOCBP T="15NOR1.sgm" D="6">04-24933</FRDOCBP>
                </SJDENT>
                <SJDENT>
                    <SJDOC>Boeing, </SJDOC>
                    <PGS>65520-65522, 65533-65535</PGS>
                    <FRDOCBP T="15NOR1.sgm" D="3">04-24931</FRDOCBP>
                    <FRDOCBP T="15NOR1.sgm" D="3">04-24936</FRDOCBP>
                </SJDENT>
                <SJDENT>
                    <SJDOC>Empresa Brasileira de Aeronautica, S.A. (EMBRAER), </SJDOC>
                    <PGS>65535-65537</PGS>
                    <FRDOCBP T="15NOR1.sgm" D="3">04-24935</FRDOCBP>
                </SJDENT>
                <SJDENT>
                    <SJDOC>McDonnell Douglas, </SJDOC>
                    <PGS>65522-65523, 65531-65533</PGS>
                    <FRDOCBP T="15NOR1.sgm" D="3">04-24932</FRDOCBP>
                    <FRDOCBP T="15NOR1.sgm" D="2">04-24934</FRDOCBP>
                </SJDENT>
                <DOCENT>
                    <DOC>Standard instrument approach procedures, </DOC>
                    <PGS>65538-65539</PGS>
                    <FRDOCBP T="15NOR1.sgm" D="2">04-25213</FRDOCBP>
                </DOCENT>
            </CAT>
            <CAT>
                <HD>NOTICES</HD>
                <DOCENT>
                    <DOC>Exemption petitions; summary and disposition, </DOC>
                    <PGS>65677</PGS>
                    <FRDOCBP T="15NON1.sgm" D="1">04-25322</FRDOCBP>
                </DOCENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>FCC</EAR>
            <HD>Federal Communications Commission</HD>
            <CAT>
                <HD>RULES</HD>
                <SJ>Digital television stations; table of assignments:</SJ>
                <SJDENT>
                    <SJDOC>California, </SJDOC>
                    <PGS>65545</PGS>
                    <FRDOCBP T="15NOR1.sgm" D="1">04-25263</FRDOCBP>
                </SJDENT>
                <DOCENT>
                    <DOC>Spectrum, efficient use promotion; secondary markets development; regulatory barriers elimination, </DOC>
                    <PGS>65544-65545</PGS>
                    <FRDOCBP T="15NOR1.sgm" D="2">04-25288</FRDOCBP>
                </DOCENT>
            </CAT>
            <CAT>
                <HD>PROPOSED RULES</HD>
                <SJ>Radio services, special:</SJ>
                <SUBSJ>Maritime services—</SUBSJ>
                <SSJDENT>
                    <SUBSJDOC>Automatic Identification Systems; electromagnetic frequency identification, </SUBSJDOC>
                    <PGS>65570-65577</PGS>
                    <FRDOCBP T="15NOP1.sgm" D="8">04-25289</FRDOCBP>
                </SSJDENT>
            </CAT>
            <CAT>
                <HD>NOTICES</HD>
                <DOCENT>
                    <DOC>Agency information collection activities; proposals, submissions, and approvals, </DOC>
                    <PGS>65597-65598</PGS>
                    <FRDOCBP T="15NON1.sgm" D="2">04-25286</FRDOCBP>
                </DOCENT>
                <SJ>Common carrier services:</SJ>
                <SJDENT>
                    <SJDOC>Foreign mobile termination rates; effect on U.S. customers, </SJDOC>
                    <PGS>65598</PGS>
                    <FRDOCBP T="15NON1.sgm" D="1">04-25287</FRDOCBP>
                </SJDENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>FDIC</EAR>
            <HD>Federal Deposit Insurance Corporation</HD>
            <CAT>
                <HD>NOTICES</HD>
                <SJ>Reports and guidance documents; availability, etc.:</SJ>
                <SJDENT>
                    <SJDOC>Retail credit risk for regulatory capital; internal ratings-based systems use; correction, </SJDOC>
                    <PGS>65679</PGS>
                    <FRDOCBP T="15NOCX.sgm" D="1">C4-23771</FRDOCBP>
                </SJDENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Federal Emergency</EAR>
            <HD>Federal Emergency Management Agency</HD>
            <CAT>
                <HD>NOTICES</HD>
                <SJ>Privacy Act:</SJ>
                <SJDENT>
                    <SJDOC>Systems of records, </SJDOC>
                    <PGS>65615-65618</PGS>
                    <FRDOCBP T="15NON1.sgm" D="4">04-25284</FRDOCBP>
                </SJDENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Federal Housing</EAR>
            <HD>Federal Housing Finance Board</HD>
            <CAT>
                <HD>NOTICES</HD>
                <DOCENT>
                    <DOC>Meetings; Sunshine Act, </DOC>
                    <PGS>65598</PGS>
                    <FRDOCBP T="15NON1.sgm" D="1">04-25404</FRDOCBP>
                </DOCENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Federal Reserve</EAR>
            <HD>Federal Reserve System</HD>
            <CAT>
                <HD>NOTICES</HD>
                <SJ>Banks and bank holding companies:</SJ>
                <SJDENT>
                    <SJDOC>Change in bank control, </SJDOC>
                    <PGS>65598</PGS>
                    <FRDOCBP T="15NON1.sgm" D="1">04-25269</FRDOCBP>
                </SJDENT>
                <SJDENT>
                    <SJDOC>Formations, acquisitions, and mergers, </SJDOC>
                    <PGS>65599</PGS>
                    <FRDOCBP T="15NON1.sgm" D="1">04-25268</FRDOCBP>
                </SJDENT>
                <SJ>Reports and guidance documents; availability, etc.:</SJ>
                <SJDENT>
                    <SJDOC>Retail credit risk for regulatory capital; internal ratings-based systems use; correction, </SJDOC>
                    <PGS>65679</PGS>
                    <FRDOCBP T="15NOCX.sgm" D="1">C4-23771</FRDOCBP>
                </SJDENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Financial</EAR>
            <HD>Financial Management Service</HD>
            <SEE>
                <HD SOURCE="HED">See</HD>
                <P> Fiscal Service</P>
            </SEE>
        </AGCY>
        <AGCY>
            <EAR>Fiscal</EAR>
            <HD>Fiscal Service</HD>
            <CAT>
                <HD>NOTICES</HD>
                <SJ>Surety companies acceptable on Federal bonds:</SJ>
                <SJDENT>
                    <SJDOC>Roche Surety &amp; Casualty Co., Inc., </SJDOC>
                    <PGS>65677-65678</PGS>
                    <FRDOCBP T="15NON1.sgm" D="2">04-25283</FRDOCBP>
                </SJDENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Fish</EAR>
            <HD>Fish and Wildlife Service</HD>
            <CAT>
                <HD>NOTICES</HD>
                <DOCENT>
                    <DOC>Agency information collection activities; proposals, submissions, and approvals, </DOC>
                    <PGS>65627-65628</PGS>
                    <FRDOCBP T="15NON1.sgm" D="2">04-25267</FRDOCBP>
                </DOCENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Food</EAR>
            <HD>Food and Drug Administration</HD>
            <CAT>
                <HD>RULES</HD>
                <SJ>Food additives:</SJ>
                <SJDENT>
                    <SJDOC>Mannitol, </SJDOC>
                    <PGS>65540-65542</PGS>
                    <FRDOCBP T="15NOR1.sgm" D="3">04-25243</FRDOCBP>
                </SJDENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>MISSING FOR: Foreign-Trade Zones Board</EAR>
            <HD>Foreign-Trade Zones Board</HD>
            <CAT>
                <HD>NOTICES</HD>
                <SJ>
                    <E T="03">Applications, hearings, determinations, etc.:</E>
                </SJ>
                <SJDENT>
                    <SJDOC>California, </SJDOC>
                    <PGS>65580</PGS>
                    <FRDOCBP T="15NON1.sgm" D="1">04-25294</FRDOCBP>
                </SJDENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Forest</EAR>
            <HD>Forest Service</HD>
            <CAT>
                <HD>NOTICES</HD>
                <SJ>Environmental statements; notice of intent:</SJ>
                <SJDENT>
                    <SJDOC>Bridger-Teton National Forest, WY, </SJDOC>
                    <PGS>65578-65579</PGS>
                    <FRDOCBP T="15NON1.sgm" D="2">04-25249</FRDOCBP>
                </SJDENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>GSA</EAR>
            <HD>General Services Administration</HD>
            <CAT>
                <HD>NOTICES</HD>
                <SJ>Federal Acquisition Regulation (FAR):</SJ>
                <SJDENT>
                    <SJDOC>Agency information collection activities; proposals, submissions, and approvals, </SJDOC>
                    <PGS>65591-65594</PGS>
                    <FRDOCBP T="15NON1.sgm" D="2">04-25291</FRDOCBP>
                    <FRDOCBP T="15NON1.sgm" D="2">04-25292</FRDOCBP>
                    <FRDOCBP T="15NON1.sgm" D="1">04-25293</FRDOCBP>
                    <FRDOCBP T="15NON1.sgm" D="2">04-25295</FRDOCBP>
                </SJDENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Health</EAR>
            <HD>Health and Human Services Department</HD>
            <SEE>
                <HD SOURCE="HED">See</HD>
                <P> Aging Administration</P>
            </SEE>
            <SEE>
                <HD SOURCE="HED">See</HD>
                <P> Centers for Medicare &amp; Medicaid Services</P>
            </SEE>
            <SEE>
                <HD SOURCE="HED">See</HD>
                <P> Food and Drug Administration</P>
            </SEE>
            <SEE>
                <HD SOURCE="HED">See</HD>
                <P> Indian Health Service</P>
            </SEE>
            <SEE>
                <HD SOURCE="HED">See</HD>
                <P> Inspector General Office, Health and Human Services Department</P>
            </SEE>
            <SEE>
                <HD SOURCE="HED">See</HD>
                <P> National Institutes of Health</P>
            </SEE>
            <SEE>
                <HD SOURCE="HED">See</HD>
                <P> Public Health Service</P>
            </SEE>
            <CAT>
                <HD>NOTICES</HD>
                <DOCENT>
                    <DOC>National Health Information Network; development and adoption; comment request, </DOC>
                    <PGS>65599-65601</PGS>
                    <FRDOCBP T="15NON1.sgm" D="3">04-25382</FRDOCBP>
                </DOCENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Homeland</EAR>
            <HD>Homeland Security Department</HD>
            <SEE>
                <HD SOURCE="HED">See</HD>
                <P> Coast Guard</P>
            </SEE>
            <SEE>
                <HD SOURCE="HED">See</HD>
                <P> Federal Emergency Management Agency</P>
            </SEE>
            <SEE>
                <HD SOURCE="HED">See</HD>
                <P> Transportation Security Administration</P>
            </SEE>
        </AGCY>
        <AGCY>
            <EAR>Housing</EAR>
            <HD>Housing and Urban Development Department</HD>
            <CAT>
                <HD>NOTICES</HD>
                <SJ>Meetings:</SJ>
                <SJDENT>
                    <SJDOC>Manufactured Housing Consensus Committee, </SJDOC>
                    <PGS>65627</PGS>
                    <FRDOCBP T="15NON1.sgm" D="1">04-25389</FRDOCBP>
                </SJDENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Indian</EAR>
            <HD>Indian Affairs Bureau</HD>
            <CAT>
                <HD>NOTICES</HD>
                <DOCENT>
                    <DOC>Agency information collection activities; proposals, submissions, and approvals, </DOC>
                    <PGS>65628-65630</PGS>
                    <FRDOCBP T="15NON1.sgm" D="2">04-25265</FRDOCBP>
                    <FRDOCBP T="15NON1.sgm" D="2">04-25266</FRDOCBP>
                </DOCENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Indian</EAR>
            <HD>Indian Health Service</HD>
            <CAT>
                <HD>NOTICES</HD>
                <SJ>Senior Executive Service:</SJ>
                <SJDENT>
                    <SJDOC>Performance Review Board; membership, </SJDOC>
                    <PGS>65603</PGS>
                    <FRDOCBP T="15NON1.sgm" D="1">04-25244</FRDOCBP>
                </SJDENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Industry</EAR>
            <HD>Industry and Security Bureau</HD>
            <CAT>
                <HD>RULES</HD>
                <SJ>Export administration regulations:</SJ>
                <SUBSJ>Entity list—</SUBSJ>
                <SSJDENT>
                    <SUBSJDOC>Russian entities; export and reexport license requirements removed, </SUBSJDOC>
                    <PGS>65539-65540</PGS>
                    <FRDOCBP T="15NOR1.sgm" D="2">04-25308</FRDOCBP>
                </SSJDENT>
            </CAT>
            <CAT>
                <HD>PROPOSED RULES</HD>
                <SJ>Export administration regulations:</SJ>
                <SJDENT>
                    <SJDOC>Knowledge and red flags; definition and guidance revisions; safe harbor, </SJDOC>
                    <PGS>65555</PGS>
                    <FRDOCBP T="15NOP1.sgm" D="1">04-25309</FRDOCBP>
                </SJDENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Inspector</EAR>
            <HD>Inspector General Office, Health and Human Services Department</HD>
            <CAT>
                <HD>NOTICES</HD>
                <DOCENT>
                    <DOC>Program exclusions; list, </DOC>
                    <PGS>65603-65608</PGS>
                    <FRDOCBP T="15NON1.sgm" D="6">04-25251</FRDOCBP>
                </DOCENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Inter-American</EAR>
            <PRTPAGE P="v"/>
            <HD>Inter-American Foundation</HD>
            <CAT>
                <HD>NOTICES</HD>
                <DOCENT>
                    <DOC>Meetings; Sunshine Act, </DOC>
                    <PGS>65627</PGS>
                    <FRDOCBP T="15NON1.sgm" D="1">04-25372</FRDOCBP>
                </DOCENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Interior</EAR>
            <HD>Interior Department</HD>
            <SEE>
                <HD SOURCE="HED">See</HD>
                <P> Fish and Wildlife Service</P>
            </SEE>
            <SEE>
                <HD SOURCE="HED">See</HD>
                <P> Indian Affairs Bureau</P>
            </SEE>
            <SEE>
                <HD SOURCE="HED">See</HD>
                <P> Minerals Management Service</P>
            </SEE>
            <SEE>
                <HD SOURCE="HED">See</HD>
                <P> National Park Service</P>
            </SEE>
            <SEE>
                <HD SOURCE="HED">See</HD>
                <P> Surface Mining Reclamation and Enforcement Office</P>
            </SEE>
        </AGCY>
        <AGCY>
            <EAR>IRS</EAR>
            <HD>Internal Revenue Service</HD>
            <CAT>
                <HD>PROPOSED RULES</HD>
                <SJ>Income taxes:</SJ>
                <SJDENT>
                    <SJDOC>Controlled foreign corporations’ subpart F income; U.S. shareholder's pro rate share; determination guidance; hearing cancellation, </SJDOC>
                    <PGS>65555</PGS>
                    <FRDOCBP T="15NOP1.sgm" D="1">04-25324</FRDOCBP>
                </SJDENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>International</EAR>
            <HD>International Trade Commission</HD>
            <CAT>
                <HD>NOTICES</HD>
                <SJ>Import investigations:</SJ>
                <SUBSJ>Tissue and crepe paper products from—</SUBSJ>
                <SSJDENT>
                    <SUBSJDOC>China, </SUBSJDOC>
                    <PGS>65632-65633</PGS>
                    <FRDOCBP T="15NON1.sgm" D="2">04-25255</FRDOCBP>
                </SSJDENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Justice</EAR>
            <HD>Justice Department</HD>
            <SEE>
                <HD SOURCE="HED">See</HD>
                <P> Antitrust Division</P>
            </SEE>
            <CAT>
                <HD>RULES</HD>
                <SJ>Organization, functions, and authority delegations:</SJ>
                <SJDENT>
                    <SJDOC>Federal Bureau of Investigation, </SJDOC>
                    <PGS>65542-65543</PGS>
                    <FRDOCBP T="15NOR1.sgm" D="2">04-25252</FRDOCBP>
                </SJDENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Labor</EAR>
            <HD>Labor Department</HD>
            <SEE>
                <HD SOURCE="HED">See</HD>
                <P> Employment and Training Administration</P>
            </SEE>
        </AGCY>
        <AGCY>
            <EAR>Minerals</EAR>
            <HD>Minerals Management Service</HD>
            <CAT>
                <HD>NOTICES</HD>
                <SJ>Environmental statements; availability, etc.:</SJ>
                <SUBSJ>Gulf of Mexico OCS—</SUBSJ>
                <SSJDENT>
                    <SUBSJDOC>Oil and gas operations, </SUBSJDOC>
                    <PGS>65630-65632</PGS>
                    <FRDOCBP T="15NON1.sgm" D="3">04-25242</FRDOCBP>
                </SSJDENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Mississippi</EAR>
            <HD>Mississippi River Commission</HD>
            <CAT>
                <HD>NOTICES</HD>
                <DOCENT>
                    <DOC>Meetings; Sunshine Act, </DOC>
                    <PGS>65656-65657</PGS>
                    <FRDOCBP T="15NON1.sgm" D="2">04-25391</FRDOCBP>
                </DOCENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>NASA</EAR>
            <HD>National Aeronautics and Space Administration</HD>
            <CAT>
                <HD>NOTICES</HD>
                <SJ>Federal Acquisition Regulation (FAR):</SJ>
                <SJDENT>
                    <SJDOC>Agency information collection activities; proposals, submissions, and approvals, </SJDOC>
                    <PGS>65591-65594</PGS>
                    <FRDOCBP T="15NON1.sgm" D="2">04-25291</FRDOCBP>
                    <FRDOCBP T="15NON1.sgm" D="2">04-25292</FRDOCBP>
                    <FRDOCBP T="15NON1.sgm" D="1">04-25293</FRDOCBP>
                    <FRDOCBP T="15NON1.sgm" D="2">04-25295</FRDOCBP>
                </SJDENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>NIH</EAR>
            <HD>National Institutes of Health</HD>
            <CAT>
                <HD>NOTICES</HD>
                <DOCENT>
                    <DOC>Agency information collection activities; proposals, submissions, and approvals, </DOC>
                    <PGS>65608-65609</PGS>
                    <FRDOCBP T="15NON1.sgm" D="2">04-25281</FRDOCBP>
                </DOCENT>
                <DOCENT>
                    <DOC>Inventions, Government-owned; availability for licensing, </DOC>
                    <PGS>65609-65611</PGS>
                    <FRDOCBP T="15NON1.sgm" D="2">04-25278</FRDOCBP>
                    <FRDOCBP T="15NON1.sgm" D="2">04-25279</FRDOCBP>
                </DOCENT>
                <SJ>Meetings:</SJ>
                <SJDENT>
                    <SJDOC>National Cancer Institute, </SJDOC>
                    <PGS>65611</PGS>
                    <FRDOCBP T="15NON1.sgm" D="1">04-25271</FRDOCBP>
                </SJDENT>
                <SJDENT>
                    <SJDOC>National Institute of Child Health and Human Development, </SJDOC>
                    <FRDOCBP T="15NON1.sgm" D="1">04-25272</FRDOCBP>
                    <PGS>65612-65613</PGS>
                    <FRDOCBP T="15NON1.sgm" D="1">04-25273</FRDOCBP>
                    <FRDOCBP T="15NON1.sgm" D="1">04-25274</FRDOCBP>
                    <FRDOCBP T="15NON1.sgm" D="1">04-25275</FRDOCBP>
                    <FRDOCBP T="15NON1.sgm" D="1">04-25276</FRDOCBP>
                </SJDENT>
                <SJDENT>
                    <SJDOC>National Institute of Diabetes and Digestive and Kidney Diseases, </SJDOC>
                    <PGS>65611-65612</PGS>
                    <FRDOCBP T="15NON1.sgm" D="2">04-25270</FRDOCBP>
                </SJDENT>
                <SJDENT>
                    <SJDOC>National Institute of General Medical Sciences, </SJDOC>
                    <PGS>65613</PGS>
                    <FRDOCBP T="15NON1.sgm" D="1">04-25277</FRDOCBP>
                </SJDENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>NOAA</EAR>
            <HD>National Oceanic and Atmospheric Administration</HD>
            <CAT>
                <HD>NOTICES</HD>
                <SJ>Committees; establishment, renewal, termination, etc.:</SJ>
                <SJDENT>
                    <SJDOC>Marine Fisheries Advisory Committee, </SJDOC>
                    <PGS>65580-65581</PGS>
                    <FRDOCBP T="15NON1.sgm" D="2">04-25314</FRDOCBP>
                </SJDENT>
                <SJ>Endangered and threatened species:</SJ>
                <SUBSJ>Anadromous fish take—</SUBSJ>
                <SSJDENT>
                    <SUBSJDOC>A.A. Rich &amp; Associates; California chinook, steelhead, and coho salmon, </SUBSJDOC>
                    <PGS>65581-65582</PGS>
                    <FRDOCBP T="15NON1.sgm" D="2">04-25316</FRDOCBP>
                </SSJDENT>
                <SJ>Environmental statements; availability, etc.:</SJ>
                <SJDENT>
                    <SJDOC>West Coast threatened salmon and steelhead, </SJDOC>
                    <PGS>65582-65583</PGS>
                    <FRDOCBP T="15NON1.sgm" D="2">04-25313</FRDOCBP>
                </SJDENT>
                <SJ>Marine mammals:</SJ>
                <SUBSJ>Taking and importation—</SUBSJ>
                <SSJDENT>
                    <SUBSJDOC>Ecuador; yellowfin tuna and tuna products harvested in the Eastern Tropical Pacific Ocean; affirmative finding renewed, </SUBSJDOC>
                    <PGS>65583</PGS>
                    <FRDOCBP T="15NON1.sgm" D="1">04-25315</FRDOCBP>
                </SSJDENT>
                <SJ>Permits:</SJ>
                <SJDENT>
                    <SJDOC>Scientific research, </SJDOC>
                    <PGS>65583-65584</PGS>
                    <FRDOCBP T="15NON1.sgm" D="2">04-25317</FRDOCBP>
                </SJDENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>National Park</EAR>
            <HD>National Park Service</HD>
            <CAT>
                <HD>PROPOSED RULES</HD>
                <SJ>Special regulations:</SJ>
                <SJDENT>
                    <SJDOC>Pictured Rocks National Lakeshore, MI; personal watercraft use, </SJDOC>
                    <PGS>65556-65563</PGS>
                    <FRDOCBP T="15NOP1.sgm" D="8">04-25318</FRDOCBP>
                </SJDENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>NRCS</EAR>
            <HD>Natural Resources Conservation Service</HD>
            <CAT>
                <HD>NOTICES</HD>
                <SJ>Reports and guidance documents; availability, etc.:</SJ>
                <SJDENT>
                    <SJDOC>National Handbook of Conservation Practices; conservation practice standards, new or revised, </SJDOC>
                    <PGS>65579</PGS>
                    <FRDOCBP T="15NON1.sgm" D="1">04-25246</FRDOCBP>
                </SJDENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Nuclear</EAR>
            <HD>Nuclear Regulatory Commission</HD>
            <CAT>
                <HD>NOTICES</HD>
                <SJ>Enforcement actions:</SJ>
                <SJDENT>
                    <SJDOC>Power reactors; notices of enforcement discretion; policy statement; revision, </SJDOC>
                    <PGS>65657-65659</PGS>
                    <FRDOCBP T="15NON1.sgm" D="3">04-25260</FRDOCBP>
                </SJDENT>
                <SJ>Environmental statements; availability, etc.:</SJ>
                <SJDENT>
                    <SJDOC>Veterans Affairs Department Chicago Health Care System, </SJDOC>
                    <PGS>65659-65660</PGS>
                    <FRDOCBP T="15NON1.sgm" D="2">04-25258</FRDOCBP>
                </SJDENT>
                <SJ>Meetings:</SJ>
                <SJDENT>
                    <SJDOC>Nuclear Waste Advisory Committee, </SJDOC>
                    <PGS>65660</PGS>
                    <FRDOCBP T="15NON1.sgm" D="1">04-25259</FRDOCBP>
                </SJDENT>
                <SJ>Source material; domestic licensing:</SJ>
                <SJDENT>
                    <SJDOC>L-Bar uranium mill tailings site, NM; DOE established as long-term custodian; Sohio Western Mining Co. source materials license terminated, </SJDOC>
                    <PGS>65661</PGS>
                    <FRDOCBP T="15NON1.sgm" D="1">04-25257</FRDOCBP>
                </SJDENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Office of U.S. Trade</EAR>
            <HD>Office of United States Trade Representative</HD>
            <SEE>
                <HD SOURCE="HED">See</HD>
                <P> Trade Representative, Office of United States</P>
            </SEE>
        </AGCY>
        <AGCY>
            <EAR>Pension</EAR>
            <HD>Pension Benefit Guaranty Corporation</HD>
            <CAT>
                <HD>RULES</HD>
                <SJ>Single-employer plans:</SJ>
                <SUBSJ>Allocation of assets—</SUBSJ>
                <SSJDENT>
                    <SUBSJDOC>Interest assumptions for valuing and paying benefits, </SUBSJDOC>
                    <PGS>65543-65544</PGS>
                    <FRDOCBP T="15NOR1.sgm" D="2">04-25320</FRDOCBP>
                </SSJDENT>
            </CAT>
            <CAT>
                <HD>NOTICES</HD>
                <SJ>Multi-employer plans:</SJ>
                <SJDENT>
                    <SJDOC>Interest rates and asumptions, </SJDOC>
                    <PGS>65661-65662</PGS>
                    <FRDOCBP T="15NON1.sgm" D="2">04-25321</FRDOCBP>
                </SJDENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Postal</EAR>
            <HD>Postal Rate Commission</HD>
            <CAT>
                <HD>PROPOSED RULES</HD>
                <SJ>Practice and procedure:</SJ>
                <SJDENT>
                    <SJDOC>Periodic reporting rules, </SJDOC>
                    <PGS>65563-65565</PGS>
                    <FRDOCBP T="15NOP1.sgm" D="3">04-25298</FRDOCBP>
                </SJDENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Presidential</EAR>
            <HD>Presidential Documents</HD>
            <CAT>
                <HD>PROCLAMATIONS</HD>
                <SJ>
                    <E T="03">Special observances:</E>
                </SJ>
                <SJDENT>
                    <SJDOC>World Freedom Day (Proc. 7845), </SJDOC>
                    <PGS>65515</PGS>
                    <FRDOCBP T="15NOD0.sgm" D="1">04-25438</FRDOCBP>
                </SJDENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Public</EAR>
            <HD>Public Debt Bureau</HD>
            <SEE>
                <HD SOURCE="HED">See</HD>
                <P> Fiscal Service</P>
            </SEE>
        </AGCY>
        <AGCY>
            <EAR>Public</EAR>
            <PRTPAGE P="vi"/>
            <HD>Public Health Service</HD>
            <CAT>
                <HD>NOTICES</HD>
                <SJ>Meetings:</SJ>
                <SUBSJ>National Toxicology Program—</SUBSJ>
                <SSJDENT>
                    <SUBSJDOC>Scientific Counselors Board, </SUBSJDOC>
                    <PGS>65613-65615</PGS>
                    <FRDOCBP T="15NON1.sgm" D="3">04-25280</FRDOCBP>
                </SSJDENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Railroad</EAR>
            <HD>Railroad Retirement Board</HD>
            <CAT>
                <HD>NOTICES</HD>
                <DOCENT>
                    <DOC>Agency information collection activities; proposals, submissions, and approvals, </DOC>
                    <PGS>65662</PGS>
                    <FRDOCBP T="15NON1.sgm" D="1">04-25290</FRDOCBP>
                </DOCENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Rural</EAR>
            <HD>Rural Business-Cooperative Service</HD>
            <CAT>
                <HD>RULES</HD>
                <SJ>Program regulations:</SJ>
                <SUBSJ>Farm Security and Rural Investment Act—</SUBSJ>
                <SSJDENT>
                    <SUBSJDOC>General credit provisions; correction, </SUBSJDOC>
                    <PGS>65520</PGS>
                    <FRDOCBP T="15NOR1.sgm" D="1">04-25285</FRDOCBP>
                </SSJDENT>
                <DOCENT>
                    <DOC>State Nonmetropolitan Median Household Income; definition clarification, </DOC>
                    <PGS>65517-65519</PGS>
                    <FRDOCBP T="15NOR1.sgm" D="3">04-25245</FRDOCBP>
                </DOCENT>
            </CAT>
            <CAT>
                <HD>PROPOSED RULES</HD>
                <SJ>Program regulations:</SJ>
                <SJDENT>
                    <SJDOC>Servicing of water and waste loan and grant programs, </SJDOC>
                    <PGS>65546-65554</PGS>
                    <FRDOCBP T="15NOP1.sgm" D="9">04-25247</FRDOCBP>
                </SJDENT>
                <SJ>Special programs:</SJ>
                <SUBSJ>Farm Security and Rural Investment Act of 2002; implementation—</SUBSJ>
                <SSJDENT>
                    <SUBSJDOC>Renewable Energy Systems and Energy Efficiency Improvements, Grant, Guaranteed Loan, and Direct Loan Program, </SUBSJDOC>
                    <PGS>65554-65555</PGS>
                    <FRDOCBP T="15NOP1.sgm" D="2">04-25239</FRDOCBP>
                </SSJDENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Rural</EAR>
            <HD>Rural Housing Service</HD>
            <CAT>
                <HD>RULES</HD>
                <SJ>Program regulations:</SJ>
                <SUBSJ>Farm Security and Rural Investment Act—</SUBSJ>
                <SSJDENT>
                    <SUBSJDOC>General credit provisions; correction, </SUBSJDOC>
                    <PGS>65520</PGS>
                    <FRDOCBP T="15NOR1.sgm" D="1">04-25285</FRDOCBP>
                </SSJDENT>
                <DOCENT>
                    <DOC>State Nonmetropolitan Median Household Income; definition clarification, </DOC>
                    <PGS>65517-65519</PGS>
                    <FRDOCBP T="15NOR1.sgm" D="3">04-25245</FRDOCBP>
                </DOCENT>
            </CAT>
            <CAT>
                <HD>PROPOSED RULES</HD>
                <SJ>Program regulations:</SJ>
                <SJDENT>
                    <SJDOC>Servicing of water and waste loan and grant programs, </SJDOC>
                    <PGS>65546-65554</PGS>
                    <FRDOCBP T="15NOP1.sgm" D="9">04-25247</FRDOCBP>
                </SJDENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>RUS</EAR>
            <HD>Rural Utilities Service</HD>
            <CAT>
                <HD>RULES</HD>
                <SJ>Program regulations:</SJ>
                <SUBSJ>Farm Security and Rural Investment Act—</SUBSJ>
                <SSJDENT>
                    <SUBSJDOC>General credit provisions; correction, </SUBSJDOC>
                    <PGS>65520</PGS>
                    <FRDOCBP T="15NOR1.sgm" D="1">04-25285</FRDOCBP>
                </SSJDENT>
                <DOCENT>
                    <DOC>State Nonmetropolitan Median Household Income; definition clarification, </DOC>
                    <PGS>65517-65519</PGS>
                    <FRDOCBP T="15NOR1.sgm" D="3">04-25245</FRDOCBP>
                </DOCENT>
            </CAT>
            <CAT>
                <HD>PROPOSED RULES</HD>
                <SJ>Program regulations:</SJ>
                <SJDENT>
                    <SJDOC>Servicing of water and waste loan and grant programs, </SJDOC>
                    <PGS>65546-65554</PGS>
                    <FRDOCBP T="15NOP1.sgm" D="9">04-25247</FRDOCBP>
                </SJDENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>SEC</EAR>
            <HD>Securities and Exchange Commission</HD>
            <CAT>
                <HD>NOTICES</HD>
                <DOCENT>
                    <DOC>Meetings; Sunshine Act, </DOC>
                    <PGS>65662</PGS>
                    <FRDOCBP T="15NON1.sgm" D="1">04-25381</FRDOCBP>
                </DOCENT>
                <SJ>Self-regulatory organizations; proposed rule changes:</SJ>
                <SJDENT>
                    <SJDOC>Fixed Income Clearing Corp., </SJDOC>
                    <PGS>65662-65664</PGS>
                    <FRDOCBP T="15NON1.sgm" D="3">E4-3157</FRDOCBP>
                </SJDENT>
                <SJDENT>
                    <SJDOC>National Association of Securities Dealers, Inc., </SJDOC>
                    <PGS>65664-65668</PGS>
                    <FRDOCBP T="15NON1.sgm" D="4">E4-3160</FRDOCBP>
                    <FRDOCBP T="15NON1.sgm" D="2">E4-3163</FRDOCBP>
                </SJDENT>
                <SJDENT>
                    <SJDOC>Pacific Exchange, Inc., </SJDOC>
                    <PGS>65668-65672</PGS>
                    <FRDOCBP T="15NON1.sgm" D="3">E4-3158</FRDOCBP>
                    <FRDOCBP T="15NON1.sgm" D="3">E4-3159</FRDOCBP>
                </SJDENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>SBA</EAR>
            <HD>Small Business Administration</HD>
            <CAT>
                <HD>NOTICES</HD>
                <SJ>Disaster loan areas:</SJ>
                <SJDENT>
                    <SJDOC>Georgia, </SJDOC>
                    <FRDOCBP T="15NON1.sgm" D="1">04-25310</FRDOCBP>
                    <PGS>65673</PGS>
                    <FRDOCBP T="15NON1.sgm" D="1">04-25311</FRDOCBP>
                </SJDENT>
                <SJ>Small business size standards:</SJ>
                <SUBSJ>Nonmanufacturer rule; waivers—</SUBSJ>
                <SSJDENT>
                    <SUBSJDOC>Sporting and athletic goods manufacturing, </SUBSJDOC>
                    <PGS>65673-65674</PGS>
                    <FRDOCBP T="15NON1.sgm" D="2">04-24973</FRDOCBP>
                </SSJDENT>
                <SJ>
                    <E T="03">Applications, hearings, determinations, etc.:</E>
                </SJ>
                <SJDENT>
                    <SJDOC>Gefus SBIC, L.P., </SJDOC>
                    <PGS>65672</PGS>
                    <FRDOCBP T="15NON1.sgm" D="1">04-25312</FRDOCBP>
                </SJDENT>
                <SJDENT>
                    <SJDOC>Psilos Group Partners II SBIC, L.P., </SJDOC>
                    <PGS>65672</PGS>
                    <FRDOCBP T="15NON1.sgm" D="1">04-25227</FRDOCBP>
                </SJDENT>
                <SJDENT>
                    <SJDOC>Telesoft Partners II SBIC, L.P., </SJDOC>
                    <FRDOCBP T="15NON1.sgm" D="1">04-25228</FRDOCBP>
                    <PGS>65673</PGS>
                    <FRDOCBP T="15NON1.sgm" D="1">04-25229</FRDOCBP>
                </SJDENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Social</EAR>
            <HD>Social Security Administration</HD>
            <CAT>
                <HD>RULES</HD>
                <SJ>Social security benefits:</SJ>
                <SUBSJ>Federal old age, survivors, and disability insurance—</SUBSJ>
                <SSJDENT>
                    <SUBSJDOC>Malignant neoplastic diseases; medical criteria evaluation, </SUBSJDOC>
                    <PGS>67017-67038</PGS>
                    <FRDOCBP T="15NOR5.sgm" D="22">04-24897</FRDOCBP>
                </SSJDENT>
            </CAT>
            <CAT>
                <HD>PROPOSED RULES</HD>
                <SJ>Social security benefits:</SJ>
                <SUBSJ>Federal old age, survivors, and disability insurance—</SUBSJ>
                <SSJDENT>
                    <SUBSJDOC>Hematological disorders and malignant neoplastic diseases; medical criteria evaluation; partially withdrawn, </SUBSJDOC>
                    <PGS>67038-67039</PGS>
                    <FRDOCBP T="15NOP2.sgm" D="2">04-24898</FRDOCBP>
                </SSJDENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Substance</EAR>
            <HD>Substance Abuse and Mental Health Services Administration</HD>
            <CAT>
                <HD>NOTICES</HD>
                <DOCENT>
                    <DOC>
                        Agency information collection activities; proposals, submissions, and approvals, 65197 [
                        <E T="04">Editorial Note</E>
                        : This document was inadvertently placed under the Centers for Disease Control and Prevention in the 
                        <E T="04">Federal Register</E>
                         table of contents for Wednesday, November 10, 2004.]
                    </DOC>
                </DOCENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Surface</EAR>
            <HD>Surface Mining Reclamation and Enforcement Office</HD>
            <CAT>
                <HD>NOTICES</HD>
                <DOCENT>
                    <DOC>Agency information collection activities; proposals, submissions, and approvals, </DOC>
                    <PGS>65632</PGS>
                    <FRDOCBP T="15NON1.sgm" D="1">04-25319</FRDOCBP>
                </DOCENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Thrift</EAR>
            <HD>Thrift Supervision Office</HD>
            <CAT>
                <HD>NOTICES</HD>
                <SJ>Reports and guidance documents; availability, etc.:</SJ>
                <SJDENT>
                    <SJDOC>Retail credit risk for regulatory capital; internal ratings-based systems use; correction, </SJDOC>
                    <PGS>65679</PGS>
                    <FRDOCBP T="15NOCX.sgm" D="1">C4-23771</FRDOCBP>
                </SJDENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Trade</EAR>
            <HD>Trade Representative, Office of United States</HD>
            <CAT>
                <HD>NOTICES</HD>
                <SJ>Andean Trade Preference Act:</SJ>
                <SJDENT>
                    <SJDOC>2003 and 2004 annual reviews, </SJDOC>
                    <PGS>65674</PGS>
                    <FRDOCBP T="15NON1.sgm" D="1">04-25240</FRDOCBP>
                </SJDENT>
                <SJ>Generalized System of Preferences:</SJ>
                <SJDENT>
                    <SJDOC>2004 annual product and country eligibility practices review, </SJDOC>
                    <PGS>65674-65676</PGS>
                    <FRDOCBP T="15NON1.sgm" D="3">04-25264</FRDOCBP>
                </SJDENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Transportation</EAR>
            <HD>Transportation Department</HD>
            <SEE>
                <HD SOURCE="HED">See</HD>
                <P> Federal Aviation Administration</P>
            </SEE>
            <CAT>
                <HD>NOTICES</HD>
                <SJ>Reports and guidance documents; availability, etc.:</SJ>
                <SJDENT>
                    <SJDOC>Airfares purchased from telephone reservations centers or airline ticket offices, and seperately listed surcharges; higher prices disclosure, </SJDOC>
                    <PGS>65676-65677</PGS>
                    <FRDOCBP T="15NON1.sgm" D="2">04-25253</FRDOCBP>
                </SJDENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Transportation</EAR>
            <HD>Transportation Security Administration</HD>
            <CAT>
                <HD>NOTICES</HD>
                <DOCENT>
                    <DOC>Secure Flight Program; test phase; privacy impact assessment, </DOC>
                    <PGS>65619-65627</PGS>
                    <FRDOCBP T="15NON1.sgm" D="9">04-25396</FRDOCBP>
                </DOCENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Treasury</EAR>
            <HD>Treasury Department</HD>
            <SEE>
                <HD SOURCE="HED">See</HD>
                <P> Comptroller of the Currency</P>
            </SEE>
            <SEE>
                <HD SOURCE="HED">See</HD>
                <P> Fiscal Service</P>
            </SEE>
            <SEE>
                <HD SOURCE="HED">See</HD>
                <P> Internal Revenue Service</P>
            </SEE>
            <SEE>
                <PRTPAGE P="vii"/>
                <HD SOURCE="HED">See</HD>
                <P> Thrift Supervision Office</P>
            </SEE>
        </AGCY>
        <PTS>
            <HD SOURCE="HED">Separate Parts In This Issue</HD>
            <HD>Part II</HD>
            <DOCENT>
                <DOC>Health and Human Services Department, Centers for Medicare &amp; Medicaid Services, </DOC>
                <PGS>65681-66233</PGS>
                <FRDOCBP T="15NOR2.sgm" D="553">04-24759</FRDOCBP>
            </DOCENT>
            <HD>Part III</HD>
            <DOCENT>
                <DOC>Health and Human Services Department, Centers for Medicare &amp; Medicaid Services, </DOC>
                <PGS>66235-66915</PGS>
                <FRDOCBP T="15NOR3.sgm" D="681">04-24758</FRDOCBP>
            </DOCENT>
            <HD>Part IV</HD>
            <DOCENT>
                <DOC>Health and Human Services Department, Centers for Medicare &amp; Medicaid Services, </DOC>
                <PGS>66917-66920</PGS>
                <FRDOCBP T="15NON2.sgm" D="4">04-24757</FRDOCBP>
            </DOCENT>
            <HD>Part V</HD>
            <DOCENT>
                <DOC>Health and Human Services Department, Centers for Medicare &amp; Medicaid Services, </DOC>
                <PGS>66921-67015</PGS>
                <FRDOCBP T="15NOR4.sgm" D="95">04-24787</FRDOCBP>
            </DOCENT>
            <HD>Part VI</HD>
            <DOCENT>
                <DOC>Social Security Administration, </DOC>
                <PGS>67017-67039</PGS>
                <FRDOCBP T="15NOR5.sgm" D="22">04-24897</FRDOCBP>
                <FRDOCBP T="15NOP2.sgm" D="2">04-24898</FRDOCBP>
            </DOCENT>
        </PTS>
        <AIDS>
            <HD SOURCE="HED">Reader Aids</HD>
            <P>Consult the Reader Aids section at the end of this issue for phone numbers, online resources, finding aids, reminders, and notice of recently enacted public laws.</P>
            <P>To subscribe to the Federal Register Table of Contents LISTSERV electronic mailing list, go to http://listserv.access.gpo.gov and select Online mailing list archives, FEDREGTOC-L, Join or leave the list (or change settings); then follow the instructions.</P>
        </AIDS>
    </CNTNTS>
    <VOL>69</VOL>
    <NO>219</NO>
    <DATE>Monday, November 15, 2004</DATE>
    <UNITNAME>Rules and Regulations</UNITNAME>
    <RULES>
        <RULE>
            <PREAMB>
                <PRTPAGE P="65517"/>
                <AGENCY TYPE="F">DEPARTMENT OF AGRICULTURE </AGENCY>
                <SUBAGY>Rural Housing Service </SUBAGY>
                <SUBAGY>Rural Business-Cooperative Service </SUBAGY>
                <SUBAGY>Rural Utilities Service </SUBAGY>
                <SUBAGY>Farm Service Agency </SUBAGY>
                <CFR>7 CFR Parts 1775, 1777, 1778, 1780, 1942, 3570, and 4274 </CFR>
                <RIN>RIN 0572-AB96 </RIN>
                <SUBJECT>Definition Clarification of State Nonmetropolitan Median Household Income (SNMHI) </SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Rural Housing Service, Rural Business-Cooperative Service, Rural Utilities Service, and Farm Service Agency, USDA. </P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Final rule. </P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The Rural Housing Service (RHS), Rural Business-Cooperative Service (RBS), and the Rural Utilities Service (RUS), agencies delivering the United States Department of Agriculture's Rural Development housing, business, and utilities programs, amend their regulations to reflect the clarification of the definition of Statewide Nonmetropolitan Median Household Income, which shall be defined as “the median household income of the state's nonmetropolitan counties and portions of metropolitan counties outside of cities, towns or places of 50,000 or more population.” This modification will enable Rural Development to more effectively serve communities across rural America. The loan and grant eligibility or priority scoring will be positively impacted for Rural Development Housing, Business, and Utilities Programs. </P>
                </SUM>
                <EFFDATE>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>
                        <E T="03">Effective Date:</E>
                          
                    </P>
                </EFFDATE>
                <FP SOURCE="FP-1">7 CFR part 1775—November 15, 2004. </FP>
                <FP SOURCE="FP-1">7 CFR part 1777—December 15, 2004. </FP>
                <FP SOURCE="FP-1">7 CFR part 1778—November 15, 2004. </FP>
                <FP SOURCE="FP-1">7 CFR part 1780—November 15, 2004. </FP>
                <FP SOURCE="FP-1">7 CFR part 1942—November 15, 2004. </FP>
                <FP SOURCE="FP-1">7 CFR part 3570—November 15, 2004. </FP>
                <FP SOURCE="FP-1">7 CFR part 4274—November 15, 2004. </FP>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Linda Scott, Loan Specialist, Water Programs Division, Rural Utilities Service, U.S. Department of Agriculture, 1400 Independence Avenue, SW., Room 2235-S, Stop 1570, Washington, DC 20250-1570. Telephone (202) 720-9639. E-Mail: 
                        <E T="03">Linda.Scott@usda.gov.</E>
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <HD SOURCE="HD1">Executive Order 12866 </HD>
                <P>This rule has been determined to be not significant for the purposes of Executive Order 12866 and, therefore, has not been reviewed by the Office of Management and Budget (OMB). </P>
                <HD SOURCE="HD1">Catalog of Federal Domestic Assistance </HD>
                <P>The programs described by this rule are listed in the Catalog of Federal Domestic Assistance Programs under numbers 10.760—Water and Waste Disposal Systems for Rural Communities; 10.761—Technical Assistance and Training Grants; 10.762 “ Solid Waste Management Grants; 10.763—Emergency Community Water Assistance Grants; 10.766—Community Facilities Loans and Grants; 10.767—Intermediary Relending Program; and 10.770—Water and Waste Disposal Loans and Grants (Section 306C). This catalog is available on a subscription basis from the Superintendent of Documents, the United States Government Printing Office, Washington, DC, 20402-9325, telephone number (202) 512-1800. </P>
                <HD SOURCE="HD1">Executive Order 12372 </HD>
                <P>The programs described by this rule that are subject to the requirements of Executive Order 12372, “Intergovernmental Review of Federal Programs,” as implemented under USDA's regulations at 7 CFR part 3015, are 10.760—Water and Waste Disposal Systems for Rural Communities; 10.763—Emergency Community Water Assistance Grants; 10.766—Community Facilities Loans and Grants; 10.767—Intermediary Relending Program; and 10.770—Water and Waste Disposal Loans and Grants (Section 306C). </P>
                <HD SOURCE="HD1">Executive Order 12988 </HD>
                <P>This rule has been reviewed under Executive Order 12988, Civil Justice Reform. RUS has determined that this rule meets the applicable standards provided in section 3 of the Executive Order. In addition all State and local laws and regulations that are in conflict with this rule will be preempted; no retroactive effect will be given to the rule; and, in accordance with Section 212(e) of the Department of Agriculture Reorganization Act of 1994 (7 U.S.C. 6912(e)) administrative appeal procedures, if any are required, must be exhausted prior to initiating any action against the Department or its agencies. </P>
                <HD SOURCE="HD1">Regulatory Flexibility Act Certification </HD>
                <P>This rule has been reviewed with regard to the requirements of the Regulatory Flexibility Act (5 U.S.C. 601-612). The undersigned has determined and certified by signature of this document that this rule will not have a significant economic impact on a substantial number of small entities since this rulemaking action does not involve a new or expanded program. </P>
                <HD SOURCE="HD1">Information Collection and Recordkeeping Requirements </HD>
                <P>This rule contains no new reporting or recordkeeping burdens under OMB control numbers 0572-0109, 0572-0110, 0572-0112, 0572-0121, 0575-0015, 0575-0173, and 0570-0021 that would require approval under the Paperwork Reduction Act of 1995 (44 U.S.C. chapter 35). </P>
                <HD SOURCE="HD1">National Environmental Policy Act Certification </HD>
                <P>
                    The Administrator of RUS has determined that this rule will not significantly affect the quality of the human environment as defined by the National Environmental Policy Act of 1969 (42 U.S.C. 4321 
                    <E T="03">et seq.</E>
                    ). Therefore, this action does not require an environmental impact statement or assessment. 
                </P>
                <HD SOURCE="HD1">Unfunded Mandates </HD>
                <P>
                    This rule contains no Federal mandates (under the regulatory provision of title II of the Unfunded Mandates Reform Act of 1995) for State, local, and tribal governments or the private sector. Thus this rule is not subject to the requirements of section 202 and 205 of the Unfunded Mandates Reform Act of 1995. 
                    <PRTPAGE P="65518"/>
                </P>
                <HD SOURCE="HD1">Executive Order 13132, Federalism </HD>
                <P>The policies contained in this rule do not have any substantial direct effect on states, on the relationship between the National Government and the States, or on the distribution of power and responsibilities among the various levels of government. Nor does this rule impose substantial direct compliance costs on State and local governments. Therefore, consultation with states is not required.</P>
                <HD SOURCE="HD1">Background </HD>
                <P>
                    The purpose of this final rule is to create a standard definition of Statewide Nonmetropolitan Median Household Income (SNMHI) that is more representative of the rural areas in a State. With respect to Rural Utilities Service Water and Environmental Programs (WEP), the definition will be used in priority scoring for WEP Technical Assistance and Training Grants (7 CFR part 1775), Section 306C Water and Waste Disposal Loans and Grants (7 CFR part 1777), and Emergency and Imminent Community Water Assistance Grants (7 CFR part 1778), and for loan and grant eligibility determinations for Water and Waste Loans and Grants (7 CFR part 1780). For the Rural Housing Service Community Facilities (CF) and Rural Business-Cooperative Service Intermediary Relending Programs (IRP), the standard definition will be used in priority scoring for the Community Facilities Loan Program (7 CFR part 1942), Community Facilities Grant Program (7 CFR part 3570) and the Intermediary Relending Program (7 CFR part 4274). Standardizing the definition of SNMHI will allow for more efficient administration of these loan and grant programs consistent with the purposes of the Consolidated Farm and Rural Development Act (codified at 7 U.S.C. 1921 
                    <E T="03">et. seq.</E>
                    ). With respect to 7 CFR parts 1775, 1778, and 1780, 1942, 3570 and 4274, the rule will be effective upon publication in the 
                    <E T="04">Federal Register</E>
                    . For 7 CFR part 1777, the rule will be effective 30 days after such publication. 
                </P>
                <P>Pursuant to 44 U.S.C. 3504(e)(3), 31 U.S.C. 1104(d) and Executive Order No. 10253 (June 11, 1951), the Office of Management and Budget (OMB) defines Metropolitan Statistical Areas (MSA), Micropolitan Statistical Areas, Combined Statistical Areas, and New England City and Town Areas for use in Federal statistical activities. Once each decade, OMB performs a comprehensive review of statistical area standards and definitions, and publishes a list which includes counties where MSAs are located, with periodic updates between decennial censuses based on Census Bureau data. </P>
                <P>
                    As a consequence of the 2000 census, the definitions of metropolitan areas were revised, resulting in larger geographical areas being considered metropolitan. These enlarged metropolitan areas include areas which are rural areas under the definition of “rural areas” in section 343 (13) of the Consolidated Farm and Rural Development Act (7 U.S.C. 1991 
                    <E T="03">et seq</E>
                    ). The expansion of the generally more affluent metropolitan areas and their consequent removal from the computation of nonmetropolitan income in the SNMHI caused the SNMHI to increase proportionately less than the increase in median household income experienced by rural communities in the metropolitan areas. While the income characteristics of the rural communities in the metropolitan areas and their need for WEP, CF and IRP assistance may not have changed, the proportionately lesser increase in SNMHI makes it less likely that a rural community in a metropolitan area can successfully compete for such assistance. 
                </P>
                <P>The inclusion of these rural areas within the enlarged metropolitan areas, and the consequent effect on the SNMHI, affects the eligibility of some WEP applicants for grant and lower interest rate loans. Based upon a review of applications on hand, and using the 2000 census median household income data for nonmetropolitan counties, there was an approximately 25 percent reduction in the number of communities eligible for grants, and a 50 percent reduction in the number of communities eligible for reduced interest rates. Additionally, priority scoring for all WEP programs is affected by the comparison of an area's income with the SNMHI.</P>
                <P>
                    The inclusion of these rural areas within the enlarged metropolitan areas did not affect the eligibility of these rural areas for CF and IRP assistance. However, applicants for CF and IRP assistance (
                    <E T="03">see</E>
                     7 CFR 1942,1(c)(2)(iii)(C)(2) for CF and 7 CFR 4274.344(c) for IRP) receive priority points in application selection criteria based on a comparison of the area's income with the SNMHI. The assignment of priority points may be negatively affected by the comparison of these rural areas within the enlarged metropolitan areas with the SNMHI. 
                </P>
                <P>The SNMHI calculations resulting from this definition modification will greatly reduce the negative impacts to numerous rural communities, and will enable such communities to continue to be eligible and receive priority points for WEP, CF and IRP loan and grant programs. </P>
                <P>
                    A proposed rule was published in the 
                    <E T="04">Federal Register</E>
                     on Monday, August 9, 2004, at 69 FR 48174. The comment period lasted 30 days and ended on September 8, 2004. Five comments were received. Each of the five comments supported the definition clarification of State Nonmetropolitan Median Household Income (SNMHI). Four of these favorable comments were from local towns, and one was from an engineering and architectural firm. 
                </P>
                <LSTSUB>
                    <HD SOURCE="HED">List of Subjects </HD>
                    <CFR>7 CFR Part 1775 </CFR>
                    <P>Business and industry; Community development; Community facilities; Grant program—housing and community development; Reporting and recordkeeping requirements; Rural areas; Waste treatment and disposal; Water supply; Watersheds.</P>
                    <CFR>7 CFR Part 1777 </CFR>
                    <P>Community development; Community facilities; Grant programs—housing and community development; Loan programs—housing and community development; Reporting and recordkeeping requirements; Rural areas; Waste treatment and disposal; Water supply; Watersheds. </P>
                    <CFR>7 CFR Part 1778 </CFR>
                    <P>Community development; Community facilities; Grant programs—housing and community development; Reporting and recordkeeping requirements; Rural areas; Waste treatment and disposal; Water supply; Watersheds. </P>
                    <CFR>7 CFR Part 1780 </CFR>
                    <P>Community development; Community facilities; Grant programs—housing and community development; Loan programs—housing and community development; Reporting and recordkeeping requirements; Rural areas; Waste treatment and disposal; Water supply; Watersheds. </P>
                    <CFR>7 CFR Part 1942 </CFR>
                    <P>Community development; Community facilities; Loan program—Housing and community development; Loan security; Reporting and recordkeeping requirements; Rural Areas; Waste treatment and disposal—Domestic; Water supply—Domestic. </P>
                    <CFR>7 CFR Part 3570 </CFR>
                    <P>
                        Accounting; Administrative practice and procedure; Conflicts of interests; Environmental impact statements; Foreclosure; Fair Housing; Grant programs—Housing and community 
                        <PRTPAGE P="65519"/>
                        development; Loan programs—Housing and community development; Rural areas; Subsidies. 
                    </P>
                    <CFR>7 CFR Part 4274 </CFR>
                    <P>Community development; Economic development; Loan programs—business; Reporting and recordkeeping requirements; Rural areas. </P>
                </LSTSUB>
                <REGTEXT TITLE="7" PART="1775">
                    <AMDPAR>For reasons set forth in the preamble, RUS amends 7 CFR chapters XVII, XVIII, and XVIV as set forth below: </AMDPAR>
                    <HD SOURCE="HD1">CHAPTER XVII—RURAL UTILITIES SERVICE, DEPARTMENT OF AGRICULTURE</HD>
                    <PART>
                        <HD SOURCE="HED">PART 1775—TECHNICAL ASSISTANCE AND TRAINING GRANTS </HD>
                    </PART>
                    <AMDPAR>1. The authority citation for part 1775 continues to read as follows: </AMDPAR>
                    <AUTH>
                        <HD SOURCE="HED">Authority:</HD>
                        <P>5 U.S.C. 301; 7 U.S.C. 1989; 16 U.S.C. 1005. </P>
                    </AUTH>
                </REGTEXT>
                <REGTEXT TITLE="7" PART="1775">
                    <AMDPAR>2. Amend § 1775.4 by adding a definition for “Statewide Nonmetropolitan Median Household Income” in alphabetical order to read as follows: </AMDPAR>
                    <SECTION>
                        <SECTNO>§ 1775.4</SECTNO>
                        <SUBJECT>Definitions. </SUBJECT>
                        <STARS/>
                        <P>
                            <E T="03">Statewide Nonmetropolitan Median Household Income (SNMHI).</E>
                             Median household income of the State's nonmetropolitan counties and portions of metropolitan counties outside of cities, towns or places of 50,000 or more population. 
                        </P>
                    </SECTION>
                </REGTEXT>
                <REGTEXT TITLE="7" PART="1777">
                    <PART>
                        <HD SOURCE="HED">PART 1777—SECTION 306C WWD LOANS AND GRANTS </HD>
                    </PART>
                    <AMDPAR>3. The authority citation for part 1777 continues to read as follows: </AMDPAR>
                    <AUTH>
                        <HD SOURCE="HED">Authority:</HD>
                        <P>5 U.S.C. 301; 7 U.S.C. 1989; 16 U.S.C. 1005. </P>
                    </AUTH>
                </REGTEXT>
                <REGTEXT TITLE="7" PART="1777">
                    <AMDPAR>4. Amend § 1777.4 by adding a definition for “Statewide Nonmetropolitan Median Household Income” in alphabetical order to read as follows: </AMDPAR>
                    <SECTION>
                        <SECTNO>§ 1777.4</SECTNO>
                        <SUBJECT>Definitions. </SUBJECT>
                        <STARS/>
                        <P>
                            <E T="03">Statewide Nonmetropolitan Median Household Income (SNMHI).</E>
                             Median household income of the State's nonmetropolitan counties and portions of metropolitan counties outside of cities, towns or places of 50,000 or more population. 
                        </P>
                    </SECTION>
                </REGTEXT>
                <REGTEXT TITLE="7" PART="1778">
                    <PART>
                        <HD SOURCE="HED">PART 1778—EMERGENCY AND IMMINENT COMMUNITY WATER ASSISTANCE GRANTS </HD>
                    </PART>
                    <AMDPAR>5. The authority citation for part 1778 continues to read as follows: </AMDPAR>
                    <AUTH>
                        <HD SOURCE="HED">Authority:</HD>
                        <P>5 U.S.C. 301; 7 U.S.C. 1989; 16 U.S.C. 1005. </P>
                    </AUTH>
                    <AMDPAR>6. Amend § 1778.4 by adding a definition for “Statewide Nonmetropolitan Median Household Income” in alphabetical order to read as follows: </AMDPAR>
                </REGTEXT>
                <REGTEXT TITLE="7" PART="1777">
                    <SECTION>
                        <SECTNO>§ 1778.4</SECTNO>
                        <SUBJECT>Definitions. </SUBJECT>
                        <STARS/>
                        <P>
                            <E T="03">Statewide Nonmetropolitan Median Household Income (SNMHI).</E>
                             Median household income of the State's nonmetropolitan counties and portions of metropolitan counties outside of cities, towns or places of 50,000 or more population. 
                        </P>
                    </SECTION>
                </REGTEXT>
                <REGTEXT TITLE="7" PART="1780">
                    <PART>
                        <HD SOURCE="HED">PART 1780—WATER AND WASTE LOANS AND GRANTS </HD>
                        <SUBPART>
                            <HD SOURCE="HED">Subpart A—General Policies and Requirements </HD>
                        </SUBPART>
                    </PART>
                    <AMDPAR>7. The authority citation for part 1780 continues to read as follows: </AMDPAR>
                    <AUTH>
                        <HD SOURCE="HED">Authority:</HD>
                        <P>5 U.S.C. 301; 7 U.S.C. 1989; 16 U.S.C. 1005. </P>
                    </AUTH>
                </REGTEXT>
                <REGTEXT TITLE="7" PART="1780">
                    <AMDPAR>8. Amend § 1780.3 (a) by revising the definition for “Statewide Nonmetropolitan Median Household Income” to read as follows: </AMDPAR>
                    <SECTION>
                        <SECTNO>§ 1780.3</SECTNO>
                        <SUBJECT>Definitions and grammatical rules of construction. </SUBJECT>
                        <P>(a) * * * </P>
                        <P>
                            <E T="03">Statewide nonmetropolitan median household income</E>
                             means the median household income of the State's nonmetropolitan counties and portions of metropolitan counties outside of cities, towns or places of 50,000 or more population. 
                        </P>
                        <STARS/>
                          
                    </SECTION>
                </REGTEXT>
                <REGTEXT TITLE="7" PART="1942">
                    <HD SOURCE="HD1">CHAPTER XVIII—RURAL HOUSING SERVICE, RURAL BUSINESS—COOPERATIVE SERVICE, RURAL UTILITIES SERVICE, AND FARM SERVICE AGENCY, DEPARTMENT OF AGRICULTURE </HD>
                    <PART>
                        <HD SOURCE="HED">PART 1942—ASSOCIATIONS </HD>
                        <SUBPART>
                            <HD SOURCE="HED">Subpart A—Community Facility Loans </HD>
                        </SUBPART>
                    </PART>
                    <AMDPAR>9. The authority citation for part 1942 continues to read: </AMDPAR>
                    <AUTH>
                        <HD SOURCE="HED">Authority:</HD>
                        <P>5 U.S.C. 301; 7 U.S.C. 1989. </P>
                    </AUTH>
                </REGTEXT>
                <REGTEXT TITLE="7" PART="1942">
                    <AMDPAR>10. Amend subpart A by adding a new § 1942.21 to read as follows: </AMDPAR>
                    <SECTION>
                        <SECTNO>§ 1942.21</SECTNO>
                        <SUBJECT>Statewide Nonmetropolitan Median Household Income. </SUBJECT>
                        <P>Statewide Nonmetropolitan Median Household Income means the median household income of the State's nonmetropolitan counties and portions of metropolitan counties outside of cities, towns or places, of 50,000 or more population. </P>
                    </SECTION>
                </REGTEXT>
                <REGTEXT TITLE="7" PART="3570">
                    <HD SOURCE="HD1">CHAPTER XXXV—RURAL HOUSING SERVICE, DEPARTMENT OF AGRICULTURE </HD>
                    <PART>
                        <HD SOURCE="HED">PART 3570—COMMUNITY PROGRAMS </HD>
                        <SUBPART>
                            <HD SOURCE="HED">Subpart B—Community Facilities Grant Program </HD>
                        </SUBPART>
                    </PART>
                    <AMDPAR>11. The authority citation for part 3570 continues to read: </AMDPAR>
                    <AUTH>
                        <HD SOURCE="HED">Authority:</HD>
                        <P>5 U.S.C. 301; 7 U.S.C. 1989. </P>
                    </AUTH>
                </REGTEXT>
                <REGTEXT TITLE="7" PART="3570">
                    <AMDPAR>12. Amend § 3570.53 by revising the definition for “State nonmetropolitan median household income” to read as follows: </AMDPAR>
                    <SECTION>
                        <SECTNO>§ 3570.53</SECTNO>
                        <SUBJECT>Definitions. </SUBJECT>
                        <STARS/>
                        <P>
                            <E T="03">State nonmetropolitan median household income.</E>
                             The median household income of the State's nonmetropolitan counties and portions of metropolitan counties outside of cities, towns or places of 50,000 or more population. 
                        </P>
                        <STARS/>
                          
                    </SECTION>
                </REGTEXT>
                <REGTEXT TITLE="7" PART="4274">
                    <HD SOURCE="HD1">CHAPTER XLII—RURAL BUSINESS—COOPERATIVE SERVICE AND RURAL UTILITIES SERVICE, DEPARTMENT OF AGRICULTURE </HD>
                    <PART>
                        <HD SOURCE="HED">PART 4274—DIRECT AND INSURED LOANMAKING </HD>
                        <SUBPART>
                            <HD SOURCE="HED">Subpart D—Intermediary Relending Program (IRP) </HD>
                        </SUBPART>
                    </PART>
                    <AMDPAR>13. The authority citation for part 4274 continues to read: </AMDPAR>
                    <AUTH>
                        <HD SOURCE="HED">Authority:</HD>
                        <P>5 U.S.C. 301; 7 U.S.C. 1932 note; 7 U.S.C. 1989. </P>
                    </AUTH>
                </REGTEXT>
                <REGTEXT TITLE="7" PART="4274">
                    <AMDPAR>14. Amend § 4274.302 (a) by adding a definition for “Statewide Nonmetropolitan Median Household Income” in alphabetical order to read as follows: </AMDPAR>
                    <SECTION>
                        <SECTNO>§ 4274.302</SECTNO>
                        <SUBJECT>Definitions and abbreviations. </SUBJECT>
                        <P>(a) * * *. </P>
                        <P>
                            <E T="03">Statewide Nonmetropolitan Median Household Income (SNMHI).</E>
                             Median household income of the State's nonmetropolitan counties and portions of metropolitan counties outside of cities, towns or places of 50,000 or more population. 
                        </P>
                        <STARS/>
                          
                    </SECTION>
                </REGTEXT>
                <SIG>
                    <DATED>Dated: November 5, 2004. </DATED>
                    <NAME>Gilbert G. Gonzalez, </NAME>
                    <TITLE>Under Secretary, Rural Development. </TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 04-25245 Filed 11-12-04; 8:45 am] </FRDOC>
            <BILCOD>BILLING CODE 3410-15-P</BILCOD>
        </RULE>
        <RULE>
            <PREAMB>
                <PRTPAGE P="65520"/>
                <AGENCY TYPE="S">DEPARTMENT OF AGRICULTURE</AGENCY>
                <SUBAGY>Rural Housing Service</SUBAGY>
                <SUBAGY>Rural Business-Cooperative Service</SUBAGY>
                <SUBAGY>Rural Utilities Service</SUBAGY>
                <SUBAGY>Farm Service Agency </SUBAGY>
                <CFR>7 CFR Part 1955</CFR>
                <RIN>RIN 0560-AG78</RIN>
                <SUBJECT>2002 Farm Bill Regulations—General Credit Provisions; Correction</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCIES:</HD>
                    <P>Rural Housing Service, Rural Business-Cooperative Service, Rural Utilities Services, and Farm Service Agency, USDA.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Final rule; correcting amendment.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>
                        This document corrects the final regulations published in the 
                        <E T="04">Federal Register</E>
                         on February 18, 2003, implementing certain provisions of the Farm Security and Rural Investment Act of 2002 (2002 Act).
                    </P>
                </SUM>
                <EFFDATE>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>
                        <E T="03">Effective Date:</E>
                         February 18, 2003.
                    </P>
                </EFFDATE>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Constance Beckwith, Senior Loan Officer, USDA/FSA/DAFLP/LSPMD/STOP 0523, Washington DC 20250-0523; telephone 202-720-9769; Facsimile: 202-690-1196; E-mail: 
                        <E T="03">constance_beckwith@wdc.usda.gov.</E>
                         Persons with disabilities who require alternative means for communication (Braille, large print, audio tape, etc.) should contact the USDA Target Center at (202) 720-2600 (voice and TDD).
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <HD SOURCE="HD1">Background</HD>
                <P>Section 5310 of the 2002 Act changed the definition of qualified beginning farmer or rancher by increasing the acres of land that these applicants could own to a maximum of 30 (instead of 25) percent of the average farm or ranch size in the county.</P>
                <HD SOURCE="HD1">Need for Correction</HD>
                <P>As published, the final regulations amended the definition of “Beginning farmer or rancher” in 7 CFR 762.102, 1941.4 and 1943.4 to comply with the requirements of the 2002 Act. The definition of “Beginning farmer or rancher” is also included in 7 CFR 1955.103; however, the necessary amendment was inadvertently not included in the February 18, 2003, final rule.</P>
                <LSTSUB>
                    <HD SOURCE="HED">List of Subjects in 7 CFR Part 1955</HD>
                    <P>Government acquired property, Sale of government acquired property, Surplus government property.</P>
                </LSTSUB>
                <REGTEXT TITLE="7" PART="1955">
                    <AMDPAR>Accordingly, chapter XVIII, title 7, Code of Federal Regulations is corrected as follows:</AMDPAR>
                    <PART>
                        <HD SOURCE="HED">PART 1955—PROPERTY MANAGEMENT</HD>
                    </PART>
                    <AMDPAR>1. The authority citation for part 1955 continues to read as follows:</AMDPAR>
                    <AUTH>
                        <HD SOURCE="HED">Authority:</HD>
                        <P>5 U.S.C. 301; 7 U.S.C. 1989, 42 U.S.C. 1480.</P>
                    </AUTH>
                </REGTEXT>
                <REGTEXT TITLE="7" PART="1955">
                    <SUBPART>
                        <HD SOURCE="HED">Subpart C—Disposal of Inventory Property</HD>
                    </SUBPART>
                    <AMDPAR>2. Amend § 1955.103 by removing the number “25” from the first sentence of paragraph (5) of the definition “Beginning farmer or rancher” and adding in its place the number “30.”</AMDPAR>
                </REGTEXT>
                <SIG>
                    <DATED>Dated: November 5, 2004.</DATED>
                    <NAME>Gilbert Gonzales,</NAME>
                    <TITLE>Acting Under Secretary for Rural Development.</TITLE>
                    <DATED>Dated: November 3, 2004.</DATED>
                    <NAME>J.B. Penn, </NAME>
                    <TITLE>Under Secretary for Farm and Foreign Agricultural Services.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 04-25285 Filed 11-12-04; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 3410-05-P</BILCOD>
        </RULE>
        <RULE>
            <PREAMB>
                <AGENCY TYPE="N">DEPARTMENT OF TRANSPORTATION </AGENCY>
                <SUBAGY>Federal Aviation Administration </SUBAGY>
                <CFR>14 CFR Part 39 </CFR>
                <DEPDOC>[Docket No. FAA-2004-18996; Directorate Identifier 2004-NM-40-AD; Amendment 39-13865; AD 2004-23-10] </DEPDOC>
                <RIN>RIN 2120-AA64 </RIN>
                <SUBJECT>Airworthiness Directives; Boeing Model 737-700 and -800 Series Airplanes </SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Federal Aviation Administration (FAA), DOT. </P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Final rule. </P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The FAA is adopting a new airworthiness directive (AD) for certain Boeing Model 737-700 and -800 series airplanes. This AD requires doing an initial inspection for pitting and cracks of the lower skin panel at the lap joint; trimming the inner skin; installing exterior doublers; replacing the fuselage skin assembly; doing repetitive supplemental inspections; and repairing if necessary; as applicable. This AD is prompted by a report indicating that localized pitting in the lower skin panels was found during production on a limited number of airplanes. We are issuing this AD to detect and correct premature fatigue cracking at certain lap splice locations and consequent rapid decompression of the airplane. </P>
                </SUM>
                <EFFDATE>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>This AD becomes effective December 20, 2004. </P>
                    <P>The incorporation by reference of a certain publication listed in the AD is approved by the Director of the Federal Register as of December 20, 2004. </P>
                </EFFDATE>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        For service information identified in this AD, contact Boeing Commercial Airplanes, P.O. Box 3707, Seattle, Washington 98124-2207. You can examine this information at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call (202) 741-6030, or go to: 
                        <E T="03">http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.</E>
                    </P>
                    <P>You can examine the contents of this AD docket on the Internet at http://dms.dot.gov, or at the Docket Management Facility, U.S. Department of Transportation, 400 Seventh Street, SW., room PL-401, on the plaza level of the Nassif Building, Washington, DC. </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P SOURCE="NPAR">
                        <E T="03">Technical information:</E>
                         Sue Lucier, Aerospace Engineer, Airframe Branch, ANM-120S, FAA, Seattle Aircraft Certification Office, 1601 Lind Avenue, SW., Renton, Washington 98055-4056; telephone (425) 917-6438; fax (425) 917-6590. 
                    </P>
                    <P>
                        <E T="03">Plain language information:</E>
                         Marcia Walters, 
                        <E T="03">marcia.walters@faa.gov.</E>
                    </P>
                    <HD SOURCE="HD1">Examining the Docket </HD>
                    <P>
                        The AD docket contains the proposed AD, comments, and any final disposition. You can examine the AD docket on the Internet at 
                        <E T="03">http://dms.dot.gov,</E>
                         or in person at the Docket Management Facility office between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The Docket Management Facility office (telephone (800) 647-5227) is located on the plaza level of the Nassif Building at the DOT street address stated in the 
                        <E T="02">ADDRESSES</E>
                         section. 
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>
                    The FAA proposed to amend 14 CFR Part 39 with an AD for certain Boeing Model 737-700 and -800 series airplanes. That action, published in the 
                    <E T="04">Federal Register</E>
                     on September 3, 2004 (69 FR 53855), proposed to require doing an initial inspection for pitting and cracks of the lower skin panel at the lap joint; trimming the inner skin; installing exterior doublers; replacing the fuselage skin assembly; doing repetitive 
                    <PRTPAGE P="65521"/>
                    supplemental inspections; and repairing if necessary; as applicable. 
                </P>
                <HD SOURCE="HD1">Comments </HD>
                <P>We provided the public the opportunity to participate in the development of this AD. No comments have been submitted on the proposed AD or on the determination of the cost to the public. </P>
                <HD SOURCE="HD1">Conclusion </HD>
                <P>We have carefully reviewed the available data and determined that air safety and the public interest require adopting the AD as proposed. </P>
                <HD SOURCE="HD1">Costs of Compliance </HD>
                <P>This AD will affect about 4 airplanes worldwide and 2 airplanes of U.S. registry. The following table provides the estimated costs to comply with this AD. </P>
                <P>The average labor rate is $65 per work hour. The cost impact of the AD on U.S. operators is estimated to be $83,855.</P>
                <GPOTABLE COLS="4" OPTS="L2,i1" CDEF="s100,xs80,xs50,14">
                    <TTITLE>Table.—Cost Impact </TTITLE>
                    <BOXHD>
                        <CHED H="1">For airplanes listed in the referenced service bulletin as group </CHED>
                        <CHED H="1">Work hours </CHED>
                        <CHED H="1">Parts cost </CHED>
                        <CHED H="1">Per airplane cost </CHED>
                    </BOXHD>
                    <ROW>
                        <ENT I="01">1 </ENT>
                        <ENT>Inspection: 2 </ENT>
                        <ENT>None </ENT>
                        <ENT>$130 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="22">  </ENT>
                        <ENT>Modification: 38 </ENT>
                        <ENT>105 </ENT>
                        <ENT>2,575 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">2 </ENT>
                        <ENT>Inspection: 2 </ENT>
                        <ENT>None </ENT>
                        <ENT>130 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="22">  </ENT>
                        <ENT>Modification: 30 </ENT>
                        <ENT>104 </ENT>
                        <ENT>2,054 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">3 </ENT>
                        <ENT>Inspection: 2 </ENT>
                        <ENT>None </ENT>
                        <ENT>130 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="22">  </ENT>
                        <ENT>Modification: 42 </ENT>
                        <ENT>106 </ENT>
                        <ENT>2,836 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">4 </ENT>
                        <ENT>Repair: 920 </ENT>
                        <ENT>16,200 </ENT>
                        <ENT>76,000 </ENT>
                    </ROW>
                </GPOTABLE>
                <HD SOURCE="HD1">Regulatory Findings</HD>
                <P>We have determined that this AD will not have federalism implications under Executive Order 13132. This AD will not have a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government. </P>
                <P>For the reasons discussed above, I certify that this AD: </P>
                <P>(1) Is not a “significant regulatory action” under Executive Order 12866; </P>
                <P>(2) Is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979); and </P>
                <P>(3) Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act. </P>
                <P>
                    We prepared a regulatory evaluation of the estimated costs to comply with this AD. See the 
                    <E T="02">ADDRESSES</E>
                     section for a location to examine the regulatory evaluation. 
                </P>
                <LSTSUB>
                    <HD SOURCE="HED">List of Subjects in 14 CFR Part 39 </HD>
                    <P>Air transportation, Aircraft, Aviation safety, Incorporation by reference, Safety.</P>
                </LSTSUB>
                <HD SOURCE="HD1">Adoption of the Amendment </HD>
                <REGTEXT TITLE="14" PART="39">
                    <AMDPAR>Accordingly, under the authority delegated to me by the Administrator, the FAA amends 14 CFR part 39 as follows: </AMDPAR>
                    <PART>
                        <HD SOURCE="HED">PART 39—AIRWORTHINESS DIRECTIVES </HD>
                    </PART>
                    <AMDPAR>1. The authority citation for part 39 continues to read as follows: </AMDPAR>
                    <AUTH>
                        <HD SOURCE="HED">Authority:</HD>
                        <P>49 U.S.C. 106(g), 40113, 44701. </P>
                    </AUTH>
                    <SECTION>
                        <SECTNO>§ 39.13 </SECTNO>
                        <SUBJECT>[Amended] </SUBJECT>
                    </SECTION>
                </REGTEXT>
                <REGTEXT TITLE="14" PART="39">
                    <AMDPAR>2. The FAA amends § 39.13 by adding the following new airworthiness directive (AD): </AMDPAR>
                    <EXTRACT>
                        <FP SOURCE="FP-2">
                            <E T="04">2004-23-10 Boeing:</E>
                             Amendment 39-13865. Docket No. FAA-2004-18996; Directorate Identifier 2004-NM-40-AD. 
                        </FP>
                        <HD SOURCE="HD1">Effective Date </HD>
                        <P>(a) This AD becomes effective December 20, 2004. </P>
                        <HD SOURCE="HD1">Affected ADs </HD>
                        <P>(b) None. </P>
                        <HD SOURCE="HD1">Applicability </HD>
                        <P>(c) This AD applies to Boeing Model 737-700 and -800 series airplanes, certificated in any category; having variable and serial numbers listed in Table 1 of this AD. </P>
                        <GPOTABLE COLS="3" OPTS="L2,i1" CDEF="s50,8,8">
                            <TTITLE>Table 1.—Applicable Variable and Serial Numbers. </TTITLE>
                            <BOXHD>
                                <CHED H="1">Variable number </CHED>
                                <CHED H="1">Serial number </CHED>
                                <CHED H="1">Group </CHED>
                            </BOXHD>
                            <ROW>
                                <ENT I="01">YA004 </ENT>
                                <ENT>27837 </ENT>
                                <ENT>1 </ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">YA005 </ENT>
                                <ENT>27836 </ENT>
                                <ENT>2 </ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">YA201 </ENT>
                                <ENT>28004 </ENT>
                                <ENT>4 </ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">YC003 </ENT>
                                <ENT>27977 </ENT>
                                <ENT>3 </ENT>
                            </ROW>
                        </GPOTABLE>
                        <HD SOURCE="HD1">Unsafe Condition </HD>
                        <P>(d) This AD was prompted by a report indicating that localized pitting in the lower skin panels was found during production on a limited number of airplanes. We are issuing this AD to detect and correct premature fatigue cracking at certain lap splice locations and consequent rapid decompression of the airplane. </P>
                        <HD SOURCE="HD1">Compliance </HD>
                        <P>(e) You are responsible for having the actions required by this AD performed within the compliance times specified, unless the actions have already been done. </P>
                        <HD SOURCE="HD1">Initial Inspection and/or Repair </HD>
                        <P>(f) At the applicable times specified in Table 1 of paragraph 1.E., “Compliance,” of Boeing Special Attention Service Bulletin 737-53-1256, dated September 18, 2003, do the applicable actions specified in Table 2 of this AD in accordance with the Accomplishment Instructions of the service bulletin. </P>
                        <GPOTABLE COLS="2" OPTS="L2,i1" CDEF="s100,r200">
                            <TTITLE>Table 2.—Initial Inspection and/or Repair </TTITLE>
                            <BOXHD>
                                <CHED H="1">For airplanes identified in the service bulletin as— </CHED>
                                <CHED H="1">Requirements— </CHED>
                            </BOXHD>
                            <ROW>
                                <ENT I="01">(1) Groups 1, 2, and 3 </ENT>
                                <ENT>Do an external ultrasonic inspection for pitting and cracks of the lower skin panel at the lap joint. </ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">(2) Groups 1 and 2</ENT>
                                <ENT>Trim the inner skin and install two exterior doublers (including related investigative actions). </ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">(3) Group 3 </ENT>
                                <ENT>Install three exterior doublers. </ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">(4) Group 4 </ENT>
                                <ENT>Replace the fuselage skin assembly with a new assembly. </ENT>
                            </ROW>
                        </GPOTABLE>
                        <PRTPAGE P="65522"/>
                        <HD SOURCE="HD1">Repetitive Inspections </HD>
                        <P>(g) For Groups 1, 2, and 3 airplanes identified in Boeing Special Attention Service Bulletin 737-53-1256, dated September 18, 2003: At the applicable times specified in Table 2 of paragraph 1.E., “Compliance,” of the service bulletin, do the repetitive supplemental inspections of the lower skins and external doublers for discrepancies in accordance with the Accomplishment Instructions of the service bulletin. </P>
                        <HD SOURCE="HD1">Corrective Action </HD>
                        <P>(h) If any discrepancy is found during any action required by this AD, before further flight, repair per a method approved by the Manager, Seattle Aircraft Certification Office (ACO), FAA; or per data meeting the type certification basis of the airplane approved by a Boeing Company Designated Engineering Representative (DER) who has been authorized by the Manager, Seattle ACO, to make such findings. For a repair method to be approved, the approval must specifically reference this AD. </P>
                        <HD SOURCE="HD1">Alternative Methods of Compliance (AMOCs) </HD>
                        <P>(i)(1) The Manager, Seattle ACO, FAA, has the authority to approve AMOCs for this AD, if requested in accordance with the procedures found in 14 CFR 39.19. </P>
                        <P>(2) An AMOC that provides an acceptable level of safety may be used for any repair required by this AD, if it is approved by a Boeing Company DER who has been authorized by the Manager, Seattle ACO, to make those findings. For a repair method to be approved, the approval must specifically refer to this AD. </P>
                        <HD SOURCE="HD1">Material Incorporated by Reference </HD>
                        <P>
                            (j) You must use Boeing Special Attention Service Bulletin 737-53-1256, dated September 18, 2003, to perform the actions that are required by this AD, unless the AD specifies otherwise. The Director of the Federal Register approves the incorporation by reference of this document in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. For copies of the service information, contact Boeing Commercial Airplanes, P.O. Box 3707, Seattle, Washington 98124-2207. For information on the availability of this material at the National Archives and Records Administration (NARA), call (202) 741-6030, or go to 
                            <E T="03">http://www.archives.gov/federal_ register/code_of_federal_regulations/ibr_locations.html.</E>
                             You may view the AD docket at the Docket Management Facility, U.S. Department of Transportation, 400 Seventh Street SW, room PL-401, Nassif Building, Washington, DC. 
                        </P>
                    </EXTRACT>
                </REGTEXT>
                <SIG>
                    <DATED>Issued in Renton, Washington, on November 1, 2004. </DATED>
                    <NAME>Kalene C. Yanamura, </NAME>
                    <TITLE>Acting Manager, Transport Airplane Directorate, Aircraft Certification Service. </TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 04-24936 Filed 11-12-04; 8:45 am] </FRDOC>
            <BILCOD>BILLING CODE 4910-13-P </BILCOD>
        </RULE>
        <RULE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF TRANSPORTATION </AGENCY>
                <SUBAGY>Federal Aviation Administration</SUBAGY>
                <CFR>14 CFR Part 39</CFR>
                <DEPDOC>[Docket No. FAA-2004-18994; Directorate Identifier 2003-NM-210-AD; Amendment 39-13866; AD 2004-23-11]</DEPDOC>
                <RIN>RIN 2120-AA64</RIN>
                <SUBJECT>Airworthiness Directives; McDonnell Douglas Model DC-9-14 and DC-9-15 Airplanes; and Model DC-9-20, DC-9-30, DC-9-40, and DC-9-50 Series Airplanes</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Federal Aviation Administration (FAA), DOT.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Final rule. </P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The FAA is adopting a new airworthiness directive (AD) for certain McDonnell Douglas Model DC-9-14 and DC-9-15 airplanes; and Model DC-9-20, DC-9-30, DC-9-40, and DC-9-50 series airplanes. This AD requires repetitive high frequency eddy current inspections to detect cracks in the vertical radius of the upper cap of the center wing rear spar, and repair if necessary. This AD is prompted by reports of cracks in the upper cap of the center wing rear spar that resulted from stress corrosion. We are issuing this AD to detect and correct cracking of the left or right upper cap of the center rear spar, which would cause a possible fuel leak and structural failure of the upper cap, and result in reduced structural integrity of the airplane.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>This AD becomes effective December 20, 2004.</P>
                    <P>The incorporation by reference of a certain publication listed in the AD is approved by the Director of the Federal Register as of December 20, 2004.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        For service information identified in this AD, contact Boeing Commercial Airplanes, Long Beach Division, 3855 Lakewood Boulevard, Long Beach, California 90846, Attention: Data and Service Management, Dept. C1-L5A (D800-0024). You can examine this information at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call (202) 741-6030, or go to: 
                        <E T="03">http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.</E>
                    </P>
                    <P>
                        You can examine the contents of this AD docket on the Internet at 
                        <E T="03">http://dms.dot.gov,</E>
                         or at the Docket Management Facility, U.S. Department of Transportation, 400 Seventh Street, SW., room PL-401, on the plaza level of the Nassif Building, Washington, DC.
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P SOURCE="NPAR">
                        <E T="03">Technical information:</E>
                         Wahib Mina, Aerospace Engineer, Airframe Branch, ANM-120L, FAA, Los Angeles Aircraft Certification Office, 3960 Paramount Boulevard, Lakewood, California 90712-4137; telephone (562) 627-5324; fax (562) 627-5210.
                    </P>
                    <P>
                        <E T="03">Plain language information:</E>
                         Marcia Walters, 
                        <E T="03">marcia.walters@faa.gov.</E>
                    </P>
                    <HD SOURCE="HD1">Examining the Docket</HD>
                    <P>
                        The AD docket contains the proposed AD, comments, and any final disposition. You can examine the AD docket on the Internet at 
                        <E T="03">http://dms.dot.gov,</E>
                         or in person at the Docket Management Facility office between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The Docket Management Facility office (telephone (800) 647-5227) is located on the plaza level of the Nassif Building at the DOT street address stated in the 
                        <E T="02">ADDRESSES</E>
                         section.
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>
                    The FAA proposed to amend 14 CFR part 39 with an AD for certain McDonnell Douglas Model DC-9-14 and DC-9-15 airplanes; and Model DC-9-20, DC-9-30, DC-9-40, and DC-9-50 series airplanes. That action, published in the 
                    <E T="04">Federal Register</E>
                     on September 3, 2004 (69 FR 53853), proposed to require repetitive high frequency eddy current inspections to detect cracks in the vertical radius of the upper cap of the center wing rear spar, and repair if necessary.
                </P>
                <HD SOURCE="HD1">Comments</HD>
                <P>We provided the public the opportunity to participate in the development of this AD. No comments have been submitted on the proposed AD or on the determination of the cost to the public.</P>
                <HD SOURCE="HD1">Explanation of Change Made to the Final Rule</HD>
                <P>We have updated the manufacturer name from McDonnell Douglas to Boeing for Service Bulletin DC9-57-223, dated July 21, 2003, which is referenced in this AD as the appropriate source of service information for the required actions. This change is necessary to adhere to the Office of the Federal Register's guidelines for materials incorporated by reference.</P>
                <HD SOURCE="HD1">Conclusion</HD>
                <P>
                    We have carefully reviewed the available data and determined that air safety and the public interest require adopting the AD with the change described previously. We have determined that this change will neither increase the economic burden on any 
                    <PRTPAGE P="65523"/>
                    operator nor increase the scope of the AD.
                </P>
                <HD SOURCE="HD1">Costs of Compliance</HD>
                <P>This AD affects about 396 airplanes of U.S. registry and 963 airplanes worldwide. The required inspection will take about 3 work hours per airplane, per inspection cycle, at an average labor rate of $65 per work hour. Based on these figures, the estimated cost of the AD for U.S operators is $77,220, or $195 per airplane, per inspection cycle.</P>
                <HD SOURCE="HD1">Regulatory Findings</HD>
                <P>We have determined that this AD will not have federalism implications under Executive Order 13132. This AD will not have a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.</P>
                <P>For the reasons discussed above, I certify that this AD:</P>
                <P>(1) Is not a “significant regulatory action” under Executive Order 12866;</P>
                <P>(2) Is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979); and</P>
                <P>(3) Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.</P>
                <P>
                    We prepared a regulatory evaluation of the estimated costs to comply with this AD. 
                    <E T="03">See</E>
                     the 
                    <E T="02">ADDRESSES</E>
                     section for a location to examine the regulatory evaluation.
                </P>
                <LSTSUB>
                    <HD SOURCE="HED">List of Subjects in 14 CFR Part 39</HD>
                    <P>Air transportation, Aircraft, Aviation safety, Incorporation by reference, Safety.</P>
                </LSTSUB>
                <HD SOURCE="HD1">Adoption of the Amendment</HD>
                <REGTEXT TITLE="14" PART="39">
                    <AMDPAR>Accordingly, under the authority delegated to me by the Administrator, the FAA amends 14 CFR part 39 as follows:</AMDPAR>
                    <PART>
                        <HD SOURCE="HED">PART 39—AIRWORTHINESS DIRECTIVES</HD>
                    </PART>
                    <AMDPAR>1. The authority citation for part 39 continues to read as follows:</AMDPAR>
                    <AUTH>
                        <HD SOURCE="HED">Authority:</HD>
                        <P>49 U.S.C. 106(g), 40113, 44701.</P>
                    </AUTH>
                    <SECTION>
                        <SECTNO>§ 39.13</SECTNO>
                        <SUBJECT>[Amended]</SUBJECT>
                    </SECTION>
                </REGTEXT>
                <REGTEXT TITLE="14" PART="39">
                    <AMDPAR>2. The FAA amends § 39.13 by adding the following new airworthiness directive (AD):</AMDPAR>
                    <EXTRACT>
                        <FP SOURCE="FP-2">
                            <E T="04">2004-23-11 McDonnell Douglas:</E>
                             Amendment 39-13866. Docket No. FAA-2004-18994; Directorate Identifier 2003-NM-210-AD.
                        </FP>
                        <HD SOURCE="HD1">Effective Date </HD>
                        <P>(A) This AD becomes effective December 20, 2004.</P>
                        <HD SOURCE="HD1">Affected ADs</HD>
                        <P>(b) None.</P>
                        <HD SOURCE="HD1">Applicability</HD>
                        <P>(c) This AD applies to certain McDonnell Douglas Model DC-9-14, DC-9-15, DC-9-21, DC-9-31, DC-9-32, DC-9-32 (VC-9C), DC-9-32F, DC-9-33F, DC-9-34, DC-9-34F, DC-9-32F (C-9A, C-9B), DC-9-41, and DC-9-51 airplanes, certificated in any category; as listed in Boeing Service Bulletin DC9-57-223, dated July 21, 2003.</P>
                        <HD SOURCE="HD1">Unsafe Condition</HD>
                        <P>(d) This AD was prompted by reports of cracks in the upper cap of the center wing rear spar that resulted from stress corrosion. We are issuing this AD to detect and correct cracking of the left or right upper cap of the center rear spar, which could cause a possible fuel leak and structural failure of the upper cap, and result in reduced structural integrity of the airplane.</P>
                        <HD SOURCE="HD1">Compliance</HD>
                        <P>(e) You are responsible for having the actions required by this AD performed within the compliance times specified, unless the actions have already been done.</P>
                        <HD SOURCE="HD1">Inspection</HD>
                        <P>(f) At the later of the times specified in paragraph (f)(1) or (f)(2) of this AD: Do a high frequency eddy current inspection to detect cracks in the vertical radius of the upper cap of the center wing rear spar, in accordance with the Accomplishment Instructions of Boeing Service Bulletin DC9-57-223, dated July 21, 2003.</P>
                        <P>(1) Before the accumulation of 25,000 total flight cycles.</P>
                        <P>(2) Within 15,000 flight cycles or 5 years after the effective date of this AD, whichever occurs first.</P>
                        <HD SOURCE="HD1">Corrective Action</HD>
                        <P>(g)(1) If no crack is found, then repeat the inspection thereafter at intervals not to exceed 15,000 flight cycles or 5 years, whichever occurs first.</P>
                        <P>(2) If any crack is found, before further flight, repair per a method approved by the Manager, Los Angeles Aircraft Certification Office (ACO), FAA. For a repair method to be approved by the Manager, Los Angeles ACO, as required by this paragraph, the Manager's approval letter must specifically refer to this AD.</P>
                        <HD SOURCE="HD1">Alternative Methods of Compliance (AMOCs)</HD>
                        <P>(h) The Manager, Los Angeles ACO, FAA, has the authority to approve AMOCs for this AD, if requested in accordance with the procedures found in 14 CFR 39.19.</P>
                        <HD SOURCE="HD1">Material Incorporated by Reference</HD>
                        <P>
                            (i) You must use Boeing Service Bulletin DC9-57-223, dated July 21, 2003, to perform the actions that are required by this AD, unless the AD specifies otherwise. The Director of the Federal Register approves the incorporation by reference of this document in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. For copies of the service information, contact Boeing Commercial Airplanes, Long Beach Division, 3855 Lakewood Boulevard, Long Beach, California 90846, Attention: Data and Service Management, Dept. CI-L5A (D800-0024). For information on the availability of this material at the National Archives and Records Administration (NARA), call (202) 741-6030, or go to 
                            <E T="03">http://www.archives.gov/federal_register/code_of_ federal_regulations/ibr_locations.html.</E>
                             You may view the AD docket at the Docket Management Facility, U.S. Department of Transportation, 400 Seventh Street, SW., room PL-401, Nassif Building, Washington, DC.
                        </P>
                    </EXTRACT>
                </REGTEXT>
                <SIG>
                    <DATED>Issued in Renton, Washington, on November 1, 2004.</DATED>
                    <NAME>Kalene C. Yanamura,</NAME>
                    <TITLE>Acting Manager, Transport Airplane Directorate, Aircraft Certification Service.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 04-24934  Filed 11-12-04; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4910-13-M</BILCOD>
        </RULE>
        <RULE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF TRANSPORTATION </AGENCY>
                <SUBAGY>Federal Aviation Administration </SUBAGY>
                <CFR>14 CFR Part 39 </CFR>
                <DEPDOC>[Docket No. 2002-NM-153-AD; Amendment 39-13859; AD 2004-23-04] </DEPDOC>
                <RIN>RIN 2120-AA64 </RIN>
                <SUBJECT>Airworthiness Directives; Airbus Model A319 and A320 Series Airplanes </SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Federal Aviation Administration, DOT. </P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Final rule. </P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>This amendment adopts a new airworthiness directive (AD), applicable to certain Airbus Model A319 and A320 series airplanes, that requires a modification and replacement affecting all fuel tanks. All affected airplanes require the installation of fuses in the wiring of the fuel quantity indicating probes of all fuel tanks. Some affected airplanes also require replacement of the high-level sensors of the additional center tanks (ACTs) with new sensors. For all affected airplanes, these actions are necessary to prevent overheating of the fuel probes due to a short circuit. For some affected airplanes, these actions are necessary to prevent fuel leakage due to inadequate space for thermal expansion within the ACTs. Such conditions could result in fuel vapors or fuel contacting an ignition source and/or consequent fire/explosion in the center fuel tanks. These actions are intended to address the identified unsafe condition. </P>
                </SUM>
                <EFFDATE>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Effective December 20, 2004. </P>
                    <P>
                        The incorporation by reference of certain publications listed in the 
                        <PRTPAGE P="65524"/>
                        regulations is approved by the Director of the Federal Register as of December 20, 2004. 
                    </P>
                </EFFDATE>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        The service information referenced in this AD may be obtained from Airbus, 1 Rond Point Maurice Bellonte, 31707 Blagnac Cedex, France. This information may be examined at the Federal Aviation Administration (FAA), Transport Airplane Directorate, Rules Docket, 1601 Lind Avenue, SW., Renton, Washington; or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call (202) 741-6030, or go to: 
                        <E T="03">http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.</E>
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>Dan Rodina, Aerospace Engineer, International Branch, ANM-116, FAA, Transport Airplane Directorate, 1601 Lind Avenue SW., Renton, Washington 98055-4056; telephone (425) 227-2125; fax (425) 227-1149. </P>
                    <HD SOURCE="HD1">Relationship of This AD to SFAR 88 </HD>
                    <P>The FAA has examined the underlying safety issues involved in recent fuel tank explosions on several large transport airplanes, including the adequacy of existing regulations, the service history of airplanes subject to those regulations, and existing maintenance practices for fuel tank systems. As a result of those findings, we issued a regulation titled “Transport Airplane Fuel Tank System Design Review, Flammability Reduction and Maintenance and Inspection Requirements” (67 FR 23086, May 7, 2001). In addition to new airworthiness standards for transport airplanes and new maintenance requirements, this rule included Special Federal Aviation Regulation No. 88 (SFAR 88). </P>
                    <P>
                        Among other actions, SFAR 88 requires certain type design (
                        <E T="03">i.e.</E>
                        , type certificate (TC) and supplemental type certificate (STC)) holders to substantiate that their fuel tank systems can prevent ignition sources in the fuel tanks. This requirement applies to type design holders for large turbine-powered transport airplanes and for subsequent modifications to those airplanes. It requires them to perform design reviews and to develop design changes and maintenance procedures if their designs do not meet the new fuel tank safety standards. As explained in the preamble to the rule, we intended to adopt airworthiness directives to mandate any changes found necessary to address unsafe conditions identified as a result of these reviews. 
                    </P>
                    <P>In evaluating these design reviews, we have established four criteria intended to define the unsafe conditions associated with fuel tank systems that require corrective actions. The percentage of operating time during which fuel tanks are exposed to flammable conditions is one of these criteria. The other three criteria address the failure types under evaluation: single failures, single failures in combination with another latent condition(s), and in-service failure experience. For all four criteria, the evaluations included consideration of previous actions taken that may mitigate the need for further action. </P>
                    <P>Based on this process, we have determined that the actions identified in this AD are necessary to reduce the potential of ignition sources inside fuel tanks, which, in combination with flammable fuel vapors, could result in fuel tank explosions and consequent loss of the airplane. </P>
                    <HD SOURCE="HD1">Proposed AD </HD>
                    <P>
                        A proposal to amend part 39 of the Federal Aviation Regulations (14 CFR part 39) to include an airworthiness directive (AD) that is applicable to certain Airbus Model A319 and A320 series airplanes was published in the 
                        <E T="04">Federal Register</E>
                         on November 17, 2003 (68 FR 64823). That action proposed to require a modification and replacement affecting the center and wing fuel tanks. All affected airplanes would require modification of the wiring of the fuel quantity indicating probes of the center and wing fuel tanks. Some affected airplanes would also require replacement of the high-level sensors of the additional center fuel tank with new, improved sensors. 
                    </P>
                    <HD SOURCE="HD1">Comments </HD>
                    <P>Interested persons have been afforded an opportunity to participate in the making of this amendment. Due consideration has been given to the comments received. </P>
                    <HD SOURCE="HD1">Supportive Comments</HD>
                    <P>One commenter supports the proposed AD; one commenter supports the intent of the proposed AD.</P>
                    <HD SOURCE="HD1">Requests To Extend Compliance Time</HD>
                    <P>One commenter notes a large disparity between the two limitations in the proposed accomplishment time of “Within 4,000 flight hours or 30 months after the effective date of the AD, whichever is first.” The commenter suggests that the FAA consider changing the timeline to flight hours or a calendar month, which is more closely tied to actual airplane utilization. The commenter adds that utilization of these airplanes could be as high as 9,000 flight hours during the proposed 30-month compliance time. The commenter asks that the compliance time be changed to 9,000 flight hours or 30 months, whichever is first. Another commenter also recommends that the compliance time be changed to 9,000 flight hours or 30 months, whichever is first, and provided no justification for the recommendation.</P>
                    <P>A third commenter states that, based on airplane utilization, the flight-hour threshold will occur first, and result in a 14-month schedule for completion. The commenter adds that, based on the instructions outlined in Airbus Service Bulletin A320-28-1087, accomplishment of the actions is possible only during a base maintenance visit. The commenter notes that the compliance limits will penalize operators with long-to-medium-range missions. The commenter recommends that the compliance time be extended to 5,500 flight hours or 30 months after the effective date of the AD, whichever occurs first. The commenter states that this will allow operators to utilize routine base maintenance visit opportunities where appropriate tooling, ground equipment, and qualified skill set are available.</P>
                    <P>A fourth commenter states that including a flight-hour limit in the compliance time suggests that the failure mode being addressed by the mandatory activity is sensitive to flight hours in service. The commenter notes that the failure mode addressed by Service Bulletin A320-28-1087 (wiring insulation breakdown/damage) is primarily related to calendar age. The commenter adds that, while the flight-hour limit may have value, it is not the crucial parameter. The commenter's in-service airplanes average about eight hours of flying per day, which means that the 4,000-flight-hour limit would require that the actions be done on all affected airplanes within about 500 days. This period is 55 percent of the calendar time afforded by the compliance time, and is less than the C-check interval. The commenter states that doing the actions on all airplanes within 4,000 flight hours would put an additional burden and cost on its operation. The commenter suggests extending the compliance time to 6,000 flight hours, which will not compromise the level of safety.</P>
                    <P>
                        We do not agree with the commenters. In developing an appropriate compliance time for this action, we considered the safety implications, operators' normal maintenance schedules, and the compliance time 
                        <PRTPAGE P="65525"/>
                        recommended by the airplane manufacturer for the timely accomplishment of the required actions. The compliance time is based on airplane utilization overall. In addition, operators provided no data to support that a compliance time extension will ensure safety. In consideration of these items, we have determined that compliance within 4,000 flight hours or 30 months after the effective date of this AD, whichever is first, will provide an acceptable level of safety and is an appropriate interval of time wherein the required actions can be accomplished during scheduled maintenance intervals for the majority of affected operators. However, according to the provisions of paragraph (b) of this AD, we may approve requests to adjust the compliance time if the request includes data that justify that a different compliance time would provide an acceptable level of safety. No change to the AD is made in this regard.
                    </P>
                    <HD SOURCE="HD1">Request To Delay Issuance of the Proposed AD</HD>
                    <P>One commenter states that it previously elected not to do the actions required by the proposed AD on affected airplanes (reference Service Bulletin A320-28-1087, Revision 02). This was because the Direction Générale de l'Aviation Civile (DGAC), which is the airworthiness authority for France, found the Special Federal Aviation Regulation No. 88 (“SFAR 88,” Amendment 21-78, and subsequent Amendments 21-82 and 21-83) compliance solution proposal submitted by Airbus to be sufficient for compliance with French airworthiness directive 2002-220(B) R1, dated October 15, 2003; although further discussions with the FAA and the DGAC were necessary. These discussions were expected to include the possibility of a requirement to install transient suppression units. Correspondence between the commenter and Airbus confirmed that, in the event that transient suppression units were specified in future rulemaking, the fused adapter/connection installation specified in the service bulletin would be revised. The commenter adds that, according to its cost model, the proposed AD would cost over $500,000 for its fleet. The commenter objects to spending the money if the solution is only interim, with introduction of transient suppression units to follow. The commenter strongly encourages a permanent solution to be introduced and regulated, and is not aware of any in-service data that would suggest that airplane safety could be compromised by delaying the interim solution until introduction of a permanent solution.</P>
                    <P>We do not agree with the commenter that an alternate solution is necessary, as the modification required by the proposed AD is not an interim action. We have examined the underlying safety issues involved in fuel tank explosions on several transport airplanes. As a result of those findings, we issued a regulation titled “Transport Airplane Fuel Tank System Design Review, Flammability Reduction and Maintenance and Inspection Requirements.” In addition to new airworthiness standards for transport airplanes and new maintenance requirements, this rule included SFAR No. 88. Among other actions, SFAR 88 requires certain type design holders to perform design reviews, and to develop design changes and maintenance procedures if necessary. We intend to adopt ADs to mandate any changes found necessary to address unsafe conditions identified during these reviews. Based on this process, we have determined that the modification required by this AD is necessary to address the identified unsafe condition.</P>
                    <HD SOURCE="HD1">Request To Clarify Summary Section</HD>
                    <P>One commenter states that the Summary section of the proposed AD has significant inaccuracies due to the assimilation of two independent unsafe conditions, as identified in the referenced French airworthiness directive. The unsafe conditions require mandatory action, which is achieved by applying the two service bulletins referenced in the proposed AD. The commenter notes that the reason there are two service bulletins, and only one French airworthiness directive, is to minimize the cost impact on the three airplanes requiring correction of both unsafe conditions.</P>
                    <P>Additionally, the commenter states that the Summary section does not properly distinguish between additional center tanks (ACTs) and center wing tanks, which could lead to misinterpretation of any corrective action necessary. The commenter notes that Airbus Service Bulletin A320-28-1086, Revision 01, dated October 23, 2002 (cited in the proposed AD as an appropriate source of service information for accomplishment of certain actions), affects the ACTs on the three airplanes specified above only. The commenter adds that the identified modifications reposition the high-level sensors to ensure there is a minimum of two percent expansion space in the applicable ACT, and correct a non-compliance to Joint Aviation Regulation (JAR) 25.969. This non-compliance issue could result in fuel overflowing from the ACT to the left wing surge tank in the event of thermal expansion of the fuel in the ACT. The commenter also adds that the bracket that the high-level sensor is attached to, not the high-level sensor, is the part that has been improved.</P>
                    <P>The commenter also states that Airbus Service Bulletin A320-28-1087, Revision 02, dated June 10, 2003 (cited in the proposed AD as an appropriate source of service information for accomplishment of certain actions), affects all fuel tanks (all wing tanks and all ACTs), on the affected airplanes. The modification identified is to install fuses in the fuel quantity indicating (FQI) harnesses at or near the fuel tank walls, which corrects a non-compliance with JAR 25.981. This non-compliance issue could result in the ignition of flammable fuel vapors in a fuel tank in the event of a short circuit between the FQI wiring and an unprotected 28-volt supply. </P>
                    <P>In conclusion, the commenter states that the Summary section should clearly distinguish between these two unsafe conditions and should provide certain wording to more clearly define the two unsafe conditions. </P>
                    <P>We agree with the commenter and have changed the applicable sections in this AD, for clarification, to separate the two unsafe conditions. </P>
                    <HD SOURCE="HD1">Request To Change Paragraph (a) of This AD </HD>
                    <P>In following up on his request to distinguish the two unsafe conditions, the commenter requests the following changes, which would include a new paragraph (b): </P>
                    <P>“(a) Within 4,000 flight hours or 30 months after the effective date of this AD, whichever is first: Do the applicable actions specified in paragraph (a)(1) of this AD. Accomplishment of the modification before the effective date of this AD per Airbus Service Bulletin A320-28-1087, dated July 17, 2001, or Revision 01, dated March 3, 2003; is acceptable for compliance with the corresponding action specified in paragraph (a)(1) of this AD. </P>
                    <P>(1) For airplanes defined in Airbus Service Bulletin A320-28-1087, Revision 02, dated June 10, 2003: Modify the wiring of the fuel quantity indicating probes of all the fuel tanks by doing all the actions specified in paragraphs 3.A. through 3.D. (including operational testing and any applicable repair) of the Accomplishment Instructions of the service bulletin. Any applicable repair must be done before further flight. </P>
                    <P>
                        (b) Within 4,000 flight hours or 30 months after the effective date of this 
                        <PRTPAGE P="65526"/>
                        AD, whichever is first: Do the applicable actions specified in paragraph (b)(1) of this AD. Accomplishment of the replacement before the effective date of this AD per Airbus Service Bulletin A320-28-1086, dated November 30, 1999; as applicable; is considered acceptable for compliance with the corresponding action specified in paragraph (b)(1) of this AD. 
                    </P>
                    <P>(1) For airplanes defined in Airbus Service Bulletin A320-28-1086, Revision 01, dated October 23, 2002: Prior to or concurrent with accomplishment of paragraph (a)(1) of this AD, replace the high-level sensors of the additional center fuel tanks by doing all the actions specified in paragraphs 3.A through 3.D. (including operational testing and any applicable repair) of the Accomplishment Instructions of the service bulletin. Do the actions per the service bulletin. Any applicable repair must be done before further flight.” The commenter provided no justification for the requested changes. </P>
                    <P>After reviewing the commenter's suggested changes to paragraph (a) of the proposed AD, we find that specifying “all the fuel tanks” instead of “the center and wing fuel tanks,” is the only significant change. We also find that moving the service bulletin references around, as suggested by the commenter, does not clarify the requirements of that paragraph. Therefore, we have changed the wording in paragraph (a)(1) of this AD to specify “all the fuel tanks,” for clarification; we made no further changes to paragraph (a) of this AD. </P>
                    <HD SOURCE="HD1">Request To Clarify Certain Sections in the Preamble </HD>
                    <P>The same commenter reiterates certain wording regarding compliance with JAR 25.989, as specified in the Discussion section of the proposed AD, and notes that the wording is incorrect. The commenter states that the referenced testing is specific to some ACTs that can be fitted only to Model A319 series airplanes with Airbus Modification 28238 installed, and does not relate to other ACTs fitted to Models A319 and A320 series airplanes, or to center (wing) tanks. The commenter adds that the correct reference is JAR 25.969, not 25.989. The commenter notes that the high-level sensor is not improved and has no regulatory deficiency, and adds that it is the bracket that the sensor is attached to that is improved to provide the required expansion space. In addition, the commenter states that there is no connection between changing the high-level sensor position and the overheating of the FQI fuel probes in the event of an external 28-volt short circuit to the FQI fuel probe wiring. The commenter adds that there is no risk of the high-level sensor overheating in the event of an external 28-volt short circuit to its wiring. </P>
                    <P>The commenter also states that there is no risk of fuel spillage resulting from inadequate expansion space, which could result in fuel vapors or fuel contacting an ignition source, and/or consequent fire/explosion in the center fuel tank. Any fuel spillage will be contained within the fuel vent system until the left wing surge tank is overfilled and subsequent limited fuel spillage from the surge tank through a flame arrestor could occur. The commenter adds that in the event of fuel spillage from the surge tank, and in the presence of an ignition source on the ground, a ground fire could be ignited. In the event of a ground fire, the flame arrestor installed for this purpose will eventually protect the fuel tank. </P>
                    <P>
                        The commenter notes that the section titled 
                        <E T="02">ADDRESSES</E>
                         incorrectly identifies the airplane manufacturer as “Airbus Industrie.” The airplane manufacturer should be identified as “Airbus.” 
                    </P>
                    <P>The same commenter states that the Explanation of Relevant Service Information section in the preamble of the proposed AD is unclear in identifying which tanks apply to Service Bulletin A320-28-1087, Revision 02. The commenter states that the text should read, “Airbus has issued Service Bulletin A320-28-1087, Revision 02, which describes procedures for modification of the wiring of the FQI probes of all fuel tanks.” The modification includes the following: </P>
                    <P>• Installation of fused plug connectors for the FQI probes of the wing tanks; and </P>
                    <P>• Installation of fused adapters between the external wiring harness and the in-tank wiring of the connectors on the ACT and center wing fuel tank walls. </P>
                    <P>The commenter notes that the term “center tank” is imprecise, as it could be interpreted to mean the center wing tank and not the ACT. This could lead to the exclusion of necessary corrective action for some fuel tanks. The fact that the modification is applicable to all fuel tanks is explicitly described by using the word “all.” </P>
                    <P>
                        We acknowledge and agree with the commenter's remarks on the preamble of the proposed AD; however, most of the sections referred to are not restated in this final rule. The name of the airplane manufacturer specified in the 
                        <E T="02">“ADDRESSES”</E>
                         section has been changed to Airbus. No other change to the AD is made in this regard. 
                    </P>
                    <HD SOURCE="HD1">Inadequate Technical Information Provided in the Service Bulletins </HD>
                    <P>One commenter states that it is apparent that the information in the service bulletins lacks adequate technical detail for the commenter to form an opinion relative to the content. The commenter adds that Service Bulletin A320-28-1087 specifies adding fused connectors/adapters to protect the fuel gauging lines from hot shorts to 28 volt direct current that enter the fuel tanks. However, there is no information regarding compliance with Advisory Circular (AC) 25.981, which provides guidance for the overall safe design of fuel systems under certain conditions. The commenter notes that compliance with the AC may require a different design approach, in which case issuance of the proposed AD, although improving the level of safety, would be premature and would cause an unnecessary financial burden for operators. The commenter is unable to render a sound technical opinion as to the accuracy of the proposed AD, due to insufficient data. </P>
                    <P>We appreciate the commenter's concerns; however, it is not standard practice to provide technical details for design changes in service bulletins. The modification required by this AD is intended to prevent excessive currents from entering the FQI probes. Investigations have shown that a short of 28-volt direct current to the probes could cause certain parts of the probe to heat up to a temperature in excess of 200 degrees centigrade. Additionally, all FQI probe wiring installed on Model A319 series airplanes is co-routed with 28-volt direct current. The service bulletin was issued to provide procedures to modify the airplane to the approved type design. We do not agree that this AD is premature. In this case, we find that to withdraw this AD and initiate new proposed rulemaking (providing for public opportunity to comment) would significantly delay the rulemaking process and would be inappropriate in light of the identified unsafe condition. We have determined that issuance of this AD is appropriate and warranted. </P>
                    <HD SOURCE="HD1">Request To Revise Cost Impact Section </HD>
                    <P>
                        One commenter states that there are presently no airplanes registered in the U.S. for which Service Bulletin A320-28-1086 applies (Models A319-115 and A319-133 series airplanes). The commenter requests that the Cost Impact section of the proposed AD be revised to provide, for future imported 
                        <PRTPAGE P="65527"/>
                        airplanes, accomplishment of the proposed actions through a Certificate of Airworthiness. 
                    </P>
                    <P>We do not agree to provide for accomplishment of the proposed actions through a Certificate of Airworthiness for future imported Models A319-115 and A319-133 series airplanes. We do agree that those airplanes are not U.S.-registered; therefore, we have added a new paragraph to the Cost Impact section to provide the estimated costs for those airplanes should the airplanes be imported and placed on the U.S. Register in the future. </P>
                    <HD SOURCE="HD1">Conclusion </HD>
                    <P>After careful review of the available data, including the comments noted above, the FAA has determined that air safety and the public interest require the adoption of the rule with the changes described previously. We have determined that these changes will neither increase the economic burden on any operator nor increase the scope of the AD. </P>
                    <HD SOURCE="HD1">Cost Impact </HD>
                    <P>We estimate that 468 Model A319-111, -112, -113, -114, -131, and -132 and Model A320 series airplanes of U.S. registry will be affected by this AD. </P>
                    <P>It will take between 10 and 22 work hours per airplane to accomplish the modification, at an average labor rate of $65 per work hour. Required parts will cost between $670 and $5,750 per airplane. Based on these figures, the cost impact of the modification required by this AD on U.S. operators is estimated to be between $617,760 and $3,360,240, or between $1,320 and $7,180 per airplane. </P>
                    <P>If an operator is required to replace the high-level sensors, it will take about 80 work hours, at an average labor rate of $65 per work hour. Required parts are free of charge. Based on these figures, the cost impact of the replacement required by this AD is estimated to be $5,200 per airplane. </P>
                    <P>The cost impact figures discussed above are based on assumptions that no operator has yet accomplished any of the requirements of this AD action, and that no operator would accomplish those actions in the future if this AD were not adopted. The cost impact figures discussed in AD rulemaking actions represent only the time necessary to perform the specific actions actually required by the AD. These figures typically do not include incidental costs, such as the time required to gain access and close up, planning time, or time necessitated by other administrative actions. </P>
                    <P>Currently, there are no affected A319-115 and A319-133 series airplanes on the U.S. Register. However, if an affected airplane is imported and placed on the U.S. Register in the future, the required modification would take between 10 and 22 work hours per airplane, at an average labor rate of $65 per work hour. Required parts will cost between $670 and $5,750 per airplane. Based on these figures, we estimate the cost of this AD to be between $1,320 and $7,180 per airplane. </P>
                    <HD SOURCE="HD1">Regulatory Impact </HD>
                    <P>The regulations adopted herein will not have a substantial direct effect on the States, on the relationship between the national Government and the States, or on the distribution of power and responsibilities among the various levels of government. Therefore, it is determined that this final rule does not have federalism implications under Executive Order 13132. </P>
                    <P>
                        For the reasons discussed above, I certify that this action (1) is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979); and (3) will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act. A final evaluation has been prepared for this action and it is contained in the Rules Docket. A copy of it may be obtained from the Rules Docket at the location provided under the caption “
                        <E T="02">ADDRESSES.</E>
                        ” 
                    </P>
                    <LSTSUB>
                        <HD SOURCE="HED">List of Subjects in 14 CFR Part 39 </HD>
                        <P>Air transportation, Aircraft, Aviation safety, Incorporation by reference, Safety.</P>
                    </LSTSUB>
                    <HD SOURCE="HD1">Adoption of the Amendment </HD>
                    <REGTEXT TITLE="14" PART="39">
                        <AMDPAR>Accordingly, pursuant to the authority delegated to me by the Administrator, the Federal Aviation Administration amends part 39 of the Federal Aviation Regulations (14 CFR part 39) as follows: </AMDPAR>
                        <PART>
                            <HD SOURCE="HED">PART 39—AIRWORTHINESS DIRECTIVES </HD>
                        </PART>
                        <AMDPAR>1. The authority citation for part 39 continues to read as follows: </AMDPAR>
                        <AUTH>
                            <HD SOURCE="HED">Authority:</HD>
                            <P>49 U.S.C. 106(g), 40113, 44701. </P>
                        </AUTH>
                    </REGTEXT>
                    <REGTEXT TITLE="14" PART="39">
                        <SECTION>
                            <SECTNO>§ 39.13 </SECTNO>
                            <SUBJECT>[Amended] </SUBJECT>
                        </SECTION>
                        <AMDPAR>2. Section 39.13 is amended by adding the following new airworthiness directive: </AMDPAR>
                        <EXTRACT>
                            <FP SOURCE="FP-2">
                                <E T="04">2004-23-04 Airbus:</E>
                                 Amendment 39-13859. Docket 2002-NM-153|AD.
                            </FP>
                            <P>
                                <E T="03">Applicability:</E>
                                 Model A319 and A320 series airplanes, certificated in any category; as listed in Airbus Service Bulletin A320-28-1087, Revision 02, dated June 10, 2003; and Airbus Service Bulletin A320-28-1086, Revision 01, dated October 23, 2002. 
                            </P>
                            <P>
                                <E T="03">Compliance:</E>
                                 Required as indicated, unless accomplished previously. 
                            </P>
                            <P>To prevent overheating of the fuel probes due to a short circuit, and fuel leakage due to inadequate space for thermal expansion within the additional center tanks, which could result in fuel vapors or fuel contacting an ignition source, accomplish the following: </P>
                            <HD SOURCE="HD1">Modification/Replacement </HD>
                            <P>(a) Within 4,000 flight hours or 30 months after the effective date of this AD, whichever is first: Do the applicable actions specified in paragraphs (a)(1) and (a)(2) of this AD. Accomplishment of the modification before the effective date of this AD per Airbus Service Bulletin A320-28-1087, dated July 17, 2001; or Revision 01, dated March 3, 2003; or accomplishment of the replacement before the effective date of this AD per Airbus Service Bulletin A320-28-1086, dated November 30, 1999; as applicable; is considered acceptable for compliance with the corresponding action specified in paragraph (a)(1) or (a)(2) of this AD. </P>
                            <P>(1) For airplanes defined in Airbus Service Bulletin A320-28-1087, Revision 02, dated June 10, 2003: Modify the wiring of the fuel quantity indicating probes of all the fuel tanks by doing all the actions specified in paragraphs 3.A. through 3.D. (including operational testing and any applicable repair) of the Accomplishment Instructions of the service bulletin. Do the actions per the service bulletin. Any applicable repair must be done before further flight. </P>
                            <P>(2) For airplanes defined in Airbus Service Bulletin A320-28-1086, Revision 01, dated October 23, 2002: Prior to or concurrent with accomplishment of paragraph (a)(1) of this AD, replace the high-level sensors of the additional center fuel tanks by doing all the actions specified in paragraphs 3.A through 3.D. (including operational testing and any applicable repair) of the Accomplishment Instructions of the service bulletin. Do the actions per the service bulletin. Any applicable repair must be done before further flight. </P>
                            <HD SOURCE="HD1">Alternative Methods of Compliance </HD>
                            <P>(b) In accordance with 14 CFR 39.19, the Manager, International Branch, ANM-116, FAA, Transport Airplane Directorate, is authorized to approve alternative methods of compliance for this AD. </P>
                            <HD SOURCE="HD1">Incorporation by Reference </HD>
                            <P>
                                (c) Unless otherwise specified in this AD, the actions shall be done in accordance with Airbus Service Bulletin A320-28-1086, Revision 01, dated October 23, 2002; or Airbus Service Bulletin A320-28-1087, Revision 02, dated June 10, 2003; as applicable. This incorporation by reference was approved by the Director of the Federal Register in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. For copies, contact Airbus, 1 Rond Point Maurice Bellonte, 31707 Blagnac Cedex, France. Inspect copies at the FAA, Transport Airplane Directorate, 
                                <PRTPAGE P="65528"/>
                                1601 Lind Avenue, SW., Renton, Washington; or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call (202) 741-6030, or go to: 
                                <E T="03">http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.</E>
                            </P>
                            <NOTE>
                                <HD SOURCE="HED">Note 1:</HD>
                                <P>The subject of this AD is addressed in French airworthiness directive 2002-220(B) R1, dated October 15, 2003. </P>
                            </NOTE>
                            <HD SOURCE="HD1">Effective Date </HD>
                            <P>(d) This amendment becomes effective on December 20, 2004. </P>
                        </EXTRACT>
                    </REGTEXT>
                    <SIG>
                        <DATED>Issued in Renton, Washington, on November 1, 2004.</DATED>
                        <NAME>Ali Bahrami, </NAME>
                        <TITLE>Manager, Transport Airplane Directorate, Aircraft Certification Service. </TITLE>
                    </SIG>
                </FURINF>
            </PREAMB>
            <FRDOC>[FR Doc. 04-24933 Filed 11-12-04; 8:45 am] </FRDOC>
            <BILCOD>BILLING CODE 4910-13-P</BILCOD>
        </RULE>
        <RULE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF TRANSPORTATION </AGENCY>
                <SUBAGY>Federal Aviation Administration </SUBAGY>
                <CFR>14 CFR Part 39 </CFR>
                <DEPDOC>[Docket No. 2002-NM-97-AD; Amendment 39-13863; AD 2004-23-08] </DEPDOC>
                <RIN>RIN 2120-AA64 </RIN>
                <SUBJECT>Airworthiness Directives; Airbus Model A300 B4-600R and A300 F4-600R Series Airplanes </SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Federal Aviation Administration, DOT. </P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Final rule. </P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>This amendment supersedes an existing airworthiness directive (AD), applicable to Airbus Model A300 B4-600R and A300 F4-600R series airplanes, that currently requires a one-time detailed inspection for damage of the center tank fuel pumps and fuel pump canisters, and replacement of damaged fuel pumps and fuel pump canisters with new or serviceable parts. That AD also requires repetitive detailed inspections of the fuel pumps and repetitive eddy current inspections of the fuel pump canisters, and replacement of damaged fuel pumps and fuel pump canisters with new or serviceable parts. This amendment mandates modification of the canisters of the center tank fuel pumps, which would terminate the repetitive inspections required by the existing AD. The actions specified by this AD are intended to prevent damage to the fuel pump and fuel pump canister, which could result in loss of flame trap capability and could provide a fuel ignition source in the center fuel tank. This action is intended to address the identified unsafe condition. </P>
                </SUM>
                <EFFDATE>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Effective December 20, 2004. </P>
                    <P>The incorporation by reference of Airbus Service Bulletin A300-28-6069, Revision 01, dated May 28, 2002; and Airbus Service Bulletin A300-28-6061, Revision 04, dated August 1, 2002; as listed in the regulations, is approved by the Director of the Federal Register as of December 20, 2004. </P>
                    <P>The incorporation by reference of Airbus All Operators Telex (AOT) 28-09, dated November 28, 1998, as listed in the regulations, was approved previously by the Director of the Federal Register as of December 28, 1998 (63 FR 70639, December 22, 1998). </P>
                    <P>The incorporation by reference of Airbus Alert Service Bulletin A300-28A6061, dated February 19, 1999, as listed in the regulations, was approved previously by the Director of the Federal Register as of February 8, 2000 (65 FR 213, January 4, 2000). </P>
                </EFFDATE>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        The service information referenced in this AD may be obtained from Airbus Industrie, 1 Rond Point Maurice Bellonte, 31707 Blagnac Cedex, France. This information may be examined at the Federal Aviation Administration (FAA), Transport Airplane Directorate, Rules Docket, 1601 Lind Avenue, SW., Renton, Washington; or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call (202) 741-6030, or go to: 
                        <E T="03">http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html</E>
                        . 
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>Tim Backman, Aerospace Engineer, International Branch, ANM-116, FAA, Transport Airplane Directorate, 1601 Lind Avenue, SW., Renton, Washington 98055-4056; telephone (425) 227-2797; fax (425) 227-1149. </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>
                    A proposal to amend part 39 of the Federal Aviation Regulations (14 CFR part 39) by superseding AD 99-27-07, amendment 39-11488 (65 FR 213, January 4, 2000), which is applicable to all Airbus Model A300 B4-600R and A300 F4-600R series airplanes, was published in the 
                    <E T="04">Federal Register</E>
                     on September 9, 2003 (68 FR 53058). The action proposed to continue to require a one-time visual inspection for damage of the center tank fuel pumps and fuel pump canisters, and replacement of damaged fuel pumps and fuel pump canisters with new or serviceable parts. The action also proposed to continue to require repetitive detailed inspections for damage of the fuel pumps and repetitive eddy current inspections of the fuel pump canisters, and replacement of damaged fuel pumps and fuel pump canisters with new or serviceable parts. The action also proposed to mandate modification of the canisters of the center tank fuel pumps, which would terminate the repetitive inspections required by the existing AD. 
                </P>
                <HD SOURCE="HD1">Comments </HD>
                <P>Interested persons have been afforded an opportunity to participate in the making of this amendment. Due consideration has been given to the comments received. </P>
                <HD SOURCE="HD1">Request To Change Compliance Time </HD>
                <P>One commenter requests that the compliance time for the terminating action (modification) specified in paragraph (d) of the proposed AD be changed to “Prior to the accumulation of 5,000 total hours, time-in-service, or within 18 months after the effective date of this AD, whichever occurs later.” The commenter notes that an equivalent level of safety is maintained by this change, as the change will still require the modification to be done prior to the first inspection required by AD 99-27-07. The commenter adds that this change will minimize the hardship of implementing the proposed AD. </P>
                <P>The FAA does not agree, as repetitive inspections for cracks are not equivalent to replacement of the canisters of the center tank fuel pumps with improved canisters for continued operational safety. Cracked canisters continue to be detected during the mandated inspections, but in view of the potential unsafe condition, we find that modification of the canisters by installation of reinforced canisters that are not subject to cracking must be done. In addition, inclusion of a 5,000 flight hour compliance time could allow certain low-time airplanes an additional year before accomplishment of the canister replacement. We do not find it necessary to change the AD in this regard. However, the commenter may request approval of an alternative method of compliance from the FAA, in accordance with paragraph (g)(1) of this AD, if technical justification, substantiation of need, and a satisfactory retrofit status of the commenter's fleet with the new canister are provided. </P>
                <HD SOURCE="HD1">Clarification of Terminating Action </HD>
                <P>
                    One commenter states that paragraph (d) of the proposed AD (New Requirements of This AD) specifies that accomplishment of Airbus Service Bulletin A300-28-6069, Revision 01, dated May 28, 2002 (modification of the canisters of the center tank fuel pumps) 
                    <PRTPAGE P="65529"/>
                    ends the repetitive inspections required by paragraph (b) of the proposed AD. The commenter adds that initial accomplishment of the paragraph (b) inspection would terminate the repetitive inspections required by paragraph (a) of the proposed AD. The commenter notes that, as written, the proposed AD seems to require the initial accomplishment of the inspection required by paragraph (b) to terminate the repetitive inspections. The commenter asks for clarification of the intent of the AD. 
                </P>
                <P>As requested, we provide the following clarification: The AD does require accomplishment of the initial inspection required by paragraph (b) of this AD to terminate the repetitive inspections required by paragraph (a) of this AD. The repetitive inspections specified in paragraphs (a) and (b) of the AD are required by AD 99-27-07 (Restatement of Requirements of AD 99-27-07), and continue to be required by this AD until the terminating action is done. The new requirements that mandate modification of the canisters of the center tank fuel pumps, as specified in paragraph (d) of this AD, terminate those repetitive inspections. </P>
                <HD SOURCE="HD1">Request To Change Terminating Action to Optional </HD>
                <P>One commenter states that AD 99-27-07 addresses the unsafe condition identified by that rule, and adds that the proposed AD does not provide justification for mandating the terminating action. The commenter provides the following reasons for changing the terminating action in the proposed AD to an optional action. </P>
                <P>• The proposed AD does not specifically identify an additional unsafe condition, so there is no need to add further financial burden for operators without justifiable cause. </P>
                <P>• Operators favor the use of terminating action in lieu of repetitive inspections; however, where either solution offers the same level of safety, this decision becomes a matter of economics. </P>
                <P>• There is no safety benefit identified for the terminating action, so the decision to continue to inspect, or implement the terminating action, should remain at the option of the operator. </P>
                <P>The commenter adds that there is no reasonable basis for the 18-month compliance time for the terminating action, as it appears arbitrary. Due to the current economic conditions of the airline industry, operators should be given the option of replacing the canister with the improved design, or continuing the scheduled inspections and replacing the canister only if a crack is found during the inspection. The commenter adds that the scheduled inspections, when done in accordance with AD 99-27-07, will provide a level of safety equivalent to that provided by the proposed AD. </P>
                <P>We do not agree. The unsafe condition specified in AD 99-27-07 has not been corrected; therefore, an additional unsafe condition does not need to be added to this AD, as there has been no final fix until now. Although we acknowledge the commenter's concerns regarding further financial burden on operators, the FAA, in conjunction with the Direction Générale de l'Aviation Civile (DGAC), which is the airworthiness authority for France, is mandating the terminating action based on the determination that, in this case, long-term continued operational safety would be better assured by a modification to remove the source of the problem, rather than by continued repetitive inspections. We consider the existing canisters of the center fuel tank to be a safety issue of sufficient significance to warrant modification of the canisters. Relying on continued repetitive inspections as an option to the modification does not ensure that affected airplanes will receive appropriately modified canisters in a timely manner, or at all. </P>
                <P>The fuel pump canister is intended to contain or trap any potential fuel pump ignition sources and consequent flames in the canister, and keep them from entering the fuel tank. A crack in the fuel pump canister has the potential to eliminate the canister fire trap capability and provide an ignition source to the center tank fuel pump. The new, improved canisters have been strengthened by thicker and re-profiled webs, the fuel aperture corner radius has been increased, the non-return valve has been strengthened, and the attachment fasteners have been increased from four to six inches. A canister locating pin (foolproofing pin) is also installed by this modification, which will prevent the installation of unmodified fuel booster-pump canisters. Accordingly, no change to the AD is made in this regard. </P>
                <HD SOURCE="HD1">Request To Change Cost Analysis </HD>
                <P>The same commenter states that the proposed AD lacks adequate cost analysis. The commenter states that the cost of the canister is omitted, and specifies the cost as $4,660 per canister. The commenter adds that the actual cost of the proposed AD, using actual industry wages and the omitted cost for parts, would be $10,548 per airplane or $886,032; not the $76,660 cost calculated by the FAA. </P>
                <P>After considering the data presented by the commenter, we agree that the parts cost for the canisters was omitted. The cost of each canister is $4,660. The cost impact information, below, has been revised to indicate this higher amount. </P>
                <HD SOURCE="HD1">Economic Analysis </HD>
                <P>The same commenter states that it appreciates the FAA economic analysis for using work time estimates consistent with industry experience; however, the FAA labor rate remains much lower than actual industry costs. The commenter adds that the average airline industry labor rate is currently $98 per work hour. </P>
                <P>We point out that our estimate of $65 per work hour is the current burdened labor rate established for use by the Office of Aviation Policy, Plans, and Management Analysis. (The burdened labor rate includes the actual labor cost, overhead, and other related costs.) Because the labor rate used in our calculations accounts for the variations in costs among those in the airline industry, we consider that $65 per work hour is appropriate. Accordingly, no change to the AD is made in this regard. </P>
                <HD SOURCE="HD1">Explanation of Change Made to Proposed AD </HD>
                <P>We have clarified the inspection requirement contained in the proposed AD. Whereas the proposed AD specifies a visual inspection, we have revised this final rule to clarify that our intent is to require a detailed inspection. Additionally, a new note has been added to the final rule to define that inspection. </P>
                <HD SOURCE="HD1">Conclusion </HD>
                <P>We have carefully reviewed the available data, including the comments that have been submitted, and determined that air safety and the public interest require adopting the AD with the changes described previously. We have determined that these changes will neither significantly increase the economic burden on any operator nor increase the scope of the AD. </P>
                <HD SOURCE="HD1">Cost Impact </HD>
                <P>This AD will affect about 84 airplanes of U.S. registry. </P>
                <P>
                    The inspections that are required by AD 99-27-07 take about 2 work hours per airplane to accomplish, at an average labor rate of $65 per work hour. Based on these figures, the cost impact of the currently required actions is estimated to be $130 per airplane, per inspection cycle. 
                    <PRTPAGE P="65530"/>
                </P>
                <P>The inspections required by AD 99-27-07 were applicable to about 67 airplanes. Based on the figures discussed above, the cost impact of the current requirements of that AD on U.S. operators is estimated to be $8,710. </P>
                <P>In this AD, the inspections are applicable to about 17 additional airplanes. Based on the figures discussed above, the new costs to U.S. operators that will be imposed by this AD are estimated to be $2,210. </P>
                <P>The new modification required by this AD action will take about 11 work hours per airplane to accomplish, at an average labor rate of $65 per work hour. Required parts will cost about $9,620 per airplane. Based on these figures, the cost impact of the modification on U.S. operators is estimated to be $868,140, or $10,335 per airplane. </P>
                <P>The cost impact figures discussed above are based on assumptions that no operator has yet accomplished any of the requirements of this AD action, and that no operator would accomplish those actions in the future if this AD were not adopted. The cost impact figures discussed in AD rulemaking actions represent only the time necessary to perform the specific actions actually required by the AD. These figures typically do not include incidental costs, such as the time required to gain access and close up, planning time, or time necessitated by other administrative actions. </P>
                <HD SOURCE="HD1">Regulatory Impact </HD>
                <P>The regulations adopted herein will not have a substantial direct effect on the States, on the relationship between the national Government and the States, or on the distribution of power and responsibilities among the various levels of government. Therefore, it is determined that this final rule does not have federalism implications under Executive Order 13132. </P>
                <P>
                    For the reasons discussed above, I certify that this action (1) is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979); and (3) will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act. A final evaluation has been prepared for this action and it is contained in the Rules Docket. A copy of it may be obtained from the Rules Docket at the location provided under the caption 
                    <E T="02">ADDRESSES</E>
                    . 
                </P>
                <LSTSUB>
                    <HD SOURCE="HED">List of Subjects in 14 CFR Part 39 </HD>
                    <P>Air transportation, Aircraft, Aviation safety, Incorporation by reference, Safety.</P>
                </LSTSUB>
                <REGTEXT TITLE="14" PART="39">
                    <HD SOURCE="HD1">Adoption of the Amendment </HD>
                    <AMDPAR>Accordingly, pursuant to the authority delegated to me by the Administrator, the Federal Aviation Administration amends part 39 of the Federal Aviation Regulations (14 CFR part 39) as follows: </AMDPAR>
                    <PART>
                        <HD SOURCE="HED">PART 39—AIRWORTHINESS DIRECTIVES </HD>
                    </PART>
                    <AMDPAR>1. The authority citation for part 39 continues to read as follows: </AMDPAR>
                    <AUTH>
                        <HD SOURCE="HED">Authority:</HD>
                        <P>49 U.S.C. 106(g), 40113, 44701.   </P>
                    </AUTH>
                </REGTEXT>
                <REGTEXT TITLE="14" PART="39">
                    <SECTION>
                        <SECTNO>§ 39.13 </SECTNO>
                        <SUBJECT>[Amended] </SUBJECT>
                    </SECTION>
                    <AMDPAR>2. Section 39.13 is amended by removing amendment 39-11488 (65 FR 213, January 4, 2000), and by adding a new airworthiness directive (AD), amendment 39-13863, to read as follows: </AMDPAR>
                    <EXTRACT>
                        <FP SOURCE="FP-2">
                            <E T="04">2004-23-08 Airbus:</E>
                             Amendment 39-13863. Docket 2002-NM-97-AD. Supersedes AD 99-27-07, Amendment 39-11488. 
                        </FP>
                        <P>
                            <E T="03">Applicability:</E>
                             Model A300 B4-600R and A300 F4-600R series airplanes, certificated in any category, on which Airbus Modification 4801 (trim tank system) has been accomplished. 
                        </P>
                        <P>
                            <E T="03">Compliance:</E>
                             Required as indicated, unless accomplished previously. 
                        </P>
                        <P>To prevent damage to the fuel pump and fuel pump canister, which could result in loss of flame trap capability and could provide a fuel ignition source in the center fuel tank, accomplish the following: </P>
                        <HD SOURCE="HD1">Restatement of Requirements of AD 99-27-07 </HD>
                        <HD SOURCE="HD2">Inspections </HD>
                        <P>(a) Prior to the accumulation of 5,000 total hours, time-in-service or within 250 hours time-in-service after February 8, 2000 (the effective date of AD 99-27-07, amendment 39-11488), whichever occurs later, perform a detailed inspection for damage of the center tank fuel pumps and fuel pump canisters, in accordance with Airbus All Operators Telex (AOT) 28-09, dated November 28, 1998. Repeat the inspection prior to the accumulation of 12,000 total hours time-in-service, or within 250 hours time-in-service after accomplishment of the initial inspection, whichever occurs later. Thereafter, repeat the inspection at intervals not to exceed 250 hours time-in-service, until accomplishment of the initial inspection required by paragraph (b) of this AD. </P>
                        <NOTE>
                            <HD SOURCE="HED">Note 1:</HD>
                            <P>For the purposes of this AD, a detailed inspection is: “An intensive examination of a specific item, installation, or assembly to detect damage, failure, or irregularity. Available lighting is normally supplemented with a direct source of good lighting at an intensity deemed appropriate. Inspection aids such as mirror, magnifying lenses, etc., may be necessary. Surface cleaning and elaborate procedures may be required.” </P>
                        </NOTE>
                        <P>(b) At the applicable time specified in paragraph (b)(1), (b)(2), or (b)(3) of this AD: Perform a detailed inspection to detect damage of the center tank fuel pumps and perform an eddy current inspection to detect damage of the fuel pump canisters, in accordance with Airbus Alert Service Bulletin A300-28A6061, dated February 19, 1999; or Airbus Service Bulletin A300-28-6061, Revision 04, dated August 1, 2002. Repeat the inspections thereafter at intervals not to exceed 1,500 flight cycles, until accomplishment of paragraph (d) of this AD. Accomplishment of the initial inspections required by this paragraph constitutes terminating action for the requirements of paragraph (a) of this AD. </P>
                        <P>(1) For airplanes that have accumulated 11,000 or more total flight cycles as of February 8, 2000: Inspect within 300 flight cycles after February 8, 2000. </P>
                        <P>(2) For airplanes that have accumulated 8,500 or more total flight cycles, but fewer than 11,000 total flight cycles, as of February 8, 2000: Inspect within 750 flight cycles after February 8, 2000. </P>
                        <P>(3) For airplanes that have accumulated fewer than 8,500 total flight cycles as of February 8, 2000: Inspect prior to the accumulation of 7,000 flight cycles, or within 1,500 flight cycles after February 8, 2000, whichever occurs later. </P>
                        <HD SOURCE="HD2">Corrective Action </HD>
                        <P>(c) If any damage is detected during any inspection required by this AD, prior to further flight, replace the damaged fuel pump or fuel pump canister with a new or serviceable part in accordance with Airbus Alert Service Bulletin A300-28A6061, dated February 19, 1999; or Airbus Service Bulletin A300-28-6061, Revision 04, dated August 1, 2002. </P>
                        <HD SOURCE="HD1">New Requirements of This AD </HD>
                        <HD SOURCE="HD2">Modification </HD>
                        <P>(d) Within 18 months after the effective date of this AD: Modify the canisters of the center tank fuel pumps (including an operational test) by doing all the actions per paragraphs 3.A., 3.B., 3.C., and 3.D. of the Accomplishment Instructions of Airbus Service Bulletin A300-28-6069, Revision 01, dated May 28, 2002. Accomplishment of this modification ends the repetitive inspections required by paragraph (b) of this AD. </P>
                        <P>(e) Accomplishment of the modification before the effective date of this AD per Airbus Service Bulletin A300-28-6069, dated September 4, 2001, is acceptable for compliance with the modification required by paragraph (d) of this AD. </P>
                        <HD SOURCE="HD1">Alternative Methods of Compliance </HD>
                        <P>(f)(1) In accordance with 14 CFR 39.19, the Manager, International Branch, ANM-116, FAA, is authorized to approve alternative methods of compliance for this AD.</P>
                        <P>
                            (2) Alternative methods of compliance, approved previously in accordance with AD 99-27-07, amendment 39-11488, are approved as alternative methods of compliance with the applicable actions in this AD. 
                            <PRTPAGE P="65531"/>
                        </P>
                        <HD SOURCE="HD1">Incorporation by Reference </HD>
                        <P>(g) The actions shall be done in accordance with the applicable service information listed in Table 1 of this AD, unless the AD specifies otherwise. </P>
                        <GPOTABLE COLS="3" OPTS="L2,i1" CDEF="s100,xs80,xs80">
                            <TTITLE>Table 1.—Materials Incorporated by Reference </TTITLE>
                            <BOXHD>
                                <CHED H="1">Airbus service information </CHED>
                                <CHED H="1">Revision level </CHED>
                                <CHED H="1">Date </CHED>
                            </BOXHD>
                            <ROW>
                                <ENT I="01">All Operators Telex 28-09 </ENT>
                                <ENT>Original </ENT>
                                <ENT>November 28, 1998. </ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">Alert Service Bulletin A300-28A6061 </ENT>
                                <ENT>Original </ENT>
                                <ENT>February 19, 1999. </ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">Service Bulletin, A300-28-6061 </ENT>
                                <ENT>04 </ENT>
                                <ENT>August 1, 2002. </ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">Service Bulletin, A300-28-6069 </ENT>
                                <ENT>01 </ENT>
                                <ENT>May 28, 2002. </ENT>
                            </ROW>
                        </GPOTABLE>
                        <P>(1) The incorporation by reference of Airbus Service Bulletin A300-28-6069, Revision 01, dated May 28, 2002; and Airbus Service Bulletin A300-28-6061, Revision 04, dated August 1, 2002; is approved by the Director of the Federal Register in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. </P>
                        <P>(2) The incorporation by reference of Airbus All Operators Telex (AOT) 28-09, dated November 28, 1998, was approved previously by the Director of the Federal Register as of December 28, 1998 (63 FR 70639, December 22, 1998). </P>
                        <P>(3) The incorporation by reference of Airbus Alert Service Bulletin A300-28A6061, dated February 19, 1999, was approved previously by the Director of the Federal Register as of February 8, 2000 (65 FR 213, January 4, 2000). </P>
                        <P>
                            (4) Copies may be obtained from Airbus, 1 Rond Point Maurice Bellonte, 31707 Blagnac Cedex, France. Copies may be inspected at the FAA, Transport Airplane Directorate, 1601 Lind Avenue, SW., Renton, Washington; or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call (202) 741-6030, or go to: 
                            <E T="03">http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.</E>
                        </P>
                        <NOTE>
                            <HD SOURCE="HED">Note 2:</HD>
                            <P>The subject of this AD is addressed in French airworthiness directive 2002-132(B), dated March 20, 2002. </P>
                        </NOTE>
                        <HD SOURCE="HD1">Effective Date </HD>
                        <P>(h) This amendment becomes effective on December 20, 2004. </P>
                    </EXTRACT>
                </REGTEXT>
                <SIG>
                    <DATED>Issued in Renton, Washington, on November 1, 2004. </DATED>
                    <NAME>Ali Bahrami, </NAME>
                    <TITLE>Manager, Transport Airplane Directorate, Aircraft Certification Service. </TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 04-24930 Filed 11-12-04; 8:45 am] </FRDOC>
            <BILCOD>BILLING CODE 4910-13-P</BILCOD>
        </RULE>
        <RULE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF TRANSPORTATION </AGENCY>
                <SUBAGY>Federal Aviation Administration </SUBAGY>
                <CFR>14 CFR Part 39 </CFR>
                <DEPDOC>[Docket No. 2000-NM-169-AD; Amendment 39-13860; AD 2004-23-05] </DEPDOC>
                <RIN>RIN 2120-AA64 </RIN>
                <SUBJECT>Airworthiness Directives; McDonnell Douglas Model DC-9-81 (MD-81), DC-9-82 (MD-82), DC-9-83 (MD-83), DC-9-87 (MD-87), and Model MD-88 Airplanes </SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Federal Aviation Administration, DOT. </P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Final rule. </P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>This amendment adopts a new airworthiness directive (AD), applicable to certain McDonnell Douglas airplanes, that requires reversing the ground stud installation of the main battery, and installing a new nameplate on the cover of the battery. This action is necessary to prevent damage to equipment or possible fire in the electrical/electronics equipment compartment due to electrical arcing between the ground stud of the main battery and adjacent structure. This action is intended to address the identified unsafe condition. </P>
                </SUM>
                <EFFDATE>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Effective December 20, 2004. </P>
                    <P>The incorporation by reference of a certain publication listed in the regulations is approved by the Director of the Federal Register as of December 20, 2004. </P>
                </EFFDATE>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        The service information referenced in this AD may be obtained from Boeing Commercial Airplanes, Long Beach Division, 3855 Lakewood Boulevard, Long Beach, California 90846, Attention: Data and Service Management, Dept. C1-L5A (D800-0024). This information may be examined at the Federal Aviation Administration (FAA), Transport Airplane Directorate, Rules Docket, 1601 Lind Avenue, SW., Renton, Washington; or at the FAA, Los Angeles Aircraft Certification Office, 3960 Paramount Boulevard, Lakewood, California; or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call (202) 741-6030, or go to: 
                        <E T="03">http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.</E>
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>Elvin Wheeler, Aerospace Engineer, Systems and Equipment Branch, ANM-130L, FAA, Los Angeles Aircraft Certification Office, 3960 Paramount Boulevard, Lakewood, California 90712-4137; telephone (562) 627-5344; fax (562) 627-5210.</P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>
                    A proposal to amend part 39 of the Federal Aviation Regulations (14 CFR part 39) to include an airworthiness directive (AD) that is applicable to certain McDonnell Douglas airplanes was published in the 
                    <E T="04">Federal Register</E>
                     on June 18, 2003 (68 FR 36518). That action proposed to require reversing the ground stud installation of the main battery, and installing a new nameplate on the cover of the battery. 
                </P>
                <HD SOURCE="HD1">Comments </HD>
                <P>Interested persons have been afforded an opportunity to participate in the making of this amendment. Due consideration has been given to the comments received. </P>
                <HD SOURCE="HD1">Support for Proposed AD </HD>
                <P>One commenter supports the proposed AD. </P>
                <HD SOURCE="HD1">Request To Allow Equivalent Nameplates </HD>
                <P>
                    One commenter requests that we allow operators to use equivalent nameplates in lieu of the original equipment manufacturer (OEM) nameplates. The commenter states that, in an effort to reduce costs, many operators manufacture equivalent nameplates with identical information, which they install at the location(s) specified in the applicable service bulletin(s) referenced in the proposed AD. 
                    <PRTPAGE P="65532"/>
                </P>
                <P>We acknowledge the operator's desire to minimize cost; however, we do not consider it appropriate to include various provisions in an AD to accommodate individual operators' unique methods for complying with the AD. However, according to paragraph (c) of this AD, operators may request to use a unique nameplate as an alternative method of compliance. We have not changed this final rule regarding this issue. </P>
                <HD SOURCE="HD1">Request To Revise the Cost Impact Figures </HD>
                <P>The same commenter states that, while the proposed AD specifies two work hours for the proposed actions, the referenced service bulletin specifies three work hours for those actions. The commenter asserts that the figure specified in the referenced service bulletin more accurately reflects the time necessary to accomplish those actions. </P>
                <P>From this comment, we infer that the commenter is requesting that we revise the Cost Impact section of the proposed AD. We do not agree. As stated in the preamble of the proposed AD, the cost impact figures discussed in AD rulemaking actions represent only the time necessary to perform the specific actions actually required by the AD. Those figures typically do not include incidental costs, such as the time required to gain access and close up, planning time, or time necessitated by other administrative actions. The work-hour figure listed in the referenced service bulletin includes time for access and close up. However, as we explain below, we have revised the labor rate used in the proposed AD. </P>
                <HD SOURCE="HD1">Conclusion </HD>
                <P>After careful review of the available data, including the comments noted above, the FAA has determined that air safety and the public interest require the adoption of the rule with the change previously described. The FAA has determined that this change will neither increase the economic burden on any operator nor increase the scope of the AD. </P>
                <HD SOURCE="HD1">Labor Rate Increase </HD>
                <P>After the proposed AD was issued, we reviewed the figures we have used over the past several years to calculate AD costs to operators. To account for various inflationary costs in the airline industry, we find it necessary to increase the labor rate used in these calculations from $60 per work hour to $65 per work hour. The cost impact information, below, reflects this increase in the specified hourly labor rate. </P>
                <HD SOURCE="HD1">Cost Impact </HD>
                <P>There are approximately 1,224 Model DC-9-81 (MD-81), DC-9-82 (MD-82), DC-9-83 (MD-83), DC-9-87 (MD-87), and Model MD-88 airplanes of the affected design in the worldwide fleet. The FAA estimates that 600 airplanes of U.S. registry will be affected by this AD, that it will take approximately 2 work hours per airplane to accomplish the required actions, and that the average labor rate is $65 per work hour. Required parts will cost approximately $38 per airplane. Based on these figures, the cost impact of the AD on U.S. operators is estimated to be $100,800, or $168 per airplane. </P>
                <P>The cost impact figure discussed above is based on assumptions that no operator has yet accomplished any of the requirements of this AD action, and that no operator would accomplish those actions in the future if this AD were not adopted. The cost impact figures discussed in AD rulemaking actions represent only the time necessary to perform the specific actions actually required by the AD. These figures typically do not include incidental costs, such as the time required to gain access and close up, planning time, or time necessitated by other administrative actions. The manufacturer may cover the cost of parts associated with this proposed AD, subject to warranty conditions. Manufacturer warranty remedies also may be available for labor costs associated with this proposed AD. As a result, the costs attributable to the proposed AD may be less than stated above. </P>
                <HD SOURCE="HD1">Regulatory Impact</HD>
                <P>The regulations adopted herein will not have a substantial direct effect on the States, on the relationship between the national Government and the States, or on the distribution of power and responsibilities among the various levels of government. Therefore, it is determined that this final rule does not have federalism implications under Executive Order 13132.</P>
                <P>
                    For the reasons discussed above, I certify that this action (1) is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979); and (3) will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act. A final evaluation has been prepared for this action and it is contained in the Rules Docket. A copy of it may be obtained from the Rules Docket at the location provided under the caption 
                    <E T="02">ADDRESSES</E>
                    .
                </P>
                <LSTSUB>
                    <HD SOURCE="HED">List of Subjects in 14 CFR Part 39</HD>
                    <P>Air transportation, Aircraft, Aviation safety, Incorporation by reference, Safety.</P>
                </LSTSUB>
                <HD SOURCE="HD1">Adoption of the Amendment </HD>
                <REGTEXT TITLE="14" PART="39">
                    <AMDPAR>Accordingly, pursuant to the authority delegated to me by the Administrator, the Federal Aviation Administration amends part 39 of the Federal Aviation Regulations (14 CFR part 39) as follows:</AMDPAR>
                    <PART>
                        <HD SOURCE="HED">PART 39—AIRWORTHINESS DIRECTIVES</HD>
                    </PART>
                    <AMDPAR>1. The authority citation for part 39 continues to read as follows:</AMDPAR>
                    <AUTH>
                        <HD SOURCE="HED">Authority:</HD>
                        <P>49 U.S.C. 106(g), 40113, 44701.</P>
                    </AUTH>
                    <SECTION>
                        <SECTNO>§ 39.13 </SECTNO>
                        <SUBJECT>[Amended]</SUBJECT>
                    </SECTION>
                </REGTEXT>
                <REGTEXT TITLE="14" PART="39">
                    <AMDPAR>2. Section 39.13 is amended by adding the following new airworthiness directive: </AMDPAR>
                    <EXTRACT>
                        <FP SOURCE="FP-2">
                            <E T="04">2004-23-05 McDonnell Douglas:</E>
                             Amendment 39-13860. Docket 2000-NM-169-AD.
                        </FP>
                        <P>
                            <E T="03">Applicability:</E>
                             Model DC-9-81 (MD-81), DC-9-82 (MD-82), DC-9-83 (MD-83), DC-9-87 (MD-87), and Model MD-88 airplanes, as listed in McDonnell Douglas Alert Service Bulletin MD80-24A159, Revision 01, dated January 24, 2000; certificated in any category.
                        </P>
                        <P>
                            <E T="03">Compliance:</E>
                             Required as indicated, unless accomplished previously.
                        </P>
                        <P>To prevent damage to equipment or possible fire in the electrical/electronics equipment compartment due to electrical arcing between the ground stud of the main battery and adjacent structure; accomplish the following:</P>
                        <HD SOURCE="HD1">Required Actions</HD>
                        <P>(a) Within 1 year after the effective date of this AD, reverse the installation of the ground stud for the main battery and install a new nameplate on the cover of the battery; in accordance with McDonnell Douglas Alert Service Bulletin MD80-24A159, Revision 01, dated January 24, 2000.</P>
                        <HD SOURCE="HD1">Credit for Previously Accomplished Actions</HD>
                        <P>(b) Accomplishment of the actions specified in paragraph (a) of this AD before the effective date of this AD, in accordance with McDonnell Douglas Service Bulletin MD80-24A159, dated March 15, 1996, is considered to be an acceptable method of compliance with paragraph (a) of this AD.</P>
                        <HD SOURCE="HD1">Alternative Methods of Compliance</HD>
                        <P>
                            (c) In accordance with 14 CFR 39.19, the Manager, Los Angeles Aircraft Certification Office, FAA, is authorized to approve alternative methods of compliance for this AD.
                            <PRTPAGE P="65533"/>
                        </P>
                        <HD SOURCE="HD1">Incorporation by Reference</HD>
                        <P>
                            (d) The actions shall be done in accordance with McDonnell Douglas Alert Service Bulletin MD80-24A159, Revision 01, dated January 24, 2000. This incorporation by reference was approved by the Director of the Federal Register in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies may be obtained from Boeing Commercial Airplanes, Long Beach Division, 3855 Lakewood Boulevard, Long Beach, California 90846, Attention: Data and Service Management, Dept. C1-L5A (D800-0024). Copies may be inspected at the FAA, Transport Airplane Directorate, 1601 Lind Avenue, SW., Renton, Washington; or at the FAA, Los Angeles Aircraft Certification Office, 3960 Paramount Boulevard, Lakewood, California; or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call (202) 741-6030, or go to: 
                            <E T="03">http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.</E>
                        </P>
                        <HD SOURCE="HD1">Effective Date</HD>
                        <P>(e) This amendment becomes effective on December 20, 2004.</P>
                    </EXTRACT>
                </REGTEXT>
                <SIG>
                    <DATED>Issued in Renton, Washington, on November 1, 2004.</DATED>
                    <NAME>Ali Bahrami,</NAME>
                    <TITLE>Manager, Transport Airplane Directorate, Aircraft Certification Service.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 04-24932 Filed 11-12-04; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4910-13-P</BILCOD>
        </RULE>
        <RULE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF TRANSPORTATION </AGENCY>
                <SUBAGY>Federal Aviation Administration </SUBAGY>
                <CFR>14 CFR Part 39 </CFR>
                <DEPDOC>[Docket No. 2002-NM-324-AD; Amendment 39-13862; AD 2004-23-07] </DEPDOC>
                <RIN>RIN 2120-AA64 </RIN>
                <SUBJECT>Airworthiness Directives; Boeing Model 737-100, -200, -300, -400, and -500 Series Airplanes </SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Federal Aviation Administration, DOT. </P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Final rule. </P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>This amendment supersedes an existing airworthiness directive (AD), applicable to certain Boeing Model 737 series airplanes, that currently requires modification of certain fuselage support structure for the number 2 galley. This amendment requires modification of the same support structure using new methods based on new calculations. This amendment also expands the applicability of the existing AD to include additional airplanes. The actions specified by this AD are intended to prevent the galley from shifting, which could limit access to the galley door during emergencies, and result in injury to passengers and flightcrew. This action is intended to address the identified unsafe condition. </P>
                </SUM>
                <EFFDATE>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Effective December 20, 2004. </P>
                    <P>The incorporation by reference of certain publications listed in the regulations is approved by the Director of the Federal Register as of December 20, 2004. </P>
                </EFFDATE>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        The service information referenced in this AD may be obtained from Boeing Commercial Airplanes, P.O. Box 3707, Seattle, Washington 98124-2207. This information may be examined at the Federal Aviation Administration (FAA), Transport Airplane Directorate, Rules Docket, 1601 Lind Avenue, SW., Renton, Washington; or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call (202) 741-6030, or go to: 
                        <E T="03">http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html</E>
                        . 
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>Keith Ladderud, Aerospace Engineer, ANM-150S, FAA, Seattle Aircraft Certification Office, 1601 Lind Avenue, SW., Renton, Washington 98055-4056; telephone (425) 917-6435; fax (425) 917-6590. </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>
                    A proposal to amend part 39 of the Federal Aviation Regulations (14 CFR part 39) by superseding AD 95-02-08, amendment 39-9127 (60 FR 8295, February 14, 1995), which is applicable to certain Boeing Model 737 series airplanes, was published in the 
                    <E T="04">Federal Register</E>
                     on May 7, 2004 (69 FR 25505). The action proposed to require modification of certain fuselage support structure for the number 2 galley. The action also proposed to expand the applicability of the existing AD to include additional airplanes. 
                </P>
                <HD SOURCE="HD1">Comments </HD>
                <P>Interested persons have been afforded an opportunity to participate in the making of this amendment. Due consideration has been given to the comments received. </P>
                <HD SOURCE="HD1">Requests To Add an Option To Reduce the Weight Limit of the Galley as an Alternative to the Modification </HD>
                <P>One commenter states that the wording in the proposed AD and the referenced service bulletin is such that, if the allowable operating weight limit of a given airplane's galley is above a certain threshold value, the proposed modification would be required. The commenter suggests that the proposed AD specify that if a galley has a weight limit above the threshold value, the operator be given the option of reducing the weight limit to the threshold value and re-placarding the galley with the new limit, instead of modifying the airplane. </P>
                <P>Another commenter proposes an option be included for operators to reduce the total weight limit of the galley, as opposed to doing the structural modification. The commenter adds that, for all airplanes other than Group 1, the proposed AD forces the operator to use Table A in the referenced service bulletin to determine the structural configuration of the airplane. Based on that configuration, and the allowable galley weight limit, the operator will do the applicable corrective action. The commenter proposes that the FAA specify a weight limit for all airplane groups which is similar to the Group 1 airplanes listed in the proposed AD. The commenter notes that, by doing this, the operator will have the option of either doing the modification and maintaining the current galley weight limit, or reducing the galley weight limit and avoiding the expensive modification. </P>
                <P>We agree. We have added a new paragraph (d) to this AD that allows reducing the galley weight limit to 995 pounds or less as an alternative to doing the required modification. The reduction in the galley weight limit will require re-placarding to specify the maximum capacity limit of 995 pounds for the galley. If necessary, re-placarding is required to specify the load limit for individual compartments, to ensure that the total of the individual compartment weights does not exceed the maximum capacity for the galley. </P>
                <HD SOURCE="HD1">Request To Change Applicability </HD>
                <P>
                    One commenter states that the applicability section in the proposed AD specifies “as listed in Boeing Special Attention Service Bulletin 737-53-1154, Revision 1, dated October 3, 2002,” and paragraph (b) of the proposed AD requires doing the proposed modification within 18 months, per the referenced service bulletin. The commenter adds that the first step specified in the service bulletin is to determine the maximum operating weight of the number 2 galley; the proposed modification is only necessary on airplanes with that galley, and that have an allowable operating weight of more than 995 pounds. The commenter suggests adding further description to the applicability section of the proposed AD to avoid unnecessary research and inspection. The commenter also adds that the applicability specified in AD 95-02-08 includes a description of the galley 
                    <PRTPAGE P="65534"/>
                    weight requirements which is similar to the requirements in this proposed AD. 
                </P>
                <P>We agree that the applicability section in this AD could be further clarified. We have changed that section to specify that the proposed AD is applicable to airplanes equipped with intercostal support structures at stringer 5R and having a number 2 galley weight that exceeds 995 pounds (including any attached equipment that imposes loads on the galley). </P>
                <HD SOURCE="HD1">Request for Changes to Paragraph (c) </HD>
                <P>One commenter states that it would be helpful if the airplanes referenced in paragraph (c) of the proposed AD are identified. The commenter adds that there will be airplanes that are different from the specified configuration and those airplanes can be addressed in the alternative methods of compliance process. </P>
                <P>We do not agree. We have determined that the service bulletin clearly identifies the specific group associated with each airplane in this AD. Identifying each airplane that has been modified, as noted in paragraph (c)(2) of this AD, would not relieve any burden on operators because we would still rely on operators to determine if the airplane was modified per the original issue of the referenced service bulletin. No change to the AD is made in this regard. </P>
                <P>The same commenter asks that paragraph (c) be changed from “* * * do the modification in paragraph (b) of this AD * * *” to “* * * modify the upper attachment support structure of galley 2 from body station 344 to 360 (inclusive) between right stringers 3 and 7.” The commenter states that this change would prevent confusion. </P>
                <P>We agree; we have changed paragraph (c) of this AD, as specified above, for clarification. </P>
                <HD SOURCE="HD1">Conclusion </HD>
                <P>After careful review of the available data, including the comments noted above, we have determined that air safety and the public interest require the adoption of the rule with the changes previously described. These changes will neither increase the economic burden on any operator nor increase the scope of the AD. </P>
                <HD SOURCE="HD1">Cost Impact </HD>
                <P>There are approximately 583 airplanes of the affected design in the worldwide fleet. We estimate that 170 airplanes of U.S. registry will be affected by this AD. </P>
                <P>The new actions that are required by this AD will take between 8 and 22 work hours per airplane to accomplish, depending on the airplane's configuration. The average labor rate is $65 per work hour. Required parts will cost between $5,200 and $23,790 per airplane, depending on the airplane's configuration. Based on these figures, the cost impact of the requirements of this AD on U.S. operators is estimated to be between $5,720 and $25,220 per airplane. </P>
                <P>The cost impact figures discussed above are based on assumptions that no operator has yet accomplished any of the requirements of this AD action, and that no operator would accomplish those actions in the future if this AD were not adopted. The cost impact figures discussed in AD rulemaking actions represent only the time necessary to perform the specific actions actually required by the AD. These figures typically do not include incidental costs, such as the time required to gain access and close up, planning time, or time necessitated by other administrative actions. </P>
                <HD SOURCE="HD1">Regulatory Impact </HD>
                <P>The regulations adopted herein will not have a substantial direct effect on the States, on the relationship between the national Government and the States, or on the distribution of power and responsibilities among the various levels of government. Therefore, it is determined that this final rule does not have federalism implications under Executive Order 13132. </P>
                <P>
                    For the reasons discussed above, I certify that this action (1) is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979); and (3) will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act. A final evaluation has been prepared for this action and it is contained in the Rules Docket. A copy of it may be obtained from the Rules Docket at the location provided under the caption 
                    <E T="02">ADDRESSES.</E>
                </P>
                <LSTSUB>
                    <HD SOURCE="HED">List of Subjects in 14 CFR Part 39 </HD>
                    <P>Air transportation, Aircraft, Aviation safety, Incorporation by reference, Safety.</P>
                </LSTSUB>
                <REGTEXT TITLE="14" PART="39">
                    <HD SOURCE="HD1">Adoption of the Amendment </HD>
                    <AMDPAR>Accordingly, pursuant to the authority delegated to me by the Administrator, the Federal Aviation Administration amends part 39 of the Federal Aviation Regulations (14 CFR part 39) as follows: </AMDPAR>
                    <PART>
                        <HD SOURCE="HED">PART 39—AIRWORTHINESS DIRECTIVES </HD>
                    </PART>
                    <AMDPAR>1. The authority citation for part 39 continues to read as follows: </AMDPAR>
                    <AUTH>
                        <HD SOURCE="HED">Authority:</HD>
                        <P>49 U.S.C. 106(g), 40113, 44701. </P>
                    </AUTH>
                </REGTEXT>
                <REGTEXT TITLE="14" PART="39">
                    <SECTION>
                        <SECTNO>§ 39.13 </SECTNO>
                        <SUBJECT>[Amended] </SUBJECT>
                    </SECTION>
                    <AMDPAR>2. Section 39.13 is amended by removing amendment 39-9127 (60 FR 8295, February 14, 1995), and by adding a new airworthiness directive (AD), amendment 39-13862, to read as follows: </AMDPAR>
                    <EXTRACT>
                        <FP SOURCE="FP-2">
                            <E T="04">2004-23-07 Boeing:</E>
                             Amendment 39-13862. Docket 2002-NM-324-AD. Supersedes AD 95-02-08, Amendment 39-9127.
                        </FP>
                        <P>
                            <E T="03">Applicability:</E>
                             Model 737-100, -200, -300, -400, and -500 series airplanes; certificated in any category; equipped with intercostal support structures at stringer 5R and having a number 2 galley weight of 996 pounds or more (including any attached equipment that imposes loads on the galley). 
                        </P>
                        <P>
                            <E T="03">Compliance:</E>
                             Required as indicated, unless accomplished previously. 
                        </P>
                        <P>To prevent the galley from shifting, which could limit access to the galley door during emergencies, and result in injury to passengers and flightcrew, accomplish the following: </P>
                        <HD SOURCE="HD1">Service Bulletin Reference </HD>
                        <P>(a) The term “service bulletin,” as used in this AD, means the Accomplishment Instructions of Boeing Special Attention Service Bulletin 737-53-1154, Revision 1, dated October 3, 2002. </P>
                        <HD SOURCE="HD1">Modification </HD>
                        <P>(b) Except as provided by paragraph (c) or (d) of this AD, as applicable: Within 18 months after the effective date of this AD, modify the upper attachment support structure of galley 2 from body station 344 to 360 inclusive, between right stringers 3 and 7, in accordance with the service bulletin. </P>
                        <P>(c) For airplanes listed in paragraphs (c)(1) through (c)(3) of this AD: Within 18 months after the effective date of this AD, modify the upper attachment support structure of galley 2 from body station 344 to 360 inclusive, between right stringers 3 and 7. Do the modification in accordance with a method approved by the Manager, Seattle Aircraft Certification Office (ACO), FAA; or in accordance with data meeting the type certification basis of the airplane approved by a Boeing Company Designated Engineering Representative (DER) who has been authorized by the Manager, Seattle ACO, to make such findings. For a modification method to be approved, the approval must specifically reference this AD. </P>
                        <P>(1) Airplanes listed as Group 1 in the service bulletin, on which the galley has an allowable operating weight of 996 pounds or more. </P>
                        <P>(2) Airplanes listed as Group 2 in the service bulletin, on which the modifications specified in the initial release of the service bulletin have been incorporated. </P>
                        <P>
                            (3) Airplanes listed as Groups 3 through 9 in the service bulletin for which the service bulletin specifies to contact Boeing. 
                            <PRTPAGE P="65535"/>
                        </P>
                        <HD SOURCE="HD1">Alternative to Accomplishing Modification </HD>
                        <P>(d) Instead of accomplishing the modification required by paragraph (b) or (c) of this AD, as applicable: Within 18 months after the effective date of this AD, do the actions specified in paragraphs (d)(1), (d)(2), and (d)(3) of this AD, in accordance with a method approved by the Manager, Seattle ACO; or in accordance with data meeting the type certification basis of the airplane approved by a Boeing Company DER who has been authorized by the Manager, Seattle ACO, to make such findings. </P>
                        <P>(1) Reduce the total weight limit of the galley to a maximum capacity of 995 pounds or less. </P>
                        <P>(2) Re-placard to specify the maximum capacity limit for the galley. </P>
                        <P>(3) Re-placard to specify the load limit for individual compartments, as necessary, to ensure that the total of the individual compartment weights does not exceed the maximum capacity for the galley. </P>
                        <HD SOURCE="HD1">Alternative Methods of Compliance </HD>
                        <P>(e) In accordance with 14 CFR 39.19, the Manager, Seattle ACO, is authorized to approve alternative methods of compliance (AMOCs) for this AD. </P>
                        <HD SOURCE="HD1">Incorporation by Reference </HD>
                        <P>
                            (f) Unless otherwise specified in this AD, the actions shall be done in accordance with Boeing Special Attention Service Bulletin 737-53-1154, Revision 1, dated October 3, 2002. This incorporation by reference was approved by the Director of the Federal Register in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies may be obtained from Boeing Commercial Airplanes, P.O. Box 3707, Seattle, Washington 98124-2207. Copies may be inspected at the FAA, Transport Airplane Directorate, 1601 Lind Avenue, SW., Renton, Washington; or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call (202) 741-6030, or go to: 
                            <E T="03">http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html</E>
                            . 
                        </P>
                        <HD SOURCE="HD1">Effective Date </HD>
                        <P>(g) This amendment becomes effective on December 20, 2004. </P>
                    </EXTRACT>
                </REGTEXT>
                <SIG>
                    <DATED>Issued in Renton, Washington, on November 1, 2004. </DATED>
                    <NAME>Ali Bahrami, </NAME>
                    <TITLE>Manager, Transport Airplane Directorate, Aircraft Certification Service. </TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 04-24931 Filed 11-12-04; 8:45 am] </FRDOC>
            <BILCOD>BILLING CODE 4910-13-P </BILCOD>
        </RULE>
        <RULE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF TRANSPORTATION </AGENCY>
                <SUBAGY>Federal Aviation Administration </SUBAGY>
                <CFR>14 CFR Part 39 </CFR>
                <DEPDOC>[Docket No. 2002-NM-346-AD; Amendment 39-13864; AD 2004-23-09] </DEPDOC>
                <RIN>RIN 2120-AA64 </RIN>
                <SUBJECT>Airworthiness Directives; Empresa Brasileira de Aeronautica S.A. (EMBRAER) Model EMB-135 and -145 Series Airplanes </SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Federal Aviation Administration, DOT. </P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Final rule. </P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>This amendment supersedes an existing airworthiness directive (AD), applicable to certain EMBRAER Model EMB-135 and -145 series airplanes, that currently requires determining whether a defective auxiliary power unit (APU) exhaust silencer is installed on the airplane; and corrective actions if necessary. For certain airplanes, this amendment requires modification of the APU exhaust silencer, and reidentification of the part number for the APU exhaust silencer once the modification is accomplished. For certain other airplanes, this amendment requires repetitive inspections to determine the structural integrity of the APU exhaust silencer; corrective actions, if necessary; eventual modification of the APU exhaust silencer, which terminates the repetitive inspections; and reidentification of the part number for the APU exhaust silencer once the modification is accomplished. This amendment also adds airplanes to the applicability of the existing AD. The actions specified by this AD are intended to prevent separation of the aft baffle assembly from the APU exhaust silencer and consequent separation of the assembly from the airplane, which could cause damage to other airplanes during takeoff and landing operations, or injury to people on the ground. This action is intended to address the identified unsafe condition. </P>
                </SUM>
                <EFFDATE>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Effective December 20, 2004. </P>
                    <P>The incorporation by reference of certain publications listed in the regulations is approved by the Director of the Federal Register as of December 20, 2004. </P>
                </EFFDATE>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        The service information referenced in this AD may be obtained from Empresa Brasileira de Aeronautica S.A. (EMBRAER), P.O. Box 343—CEP 12.225, Sao Jose dos Campos—SP, Brazil. This information may be examined at the Federal Aviation Administration (FAA), Transport Airplane Directorate, Rules Docket, 1601 Lind Avenue, SW., Renton, Washington; or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call (202) 741-6030, or go to: 
                        <E T="03">http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html</E>
                        . 
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>Todd Thompson, Aerospace Engineer, International Branch, ANM-116, FAA, Transport Airplane Directorate, 1601 Lind Avenue, SW., Renton, Washington 98055-4056; telephone (425) 227-1175; fax (425) 227-1149. </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>
                    A proposal to amend part 39 of the Federal Aviation Regulations (14 CFR part 39) by superseding AD 2002-16-06, amendment 39-12845 (67 FR 52398, August 12, 2002), which is applicable to certain EMBRAER Model EMB-135 and -145 series airplanes, was published in the 
                    <E T="04">Federal Register</E>
                     on April 6, 2004 (69 FR 17993). For certain airplanes, the action proposed to require modification of the APU exhaust silencer, and reidentification of the part number for the APU exhaust silencer once the modification is accomplished. For certain other airplanes, the action proposed to require repetitive inspections to determine the structural integrity of the APU exhaust silencer; corrective actions, if necessary; eventual modification of the APU exhaust silencer, which terminates the repetitive inspections; and reidentification of the part number for the APU exhaust silencer once the modification is accomplished. That action also proposed to add airplanes to the applicability of the existing AD. 
                </P>
                <HD SOURCE="HD1">Comments </HD>
                <P>Interested persons have been afforded an opportunity to participate in the making of this amendment. Due consideration has been given to the comments received. </P>
                <HD SOURCE="HD1">Request To Accomplish Terminating Action Without First Doing the Inspections </HD>
                <P>
                    The commenter, an operator, requests that the proposed AD be revised to allow operators to “bypass” the inspections in Part I of the Accomplishment Instructions of EMBRAER Service Bulletin 145-49-0021, Change 03, dated September 12, 2003, and do just the modification in Part II of the Accomplishment Instructions of that service bulletin. The modification is the terminating action 
                    <PRTPAGE P="65536"/>
                    for the repetitive inspections in the proposed AD. 
                </P>
                <P>We agree with the commenter's request to allow operators to do just the modification in Part II of the Accomplishment Instructions of EMBRAER Service Bulletin 145-49-0021, Change 03, instead of first doing the inspections in Part I of the Accomplishment Instructions. The purpose of this AD is to require operators to modify the auxiliary power unit (APU) exhaust silencer. The inspections specified in paragraphs (c) and (d) of the proposed AD are relieving actions that allow airplanes that do not have defective APU exhaust silencers to continue operating for a specified period of time before operators perform the terminating modification. The inspections are the means of determining whether an APU exhaust silencer is defective. We have revised paragraphs (c) and (d) of this AD to specify that operators that have done the terminating modification required by paragraph (e) of this AD do not have to do the inspections required by paragraphs (c) and (d). </P>
                <HD SOURCE="HD1">Request for Credit for Accomplishment of Previous Revisions of Service Information </HD>
                <P>The commenter requests that the proposed AD be revised to give credit for actions accomplished previously per the original issue of EMBRAER Service Bulletin 145-49-0021, dated July 11, 2002; or per Change 01 of that service bulletin, dated July 31, 2002. </P>
                <P>We agree with the commenter's request. We have determined that the Accomplishment Instructions are essentially the same in the original issue, Change 01, Change 02, and Change 03, of Service Bulletin 145-49-0021. The primary difference between the change levels is the effectivity of the airplanes. We have revised paragraph (g) of this final rule to include the original issue and Change 01 of Service Bulletin 145-49-0021 as additional appropriate sources of service information. </P>
                <HD SOURCE="HD1">Conclusion </HD>
                <P>After careful review of the available data, including the comments noted above, we have determined that air safety and the public interest require the adoption of the rule with the changes previously described. We have determined that these changes will neither increase the economic burden on any operator nor increase the scope of the AD. </P>
                <HD SOURCE="HD1">Cost Impact </HD>
                <P>There are approximately 394 airplanes of U.S. registry that will be affected by this AD. </P>
                <P>The repetitive inspections specified in Part I of EMBRAER Service Bulletin 145-49-0021, Change 03, dated September 12, 2003; and EMBRAER Service Bulletin 145LEG-49-0001, Change 01, dated August 29, 2002; that are required by this AD will take approximately 1 work hour per airplane to accomplish, at an average labor rate of $65 per work hour. Based on these figures, the cost impact of the repetitive inspections on U.S. operators is estimated to be $65 per airplane, per inspection cycle. </P>
                <P>The modification, including the part number reidentification, specified in Part I of EMBRAER Service Bulletin 145-49-0021, Change 03; and EMBRAER Service Bulletin 145LEG-49-0001, Change 01; will take approximately 4 work hours per airplane to accomplish, at an average labor rate of $65 per work hour. Required parts will be supplied by the part manufacturer at no cost to operators. Based on these figures, the cost impact of the modification is estimated to be $102,440, or $260 per airplane. </P>
                <P>The modification, including the part number reidentification, specified in Part II of EMBRAER Service Bulletin 145-49-0021, Change 03, will take approximately 1 work hour per airplane to accomplish, at an average labor rate of $65 per work hour. Based on these figures, the cost impact of the modification is estimated to be $65 per airplane. </P>
                <P>The cost impact figures discussed above are based on assumptions that no operator has yet accomplished any of the requirements of this AD action, and that no operator would accomplish those actions in the future if this AD were not adopted. The cost impact figures discussed in AD rulemaking actions represent only the time necessary to perform the specific actions actually required by the AD. These figures typically do not include incidental costs, such as the time required to gain access and close up, planning time, or time necessitated by other administrative actions. </P>
                <HD SOURCE="HD1">Regulatory Impact </HD>
                <P>The regulations adopted herein will not have a substantial direct effect on the States, on the relationship between the national Government and the States, or on the distribution of power and responsibilities among the various levels of government. Therefore, it is determined that this final rule does not have federalism implications under Executive Order 13132. </P>
                <P>
                    For the reasons discussed above, I certify that this action (1) is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979); and (3) will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act. A final evaluation has been prepared for this action and it is contained in the Rules Docket. A copy of it may be obtained from the Rules Docket at the location provided under the caption 
                    <E T="02">ADDRESSES.</E>
                </P>
                <LSTSUB>
                    <HD SOURCE="HED">List of Subjects in 14 CFR Part 39 </HD>
                    <P>Air transportation, Aircraft, Aviation safety, Incorporation by reference, Safety.</P>
                </LSTSUB>
                <HD SOURCE="HD1">Adoption of the Amendment </HD>
                <REGTEXT TITLE="14" PART="39">
                    <AMDPAR>Accordingly, pursuant to the authority delegated to me by the Administrator, the Federal Aviation Administration amends part 39 of the Federal Aviation Regulations (14 CFR part 39) as follows: </AMDPAR>
                    <PART>
                        <HD SOURCE="HED">PART 39—AIRWORTHINESS DIRECTIVES </HD>
                    </PART>
                    <AMDPAR>1. The authority citation for part 39 continues to read as follows: </AMDPAR>
                    <AUTH>
                        <HD SOURCE="HED">Authority:</HD>
                        <P>49 U.S.C. 106(g), 40113, 44701. </P>
                    </AUTH>
                </REGTEXT>
                <REGTEXT TITLE="14" PART="39">
                    <SECTION>
                        <SECTNO>§ 39.13 </SECTNO>
                        <SUBJECT>[Amended] </SUBJECT>
                    </SECTION>
                    <AMDPAR>2. Section 39.13 is amended by removing amendment 39-12845 (67 FR 52398, August 12, 2002), and by adding a new airworthiness directive (AD), amendment 39-13864, to read as follows: </AMDPAR>
                    <EXTRACT>
                        <FP SOURCE="FP-2">
                            <E T="04">2004-23-09 Empresa Brasileira De Aeronautica S.A. (EMBRAER):</E>
                             Amendment 39-13864. Docket 2002-NM-346-AD. Supersedes AD 2002-16-06, amendment 39-12845. 
                        </FP>
                        <P>
                            <E T="03">Applicability:</E>
                             Model EMB-135BJ series airplanes, as listed in EMBRAER Service Bulletin 145LEG-49-0001, Change 01, dated August 29, 2002; and Model EMB-135 and -145 series airplanes, as listed in EMBRAER Service Bulletin 145-49-0021, Change 03, dated September 12, 2003; certificated in any category. 
                        </P>
                        <P>
                            <E T="03">Compliance:</E>
                             Required as indicated, unless accomplished previously. 
                        </P>
                        <P>
                            To prevent separation of the aft baffle assembly from the APU exhaust silencer and consequent separation of the assembly from the airplane, which could cause damage to other airplanes during takeoff and landing operations, or injury to people on the ground, accomplish the following: 
                            <PRTPAGE P="65537"/>
                        </P>
                        <HD SOURCE="HD1">Modification </HD>
                        <P>(a) For airplanes that have incorporated EMBRAER Alert Service Bulletin 145-49-A021, Change 01, dated May 13, 2002: Within 1,500 flight hours after the effective date of this AD, install a spacer and bolts (including torquing the bolts) in the APU exhaust silencer assembly per the Accomplishment Instructions of EMBRAER Service Bulletin 145LEG-49-0001, Change 01, dated August 29, 2002, (for Model EMB-135BJ series airplanes); or Part II of the Accomplishment Instructions of EMBRAER Service Bulletin 145-49-0021, Change 03, dated September 12, 2003, (for Model EMB-135 and -145 series airplanes); as applicable. </P>
                        <HD SOURCE="HD1">Reidentification of Modified Part </HD>
                        <P>(b) For airplanes that have incorporated EMBRAER Alert Service Bulletin 145-49-A021, Change 01, dated May 13, 2002: After accomplishment of the modification required by paragraph (a) of this AD, before further flight, change the part number of the modified APU exhaust silencer assembly from 4503801B to 4503801C per the Accomplishment Instructions of EMBRAER Service Bulletin 145LEG-49-0001, Change 01, dated August 29, 2002; or Part II of the Accomplishment Instructions of EMBRAER Service Bulletin 145-49-0021, Change 03, dated September 12, 2003; as applicable. </P>
                        <HD SOURCE="HD1">Inspections </HD>
                        <P>(c) For airplanes that have not incorporated EMBRAER Alert Service Bulletin 145-49-A021, Change 01, dated May 13, 2002; or that have not accomplished the modification required by paragraph (e) of this AD: Within 500 flight hours or 3 months after the effective date of this AD, whichever is first, do a one-time general visual inspection of the APU exhaust silencer to determine if the aft baffle is flush with the end of the cylindrical portion, and an inspection of the movement of the cylindrical portion of the APU exhaust silencer shell assembly, per the Accomplishment Instructions of EMBRAER Service Bulletin 145LEG-49-0001, Change 01, dated August 29, 2002; or Part I of the Accomplishment Instructions of EMBRAER Service Bulletin 145-49-0021, Change 03, dated September 12, 2003; as applicable. </P>
                        <P>(1) If the APU exhaust silencer assembly passes the inspections: Do the actions in paragraph (d) of this AD. </P>
                        <P>(2) If the APU exhaust silencer assembly does not pass one or both inspections: Before further flight, secure or remove the affected parts from the silencer, and placard the APU as “Inoperative” per the Accomplishment Instructions of the applicable service bulletin. No further action is required unless the APU is reactivated. To reactivate the APU: Before further flight, do the actions required by paragraph (e) of this AD. </P>
                        <NOTE>
                            <HD SOURCE="HED">Note 1:</HD>
                            <P>For the purposes of this AD, a general visual inspection is defined as: “A visual examination of an interior or exterior area, installation, or assembly to detect obvious damage, failure, or irregularity. This level of inspection is made from within touching distance unless otherwise specified. A mirror may be necessary to enhance visual access to all exposed surfaces in the inspection area. This level of inspection is made under normally available lighting conditions such as daylight, hangar lighting, flashlight, or droplight and may require removal or opening of access panels or doors. Stands, ladders, or platforms may be required to gain proximity to the area being checked.” </P>
                        </NOTE>
                        <HD SOURCE="HD1">Repetitive Inspections </HD>
                        <P>(d) For airplanes that have not incorporated EMBRAER Alert Service Bulletin 145-49-A021, Change 01, dated May 13, 2002; or that have not accomplished the modification required by paragraph (e) of this AD: After doing the inspections required by paragraph (c) of this AD, before further flight, do a mechanical integrity inspection of the APU exhaust silencer assembly per the Accomplishment Instructions of EMBRAER Service Bulletin 145LEG-49-0001, Change 01, dated August 29, 2002; or Part I of the Accomplishment Instructions of EMBRAER Service Bulletin 145-49-0021, Change 03, dated September 12, 2003; as applicable. </P>
                        <P>(1) If the APU exhaust silencer assembly passes the inspection required by paragraph (d) of this AD: Do the same steps for the mechanical integrity inspection required by paragraph (d) of this AD in a counter-clockwise direction, per the Accomplishment Instructions of the applicable service bulletin. Repeat the inspections required by paragraphs (d) and (d)(1) of this AD thereafter at intervals not to exceed 500 flight hours or 3 months, whichever is first. The inspections may be repeated up to two times before accomplishment of the requirements of paragraph (e) of this AD. </P>
                        <P>(2) If the APU exhaust silencer assembly does not pass the inspection required by paragraph (d) of this AD: Before further flight, disassemble the APU exhaust silencer assembly or placard the APU as “Inoperative” per the Accomplishment Instructions of the applicable service bulletin. No further action is required unless the APU is reactivated. To reactivate the APU: Before further flight, do the actions required by paragraph (e) of this AD. </P>
                        <HD SOURCE="HD1">Modification/Terminating Action </HD>
                        <P>(e) For airplanes that have not incorporated EMBRAER Alert Service Bulletin 145-49-A021, Change 01, dated May 13, 2002: Within 1,500 flight hours or 12 months after the effective date of this AD, whichever is first, except as provided by paragraphs (c)(2) and (d)(2) of this AD, do all of the applicable actions per the Accomplishment Instructions of EMBRAER Service Bulletin 145LEG-49-0001, Change 01, dated August 29, 2002; or Part I of the Accomplishment Instructions of EMBRAER Service Bulletin 145-49-0021, Change 03, dated September 12, 2003; as applicable. This constitutes terminating action for the repetitive inspections required by paragraph (d) of this AD. </P>
                        <HD SOURCE="HD1">Reidentification of Modified Part </HD>
                        <P>(f) For airplanes that have not incorporated EMBRAER Alert Service Bulletin 145-49-A021, Change 01, dated May 13, 2002: After accomplishment of the modification required by paragraph (e) of this AD, before further flight, change the part number of the modified APU exhaust silencer assembly from 4503801B to 4503801C per the Accomplishment Instructions of EMBRAER Service Bulletin 145LEG-49-0001, Change 01, dated August 29, 2002; or Part I of the Accomplishment Instructions of EMBRAER Service Bulletin 145-49-0021, Change 03, dated September 12, 2003; as applicable. </P>
                        <HD SOURCE="HD1">Actions Previously Accomplished </HD>
                        <P>(g) Accomplishment of the specified actions before the effective date of this AD per EMBRAER Service Bulletin 145-49-0021, dated July 11, 2002; Change 01, dated July 31, 2002; or Change 02, dated November 12, 2002; is considered acceptable for compliance with the applicable requirements of paragraphs (a), (b), (c), (d), (e), and (f) of this AD. </P>
                        <HD SOURCE="HD1">Parts Installation </HD>
                        <P>(h) As of the effective date of this AD, no person may install on any airplane an APU exhaust silencer having P/N 4503801B. </P>
                        <HD SOURCE="HD1">Alternative Methods of Compliance </HD>
                        <P>(i) In accordance with 14 CFR 39.19, the Manager, International Branch, ANM-116, FAA, Transport Airplane Directorate, is authorized to approve alternative methods of compliance for this AD. </P>
                        <HD SOURCE="HD1">Incorporation by Reference </HD>
                        <P>
                            (j) Unless otherwise specified in this AD, the actions must be done in accordance with EMBRAER Service Bulletin 145LEG-49-0001, Change 01, dated August 29, 2002; or EMBRAER Service Bulletin 145-49-0021, Change 03, dated September 12, 2003; as applicable. This incorporation by reference was approved by the Director of the Federal Register in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies may be obtained from Empresa Brasileira de Aeronautica S.A. (EMBRAER), P.O. Box 343—CEP 12.225, Sao Jose dos Campos—SP, Brazil. Copies may be inspected at the FAA, Transport Airplane Directorate, 1601 Lind Avenue, SW., Renton, Washington; or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call (202) 741-6030, or go to: 
                            <E T="03">http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.</E>
                        </P>
                        <NOTE>
                            <HD SOURCE="HED">Note 2:</HD>
                            <P>The subject of this AD is addressed in Brazilian airworthiness directive 2002-05-01R2, dated January 6, 2003. </P>
                        </NOTE>
                        <HD SOURCE="HD1">Effective Date </HD>
                        <P>(k) This amendment becomes effective on December 20, 2004. </P>
                    </EXTRACT>
                </REGTEXT>
                <SIG>
                    <DATED>Issued in Renton, Washington, on November 1, 2004. </DATED>
                    <NAME>Kalene C. Yanamura, </NAME>
                    <TITLE>Acting Manager, Transport Airplane Directorate, Aircraft Certification Service. </TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 04-24935 Filed 11-12-04; 8:45 am] </FRDOC>
            <BILCOD>BILLING CODE 4910-13-P</BILCOD>
        </RULE>
        <RULE>
            <PREAMB>
                <PRTPAGE P="65538"/>
                <AGENCY TYPE="S">DEPARTMENT OF TRANSPORTATION </AGENCY>
                <SUBAGY>Federal Aviation Administration </SUBAGY>
                <CFR>14 CFR Part 97 </CFR>
                <DEPDOC>[Docket No. 30429 ; Amdt. No. 3109] </DEPDOC>
                <SUBJECT>Standard Instrument Approach Procedures; Miscellaneous Amendments </SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Federal Aviation Administration (FAA), DOT. </P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Final rule. </P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>This amendment establishes, amends, suspends, or revokes Standard Instrument Approach Procedures (SIAPs) for operations at certain airports. These regulatory actions are needed because of the adoption of new or revised criteria, or because of changes occurring in the National Airspace System, such as the commissioning of new navigational facilities, addition of new obstacles, or changes in air traffic requirements. These changes are designed to provide safe and efficient use of the navigable airspace and to promote safe flight operations under instrument flight rules at the affected airports. </P>
                </SUM>
                <EFFDATE>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>This rule is effective November 15, 2004. The compliance date for each SIAP is specified in the amendatory provisions. </P>
                    <P>The incorporation by reference of certain publications listed in the regulations is approved by the Director of the Federal Register as of November 15, 2004. </P>
                </EFFDATE>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>Availability of matters incorporated by reference in the amendment is as follows: </P>
                    <P>
                        <E T="03">For Examination</E>
                        —
                    </P>
                    <P>1. FAA Rules Docket, FAA Headquarters Building, 800 Independence Avenue, SW., Washington, DC 20591; </P>
                    <P>2. The FAA Regional Office of the region in which the affected airport is located; </P>
                    <P>3. The Flight Inspection Area Office which originated the SIAP; or, </P>
                    <P>
                        4. The National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call (202) 741-6030, or go to: 
                        <E T="03">http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.</E>
                    </P>
                    <P>
                        <E T="03">For Purchase</E>
                        —Individual SIAP copies may be obtained from: 
                    </P>
                    <P>1. FAA Public Inquiry Center (APA-200), FAA Headquarters Building, 800 Independence Avenue, SW., Washington, DC 20591; or </P>
                    <P>2. The FAA Regional Office of the region in which the affected airport is located. </P>
                    <P>
                        <E T="03">By Subscription</E>
                        —Copies of all SIAPs, mailed once every 2 weeks, are for sale by the Superintendent of Documents, U.S. Government Printing Office, Washington, DC 20402. 
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>Donald P. Pate, Flight Procedure Standards Branch (AMCAFS-420), Flight Technologies and Programs Division, Flight Standards Service, Federal Aviation Administration, Mike Monroney Aeronautical Center, 6500 South MacArthur Boulevard, Oklahoma City, OK 73169 (Mail Address: P.O. Box 25082 Oklahoma City, OK 73125) telephone: (405) 954-4164. </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>This amendment to part 97 of the Federal Aviation Regulations (14 CFR part 97) establishes, amends, suspends, or revokes Standard Instrument Approach Procedures (SIAPs). The complete regulatory description of each SIAP is contained in official FAA form documents which are incorporated by reference in this amendment under 5 U.S.C. 552(a), 1 CFR part 51, and § 97.20 of the Federal Aviation Regulations (FAR). The applicable FAA Forms are identified as FAA Forms 8260-3, 8260-4, and 8260-5. Materials incorporated by reference are available for examination or purchase as stated above. </P>
                <P>
                    The large number of SIAPs, their complex nature, and the need for a special format make their verbatim publication in the 
                    <E T="04">Federal Register</E>
                     expensive and impractical. Further, airmen do not use the regulatory text of the SIAPs, but refer to their graphic depiction on charts printed by publishers of aeronautical materials. Thus, the advantages of incorporation by reference are realized and publication of the complete description of each SIAP contained in FAA form documents is unnecessary. The provisions of this amendment state the affected CFR (and FAR) sections, with the types and effective dates of the SIAPs. This amendment also identifies the airport, its location, the procedure identification and the amendment number. 
                </P>
                <HD SOURCE="HD1">The Rule </HD>
                <P>This amendment to part 97 is effective upon publication of each separate SIAP as contained in the transmittal. Some SIAP amendments may have been previously issued by the FAA in a National Flight Data Center (NFDC) Notice to Airmen (NOTAM) as an emergency action of immediate flight safety relating directly to published aeronautical charts. The circumstances which created the need for some SIAP amendments may require making them effective in less than 30 days. For the remaining SIAPs, an effective date at least 30 days after publication is provided. </P>
                <P>Further, the SIAPs contained in this amendment are based on the criteria contained in the U.S. Standard for Terminal Instrument Procedures (TERPS). In developing these SIAPs, the TERPS criteria were applied to the conditions existing or anticipated at the affected airports. Because of the close and immediate relationship between these SIAPs and safety in air commerce, I find that notice and public procedure before adopting these SIAPs are impracticable and contrary to the public interest and, where applicable, that good cause exists for making some SIAPs effective in less than 30 days. </P>
                <HD SOURCE="HD1">Conclusion </HD>
                <P>The FAA has determined that this regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current. It, therefore—(1) is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a regulatory evaluation as the anticipated impact is so minimal. For the same reason, the FAA certifies that this amendment will not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act. </P>
                <LSTSUB>
                    <HD SOURCE="HED">List of Subjects in 14 CFR Part 97 </HD>
                    <P>Air traffic control, Airports, Incorporation by reference, and Navigation (air).</P>
                </LSTSUB>
                <SIG>
                    <DATED>Issued in Washington, DC on November 5, 2004. </DATED>
                    <NAME>James J. Ballough, </NAME>
                    <TITLE>Director, Flight Standards Service. </TITLE>
                </SIG>
                <REGTEXT TITLE="14" PART="97">
                    <HD SOURCE="HD1">Adoption of the Amendment </HD>
                    <AMDPAR>Accordingly, pursuant to the authority delegated to me, part 97 of the Federal Aviation Regulations (14 CFR part 97) is amended by establishing, amending, suspending, or revoking Standard Instrument Approach Procedures, effective at 0901 UTC on the dates specified, as follows: </AMDPAR>
                    <PART>
                        <PRTPAGE P="65539"/>
                        <HD SOURCE="HED">PART 97—STANDARD INSTRUMENT APPROACH PROCEDURES </HD>
                    </PART>
                    <AMDPAR>1. The authority citation for part 97 continues to read as follows: </AMDPAR>
                    <AUTH>
                        <HD SOURCE="HED">Authority:</HD>
                        <P>49 U.S.C. 106(g), 40103, 40106, 40113, 40114, 40120, 44502, 44514, 44701, 44719, 44721-44722. </P>
                    </AUTH>
                </REGTEXT>
                <REGTEXT TITLE="14" PART="97">
                    <AMDPAR>2. Part 97 is amended to read as follows: </AMDPAR>
                    <EXTRACT>
                        <HD SOURCE="HD2">Effective December 23, 2004 </HD>
                        <FP SOURCE="FP-1">Fargo, ND, Hector Intl, RADAR-1, Amdt 11 </FP>
                        <HD SOURCE="HD2">Effective January 20, 2005 </HD>
                        <FP SOURCE="FP-1">Mobile, AL, Mobile Downtown, ILS OR LOC RWY 32, Amdt 1 </FP>
                        <FP SOURCE="FP-1">Mobile, AL, Mobile Downtown, VOR RWY 14, Amdt 7 </FP>
                        <FP SOURCE="FP-1">Mobile, AL, Mobile Downtown, VOR RWY 18, Amdt 1 </FP>
                        <FP SOURCE="FP-1">Mobile, AL, Mobile Downtown, VOR RWY 32, Amdt 11 </FP>
                        <FP SOURCE="FP-1">Mobile, AL, Mobile Downtown, VOR/DME RNAV OR GPS RWY 36, Orig, CANCELLED </FP>
                        <FP SOURCE="FP-1">Mobile, AL, Mobile Downtown, RNAV (GPS) RWY 14, Orig </FP>
                        <FP SOURCE="FP-1">Mobile, AL, Mobile Downtown, RNAV (GPS) RWY 18, Orig </FP>
                        <FP SOURCE="FP-1">Mobile, AL, Mobile Downtown, RNAV (GPS) RWY 32, Orig </FP>
                        <FP SOURCE="FP-1">Mobile, AL, Mobile Downtown, RNAV (GPS) RWY 36, Orig </FP>
                        <FP SOURCE="FP-1">Wasilla, AK, Wasilla, RNAV (GPS) RWY 3, Orig </FP>
                        <FP SOURCE="FP-1">Crossett, AR, Z M Jack Stell Field, VOR/DME-A, Orig-C </FP>
                        <FP SOURCE="FP-1">Napa, CA, Napa County, VOR RWY 6, Amdt 12A </FP>
                        <FP SOURCE="FP-1">Monte Vista, CO, Monte Vista Muni, NDB RWY 20, Orig-A, CANCELLED </FP>
                        <FP SOURCE="FP-1">Fort Wayne, IN, Fort Wayne Intl, RNAV (GPS) RWY 5, Orig </FP>
                        <FP SOURCE="FP-1">Fort Wayne, IN, Fort Wayne Intl, RNAV (GPS) RWY 14, Orig </FP>
                        <FP SOURCE="FP-1">Fort Wayne, IN, Fort Wayne Intl, RNAV (GPS) RWY 23, Orig </FP>
                        <FP SOURCE="FP-1">Fort Wayne, IN, Fort Wayne Intl, RNAV (GPS) RWY 32, Orig </FP>
                        <FP SOURCE="FP-1">Fort Wayne, IN, Fort Wayne Intl, RADAR-1, Amdt 24 </FP>
                        <FP SOURCE="FP-1">Fort Wayne, IN, Fort Wayne Intl, NDB RWY 32, Amdt 26 </FP>
                        <FP SOURCE="FP-1">Fort Wayne, IN, Fort Wayne Intl, VOR OR TACAN RWY 5, Amdt 19 </FP>
                        <FP SOURCE="FP-1">Fort Wayne, IN, Fort Wayne Intl, VOR OR TACAN RWY 14, Amdt 16 </FP>
                        <FP SOURCE="FP-1">Fort Wayne, IN, Fort Wayne Intl, LOC BC RWY 23, Amdt 8, CANCELLED </FP>
                        <FP SOURCE="FP-1">De Quincy, LA, De Quincy Industrial Airpark, RNAV (GPS) RWY 15, Orig </FP>
                        <FP SOURCE="FP-1">De Quincy, LA, De Quincy Industrial Airpark, NDB RWY 15, Amdt 1A </FP>
                        <FP SOURCE="FP-1">De Quincy, LA, De Quincy Industrial Airpark, GPS RWY 15, Orig-A, CANCELLED </FP>
                        <FP SOURCE="FP-1">De Quincy, LA, De Quincy Industrial Airpark, RNAV (GPS) RWY 33, Orig </FP>
                        <FP SOURCE="FP-1">De Quincy, LA, De Quincy Industrial Airpark, VOR/DME RWY 33, Amdt 1 </FP>
                        <FP SOURCE="FP-1">De Quincy, LA, De Quincy Industrial Airpark, GPS RWY 33, Orig-A, CANCELLED </FP>
                        <FP SOURCE="FP-1">Charlevoix, MI, Charlevoix Muni, RNAV (GPS) RWY 9, Orig </FP>
                        <FP SOURCE="FP-1">Charlevoix, MI, Charlevoix Muni, RNAV (GPS) RWY 27, Orig </FP>
                        <FP SOURCE="FP-1">Charlevoix, MI, Charlevoix Muni, NDB RWY 9, Amdt 10 </FP>
                        <FP SOURCE="FP-1">Charlevoix, MI, Charlevoix Muni, NDB RWY 27, Amdt 11 </FP>
                        <FP SOURCE="FP-1">Holland, MI, Tulip City, RNAV (GPS) RWY 8, Orig-A </FP>
                        <FP SOURCE="FP-1">Menominee , MI, Menominee-Marinette Twin County, RNAV (GPS) RWY 32, Orig-A </FP>
                        <FP SOURCE="FP-1">Owosso, MI, Owosso Community, RNAV (GPS) RWY 10, Orig-A </FP>
                        <FP SOURCE="FP-1">Alamogordo, NM, Alamogordo-White Sands Regional, NDB RWY 3, Amdt 5A, CANCELLED </FP>
                        <FP SOURCE="FP-1">Harrisburg, PA, Harrisburg Intl, ILS OR LOC RWY 13, Amdt 2; ILS RWY 13 (CAT II), Amdt 2; ILS RWY 13 (CAT III), Amdt 2 </FP>
                        <FP SOURCE="FP-1">Honesdale, PA, Cherry Ridge, RNAV (GPS) RWY 36, Orig </FP>
                        <FP SOURCE="FP-1">Honesdale, PA, Cherry Ridge, VOR-A, Amdt 5 </FP>
                        <FP SOURCE="FP-1">Pawtucket, RI, North Central State, NDB RWY 5, Amdt 2A, CANCELLED </FP>
                        <FP SOURCE="FP-1">Fredericksburg, TX, Gillespie County, RNAV (GPS) RWY 14, Orig </FP>
                        <FP SOURCE="FP-1">Fredericksburg, TX, Gillespie County, RNAV (GPS) RWY 32, Orig </FP>
                        <FP SOURCE="FP-1">Fredericksburg, TX, Gillespie County, VOR/DME-A, Amdt 3 </FP>
                        <FP SOURCE="FP-1">Chetek, WI, Chetek Muni-Southworth, RNAV (GPS) RWY 17, Orig-A </FP>
                        <FP SOURCE="FP-1">Chetek, WI, Chetek Muni-Southworth, RNAV (GPS) RWY 35, Orig-A </FP>
                        <FP SOURCE="FP-1">Delavan, WI, Lake Lawn, RNAV (GPS) RWY 18, Orig-A </FP>
                        <FP SOURCE="FP-1">Manitowoc, WI, Manitowoc County, RNAV (GPS) RWY 35, Orig-A </FP>
                        <FP SOURCE="FP-1">Milwaukee, WI, General Mitchell Intl, RNAV (GPS) RWY 25R, Orig-A </FP>
                        <FP SOURCE="FP-1">Milwaukee, WI, General Mitchell Intl, RNAV (GPS) RWY 25L, Orig-A </FP>
                        <FP SOURCE="FP-1">Necedah, WI, Necedah, RNAV (GPS) RWY 36, Orig-A </FP>
                        <FP SOURCE="FP-1">New Richmond, WI, New Richmond Regional, RNAV (GPS) RWY 14, Orig-A </FP>
                        <FP SOURCE="FP-1">Park Falls, WI, Park Falls Muni, RNAV (GPS) RWY 18, Orig-A </FP>
                        <FP SOURCE="FP-1">Park Falls, WI, Park Falls Muni, RNAV (GPS) RWY 36, Orig-A </FP>
                        <FP SOURCE="FP-1">Rhinelander, WI, Rhinelander-Oneida County, RNAV (GPS) Y RWY 27, Orig-A </FP>
                        <FP SOURCE="FP-1">Rhinelander, WI, Rhinelander-Oneida County, RNAV (GPS) RWY 33, Orig-A </FP>
                        <FP SOURCE="FP-1">Viroqua, WI, Viroqua Muni, RNAV (GPS) RWY 11, Orig-A </FP>
                        <FP SOURCE="FP-1">Viroqua, WI, Viroqua Muni, RNAV (GPS) RWY 29, Orig-A </FP>
                        <P>
                            The FAA published an Amendment in Docket No. 
                            <E T="03">30428,</E>
                             Amdt No. 
                            <E T="03">3108</E>
                             to Part 97 of the Federal Aviation Regulations (Vol. 
                            <E T="03">69</E>
                             FR No. 
                            <E T="03">210,</E>
                             Page 63318; dated 
                            <E T="03">Monday, November 1, 2004</E>
                            ) under section 97.
                            <E T="03">31</E>
                             effective 
                            <E T="03">20 Jan, 2005,</E>
                             which is hereby rescinded as follows: 
                        </P>
                        <FP SOURCE="FP-1">Columbus, GA., Columbus Metropolitan, Radar-1, Amdt 9 </FP>
                    </EXTRACT>
                </REGTEXT>
            </SUPLINF>
            <FRDOC>[FR Doc. 04-25213 Filed 11-12-04; 8:45 am] </FRDOC>
            <BILCOD>BILLING CODE 4910-13-P</BILCOD>
        </RULE>
        <RULE>
            <PREAMB>
                <AGENCY TYPE="N">DEPARTMENT OF COMMERCE </AGENCY>
                <SUBAGY>Bureau of Industry and Security </SUBAGY>
                <CFR>15 CFR Part 744 </CFR>
                <DEPDOC>[Docket No.041103304-4304-01] </DEPDOC>
                <RIN>RIN 0694-AD12 </RIN>
                <SUBJECT>Entity List: Removal of Four Russian Entities </SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Bureau of Industry and Security, Commerce. </P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Final rule. </P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>This final rule amends the Export Administration Regulations by removing four Russian entities from the Entity List, and by removing certain license requirements for exports and reexports to these entities, in conformance with a determination of the Department of State to remove nonproliferation measures imposed on these entities in 1998 and 1999. </P>
                </SUM>
                <EFFDATE>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>This rule is effective November 15, 2004. </P>
                </EFFDATE>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>You may submit comments, identified by RIN 0694-AD12, by any of the following methods: </P>
                    <P>
                        • 
                        <E T="03">E-mail: scook@bis.doc.gov.</E>
                         Include “RIN 0694-AD12” in the subject line of the message. 
                    </P>
                    <P>
                        • 
                        <E T="03">Fax:</E>
                         (202)482-3355 
                    </P>
                    <P>
                        • 
                        <E T="03">Mail or Hand Delivery/Courier:</E>
                         Sharron Cook, U.S. Department of Commerce, Bureau of Industry and Security, Regulatory Policy Division, 14th &amp; Pennsylvania Avenue, NW., Room 2705, Washington, DC 20230, ATTN: RIN 0694-AD12. 
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>Eileen M. Albanese, Office of Exporter Services, Bureau of Industry and Security, Telephone: (202) 482-0436. </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <HD SOURCE="HD1">Background </HD>
                <P>In 1998 and 1999, the Department of Commerce imposed license requirements on four Russian entities, under section 744.10 of the Export Administration Regulations (EAR), in conformance with determinations by the Department of State that these entities had engaged in nuclear or missile technology proliferation activities that required the imposition of measures pursuant to Executive Order 12938, as amended (“Proliferation of Weapons of Mass Destruction”). These entities were added to the Entity List, set forth in Supplement No. 4 to part 744 of the EAR, as follows: </P>
                <P>1. Europalace 2000 </P>
                <P>
                    2. Grafit (aka State Scientific Research Institute of Graphite or NIIGRAFIT) 
                    <PRTPAGE P="65540"/>
                </P>
                <P>3. MOSO Company </P>
                <P>4. The Scientific Research and Design Institute of Power Technology (aka NIKIET, Research and Development Institute of Power Engineering (RDIPE), and ENTEK). </P>
                <P>The Department of State made its determination with regard to, and imposed nonproliferation measures against, Europalace 2000, Grafit, and MOSO Company on July 30, 1998 (63 FR 42089). BIS imposed conforming license requirements on these three entities under the EAR on July 29, 1998 (63 FR 40363). The Department of State made its determination with regard to, and imposed nonproliferation measures against, the Scientific Research and Design Institute of Power Technology on January 8, 1999 (64 FR 2935), and BIS imposed license requirements on this entity under the EAR on March 26, 1999 (64 FR 14605). </P>
                <P>On March 23, 2004, the Department of State determined that it is in the foreign policy and national security interests of the United States to remove nonproliferation measures imposed on these four Russian entities (69 FR 17262). In conformance with this determination, this final rule removes the license requirements under section 744.10 for exports and reexports to these entities, and removes these entities from the Entity List. </P>
                <P>The removal of these entities from the Entity List eliminates the license requirements under section 744.10 of the EAR for exports and reexports to these entities. However, license requirements for exports and reexports set forth in part 744 still apply to these entities when the exporter or reexporter knows that the item will be used in a prohibited activity. BIS strongly urges the use of Supplement No. 3 to part 732 of the EAR, “BIS's ‘Know Your Customer’ Guidance and Red Flags” when exporting or reexporting. </P>
                <P>Although the Export Administration Act expired on August 20, 2001, Executive Order 13222 of August 17, 2001 (66 FR 44025, August 22, 2001), extended by the Notice of August 6, 2004, 69 FR 48763 (August 10, 2004), continues the EAR in effect under the International Emergency Economic Powers Act. </P>
                <HD SOURCE="HD1">Rulemaking Requirements </HD>
                <P>1. This final rule has been determined to be not significant for purposes of E.O. 12866. </P>
                <P>
                    2. Notwithstanding any other provision of law, no person is required to respond to, nor shall any person be subject to a penalty for failure to comply with a collection of information, subject to the requirements of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 
                    <E T="03">et seq.</E>
                    ) (PRA), unless that collection of information displays a currently valid Office of Management and Budget (OMB) Control Number. This rule involves a collection of information subject to the PRA. This collection has been approved by OMB under control number 0694-0088, “Multi-Purpose Application,” which carries a burden hour estimate of 58 minutes for a manual or electronic submission. Send comments regarding these burden estimates or any other aspect of these collections of information, including suggestions for reducing the burden, to David Rostker, Office of Management and Budget (OMB), by e-mail to 
                    <E T="03">David_Rostker@omb.eop.gov,</E>
                     or by fax to (202)395-7285; and to the Office of Administration, Bureau of Industry and Security, Department of Commerce, 14th and Pennsylvania Avenue, NW., Room 6883, Washington, DC 20230. 
                </P>
                <P>3. This rule does not contain policies with Federalism implications as that term is defined under E.O. 13132. </P>
                <P>
                    4. The provisions of the Administrative Procedure Act (5 U.S.C. 553) requiring notice of proposed rulemaking, the opportunity for public participation, and a delay in effective date, are inapplicable because this regulation involves a military and foreign affairs function of the United States (5 U.S.C. 553(a)(1)). Further, no other law requires that a notice of proposed rulemaking and an opportunity for public comment be given for this final rule. Because a notice of proposed rulemaking and an opportunity for public comment are not required to be given for this rule under the Administrative Procedure Act or by any other law, the analytical requirements of the Regulatory Flexibility Act (5 U.S.C. 601 
                    <E T="03">et seq.</E>
                    ) are not applicable. 
                </P>
                <P>
                    Therefore, this regulation is issued in final form. Although there is no formal comment period, public comments on this regulation are welcome on a continuing basis. Please refer to the 
                    <E T="02">ADDRESSES</E>
                     section cited above for comment submission. 
                </P>
                <LSTSUB>
                    <HD SOURCE="HED">List of Subjects in 15 CFR Part 744 </HD>
                    <P>Exports, Foreign trade, Reporting and recordkeeping requirements.</P>
                </LSTSUB>
                <REGTEXT TITLE="15" PART="744">
                    <AMDPAR>Accordingly, part 744 of the Export Administration Regulations (15 CFR parts 730-799) is amended as follows: </AMDPAR>
                    <PART>
                        <HD SOURCE="HED">PART 744—[AMENDED] </HD>
                    </PART>
                    <AMDPAR>1. The authority citation for 15 CFR part 744 continues to read as follows: </AMDPAR>
                    <AUTH>
                        <HD SOURCE="HED">Authority:</HD>
                        <P>
                            50 U.S.C. app. 2401 
                            <E T="03">et seq.</E>
                            ; 50 U.S.C. 1701 
                            <E T="03">et seq.</E>
                            ; 22 U.S.C. 3201 
                            <E T="03">et seq.</E>
                            ; 42 U.S.C. 2139a; Sec. 901-911, Pub. L. 106-387; Sec. 221, Pub. L. 107-56; E.O. 12058, 43 FR 20947, 3 CFR, 1978 Comp., p. 179; E.O. 12851, 58 FR 33181, 3 CFR, 1993 Comp., p. 608; E.O. 12938, 59 FR 59099, 3 CFR, 1994 Comp., p. 950; E.O. 12947, 60 FR 5079, 3 CFR, 1995 Comp., p. 356; E.O. 13026, 61 FR 58767, 3 CFR, 1996 Comp., p. 228; E.O. 13099, 63 FR 45167, 3 CFR, 1998 Comp., p. 208; E.O. 13222, 66 FR 44025, 3 CFR, 2001 Comp., p. 783; E.O. 13224, 66 FR 49079, 3 CFR, 2001 Comp., p. 786; Notice of November 9, 2001, 66 FR 56965, 3 CFR, 2001 Comp., p. 917; Notice of August 6, 2004, 69 FR 48763 (August 10, 2004). 
                        </P>
                    </AUTH>
                </REGTEXT>
                <REGTEXT TITLE="15" PART="744">
                    <AMDPAR>2. Supplement No. 4 to part 744 is amended by removing entries for the entities “Europalace 2000, Moscow,” “Grafit (a.k.a. State Scientific Research Institute of Graphite or NIIGRAFIT), 2 Ulitsa Elektrodnaya, 111524, Moscow,” “MOSO Company, Moscow,” and “The Scientific Research and Design Institute of Power Technology (a.k.a. NIKIET, Research and Development Institute of Power Engineering (RDIPE), and ENTEK) (including at 101000, P.O. Box 788, Moscow, Russia)” under the country of “Russia”. </AMDPAR>
                </REGTEXT>
                <SIG>
                    <DATED>Dated: November 8, 2004. </DATED>
                    <NAME>Peter Lichtenbaum, </NAME>
                    <TITLE>Assistant Secretary for Export Administration. </TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 04-25308 Filed 11-12-04; 8:45 am] </FRDOC>
            <BILCOD>BILLING CODE 3510-33-P </BILCOD>
        </RULE>
        <RULE>
            <PREAMB>
                <AGENCY TYPE="N">DEPARTMENT OF HEALTH AND HUMAN SERVICES</AGENCY>
                <SUBAGY>Food and Drug Administration</SUBAGY>
                <CFR>21 CFR Part 180</CFR>
                <DEPDOC>[Docket No. 2004F-0066]</DEPDOC>
                <SUBJECT>Food Additives Permitted in Food on an Interim Basis or in Contact With Food Pending Additional Study; Mannitol</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Food and Drug Administration, HHS.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Final rule.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>
                        The Food and Drug Administration (FDA) is amending the food additive regulations to permit the manufacture of mannitol by fermentation of sugars such as fructose, glucose, or maltose by the action of the microorganism 
                        <E T="03">Lactobacillus intermedius</E>
                         (
                        <E T="03">fermentum</E>
                        ).  This action is in response to a petition filed by zuChem, Inc.
                    </P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>This rule is effective November 15, 2004.  Submit written or electronic objections and requests for a hearing by December 15, 2004.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        You may submit written objections and requests for a hearing, 
                        <PRTPAGE P="65541"/>
                        identified by Docket No. 2004F-0066, by any of the following methods:
                    </P>
                    <P>
                        • Federal eRulemaking Portal: 
                        <E T="03">http://www.regulations.gov</E>
                        . Follow the instructions for submitting comments.
                    </P>
                    <P>
                        • Agency Web site: 
                        <E T="03">http://www.fda.gov/dockets/ecomments</E>
                        .  Follow the instructions for submitting comments on the agency Web site.
                    </P>
                    <P>
                        • E-mail: 
                        <E T="03">fdadockets@oc.fda.gov</E>
                        .  Include Docket No. 2004F-0066 in the subject line of your e-mail message.
                    </P>
                    <P>• FAX:  301-827-6870.</P>
                    <P>• Mail/Hand delivery/Courier [For paper, disk, or CD-ROM submissions]:  Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD  20852.</P>
                    <P>
                        <E T="03">Instructions</E>
                        :  All submissions received must include the agency name and docket number for this rulemaking. All objections received will be posted without change to 
                        <E T="03">http://www.fda.gov/ohrms/dockets/default.htm</E>
                        , including any personal information provided. For detailed instructions on submitting objections, see the “Objections” heading of the 
                        <E T="02">SUPPLEMENTARY INFORMATION</E>
                         section of this document.
                    </P>
                    <P>
                        <E T="03">Docket</E>
                        :  For access to the docket to read background documents or comments received, go to 
                        <E T="03">http://www.fda.gov/ohrms/dockets/default.htm</E>
                         and insert the docket number, found in brackets in the heading of this document, into the “Search” box and follow the prompts and/or go to the Division of Dockets Management, 5630 Fishers Lane, rm. 1061, Rockville, MD  20852.
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>Celeste Johnston, Center for Food Safety and Applied Nutrition (HFS-265), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD  20740-3835, 301-436-1282.</P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <HD SOURCE="HD1">I.  Background</HD>
                <P>
                    In a notice published in the 
                    <E T="04">Federal Register</E>
                     of February 19, 2004 (69 FR 7759), FDA announced that a food additive petition (FAP 4A4754) had been filed by zuChem, Inc., c/o Hyman, Phelps and McNamara, P.C., 700 13th Street NW., Washington, DC 20005.  The petition proposed to amend the food additive regulations in § 180.25 
                    <E T="03">Mannitol</E>
                     (21 CFR 180.25) to permit the manufacture of mannitol by fermentation of sugars such as fructose, glucose, and maltose by the action of the microorganism 
                    <E T="03">L. intermedius</E>
                     (
                    <E T="03">fermentum</E>
                    ).
                </P>
                <P>
                    In 1973, the agency proposed to affirm mannitol as generally recognized as safe (GRAS) based on the findings by the Select Committee on GRAS Substances from the Life Sciences Research Office of the Federation of American Societies for Experimental Biology (38 FR 20046, July 26, 1973).  In response to the proposal, the agency received comments, including information raising questions about the safety of mannitol.  Rather than affirm the GRAS status of mannitol, the agency instead decided to establish an interim food additive regulation for mannitol, pending additional study of the ingredient (39 FR 34178, September 23, 1974) and based on the conclusion that there would be no increased risk to the public health to continue existing uses and levels of use of mannitol while additional studies were carried out.  The regulation was subsequently amended (61 FR 7990, March 1, 1996) to permit the manufacture of mannitol by fermentation of sugars or sugar alcohols by the action of the yeast 
                    <E T="03">Zygosaccharomyces rouxii</E>
                    .
                </P>
                <P>
                    The proposed fermentation organism, 
                    <E T="03">L. fermentum</E>
                    , is currently used in various food applications.  For example, strains of 
                    <E T="03">L. fermentum</E>
                     are used in sourdough bread and pressed curd cheeses, and FDA has affirmed as GRAS a urease preparation from 
                    <E T="03">L. fermentum</E>
                     for use in the manufacture of wine.  The petitioner has submitted data in support of the microbiological safety of mannitol produced by this bacterium.  In addition, the petitioner has provided detailed information on the process used to produce mannitol by this fermentation method, including information on the purification steps that are used.  FDA concludes, having considered the evidence concerning the production organism and the purification procedures, that 
                    <E T="03">L. intermedius</E>
                     (
                    <E T="03">fermentum</E>
                    ) will not be present in the final product and can be safely used in the fermentation of fructose and other sugars to produce mannitol provided that the purity of the culture is maintained, and that a nonpathogenic, nontoxicogenic strain of 
                    <E T="03">L. intermedius</E>
                     (
                    <E T="03">fermentum</E>
                    ) is used (Ref. 1).
                </P>
                <HD SOURCE="HD1">II.  Conclusion</HD>
                <P>
                    The current interim regulation for mannitol specifies manufacturing procedures that do not include the proposed fermentation process.  FDA has reviewed data and information in the petition on the chemical equivalence of mannitol produced using 
                    <E T="03">L. intermedius</E>
                     (
                    <E T="03">fermentum</E>
                    ) and mannitol produced by the currently-regulated methods.  Based on its review, the agency concludes that mannitol manufactured by fermentation of sugars by the action of 
                    <E T="03">L. intermedius</E>
                     (
                    <E T="03">fermentum</E>
                    ) is equivalent to mannitol produced by the currently-regulated methods as described in § 180.25.  In addition, mannitol manufactured by the proposed fermentation process will have the same intended technical effect and uses as mannitol produced by the currently-regulated methods.  Consequently, there will be no change in exposure to mannitol (Refs. 2 and 3).  Therefore, FDA concludes that § 180.25 should be amended as set forth in this document.
                </P>
                <HD SOURCE="HD1">III.  Public Disclosure</HD>
                <P>
                    In accordance with § 171.1(h) (21 CFR 171.1(h)), the petition and the documents that FDA considered and relied upon in reaching its decision to approve the petition are available for inspection at the Center for Food Safety and Applied Nutrition by appointment with the information contact person listed (see 
                    <E T="02">FOR FURTHER INFORMATION CONTACT</E>
                    ).  As provided in § 171.1(h), the agency will delete from the documents any materials that are not available for public disclosure before making the documents available for inspection.
                </P>
                <HD SOURCE="HD1">IV.  Environmental Impact</HD>
                <P>The agency has previously considered the environmental effects of this rule as announced in the notice of filing for FAP 4A4754.  No new information or comments have been received that would affect the agency's previous determination that there is no significant impact on the human environment and that an environmental impact statement is not required.</P>
                <HD SOURCE="HD1">V.  Paperwork Reduction Act of 1995</HD>
                <P>This final rule contains no collection of information.  Therefore, clearance by the Office of Management and Budget under the Paperwork Reduction Act of 1995 is not required.</P>
                <HD SOURCE="HD1">VI.  Objections</HD>
                <P>
                    Any person who will be adversely affected by this regulation may file with the Division of Dockets Management (see 
                    <E T="02">ADDRESSES</E>
                    ) written or electronic objections (see 
                    <E T="02">DATES</E>
                    ).   Each objection shall be separately numbered, and each numbered objection shall specify with particularity the provisions of the regulation to which objection is made and the grounds for the objection.  Each numbered objection on which a hearing is requested shall specifically so state.  Failure to request a hearing for any particular objection shall constitute a waiver of the right to a hearing on that objection.  Each numbered objection for which a hearing is requested shall include a detailed description and analysis of the specific factual information intended to be presented in support of the objection in the event 
                    <PRTPAGE P="65542"/>
                    that a hearing is held.  Failure to include such a description and analysis for any particular objection shall constitute a waiver of the right to a hearing on the objection.   Three copies of all documents are to be submitted and are to be identified with the docket number found in brackets in the heading of this document.  Any objections received in response to the regulation may be seen in the Division of Dockets Management (see 
                    <E T="02">ADDRESSES</E>
                    ) between 9 a.m. and 4 p.m., Monday through Friday.
                </P>
                <HD SOURCE="HD1">VII.  References</HD>
                <P>
                    The following references have been placed on display in the Division of Dockets Management (see 
                    <E T="02">ADDRESSES</E>
                    ) and may be seen by interested persons between 9 a.m. and 4 p.m., Monday through Friday.
                </P>
                <EXTRACT>
                    <P>1.  FDA memorandum from P. C. DeLeo, Division of Petition Review, to C. Johnston, Division of Petition Review, April 21, 2004.</P>
                    <P>2. FDA memorandum from D. E. Folmer, Division of Petition Review, to C. Johnston, Division of Petition Review, April 20, 2004.</P>
                    <P>3. FDA memorandum from D. E. Folmer, Division of Petition Review, to C. Johnston, Division of Petition Review, July 29, 2004.</P>
                </EXTRACT>
                <LSTSUB>
                    <HD SOURCE="HED">List of Subjects in 21 CFR Part 180</HD>
                    <P>Food additives.</P>
                </LSTSUB>
                <REGTEXT TITLE="21" PART="180">
                    <AMDPAR>Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs and redelegated to the Director, Center for Food Safety and Applied Nutrition, 21 CFR part 180 is amended as follows:</AMDPAR>
                    <PART>
                        <HD SOURCE="HED">PART 180—FOOD ADDITIVES PERMITTED IN FOOD ON AN INTERIM BASIS OR IN CONTACT WITH FOOD PENDING ADDITIONAL STUDY</HD>
                    </PART>
                </REGTEXT>
                <REGTEXT TITLE="21" PART="180">
                    <AMDPAR>1. The authority citation for 21 CFR part 180 continues to read as follows:</AMDPAR>
                    <AUTH>
                        <HD SOURCE="HED">Authority:</HD>
                        <P>21 U.S.C. 321, 342, 343, 348, 371; 42 U.S.C. 241.</P>
                    </AUTH>
                </REGTEXT>
                <REGTEXT TITLE="21" PART="180">
                    <AMDPAR>2. Section 180.25 is amended by adding paragraph (a)(3) to read as follows:</AMDPAR>
                    <SECTION>
                        <SECTNO>§ 180.25</SECTNO>
                        <SUBJECT>Mannitol.</SUBJECT>
                    </SECTION>
                    <P>(a) * * * </P>
                    <P>
                        (3) A pure culture fermentation of sugars such as fructose, glucose, or maltose using the nonpathogenic, nontoxicogenic bacterium 
                        <E T="03">Lactobacillus intermedius</E>
                         (
                        <E T="03">fermentum</E>
                        ).
                    </P>
                    <STARS/>
                </REGTEXT>
                <SIG>
                    <DATED>Dated: October 27, 2004.</DATED>
                    <NAME>Leslye M. Fraser,</NAME>
                    <TITLE>Director, Office of Regulations and Policy, Center for Food Safety and Applied Nutrition.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 04-25243 Filed 11-12-04; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4160-01-S</BILCOD>
        </RULE>
        <RULE>
            <PREAMB>
                <AGENCY TYPE="N">DEPARTMENT OF JUSTICE</AGENCY>
                <CFR>28 CFR Part 0</CFR>
                <DEPDOC>[AG Order No. 2738-2004]</DEPDOC>
                <SUBJECT>Delegations of Authority; Federal Bureau of Investigation</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Department of Justice.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Final rule.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>Recent consultations between criminal law enforcement investigative agencies and the Department of Justice have suggested the need to simplify and clarify the delegations of authority to the Federal Bureau of Investigation to investigate any criminal violations of law in certain foreign counterintelligence areas. This final rule changes the language of the delegations of authority to eliminate confusion about the scope of the delegation.</P>
                </SUM>
                <EFFDATE>
                    <HD SOURCE="HED">EFFECTIVE DATE:</HD>
                    <P>November 15, 2004.</P>
                </EFFDATE>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>Bruce C. Swartz, Deputy Assistant Attorney General, Criminal Division, United States Department of Justice, Washington, DC 20530 (202) 514-2333 (this is not a toll-free number).</P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>The Attorney General has authority to investigate any violation of the criminal laws of the United States. 28 U.S.C. 533. As a general proposition, the Attorney General has delegated general investigative authority to the Federal Bureau of Investigation. 28 CFR 0.85(a). Recent consultations among investigative agencies have indicated that confusion has been created by the use of limiting language in the formal delegations of authority within the Department. The limitation of the Federal Bureau of Investigation's authority to the extent that investigative authority is assigned elsewhere was not intended as other than an internal management tool. The Department has determined that the limitation should be stated more clearly and applicable only when statute or other authority, such as an Executive Order or Attorney General delegation, assigns investigative authority exclusively to another agency or component. Accordingly, this final rule amends the language in 28 CFR part 0.</P>
                <HD SOURCE="HD1">Administrative Procedure Act</HD>
                <P>
                    This rule relates to matters of agency management and personnel and, therefore, is exempt from the usual requirements of prior notice and comment and a 30-day delay in effective date. 
                    <E T="03">See</E>
                     5 U.S.C. 553(a)(2) and (d). The rule only alters an internal delegation to the Federal Bureau of Investigation.
                </P>
                <HD SOURCE="HD1">Regulatory Flexibility Act</HD>
                <P>The Attorney General, in accordance with the Regulatory Flexibility Act, 5 U.S.C. 605(b), has reviewed this rule and, by approving it, certifies that it will not have a significant economic impact on a substantial number of small entities because it pertains to personnel and administrative matters affecting the Department. Further, a Regulatory Flexibility Analysis is not required for this final rule because the Department was not required to publish a general notice of proposed rulemaking for this matter.</P>
                <HD SOURCE="HD1">Executive Order 12866</HD>
                <P>This rule has been drafted and reviewed in accordance with Executive Order 12866, Regulatory Planning and Review, section 1(b), Principles of Regulation. This rule is limited to agency organization, management and personnel matters as described by Executive Order 12866, § 3(d)(3) and, therefore, is not a “regulation” or “rule” as defined by that Executive Order.</P>
                <HD SOURCE="HD1">Executive Order 12988</HD>
                <P>This regulation meets the applicable standards set forth in sections 3(a) and 3(b)(2) of Executive Order 12988, Civil Justice Reform.</P>
                <HD SOURCE="HD1">Executive Order 13132</HD>
                <P>This rule will not have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government. Therefore, in accordance with Executive Order 13132, Federalism, the Department has determined that this rule does not have sufficient federalism implications to warrant the preparation of a federalism summary impact statement.</P>
                <HD SOURCE="HD1">Unfunded Mandates Reform Act of 1995</HD>
                <P>
                    This rule will not result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100 million or more in any one year, and it will not significantly or uniquely affect small governments. Therefore, no actions are necessary under the provisions of the Unfunded Mandates Reform Act of 1995, 2 U.S.C. 1501 
                    <E T="03">et seq.</E>
                </P>
                <HD SOURCE="HD1">Small Business Regulatory Enforcement Fairness Act of 1996</HD>
                <P>
                    This rule is not a major rule as defined by section 251 of the Small Business Regulatory Enforcement Fairness Act of 1996 (SBREFA), 5 U.S.C. 804. This rule will not result in an 
                    <PRTPAGE P="65543"/>
                    annual effect on the economy of $100 million or more, a major increase in costs or prices, or significant adverse effects on competition, employment, investment, productivity, innovation, or the ability of United States-based enterprises to compete with foreign-based enterprises in domestic and export markets.
                </P>
                <P>This action pertains to agency management, personnel, and organization and does not substantially affect the rights or obligations of non-agency parties. Accordingly, it is not a rule for purposes of the reporting requirement of 5 U.S.C. 801.</P>
                <HD SOURCE="HD1">Congressional Review Act</HD>
                <P>This action pertains to agency management, personnel and organization and does not substantially affect the rights or obligations of non-agency parties and, accordingly, is not a “rule” as that term is used by the Congressional Review Act (Subtitle E of the Small Business Regulatory Enforcment Fairness Act of 1996 (SBREFA)). Therefore, the reporting requirement of 5 U.S.C. 801 does not apply.</P>
                <LSTSUB>
                    <HD SOURCE="HED">List of Subjects in 28 CFR Part 0</HD>
                    <P>Authority delegations (Government agencies), Government employees, Organization and functions (Government agencies), Whistleblowing.</P>
                </LSTSUB>
                <REGTEXT TITLE="28" PART="0">
                    <AMDPAR>Accordingly, chapter 1 of title 28 of the Code of Federal Regulations is amended as follows:</AMDPAR>
                    <PART>
                        <HD SOURCE="HED">PART 0—ORGANIZATION OF THE DEPARTMENT OF JUSTICE</HD>
                    </PART>
                    <AMDPAR>1. The authority citation for part 0 continues to read as follows:</AMDPAR>
                    <AUTH>
                        <HD SOURCE="HED">Authority:</HD>
                        <P>5 U.S.C. 301; 28 U.S.C. 509, 510, 515-519.</P>
                    </AUTH>
                </REGTEXT>
                <REGTEXT TITLE="28" PART="0">
                    <AMDPAR>2. In § 0.85, paragraph (a) is amended by removing “specifically” and adding in its place “exclusively,” and paragraph (d) is revised to read as follows:</AMDPAR>
                    <SECTION>
                        <SECTNO>§ 0.85 </SECTNO>
                        <SUBJECT>General functions. </SUBJECT>
                        <STARS/>
                        <P>(d) Carry out the Presidential directive of September 6, 1939, as reaffirmed by Presidential directives of January 8, 1943, July 24, 1950, and December 15, 1953, designating the Federal Bureau of Investigation to take charge of investigative work in matters relating to espionage, sabotage, subversive activities, and related matters, including investigating any potential violations of the Arms Export Control Act, the Export Administration Act, the Trading with the Enemy Act, or the International Emergency Economic Powers Act, relating to any foreign counterintelligence matter.</P>
                        <STARS/>
                    </SECTION>
                </REGTEXT>
                <SIG>
                    <DATED>Dated: November 5, 2004.</DATED>
                    <NAME>John Ashcroft, </NAME>
                    <TITLE>Atorney General.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 04-25252  Filed 11-12-04; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4410-02-M</BILCOD>
        </RULE>
        <RULE>
            <PREAMB>
                <AGENCY TYPE="N">PENSION BENEFIT GUARANTY CORPORATION </AGENCY>
                <CFR>29 CFR Parts 4022 and 4044 </CFR>
                <SUBJECT>Benefits Payable in Terminated Single-Employer Plans; Allocation of Assets in Single-Employer Plans; Interest Assumptions for Valuing and Paying Benefits </SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Pension Benefit Guaranty Corporation. </P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Final rule. </P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>
                        The Pension Benefit Guaranty Corporation's regulations on Benefits Payable in Terminated Single-Employer Plans and Allocation of Assets in Single-Employer Plans prescribe interest assumptions for valuing and paying benefits under terminating single-employer plans. This final rule amends the regulations to adopt interest assumptions for plans with valuation dates in December 2004. Interest assumptions are also published on the PBGC's Web site (
                        <E T="03">http://www.pbgc.gov</E>
                        ). 
                    </P>
                </SUM>
                <EFFDATE>
                    <HD SOURCE="HED">EFFECTIVE DATES:</HD>
                    <P>December 1, 2004. </P>
                </EFFDATE>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>Harold J. Ashner, Assistant General Counsel, Office of the General Counsel, Pension Benefit Guaranty Corporation, 1200 K Street, NW., Washington, DC 20005, 202-326-4024. (TTY/TDD users may call the Federal relay service toll-free at 1-800-877-8339 and ask to be connected to 202-326-4024.) </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>The PBGC's regulations prescribe actuarial assumptions—including interest assumptions—for valuing and paying plan benefits of terminating single-employer plans covered by title IV of the Employee Retirement Income Security Act of 1974. The interest assumptions are intended to reflect current conditions in the financial and annuity markets. </P>
                <P>Three sets of interest assumptions are prescribed: (1) a set for the valuation of benefits for allocation purposes under section 4044 (found in Appendix B to Part 4044), (2) a set for the PBGC to use to determine whether a benefit is payable as a lump sum and to determine lump-sum amounts to be paid by the PBGC (found in Appendix B to Part 4022), and (3) a set for private-sector pension practitioners to refer to if they wish to use lump-sum interest rates determined using the PBGC's historical methodology (found in Appendix C to Part 4022). </P>
                <P>Accordingly, this amendment (1) adds to Appendix B to Part 4044 the interest assumptions for valuing benefits for allocation purposes in plans with valuation dates during December 2004, (2) adds to Appendix B to Part 4022 the interest assumptions for the PBGC to use for its own lump-sum payments in plans with valuation dates during December 2004, and (3) adds to Appendix C to Part 4022 the interest assumptions for private-sector pension practitioners to refer to if they wish to use lump-sum interest rates determined using the PBGC's historical methodology for valuation dates during December 2004. </P>
                <P>For valuation of benefits for allocation purposes, the interest assumptions that the PBGC will use (set forth in Appendix B to part 4044) will be 3.80 percent for the first 20 years following the valuation date and 5.00 percent thereafter. These interest assumptions are unchanged from those in effect for November 2004. </P>
                <P>The interest assumptions that the PBGC will use for its own lump-sum payments (set forth in Appendix B to part 4022) will be 2.75 percent for the period during which a benefit is in pay status and 4.00 percent during any years preceding the benefit's placement in pay status. These interest assumptions are unchanged from those in effect for November 2004. </P>
                <P>For private-sector payments, the interest assumptions (set forth in Appendix C to part 4022) will be the same as those used by the PBGC for determining and paying lump sums (set forth in Appendix B to part 4022). </P>
                <P>The PBGC has determined that notice and public comment on this amendment are impracticable and contrary to the public interest. This finding is based on the need to determine and issue new interest assumptions promptly so that the assumptions can reflect, as accurately as possible, current market conditions. </P>
                <P>Because of the need to provide immediate guidance for the valuation and payment of benefits in plans with valuation dates during December 2004, the PBGC finds that good cause exists for making the assumptions set forth in this amendment effective less than 30 days after publication. </P>
                <P>
                    The PBGC has determined that this action is not a “significant regulatory action” under the criteria set forth in Executive Order 12866. 
                    <PRTPAGE P="65544"/>
                </P>
                <P>Because no general notice of proposed rulemaking is required for this amendment, the Regulatory Flexibility Act of 1980 does not apply. See 5 U.S.C. 601(2). </P>
                <LSTSUB>
                    <HD SOURCE="HED">List of Subjects </HD>
                    <CFR>29 CFR Part 4022 </CFR>
                    <P>Employee benefit plans, Pension insurance, Pensions, Reporting and recordkeeping requirements. </P>
                    <CFR>29 CFR Part 4044 </CFR>
                    <P>Employee benefit plans, Pension insurance, Pensions.</P>
                </LSTSUB>
                <REGTEXT TITLE="29" PART="4022">
                    <AMDPAR>In consideration of the foregoing, 29 CFR parts 4022 and 4044 are amended as follows: </AMDPAR>
                    <PART>
                        <HD SOURCE="HED">PART 4022—BENEFITS PAYABLE IN TERMINATED SINGLE-EMPLOYER PLANS </HD>
                    </PART>
                    <AMDPAR>1. The authority citation for part 4022 continues to read as follows: </AMDPAR>
                    <AUTH>
                        <HD SOURCE="HED">Authority:</HD>
                        <P>29 U.S.C. 1302, 1322, 1322b, 1341(c)(3)(D), and 1344.   </P>
                    </AUTH>
                </REGTEXT>
                <REGTEXT TITLE="29" PART="4022">
                    <AMDPAR>2. In appendix B to part 4022, Rate Set 134, as set forth below, is added to the table. (The introductory text of the table is omitted.) </AMDPAR>
                    <APPENDIX>
                        <HD SOURCE="HED">Appendix B to Part 4022—Lump Sum Interest Rates for PBGC Payments </HD>
                        <STARS/>
                        <GPOTABLE COLS="9" OPTS="L1,tp0,i1" CDEF="10C,10C,10C,10C,10C,10C,10C,10C">
                            <TTITLE>  </TTITLE>
                            <BOXHD>
                                <CHED H="1">Rate set </CHED>
                                <CHED H="1">For plans with a valuation date </CHED>
                                <CHED H="2">On or after </CHED>
                                <CHED H="2">Before </CHED>
                                <CHED H="1">
                                    Immediate annuity rate 
                                    <LI>(percent) </LI>
                                </CHED>
                                <CHED H="1">Deferred annuities (percent) </CHED>
                                <CHED H="2">
                                    i
                                    <E T="52">1</E>
                                </CHED>
                                <CHED H="2">
                                    i
                                    <E T="52">2</E>
                                </CHED>
                                <CHED H="2">
                                    i
                                    <E T="52">3</E>
                                </CHED>
                                <CHED H="2">
                                    n
                                    <E T="52">1</E>
                                </CHED>
                                <CHED H="2">
                                    n
                                    <E T="52">2</E>
                                </CHED>
                            </BOXHD>
                            <ROW>
                                <ENT I="22">  </ENT>
                            </ROW>
                            <ROW>
                                <ENT I="28">*          *          *          *          *          *          * </ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">134 </ENT>
                                <ENT>12-1-04 </ENT>
                                <ENT>1-1-05 </ENT>
                                <ENT>2.75 </ENT>
                                <ENT>4.00 </ENT>
                                <ENT>4.00 </ENT>
                                <ENT>4.00 </ENT>
                                <ENT>7 </ENT>
                                <ENT>8 </ENT>
                            </ROW>
                        </GPOTABLE>
                        <P>3. In appendix C to part 4022, Rate Set 134, as set forth below, is added to the table. (The introductory text of the table is omitted.) </P>
                    </APPENDIX>
                    <APPENDIX>
                        <HD SOURCE="HED">Appendix C to Part 4022—Lump Sum Interest Rates for Private-Sector Payments </HD>
                        <STARS/>
                        <GPOTABLE COLS="9" OPTS="L1,tp0,i1" CDEF="10C,10C,10C,10C,10C,10C,10C,10C">
                            <TTITLE>  </TTITLE>
                            <BOXHD>
                                <CHED H="1">Rate set </CHED>
                                <CHED H="1">For plans with a valuation date </CHED>
                                <CHED H="2">On or after </CHED>
                                <CHED H="2">Before </CHED>
                                <CHED H="1">
                                    Immediate annuity rate 
                                    <LI>(percent) </LI>
                                </CHED>
                                <CHED H="1">Deferred annuities (percent) </CHED>
                                <CHED H="2">
                                    i
                                    <E T="52">1</E>
                                </CHED>
                                <CHED H="2">
                                    i
                                    <E T="52">2</E>
                                </CHED>
                                <CHED H="2">
                                    i
                                    <E T="52">3</E>
                                </CHED>
                                <CHED H="2">
                                    n
                                    <E T="52">1</E>
                                </CHED>
                                <CHED H="2">
                                    n
                                    <E T="52">2</E>
                                </CHED>
                            </BOXHD>
                            <ROW>
                                <ENT I="22">  </ENT>
                            </ROW>
                            <ROW>
                                <ENT I="28">*          *          *          *          *          *          * </ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">134 </ENT>
                                <ENT>12-1-04 </ENT>
                                <ENT>1-1-05 </ENT>
                                <ENT>2.75 </ENT>
                                <ENT>4.00 </ENT>
                                <ENT>4.00 </ENT>
                                <ENT>4.00 </ENT>
                                <ENT>7 </ENT>
                                <ENT>8 </ENT>
                            </ROW>
                        </GPOTABLE>
                    </APPENDIX>
                </REGTEXT>
                <REGTEXT TITLE="29" PART="4044">
                    <PART>
                        <HD SOURCE="HED">PART 4044—ALLOCATION OF ASSETS IN SINGLE-EMPLOYER PLANS </HD>
                    </PART>
                    <AMDPAR>4. The authority citation for part 4044 continues to read as follows: </AMDPAR>
                    <AUTH>
                        <HD SOURCE="HED">Authority:</HD>
                        <P>29 U.S.C. 1301(a), 1302(b)(3), 1341, 1344, 1362.   </P>
                    </AUTH>
                </REGTEXT>
                <REGTEXT TITLE="29" PART="401">
                    <AMDPAR>5. In appendix B to part 4044, a new entry, as set forth below, is added to the table. (The introductory text of the table is omitted.) </AMDPAR>
                    <APPENDIX>
                        <HD SOURCE="HED">Appendix B to Part 4044—Interest Rates Used To Value Benefits </HD>
                        <STARS/>
                        <GPOTABLE COLS="7" OPTS="L1,tp0,i1" CDEF="s25,10C,10C,10C,10C,10C,10C">
                            <TTITLE>  </TTITLE>
                            <BOXHD>
                                <CHED H="1">For valuation dates occurring in the month— </CHED>
                                <CHED H="1">
                                    The values of i
                                    <E T="52">t</E>
                                     are: 
                                </CHED>
                                <CHED H="2">
                                    i
                                    <E T="52">t</E>
                                </CHED>
                                <CHED H="2">for t = </CHED>
                                <CHED H="2">
                                    i
                                    <E T="52">t</E>
                                </CHED>
                                <CHED H="2">for t = </CHED>
                                <CHED H="2">
                                    i
                                    <E T="52">t</E>
                                </CHED>
                                <CHED H="2">for t = </CHED>
                            </BOXHD>
                            <ROW>
                                <ENT I="22">  </ENT>
                            </ROW>
                            <ROW>
                                <ENT I="28">*          *          *          *          *          *         *</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">December 2004 </ENT>
                                <ENT>.0380 </ENT>
                                <ENT>1-20 </ENT>
                                <ENT>.0500 </ENT>
                                <ENT>&gt;20 </ENT>
                                <ENT>N/A </ENT>
                                <ENT>N/A </ENT>
                            </ROW>
                        </GPOTABLE>
                    </APPENDIX>
                </REGTEXT>
                <SIG>
                    <DATED>Issued in Washington, DC, on this 9th day of December 2004. </DATED>
                    <NAME>Joseph H. Grant, </NAME>
                    <TITLE>Deputy Executive Director and Chief Operating Officer, Pension Benefit Guaranty Corporation. </TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 04-25320 Filed 11-12-04; 8:45 am] </FRDOC>
            <BILCOD>BILLING CODE 7708-01-P </BILCOD>
        </RULE>
        <RULE>
            <PREAMB>
                <AGENCY TYPE="N">FEDERAL COMMUNICATIONS COMMISSION</AGENCY>
                <CFR>47 CFR Part 1</CFR>
                <DEPDOC>[WT Docket No. 00-230; FCC 03-113; DA 04-239; DA 04-252]</DEPDOC>
                <SUBJECT>Promoting Efficient Use of Spectrum Through Elimination of Barriers to the Development of Secondary Markets</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Federal Communications Commission.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Final rule, announcement of effective date.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The Wireless Telecommunications Bureau (Bureau) of the Federal Communications Commission (Commission) announces that certain Commission rules adopted in the Secondary Markets proceeding (WT Docket No. 00-230) in 2003, to the extent they contained information collection requirements relating to spectrum leasing notifications and applications that required approval by the Office of Management and Budget (OMB), are now in effect with the issuance of FCC Form 603-T.</P>
                </SUM>
                <EFFDATE>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>
                        Sections 1.913(a), 1.913(a)(3), 1.2002(d), 1.2003, 1.9003, 1.9020(e), 1.9030(e), and 1.9035(e), published at 68 FR 66252 (Nov. 25, 2003), contained information collection requirements that 
                        <PRTPAGE P="65545"/>
                        became effective on February 2, 2004, following approval by the Office of Management and Budget (OMB).
                    </P>
                </EFFDATE>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Paul Murray, Wireless Telecommunications Bureau, at (202) 418-7240, or via the Internet at 
                        <E T="03">Paul.Murray@fcc.gov;</E>
                         for additional information concerning the information collections contained in this document, contact Judith-B.Herman at (202) 418-0214, or via the Internet at 
                        <E T="03">Judith.B-Herman@fcc.gov.</E>
                    </P>
                    <HD SOURCE="HD1">Announcement of Effective Date of Certain Commission Rules</HD>
                    <P>
                        1. In the February 2, 2004 
                        <E T="03">Public Notice,</E>
                         DA 04-252, 19 FCC Rcd 1911, the Wireless Telecommunications Bureau announced the availability of FCC Form 603-T for use by spectrum leasing parties filing spectrum leasing notifications and applications with the Commission, and the rules requiring use of FCC Form 603-T became effective as of that date. FCC Form 603-T contain information collection necessary for the implementation of certain spectrum leasing rules adopted by the Commission in 2003 in the 
                        <E T="03">Secondary Markets First Report and Order,</E>
                         published at 68 Fed. Reg. 66252 (Nov. 25, 2003). As noted therein, the effective date of certain of the Commission's spectrum leasing rules adopted in the 
                        <E T="03">Secondary Markets First Report and Order</E>
                        —specifically sections 1.913(a), 1.913(a)(3), 1.2002(d), 1.2003, 1.9003, 1.9020(e), 1.9030(e), and 1.9035(e)—would not become effective until the information collection requirements contained in those rules were approved by the Office of Management and Budget (OMB). The Bureau reiterated this discussion regarding the effective date of certain spectrum leasing rules in its 
                        <E T="03">Memorandum Opinion and Order,</E>
                         DA 04-239, 19 FCC Rcd 1542, January 30, 2004.
                    </P>
                    <P>2. On January 29, 2004, OMB approved of the use of Form 603-T on an interim basis. Accordingly, the revisions to sections 1.913(a), 1.913(a)(3), 1.2002(d), 1.2003, and the new rules involving use of certain forms of information collection as set forth of 1.9003, 1.9020(e), 1.9030(e), and 1.9035(e) of the Commission's spectrum leasing rules, 47 CFR 1.913(a), 1.913(a)(3), 1.2002(d), 1.2003, 1.9003, 1.9020(e), 1.9030(e), and 1.9035(e), became effective with the issuance of FCC Form 603-T on February 2, 2004.</P>
                    <SIG>
                        <FP>Federal Communications Commission.</FP>
                        <NAME>Marlene H. Dortch, </NAME>
                        <TITLE>Secretary.</TITLE>
                    </SIG>
                </FURINF>
            </PREAMB>
            <FRDOC>[FR Doc. 04-25288 Filed 11-12-04; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 6712-01-P</BILCOD>
        </RULE>
        <RULE>
            <PREAMB>
                <AGENCY TYPE="S">FEDERAL COMMUNICATIONS COMMISSION</AGENCY>
                <CFR>47 CFR Part 73</CFR>
                <DEPDOC>[DA 04-3482, MB Docket No. 04-236, RM-11001]</DEPDOC>
                <SUBJECT>Digital Television Broadcast Service; Fresno, CA.</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Federal Communications Commission.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Final rule.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>
                        The Commission, at the request of KSEE License, Inc., substitutes DTV channel 38 for DTV channel 16 at Fresno, California. 
                        <E T="03">See</E>
                         69 FR 41444, July 9, 2004. DTV channel 38 can be allotted to Fresno, California, in compliance with the principle community coverage requirements of Section 73.625(a) at reference coordinates 37-04-19 N. and 119-25-48 W. with a power of 326, HAAT of 601 meters and with a DTV service population of 1224 thousand. With this action, this proceeding is terminated.
                    </P>
                </SUM>
                <EFFDATE>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Effective December 20, 2004.</P>
                </EFFDATE>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>Pam Blumenthal, Media Bureau, (202) 418-1600.</P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>
                    This is a synopsis of the Commission's Report and Order, MB Docket No. 04-236, adopted October 29, 2004, and released November 5, 2004. The full text of this document is available for public inspection and copying during regular business hours in the FCC Reference Information Center, Portals II, 445 12th Street, SW., Room CY-A257, Washington, DC. This document may also be purchased from the Commission's duplicating contractor, Best Copy and Printing, Inc., 445 12th Street, SW., Room CY-B402, Washington, DC, 20554, telephone 301-816-2820, facsimile 301-816-0169, or via-e-mail 
                    <E T="03">joshir@erols.com.</E>
                </P>
                <P>
                    This document does not contain [new or modified] information collection requirements subject to the Paperwork Reduction Act of 1995 (PRA), Public Law 104-13. In addition, therefore, it does not contain any new or modified “information collection burden for small business concerns with fewer than 25 employees,” pursuant to the Small Business Paperwork Relief Act of 2002, Public Law 107-198, 
                    <E T="03">see</E>
                     44 U.S.C. 3506(c)(4).
                </P>
                <P>
                    The Commission will send a copy of this [Report &amp; Order 
                    <E T="03">etc.</E>
                    ] in a report to be sent to Congress and the General Accounting Office pursuant to the Congressional Review Act, 
                    <E T="03">see</E>
                     5 U.S.C. 801(a)(1)(A).
                </P>
                <LSTSUB>
                    <HD SOURCE="HED">List of Subjects in 47 CFR Part 73</HD>
                    <P>Digital television broadcasting, Television.</P>
                </LSTSUB>
                <REGTEXT TITLE="47" PART="73">
                    <AMDPAR>Part 73 of title 47 of the Code of Federal Regulations is amended as follows:</AMDPAR>
                    <PART>
                        <HD SOURCE="HED">PART 73—[AMENDED]</HD>
                    </PART>
                    <AMDPAR>1. The authority citation for part 73 continues to read as follows:</AMDPAR>
                    <AUTH>
                        <HD SOURCE="HED">Authority:</HD>
                        <P>47 U.S.C. 154, 303, 334 and 336.</P>
                    </AUTH>
                </REGTEXT>
                <REGTEXT TITLE="47" PART="73">
                    <SECTION>
                        <SECTNO>§ 73.622 </SECTNO>
                        <SUBJECT>[Amended]</SUBJECT>
                    </SECTION>
                    <AMDPAR>2. Section 73.622(b), the Table of Digital Television Allotments under California, is amended by removing DTV channel 16 and adding DTV channel 38 at Fresno.</AMDPAR>
                </REGTEXT>
                <SIG>
                    <FP>Federal Communications Commission.</FP>
                    <NAME>Barbara A. Kreisman, </NAME>
                    <TITLE>Chief, Video Division, Media Bureau.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 04-25263 Filed 11-12-04; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 6712-01-P</BILCOD>
        </RULE>
    </RULES>
    <VOL>69</VOL>
    <NO>219</NO>
    <DATE>Monday, November 15, 2004</DATE>
    <UNITNAME>Proposed Rules</UNITNAME>
    <PRORULES>
        <PRORULE>
            <PREAMB>
                <PRTPAGE P="65546"/>
                <AGENCY TYPE="F">DEPARTMENT OF AGRICULTURE </AGENCY>
                <SUBAGY>Rural Housing Service </SUBAGY>
                <SUBAGY>Rural Business-Cooperative Service </SUBAGY>
                <SUBAGY>Rural Utilities Service </SUBAGY>
                <SUBAGY>Farm Service Agency </SUBAGY>
                <CFR>7 CFR Parts 1782, 1951, 1955, and 1956 </CFR>
                <RIN>RIN 0572-AB59 </RIN>
                <SUBJECT>Servicing of Water Programs Loans and Grants </SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Rural Utilities Service, USDA. </P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Proposed rule. </P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The Rural Utilities Service (RUS) proposes to consolidate and amend the regulations utilized to service water and waste loan and grant programs. The proposed rule will combine the water and waste loan and grant servicing regulations found in 7 CFR parts 1951, 1955 and 1956 into one regulation. Unnecessary and burdensome requirements for water and waste loan and grant servicing under the program will be eliminated. The streamlining of the water and waste loan and grant servicing regulation will allow RUS to provide better service to entities needing assistance in resolving financial and economic problems in their communities and in general improve the quality of life in rural areas. Additionally, this rule proposes to implement Section 6018 of the Farm Security and Rural Investment Act of 2002 (7 U.S.C. 1936a) for the Rural Business-Cooperative Service (RBS), Rural Housing Service (RHS) and RUS. </P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Comments on the proposed rule must be received on or before January 14, 2005. </P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>You may submit comments by any of the following methods: </P>
                    <P>
                        • Federal eRulemaking Portal: Go to 
                        <E T="03">http://www.regulations.gov.</E>
                         Follow the online instructions for submitting comments. 
                    </P>
                    <P>
                        • Agency Web Site: 
                        <E T="03">http://www.usda.gov/rus/index2/Comments.htm.</E>
                         Follow the instructions for submitting comments. 
                    </P>
                    <P>
                        • E-mail: 
                        <E T="03">RUSComments@usda.gov.</E>
                         Include in the subject line of the message “7 CFR 1782.” 
                    </P>
                    <P>• Mail: Addressed to Richard Annan, Acting Director, Program Development and Regulatory Analysis, Rural Utilities Service, United States Department of Agriculture, 1400 Independence Avenue, SW., STOP 1522, Washington, DC 20250-1522. </P>
                    <P>• Hand Delivery/Courier: Addressed to Richard Annan, Acting Director, Program Development and Regulatory Analysis, Rural Utilities Service, United States Department of Agriculture, 1400 Independence Avenue, SW., Room 5168-S, Washington, DC 20250-1522. </P>
                    <P>
                        <E T="03">Instructions:</E>
                         All submissions received must include the agency name and the subject heading “7 CFR 1782”. All comments received must identify the name of the individual (and the name of the entity, if applicable) who is submitting the comment. All comments received will be posted without change to 
                        <E T="03">http://www.usda.gov/rus/index2/Comments.htm</E>
                        , including any personal information provided. 
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Anita O'Brien, Loan Specialist, Water and Environmental Programs, Rural Utilities Service, Room 2230 South Building, Stop 1570, 1400 Independence Ave., SW., Washington, DC 20250-1570. Telephone: (202) 690-3789, FAX: (202) 690-0649, e-mail: 
                        <E T="03">anita.obrien@usda.gov.</E>
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <HD SOURCE="HD1">Classification </HD>
                <HD SOURCE="HD2">Executive Order 12866 </HD>
                <P>This proposed rule has been determined to be not significant for purposes of Executive Order 12866 and, therefore, has not been reviewed by the Office of Management and Budget (OMB). </P>
                <HD SOURCE="HD2">Executive Order 12988 </HD>
                <P>This proposed rule has been reviewed in accordance with Executive Order 12988, Civil Justice Reform. RUS has determined that this proposed rule meets the applicable standards provided in section 3 of the Executive Order. In addition, all State and local laws and regulations that are in conflict with this rule will be pre-empted; no retroactive effect will be given to the rule; and in accordance with sec. 212(e) of the Department of Agriculture Reorganization Act of 1994 (7 U.S.C. sec. 6912(e)), appeal procedures must be exhausted before an action against the Department or its agencies may be initiated. </P>
                <HD SOURCE="HD2">Regulatory Flexibility Act Certification </HD>
                <P>
                    It has been determined that the Regulatory Flexibility Act is not applicable to this rule since the Rural Utilities Service is not required by 5 U.S.C. 551 
                    <E T="03">et seq.</E>
                     or any other provision of law to publish a notice of proposed rulemaking with respect to the subject matter of this rule. 
                </P>
                <HD SOURCE="HD2">Information Collection and Recordkeeping Requirements </HD>
                <P>In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. chapter 35), RUS is requesting comments on the collection of information incorporated in this proposed rule. The reporting burden will be transferred from nine existing regulations into regulation 1782 and where possible, the reporting burden will be reduced. </P>
                <P>
                    <E T="03">Title:</E>
                     Servicing of Water and Waste Programs. 
                </P>
                <P>
                    <E T="03">Type of Request:</E>
                     New collection. 
                </P>
                <P>
                    <E T="03">Abstract:</E>
                     RUS' Water and Environmental Programs (WEP) provide financing and technical assistance for development and operation of safe and affordable water supply systems and sewage and other waste disposal facilities. WEP provides loans, guaranteed loans and grants for water, sewer, storm water, and solid waste disposal facilities in rural areas and towns of up to 10,000 people. The recipients of the assistance covered by 7 CFR part 1782 must be public entities. These can include municipalities, counties, special purpose districts; federally designated Indian tribes, land corporations not operated for profit, including cooperatives. The information, which is for the most part financial in nature, is needed by the Agency to determine if borrowers, based on their individual situations, qualify for the various servicing options. 
                </P>
                <P>
                    <E T="03">Estimate of Burden:</E>
                     Public reporting burden for this collection of information is estimated to average 30 hours per response. 
                    <PRTPAGE P="65547"/>
                </P>
                <P>
                    <E T="03">Respondents:</E>
                     Business or other for profit and non-profit institutions, and state and local governments. 
                </P>
                <P>
                    <E T="03">Estimated Number of Respondents:</E>
                     2,000. 
                </P>
                <P>
                    <E T="03">Estimated Number of Responses per Respondents:</E>
                     1.35. 
                </P>
                <P>
                    <E T="03">Estimated Total Annual Burden on Respondents:</E>
                     80,976 hours. 
                </P>
                <P>The subject regulation is published for public review and comment. Copies of this information collection can be obtained from Michele Brooks, Program Development and Regulatory Analysis, Rural Utilities Service. Telephone: (202) 690-1078. </P>
                <P>Comments on this information collection must be received by January 14, 2005. </P>
                <P>Comments are invited on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; (b) the accuracy of the agency's estimate of the burden of the proposed collection of information including the validity of the methodology and assumptions used; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including the use of automated collection techniques or other forms of information technology. </P>
                <P>Send comments regarding this information collection requirement to Michele Brooks, Program Development and Regulatory Analysis, USDA, Rural Utilities Service, 1400 Independence Ave., SW., Room 5166, Stop 1522, Washington, DC 20250-1522. </P>
                <P>
                    Comments are best assured of having full effect if OMB receives them within 30 days of publication in the 
                    <E T="04">Federal Register</E>
                    . All comments will be summarized, included in the request for OMB approval, and will become a matter of public record. 
                </P>
                <HD SOURCE="HD2">National Environmental Policy Act Certification </HD>
                <P>
                    The Administrator of RUS has determined that this proposed rule will not significantly affect the quality of the human environment as defined by the National Environmental Policy Act of 1969 (42 U.S.C. 4321 
                    <E T="03">et seq.</E>
                    ). Therefore, this action does not require an environmental impact statement or assessment. 
                </P>
                <HD SOURCE="HD2">Catalog of Federal Domestic Assistance </HD>
                <P>The program described by this proposed rule is listed in the Catalog of Federal Domestic Assistance Programs under numbers (1) 10.760—Water and Waste Disposal System for Rural Communities, (2) 10.761—Technical Assistance and Training Grants, (3) 10.762—Solid Waste Management Grants (4) 10.763—Emergency Community Assistance Grants, and (5) 10.770—section 306C Water and Waste Loans and Grants. This catalog is available on a subscription basis from the Superintendent of Documents, the United States Government Printing Office, Washington, DC 20402-9325, telephone number (202) 512-1800. </P>
                <HD SOURCE="HD2">Executive Order 12372 </HD>
                <P>This program is listed in the Catalog of Federal Domestic Assistance under numbers (1) 10.760—Water and Waste Disposal (WWD) System for Rural Communities, (2) 10.763—Emergency Community Assistance Grants, and (3) 10.770—Water and Waste Loans and Grants (section 306C), and is subject to the provisions of Executive Order 12372 which requires intergovernmental consultation with State and local officials. </P>
                <HD SOURCE="HD2">Unfunded Mandates </HD>
                <P>This rule contains no Federal mandates (under the regulatory provision of title II of the Unfunded Mandates Reform Act of 1995) for State, local, and tribal governments or the private sector. Therefore, this rule is not subject to the requirements of section 202 and 205 of the Unfunded Mandates Reform Act. </P>
                <HD SOURCE="HD2">Executive Order 13132, Federalism </HD>
                <P>The policies contained in this proposed rule do not have any substantial direct effect on states, on the relationship between the national government and the states, or on the distribution of power and responsibilities among the various levels of government. Nor does this proposed rule impose substantial direct compliance costs on state and local governments. Therefore, consultation with states is not required. </P>
                <HD SOURCE="HD1">Background </HD>
                <P>
                    RUS' water and waste program is administered by Water and Environmental Programs (WEP). The water and waste loan and grant programs are authorized by various sections of the Consolidated Farm and Rural Development Act (7 U.S.C. 1921 
                    <E T="03">et seq.</E>
                    ), as amended. The regulations for these programs have not been completely reviewed for many years. The 1994 streamlining and reorganization of the Department of Agriculture provided an opportunity to review and rewrite the water and waste loan and grant servicing regulations. A task force was formed for that purpose. The aim of the task force was to make the regulations easier to understand, eliminate unnecessary requirements, and continue to protect the interest of the U. S. taxpayer. The program provides loan servicing options for communities facing financial problems. Servicing options should result in reasonable user costs for rural residents, rural businesses, and other rural users. Additionally, in order to provide uniformity, servicing provisions for grants are addressed in the Departmental Grant Regulations listed cited in 1782.7. 
                </P>
                <P>
                    <E T="03">Major changes are:</E>
                </P>
                <P>1. Combines servicing regulations found in 7 CFR parts 1951, 1955 and 1956 into one regulation. </P>
                <P>2. The field staff is provided with more authority to service water and waste loans and grants. </P>
                <P>3. The application process for servicing actions has been streamlined to reduce unnecessary paperwork and improve service to the rural communities. There will be fewer regulations and the number of pages in the Code of Federal Regulations will be greatly reduced. </P>
                <P>
                    4. The functions of the former Farmers Home Administration (FmHA) and the Rural Development Administration (RDA) relating to the water and waste loan and grant programs authorized by various sections of the Consolidated Farm and Rural Development Act, (7 U.S.C. 1926(a)), have been transferred to RUS based on the Department of Agriculture Reorganization Act of 1994, 7 U.S.C. 6942. Therefore in order to enhance the delivery of borrower services and better assist the public, RUS is simplifying and rewriting regulations originally published by FmHA and RDA. All parts pertaining to the water and waste loan program will be moved into 7 CFR part 1782. This action will have no effect on the Rural Housing Services (RHS) community facilities loan program, as this action makes no policy changes in the regulation with the exception of implementing section 6018 of the Farm Security and Rural Investment Act of 2002 (7 U.S.C. 1936a). The following programs are affected by these amendments: (1) Water and Waste Disposal Loans and Grants, (2) Watershed loans and advances, (3) Resource Conservation and Development loans, (4) Technical Assistance and Training grants, (5) Emergency Community Assistance grants, (6) Solid Waste Management grants, and (7) Section 306C Water and Waste Facility Loans and Grants to Alleviate Health Risks. 
                    <PRTPAGE P="65548"/>
                </P>
                <P>5. Implement Sec. 6018 of the Farm Security and Rural Investment Act of 2002. This change will allow the borrower or grant recipient to use property (real and personal) purchased or improved with the loan or grant funds or proceeds from the sale of property (real and personal) purchased with such funds, for another project or activity. The RUS proposes to include language to implement this provision in 7 CFR 1782.23. These provisions will also be applicable to the RBS and RHS programs by adding § 1951.218 to 7 CFR part 1951, subpart E. </P>
                <HD SOURCE="HD1">The Regulations </HD>
                <P>RUS has completed a consolidation of regulations affecting WEP loans and grants. Prior to this rule becoming effective, WEP borrowers were affected, in part, by the following regulations: </P>
                <P>7 CFR part 1951, subpart A—Account Servicing Policies. </P>
                <P>7 CFR part 1951, subpart D—Final Payment on Loans. </P>
                <P>7 CFR part 1951, subpart E—Servicing of Community and Direct Business Programs Loans and Grants. </P>
                <P>7 CFR part 1951, subpart F—Analyzing Credit Needs and Graduation of Borrowers. </P>
                <P>7 CFR part 1951, subpart O—Servicing Cases Where Unauthorized Loan(s) or Other Financial Assistance Was Received—Community and Insured Business Programs. </P>
                <P>7 CFR part 1955, subpart A—Liquidation of Loans Secured by Real Estate and Acquisition of Real and Chattel Property. </P>
                <P>7 CFR part 1955, subpart B—Management of Property. </P>
                <P>7 CFR part 1955, subpart C—Disposal of Inventory Property. </P>
                <P>7 CFR part 1956, subpart C—Debt Settlement—Community and Business Programs. </P>
                <P>All of the above mentioned regulations include regulatory provisions of other programs of the former FmHA such as farm loans, business and industrial loans, single family housing, and multi-family housing. RUS is consolidating all regulatory actions in the above mentioned regulations which affect WEP loan and grant servicing into one new regulation—7 CFR part 1782. This consolidated regulation will clarify for our borrowers and grantees, the available servicing tools and the requirements to utilize these tools. </P>
                <P>Additionally, RUS proposes to remove all administrative processes from the regulations, leaving only regulatory actions that impact the public. This streamlining will make the regulation more concise and much easier to read and understand. The Agency will issue a Staff Instruction that will include the administrative portion, which outlines the Agency's internal processing procedures. The Staff Instruction will be available to the public upon request at no cost. </P>
                <HD SOURCE="HD1">Conclusion </HD>
                <P>RUS believes the consolidation and streamlining of the regulations for this program will maximize the ability of the Borrowers to use and understand the available servicing tools under this program. This consolidation is consistent with the Administration's efforts to streamline Government functions, improve the efficiency and effectiveness of Government activities, and strive to be more borrower friendly. This effort will enable the Agency to reduce regulations, streamline Agency operations and provide servicing assistance with fewer staff resources. </P>
                <LSTSUB>
                    <HD SOURCE="HED">List of Subjects </HD>
                    <CFR>7 CFR Part 1782 </CFR>
                    <P>Accounting, Appeal procedures, Auditing, Debts, Delinquency, Grant programs—Agriculture, Insurance, Loan programs—Agriculture.</P>
                    <CFR>7 CFR Part 1951 </CFR>
                    <P>Accounting, Credit, Grant programs—Agriculture, Loan Programs—Agriculture, Low and moderate-income housing loans—Rent subsidies, reporting, and recordkeeping requirements, Rural areas. </P>
                    <CFR>7 CFR Part 1955 </CFR>
                    <P>Government property, Government property management, Surplus government property. </P>
                    <CFR>7 CFR Part 1956 </CFR>
                    <P>Accounting, Loan programs—Agriculture, Rural areas. </P>
                </LSTSUB>
                <REGTEXT TITLE="7" PART="1782">
                    <P>Therefore, chapters XVII and XVIII of title 7, Code of Federal Regulations are proposed to be amended as follows: </P>
                    <CHAPTER>
                        <HD SOURCE="HED">CHAPTER XVII—RURAL UTILITIES SERVICE, DEPARTMENT OF AGRICULTURE </HD>
                    </CHAPTER>
                    <P>1. Part 1782 is added to read as follows: </P>
                    <PART>
                        <HD SOURCE="HED">PART 1782—SERVICING OF WATER AND WASTE PROGRAMS </HD>
                        <CONTENTS>
                            <SECHD>Sec. </SECHD>
                            <SECTNO>1782.1 </SECTNO>
                            <SUBJECT>Purpose. </SUBJECT>
                            <SECTNO>1782.2 </SECTNO>
                            <SUBJECT>Objectives. </SUBJECT>
                            <SECTNO>1782.3 </SECTNO>
                            <SUBJECT>Definitions. </SUBJECT>
                            <SECTNO>1782.4 </SECTNO>
                            <SUBJECT>Availability of forms and regulations. </SUBJECT>
                            <SECTNO>1782.5 </SECTNO>
                            <SUBJECT>Nondiscrimination. </SUBJECT>
                            <SECTNO>1782.6 </SECTNO>
                            <SUBJECT>[Reserved]. </SUBJECT>
                            <SECTNO>1782.7 </SECTNO>
                            <SUBJECT>Grants. </SUBJECT>
                            <SECTNO>1782.8 </SECTNO>
                            <SUBJECT>Payments. </SUBJECT>
                            <SECTNO>1782.9 </SECTNO>
                            <SUBJECT>Environmental requirements. </SUBJECT>
                            <SECTNO>1782.10 </SECTNO>
                            <SUBJECT>Audit requirements. </SUBJECT>
                            <SECTNO>1782.11 </SECTNO>
                            <SUBJECT>Refinancing requirements. </SUBJECT>
                            <SECTNO>1782.12 </SECTNO>
                            <SUBJECT>Sale or exchange of security property. </SUBJECT>
                            <SECTNO>1782.13 </SECTNO>
                            <SUBJECT>Transfer of Security and Assumption of Loans. </SUBJECT>
                            <SECTNO>1782.14 </SECTNO>
                            <SUBJECT>Protection of Service Areas—7 U.S.C. 1926(b). </SUBJECT>
                            <SECTNO>1782.15 </SECTNO>
                            <SUBJECT>Mergers and consolidations. </SUBJECT>
                            <SECTNO>1782.16 </SECTNO>
                            <SUBJECT>Defeasance of RUS indebtedness. </SUBJECT>
                            <SECTNO>1782.17 </SECTNO>
                            <SUBJECT>Subordination of security or parity lien. </SUBJECT>
                            <SECTNO>1782.18 </SECTNO>
                            <SUBJECT>[Reserved]. </SUBJECT>
                            <SECTNO>1782.19 </SECTNO>
                            <SUBJECT>Third party agreements. </SUBJECT>
                            <SECTNO>1782.20 </SECTNO>
                            <SUBJECT>Debt Settlement. </SUBJECT>
                            <SECTNO>1782.21 </SECTNO>
                            <SUBJECT>[Reserved] </SUBJECT>
                            <SECTNO>1782.22 </SECTNO>
                            <SUBJECT>Exception authority. </SUBJECT>
                            <SECTNO>1782.23 </SECTNO>
                            <SUBJECT>Use of Rural Development Loans and Grants for Other Purposes. </SUBJECT>
                            <SECTNO>1782.24—1782.99 </SECTNO>
                            <SUBJECT>[Reserved]. </SUBJECT>
                            <SECTNO>1782.100 </SECTNO>
                            <SUBJECT>OMB Control Number. </SUBJECT>
                        </CONTENTS>
                        <AUTH>
                            <HD SOURCE="HED">Authority:</HD>
                            <P>5 U.S.C. 301; 7 U.S.C. 1981; 16 U.S.C. 1005. </P>
                        </AUTH>
                        <SECTION>
                            <SECTNO>§ 1782.1 </SECTNO>
                            <SUBJECT>Purpose. </SUBJECT>
                            <P>This part outlines the Rural Utilities Service's (RUS) policies and procedures for servicing direct and insured Water and Waste Disposal loans and grants; Watershed loans and advances; Resource Conservation and Development loans; Technical Assistance and Training grants; Emergency Community Water Assistance grants; Solid Waste Management grants; and section 306C WWD loans and grants. </P>
                        </SECTION>
                        <SECTION>
                            <SECTNO>§ 1782.2 </SECTNO>
                            <SUBJECT>Objectives. </SUBJECT>
                            <P>Loan and grant servicing is provided by RUS in order to assist recipients in complying with the established objectives and requirements for loans and grants, repaying loans on schedule, acting in accordance with any necessary agreements, and protecting RUS’ financial interest. Servicing by RUS includes, but is not limited to, the review of budgets, management reports, audits and financial statements; performing security inspections; providing, arranging or recommending technical assistance; evaluating environmental impacts of proposed actions by the Borrower; and performing civil rights compliance and graduation reviews. </P>
                        </SECTION>
                        <SECTION>
                            <SECTNO>§ 1782.3 </SECTNO>
                            <SUBJECT>Definitions. </SUBJECT>
                            <P>
                                <E T="03">Acceleration.</E>
                                 A written notice informing the borrower that the total unpaid principal and interest is due and payable immediately. 
                            </P>
                            <P>
                                <E T="03">Adjustment.</E>
                                 Satisfaction of a debt, including release of liability, when acceptance by the agency is conditioned upon completion of payment of the adjusted amount at a specific time or times; with or without the payment of 
                                <PRTPAGE P="65549"/>
                                any consideration when the adjustment offer is approved. An adjustment is not a final settlement until all payments under the adjustment agreement have been made. 
                            </P>
                            <P>
                                <E T="03">Administrator.</E>
                                 Administrator of RUS. 
                            </P>
                            <P>
                                <E T="03">Agency.</E>
                                 RUS or any employee acting on its behalf in accordance with appropriate delegations of authority. 
                            </P>
                            <P>
                                <E T="03">Assumption of debt.</E>
                                 Agreement by one party to legally bind itself to pay the debt incurred by another. 
                            </P>
                            <P>
                                <E T="03">Borrower.</E>
                                 Recipient of RUS or predecessor agency loan assistance. 
                            </P>
                            <P>
                                <E T="03">Cancellation.</E>
                                 Final discharge of debt with a release of liability. 
                            </P>
                            <P>
                                <E T="03">Chargeoff.</E>
                                 Write off of a debt and termination of servicing activity without release of liability. A Chargeoff is a decision upon the part of the Agency to remove debt from Agency receivables; however, future payments may be received. 
                            </P>
                            <P>
                                <E T="03">Compromise.</E>
                                 Satisfaction of a debt including a release of liability by accepting a lump-sum payment of less than the total amount owed. 
                            </P>
                            <P>
                                <E T="03">Defeasance.</E>
                                 Defeasance is the use of invested proceeds from a new bond issue to repay outstanding bonds in accordance with the repayment schedule of the outstanding bonds. The new issue supersedes the contractual agreements from the prior issue. 
                            </P>
                            <P>
                                <E T="03">Disposition of facility.</E>
                                 Relinquishing control of a facility to another entity. 
                            </P>
                            <P>
                                <E T="03">False information.</E>
                                 Information, known to be incorrect, provided with the intent to obtain benefits which would not have been obtainable based on correct information. 
                            </P>
                            <P>
                                <E T="03">Government.</E>
                                 The United States of America acting through the RUS, USDA. USDA and RUS may be used interchangeably throughout this part. 
                            </P>
                            <P>
                                <E T="03">Grantee.</E>
                                 Recipient of RUS or predecessor agency grant assistance, technical assistance, or services. 
                            </P>
                            <P>
                                <E T="03">Letter of Conditions.</E>
                                 A written document that describes the conditions which the borrower and/or grantee must meet for funds to be advanced and the loan and/or grant to be closed. 
                            </P>
                            <P>
                                <E T="03">Liquidation.</E>
                                 To satisfy a debt through the sale of a borrower's assets and discharge of liabilities. 
                            </P>
                            <P>
                                <E T="03">Parity Lien.</E>
                                 A lien having an equal lien position to another lender's lien on a borrower's asset. 
                            </P>
                            <P>
                                <E T="03">Reasonable rates and terms.</E>
                                 Commercial rates and terms borrowers are expected to pay when borrowing for similar purposes and periods of time. 
                            </P>
                            <P>
                                <E T="03">Rural Development.</E>
                                 The mission area of the Under Secretary for Rural Development. Rural Development State and local offices administer the water and waste programs on behalf of RUS. 
                            </P>
                            <P>
                                <E T="03">Rural Utilities Service (RUS).</E>
                                 An Agency of the USDA established pursuant to section 232 of the Department of Agriculture Reorganization Act of 1994 (Pub. L. 103-354). 
                            </P>
                            <P>
                                <E T="03">Servicing office.</E>
                                 The USDA office which maintains the official file of the borrower or grantee and is responsible for the routine servicing of the loan and grant account. 
                            </P>
                            <P>
                                <E T="03">Servicing official.</E>
                                 A USDA official who has been delegated loan and grant approval and servicing authorities subject to any dollar limitations within applicable programs. 
                            </P>
                            <P>
                                <E T="03">Settlement.</E>
                                 Compromise, adjustment, cancellation, or chargeoff of a debt owed USDA. The term “settlement” is used for convenience in referring to compromise, adjustment, cancellation, or chargeoff action, individually or collectively. 
                            </P>
                            <P>
                                <E T="03">Subordination agreement.</E>
                                 A formal agreement whereby RUS permits another lender to have a senior or prior lien position on a borrower's assets to facilitate the borrower's obtaining financing from another source of credit. A subordinate lien position is an inferior or junior lien position. 
                            </P>
                            <P>
                                <E T="03">USDA.</E>
                                 United States Department of Agriculture. 
                            </P>
                            <P>
                                <E T="03">Unliquidated obligations.</E>
                                 Obligated loan or grant funds that have not been advanced. 
                            </P>
                            <P>
                                <E T="03">Voluntary conveyance.</E>
                                 A method by which title to security is voluntarily transferred to the Government. 
                            </P>
                        </SECTION>
                        <SECTION>
                            <SECTNO>§ 1782.4 </SECTNO>
                            <SUBJECT>Availability of forms and regulations. </SUBJECT>
                            <P>
                                Information about the availability of forms, regulations, bulletins, and procedures referenced in this chapter are available in any office of the USDA/Rural Development or RUS, United States Department of Agriculture, Washington, DC 20250-1500 or at the Web site 
                                <E T="03">http://www.usda.gov/rus/water.</E>
                            </P>
                        </SECTION>
                        <SECTION>
                            <SECTNO>§ 1782.5 </SECTNO>
                            <SUBJECT>Nondiscrimination. </SUBJECT>
                            <P>Each instrument of conveyance required for a transfer, assumption, sale of facility, or other servicing action under this subpart will comply with Title VI of the Civil Rights Act of 1964, Title IX of the Education Amendments of 1972, section 504 of the Rehabilitation Act of 1973, and other similarly worded Federal statutes and regulations issued pursuant thereto that prohibits discrimination on the basis of race, color, national origin, handicap, religion, age, or sex in programs or activities receiving Federal financial assistance. Such provisions apply for as long as the property continues to be used for the same or similar purposes for which the Federal assistance was extended, or for so long as the purchaser owns it, whichever is later. </P>
                        </SECTION>
                        <SECTION>
                            <SECTNO>§ 1782.6 </SECTNO>
                            <SUBJECT>[Reserved] </SUBJECT>
                        </SECTION>
                        <SECTION>
                            <SECTNO>§ 1782.7 </SECTNO>
                            <SUBJECT>Grants. </SUBJECT>
                            <P>Servicing actions relating to RUS grants are governed by the provisions of 7 CFR parts 3015, 3016, 3017, 3018, 3019, 3021, and 3052 as applicable, and Executive Order (E.O.) 12803. Grantees remain responsible for property acquired with grant funds in accordance with terms of a grant agreement and applicable regulations. </P>
                        </SECTION>
                        <SECTION>
                            <SECTNO>§ 1782.8 </SECTNO>
                            <SUBJECT>Payments. </SUBJECT>
                            <P>Payments will be applied in accordance with the terms of the debt instrument. Information on non-typical payments can be obtained from the Servicing official or office. All new borrowers will use pre-authorized debits as required in their Letter of Conditions. </P>
                        </SECTION>
                        <SECTION>
                            <SECTNO>§ 1782.9 </SECTNO>
                            <SUBJECT>Environmental requirements. </SUBJECT>
                            <P>Servicing actions involving subordination and lease or sale of RUS owned property will be reviewed for compliance with 7 CFR part 1794 as required in § 1794.3. The appropriate environmental review will be completed prior to approval of the servicing action. </P>
                        </SECTION>
                        <SECTION>
                            <SECTNO>§ 1782.10 </SECTNO>
                            <SUBJECT>Audit requirements. </SUBJECT>
                            <P>Audits for loans will be required in accordance with § 1780.47 of this title. If the borrower becomes delinquent or is experiencing problems, the servicing official will require an audit or other documentation deemed necessary to resolve the delinquency. The provisions of 7 CFR part 3052 address audit requirements for recipients of federal grants. </P>
                        </SECTION>
                        <SECTION>
                            <SECTNO>§ 1782.11 </SECTNO>
                            <SUBJECT>Refinancing requirements. </SUBJECT>
                            <P>If at any time it appears to the Government that the borrower is able to refinance the amount of the indebtedness then outstanding, in whole or in part, by obtaining a loan for such purposes from responsible cooperative or private credit sources, at reasonable rates and terms, the borrower will, upon request of the Government, apply for and accept such loan in sufficient amount to repay the Government and will take all such actions as may be required in connection with such loan. </P>
                        </SECTION>
                        <SECTION>
                            <SECTNO>§ 1782.12 </SECTNO>
                            <SUBJECT>Sale or exchange of security property. </SUBJECT>
                            <P>
                                A cash sale of all or a portion of a borrower's assets or an exchange of security property may be approved subject to the conditions set forth in this section. 
                                <PRTPAGE P="65550"/>
                            </P>
                            <P>
                                (a) 
                                <E T="03">Approval conditions.</E>
                                 Approval may be given when the servicing official determines that: 
                            </P>
                            <P>(1) The consideration is for the full amount of the debt or the present fair market value as determined by an appraisal completed by a qualified Rural Development employee or an independent appraiser as determined appropriate by the approval official; </P>
                            <P>(2) The sale or exchange will not prevent carrying out the purpose of the loan; </P>
                            <P>(3) The remaining property is adequate security for the loan and the transaction will not adversely affect RUS' security position; </P>
                            <P>(4) If the property to be sold or exchanged will be used for similar purposes that the loan was made, the purchaser will: </P>
                            <P>(i) Execute Form RD 400-4, “Assurance Agreement.” The instrument of conveyance will contain the civil rights covenant referenced in 7 CFR 1901.202(e); and </P>
                            <P>(ii) Provide RUS with a written agreement assuming all rights and obligations of the original borrower, and </P>
                            <P>(5) Proceeds remaining after paying any reasonable and necessary selling expenses are to be used for one or more of the following purposes: </P>
                            <P>(i) To pay RUS debt, pay on debts secured by a prior lien, and pay on debts secured by a parity or subsequent lien if it is to RUS' advantage; </P>
                            <P>(ii) To purchase or acquire property more suited to the borrower's needs, providing RUS security position is maintained; and </P>
                            <P>(iii) To develop or enlarge the facility if necessary to improve the borrower's debt-paying ability, place the operation on a sounder financial basis, or further the loan objectives and purposes. </P>
                            <P>
                                (b) 
                                <E T="03">Sale of assets financed with RUS grants.</E>
                                 The requirements for the sale or disposition of assets financed with RUS grants are determined by the terms of the grant agreement, 7 CFR parts 3015, 3016, and 3019, and E.O. 12803, as applicable. 
                            </P>
                            <P>
                                (c) 
                                <E T="03">Release from liability.</E>
                                 If a borrower can no longer meet the objectives of the loan, the property may be sold. If the full amount of the borrower's debt is paid or assumed, the State Director may release the borrower from liability. 
                            </P>
                        </SECTION>
                        <SECTION>
                            <SECTNO>§ 1782.13 </SECTNO>
                            <SUBJECT>Transfer of Security and Assumption of Loans. </SUBJECT>
                            <P>It is RUS policy to approve transfers and assumptions to transferees that will continue the original purpose of the loan. Assistant Administrator written concurrence is required when the transfer exceeds the State Director's loan approval authority. The transfer will be approved in accordance with the following requirements:</P>
                            <P>
                                (a) 
                                <E T="03">General requirements for transferees.</E>
                                 The fulfillment of the following requirements for transfers will be determined by the approval official, in his or her discretion: 
                            </P>
                            <P>(1) The transferees must meet the eligibility requirements of 7 CFR 1780.7 and provide the same information required in 7 CFR Part 1780, subpart B for application processing. </P>
                            <P>(2) The transfer will not be disadvantageous to the Government as determined by the approval official. </P>
                            <P>(3) If the RUS debt(s) exceeds the present market value of the security as determined by an appraisal, the transferee will assume an amount at least equal to the present market value. </P>
                            <P>(4) RUS must concur in plans for disposition of funds in any reserve account, including project construction bank accounts. A reserve account may be considered as a transferable asset. </P>
                            <P>(5) The transferee will assume all of the borrower's responsibilities regarding loans. The transferee will also agree to accept the original loan conditions plus any conditions set forth by RUS with regard to the transfer. </P>
                            <P>(6) A current appraisal will be completed to establish the present market value of the security when the full debt is not being assumed. </P>
                            <P>(7) There must be no lien, judgement, or similar claims of other parties against the RUS security being transferred unless the transferee is willing to accept such claims. RUS must also determine that the claims will not prevent the transferee from repaying the RUS debt, meeting all operating and maintenance costs, and maintaining required reserves. The written consent of any other lienholder will be obtained where required. </P>
                            <P>(8) A letter of conditions establishing requirements to be met in connection with the transfer will be issued, and the transferee will be required to execute Form RD 1942-46, “Letter of Intent to Meet Conditions,” prior to closing of the transfer. </P>
                            <P>(9) The transferee will obtain insurance according to RUS requirements. </P>
                            <P>(10) The effective date of the transfer is the date the transfer is closed, which is the same date Form RD 1951-15, “Community Programs Assumption Agreement,” or other appropriate assumption agreement, which is executed and delivered by all necessary parties. </P>
                            <P>
                                (11) Title to all assets will be conveyed from the transferor to the transferee unless all parties concerned, including RUS, agree upon other arrangements. All instruments of conveyance will contain the necessary nondiscrimination covenant as referred to in 
                                <E T="03">§ 1782.5.</E>
                            </P>
                            <P>(12) If the transfer and assumption is to one or more members of the borrower's organization, there must not be a loss to the Government. </P>
                            <P>(13) The State Director is authorized to approve transfers to eligible transferees at the same interest rate as on the borrower's note(s) or bond(s). The maturity of the debt instrument for the assumed debt may not exceed the lesser of the repayment period authorized in 7 CFR 1780.13(e) for a “new” loan or the expected life of the facility. </P>
                            <P>(14) RUS National Office concurrence is required for transfers not in compliance with paragraphs (a)(1) through (14) of this section. </P>
                            <P>
                                (b) 
                                <E T="03">Loan requirements for eligible transferees.</E>
                                 If a loan is evidenced and secured by a note and lien on real or chattel property, Form RD 1951-15, or other appropriate assumption agreement will be executed by the transferee. If a bond secures a loan, transfer documents will be developed by bond counsel and approved by Office of the General Counsel, USDA (OGC). 
                            </P>
                            <P>(1) Loans being transferred and assumed may be combined when the security is the same, new terms are being provided, a new debt instrument will be issued, and the loans have the same interest rate and are for the same purpose. If applicable, 7 CFR 1780.94(l) will govern the preparation of any new debt instruments required. </P>
                            <P>(2) A loan may be made in connection with a transfer if the transferee meets all eligibility and other requirements for the kind of loan being made. Such a loan will be considered as a separate loan, and must be evidenced by a separate debt instrument. However, it is permissible to have one authorizing loan resolution or ordinance if permitted by State statutes. </P>
                            <P>(3) Any development funds remaining in a bank account that are not refunded to RUS will be transferred to a bank account for the transferee. This will occur simultaneously with the closing of the transfer and the funds will be used in completing planned development. </P>
                            <P>
                                (c) 
                                <E T="03">Release from liability.</E>
                                 Transferors may be released from liability when their debt is paid in full or when the debt is settled in accordance with § 1782.20 of this part. 
                            </P>
                            <P>
                                (d) 
                                <E T="03">Transfer of facility financed with RUS grants.</E>
                                 The requirements for the sale or disposition of assets financed with RUS grants are determined by the terms of the grant agreement, 7 CFR 
                                <PRTPAGE P="65551"/>
                                parts 3015, 3016, and 3019, and E.O. 12803, as applicable. 
                            </P>
                        </SECTION>
                        <SECTION>
                            <SECTNO>§ 1782.14 </SECTNO>
                            <SUBJECT>Protection of Service Areas—7 U.S.C. 1926(b). </SUBJECT>
                            <P>(a) 7 U.S.C. 1926(b) was enacted to protect the service area of RUS borrowers with outstanding loans, or those loans sold in the sale of assets authorized by the “Joint Resolution Making Continuing Appropriations for the Fiscal Year 1987, Pub. L. 99-591, 100 Stat. 3341 (1986),” from loss of users due to actions or activities of other entities in the service area of the RUS financed system. Without this protection, other entities could extend service to users within the service area and thereby undermine the purpose of the congressionally mandated water and waste loan and grant programs; and jeopardize the borrower's ability to repay its RUS debt. </P>
                            <P>(b) Responsibility for initiating action in response to those actions prohibited by 7 U.S.C. 1926(b) rests with the borrower.</P>
                        </SECTION>
                        <SECTION>
                            <SECTNO>§ 1782.15 </SECTNO>
                            <SUBJECT>Mergers and consolidations. </SUBJECT>
                            <P>Mergers and consolidations will be processed the same as a transfer and assumption, although approvals by RUS will give consideration to the differences under the applicable law regarding the type of transaction under consideration. Mergers occur when two or more entities combine in such a manner that only one remains in existence. Consolidations occur when two or more entities combine to form a new consolidated entity, and the original entities cease to exist. In both mergers and consolidations, the surviving or emerging entity acquires the assets and assumes the liabilities of the entity or entities that ceased to exist. </P>
                        </SECTION>
                        <SECTION>
                            <SECTNO>§ 1782.16 </SECTNO>
                            <SUBJECT>Defeasance of RUS indebtedness. </SUBJECT>
                            <P>Defeasance, or amending outstanding loan instruments and agreements to permit defeasance of RUS debt instruments, is not authorized. </P>
                        </SECTION>
                        <SECTION>
                            <SECTNO>§ 1782.17 </SECTNO>
                            <SUBJECT>Subordination of security or parity lien. </SUBJECT>
                            <P>In order for RUS to agree to either a subordination or to a parity lien position, the borrower must submit a written request to the servicing office. </P>
                            <P>(a) The written request for parity or subordination must contain the following items: </P>
                            <P>(1) An explanation of the purpose of the request for parity or subordination; amount of loan for which parity or subordination is requested; description of security property; type of security instrument; name, and address of financial institution requesting the transaction; and other information determined necessary by the servicing official to evaluate the request. </P>
                            <P>(2) Current financial statements or an audit, if available or determined necessary by the servicing official. </P>
                            <P>(3) An annual operating budget which projects income and expenses for a typical year's operation. If construction is involved, the budget must be projected through the first full year of operation following completion of the planned improvements. </P>
                            <P>(4) A copy of the proposed security instrument. </P>
                            <P>(5) A certification from the borrower that the RUS debt cannot be refinanced at reasonable rates and terms. </P>
                            <P>(6) An appraisal, when the primary security is real estate or determined necessary by the servicing official in order to determine the adequacy of loan security or repayment ability. </P>
                            <P>(7) A certification that any development work will comply with subpart C of part 1780 of this chapter. </P>
                            <P>(8) Requests for a subordination of security are subject to the appropriate environmental review as required by § 1794.3 of this chapter. </P>
                            <P>(b) Requests for parity or subordination must comply with requirements of paragraph (a) of this section, requirements as specified in the bond or loan documents, the requirements as specified in § 1780.94(i) of this chapter, and as provided in applicable State law. </P>
                            <P>(c) Proposals for tax exempt issues will be considered for parity only. </P>
                            <P>(d) Once the borrower has met all of the requirements in paragraphs (a), (b) and (c) of this section and the proposal is determined to be in the Government's interest, RUS will then grant approval of the borrower's request for parity or subordination. </P>
                        </SECTION>
                        <SECTION>
                            <SECTNO>§ 1782.18 </SECTNO>
                            <SUBJECT>[Reserved] </SUBJECT>
                        </SECTION>
                        <SECTION>
                            <SECTNO>§ 1782.19 </SECTNO>
                            <SUBJECT>Third party agreements. </SUBJECT>
                            <P>The State Director may authorize third party operation, maintenance, and management of an RUS financed facility. The borrower's attorney must review the contract, management agreement, written lease or other third party agreement and issue an opinion to the agency as to their legal sufficiency. The borrower shall retain the legal authority necessary for owning, constructing, operating and maintaining the facility. </P>
                        </SECTION>
                        <SECTION>
                            <SECTNO>§ 1782.20 </SECTNO>
                            <SUBJECT>Debt settlement. </SUBJECT>
                            <P>Pursuant to 7 U.S.C. 1981 this section prescribes policies for debt settlement of Water and Waste Disposal Loans; Watershed loans and advances; Resource Conservation and Development loans; and 306(c) Water and Waste Facility loans. </P>
                            <P>
                                (a) 
                                <E T="03">General requirements for debt settlement.</E>
                                 (1) The debt or any extension thereof on which settlement is requested must be due and payable. The debt will be due and payable either under the terms of the note or other instrument, or by acceleration, unless the debt is to be cancelled without application under paragraph (e)(2) of this section or charged off under paragraph (f) of this section. 
                            </P>
                            <P>(2) Normally, all security will be disposed of prior to the date of application for debt settlement unless it is necessary to abandon security through the debt settlement process. In such cases, debt settlement may proceed if the servicing official determines that further collection efforts would be ineffective, uneconomical, and not in the best interests of the Government. </P>
                            <P>(3) Debtors will not be permitted to sell security and use the proceeds as part or all of a compromise/adjustment debt settlement offer. </P>
                            <P>
                                (4) Request for debt settlement will consist of Form RD 1956-1 “Application For Settlement of Indebtedness,” current financial information, description and estimated market value of collateral, and status of operation (
                                <E T="03">i.e.</E>
                                 number of users, compliance with environmental issues, etc.). 
                            </P>
                            <P>(5) OGC advice on compliance with State or Federal statutes that may affect the debt settlement action must be requested. </P>
                            <P>
                                (b) 
                                <E T="03">Debts ineligible for settlement.</E>
                                 Debts will not be settled if: 
                            </P>
                            <P>(1) Referral to OIG and/or to OGC is contemplated or pending because of suspected criminal violation, or </P>
                            <P>(2) Civil action to protect the interest of the Government is contemplated or pending, or </P>
                            <P>(3) An investigation for suspected fiscal irregularity is contemplated or pending, or </P>
                            <P>(4) The debtor requests settlement of a claim that has been referred to or a judgment obtained by the United States Attorney. The settlement offer and any related payment must be submitted directly to the United States Attorney for consideration. </P>
                            <P>
                                (c) 
                                <E T="03">Types of debt settlement.</E>
                                 Typically, debt settlement will be accomplished through compromise/adjustment, chargeoff, or cancellation. Any debt remaining after the security has been liquidated, by sale or transfer, will be cancelled if there are no other assets from which to collect the debt. The servicing official will proceed with 
                                <PRTPAGE P="65552"/>
                                advice from OGC and the National Office, as required. 
                            </P>
                            <P>
                                (d) 
                                <E T="03">Compromise and adjustment.</E>
                                 Debts may be compromised or adjusted and security retained by the debtor, provided: 
                            </P>
                            <P>(1) The debtor is unable to pay the indebtedness in full, and </P>
                            <P>(2) The debtor has offered an amount equal to the present fair market value of all security or facility financed, and </P>
                            <P>(3) The debtor has offered any additional amount that the debtor is able to pay. </P>
                            <P>
                                (e) 
                                <E T="03">Cancellation.</E>
                                 Nonjudgment debts, regardless of the amount, may be cancelled with or without application by the debtor. 
                            </P>
                            <P>
                                (1) 
                                <E T="03">With application by the debtor.</E>
                                 Debts may be cancelled upon application of the debtor, subject to the following conditions: 
                            </P>
                            <P>(i) The servicing official furnishes a favorable recommendation concerning the cancellation; </P>
                            <P>(ii) There is no known security for the debt and the debtor has no other assets from which the debt could be collected; </P>
                            <P>(iii) The debtor is unable to pay any part of the debt and has no reasonable prospect of being able to do so; and </P>
                            <P>(iv) The debt or any extension thereof is due and payable under the terms of the note or other instrument, or due to acceleration by written notice prior to the date of application. </P>
                            <P>
                                (2) 
                                <E T="03">Without application by debtor.</E>
                                 Debts may be cancelled upon a favorable recommendation of the servicing official in the following instances: 
                            </P>
                            <P>
                                (i) 
                                <E T="03">Debtors discharged in bankruptcy.</E>
                                 If there is no security for the debt, debts discharged in bankruptcy shall be cancelled by the use of Form RD 1956-1. A copy of the Bankruptcy Court's Discharge Order must be attached. 
                            </P>
                            <P>
                                (ii) 
                                <E T="03">Impractical to obtain debtor's signature.</E>
                                 Debts may be cancelled if it is impractical to obtain a signed application and the requirements of paragraphs (e)(1) of this section are met. Form RD 1956-1 will document the specific reason(s) why it was impossible or impracticable to obtain the signature of the debtor. If the debtor refused to sign the application, the reason(s) should be documented. 
                            </P>
                            <P>
                                (f) 
                                <E T="03">Chargeoff.</E>
                                 (1) 
                                <E T="03">Judgment debts.</E>
                                 Judgment debts, regardless of the amount, may be charged off without the debtor's signature upon a favorable recommendation of the servicing official provided: 
                            </P>
                            <P>(i) The United States Attorney's file is closed, and </P>
                            <P>(ii) The requirements of paragraph (e)(2)(ii) of this section, if applicable, have been met, or 2 years have elapsed since any collections were made on the judgment. The debtor must also have no equity in the property subject to the lien or upon which a lien can be obtained. </P>
                            <P>
                                (2) 
                                <E T="03">Nonjudgment debts.</E>
                                 Debts that cannot be settled under other sections of this part may be charged off without the debtor's signature upon a favorable recommendation of the servicing official in the following instances: 
                            </P>
                            <P>(i) When OGC advises in writing that the claim is legally without merit, or that evidence necessary to prove the claim in court cannot be provided; or </P>
                            <P>(ii) When there is no known security for the debt, the debtor has no other assets from which the debt could be collected, and the debtor: </P>
                            <P>(A) Is unable to pay any part of the debt and has no reasonable prospect of being able to do so; or </P>
                            <P>(B) Is able to pay part or all of the debt but refuses to do so, and OGC provides an opinion to the effect that the Government cannot enforce collection of a significant amount from assets or income. </P>
                        </SECTION>
                        <SECTION>
                            <SECTNO>§ 1782.21 </SECTNO>
                            <SUBJECT>[Reserved] </SUBJECT>
                        </SECTION>
                        <SECTION>
                            <SECTNO>§ 1782.22 </SECTNO>
                            <SUBJECT>Exception authority. </SUBJECT>
                            <P>The Administrator may, in individual cases, make an exception to any requirement or provision of this part which is not inconsistent with the authorizing statute or other applicable law and is determined to be in the Government's interest. Requests for exceptions must be made in writing by the State Director and supported with documentation to explain the adverse effect on the Government's interest, propose alternative course(s) of action, and show how the adverse affect will be eliminated or minimized if the exception is granted. The exception decision will be documented in writing, signed by the Administrator, and retained in the files. </P>
                        </SECTION>
                        <SECTION>
                            <SECTNO>§ 1782.23 </SECTNO>
                            <SUBJECT>Use of Rural Development Loans and Grants for other purposes. </SUBJECT>
                            <P>(a) If, after making a loan or a grant, the Administrator determines that the circumstances under which the loan or grant was made have sufficiently changed to make the project or activity for which the loan or grant was made available no longer appropriate, the Administrator may allow the borrower or grantee to use property (real and personal) purchased or improved with the loan or grant funds, or proceeds from the sale of property (real and personal) purchased with such funds, for another project or activity that: </P>
                            <P>(1) Will be carried out in the same area as the original project or activity; </P>
                            <P>(2) Meets the criteria for a loan or grant described in section 381E(d) of the Consolidated Farm and Rural Development Act, as amended; and </P>
                            <P>(3) Satisfies such additional requirements as are established by the Administrator. </P>
                            <P>(b) If the new use of the property is under the authority of another USDA Agency Administrator, the other Administrator will be consulted on whether the new use will meet the criteria of the other program. Since the new project or activity must be carried out in the same area as the original project or activity, a new rural area determination will not be necessary. </P>
                            <P>(c) Borrowers and grantees that wish to use the proceeds for other purposes may make their request through the appropriate Rural Development State Office. Permission to use this option will be exercised on a case-by-case-basis on applications submitted through the State Office to the Administrator for consideration. If the proposal is approved, the Administrator will issue a memorandum to the State Director outlining the conditions necessary to complete the transaction. </P>
                        </SECTION>
                        <SECTION>
                            <SECTNO>§ 1782.24-1782.99 </SECTNO>
                            <SUBJECT>[Reserved] </SUBJECT>
                        </SECTION>
                        <SECTION>
                            <SECTNO>§ 1782.100 </SECTNO>
                            <SUBJECT>OMB Control Number. </SUBJECT>
                            <P>The information collection requirements in this part are approved by the Office of Management and Budget (OMB) and assigned OMB Control Number 0572-XXXX. </P>
                        </SECTION>
                    </PART>
                    <CHAPTER>
                        <HD SOURCE="HED">CHAPTER XVIII—RURAL HOUSING SERVICE, RURAL BUSINESS—COOPERATIVE SERVICE, RURAL UTILITIES SERVICE, AND FARM SERVICE AGENCY, DEPARTMENT OF AGRICULTURE. </HD>
                        <PART>
                            <HD SOURCE="HED">PART 1951—SERVICING AND COLLECTIONS </HD>
                            <P>2. The authority citation for part 1951 continues to read as follows: </P>
                            <AUTH>
                                <HD SOURCE="HED">Authority:</HD>
                                <P>5 U.S.C. 301; 7 U.S.C. 1989; 42 U.S.C. 1480. </P>
                            </AUTH>
                            <SUBPART>
                                <HD SOURCE="HED">Subpart A—Account Servicing Policies </HD>
                            </SUBPART>
                            <P>3. Amend § 1951.1 by adding the following sentence to the end of the section: </P>
                            <SECTION>
                                <SECTNO>§ 1951.1 </SECTNO>
                                <SUBJECT>Purpose. </SUBJECT>
                                <P>* * * This subpart does not apply to Water and Waste Programs of the Rural Utilities Service, Watershed loans, or Resource Conservation and Development loans, which are serviced under part 1782 of this title. </P>
                            </SECTION>
                            <SUBPART>
                                <HD SOURCE="HED">Subpart D—Final Payment on Loans </HD>
                            </SUBPART>
                            <P>4. Revise § 1951.151 to read as follows: </P>
                            <SECTION>
                                <PRTPAGE P="65553"/>
                                <SECTNO>§ 1951.151 </SECTNO>
                                <SUBJECT>Purpose. </SUBJECT>
                                <P>This subpart prescribes authorizations, policies and procedures of the Farm Service Agency (FSA), Rural Housing Service (RHS), and Rural Business—Cooperative Service (RBS), herein referred to as “Agency,” for processing final payment of all loans. This subpart does not apply to direct Single Family Housing customers of the RHS. This subpart does not apply to Water and Waste Programs of the Rural Utilities Service, Watershed loans, Resource Conservation and Development loans, which are serviced under part 1782 of this title.</P>
                            </SECTION>
                            <SUBPART>
                                <HD SOURCE="HED">Subpart E—Servicing of Community and Direct Business Programs Loans and Grants </HD>
                            </SUBPART>
                            <P>5. Revise § 1951.201 to read as follows: </P>
                            <SECTION>
                                <SECTNO>§ 1951.201 </SECTNO>
                                <SUBJECT>Purposes. </SUBJECT>
                                <P>This subpart prescribes the Rural Development mission area policies, authorizations, and procedures for servicing Community Facility loans and grants; Rural Business Enterprise/Television Demonstration grants; Association Recreation loans; Direct Business loans; Economic Opportunity Cooperative loans; Rural Renewal loans; Energy Impacted Area Development Assistance Program grants; National Nonprofit Corporation grants; System for Delivery of Certain Rural Development Programs panel grants; and Rural Cooperative Development Grants in subpart F of part 4284 of this title. Rural Development State Offices act on behalf of the Rural Business-Cooperative Service, and the Farm Service Agency as to loan and grant programs formerly administered by the Farmers Home Administration and the Rural Development Administration. Loans sold without insurance to the private sector will be serviced in the private sector and will not be serviced under this subpart. The provisions of this subpart are not applicable to such loans. Future changes to this subpart will not be made applicable to such loans. This subpart does not apply to Water and Waste Programs of the Rural Utilities Service, Watershed loans, and Resource Conservation and Development Loans, which are serviced under part 1782 of this title. </P>
                                <P>6. Add § 1951.218 to read as follows: </P>
                            </SECTION>
                            <SECTION>
                                <SECTNO>§ 1951.218 </SECTNO>
                                <SUBJECT>Use of Rural Development Loans and Grants for other purposes. </SUBJECT>
                                <P>(a) If, after making a loan or a grant, the Administrator determines that the circumstances under which the loan or grant was made have sufficiently changed to make the project or activity for which the loan or grant was made available no longer appropriate, the Administrator may allow the loan borrower or grant recipient to use property (real and personal) purchased or improved with the loan or grant funds, or proceeds from the sale of property (real and personal) purchased with such funds, for another project or activity that: </P>
                                <P>(1) Will be carried out in the same area as the original project or activity; </P>
                                <P>(2) Meets the criteria for a loan or grant described in section 381E(d) of the Consolidated Farm and Rural Development Act, as amended; and </P>
                                <P>(3) Satisfies such additional requirements as are established by the Administrator. </P>
                                <P>(b) For the purpose of this section, Administrator means the Administrator of the Rural Housing Service or Rural Business-Cooperative Service that has the delegated authority to administer the loan or grant program that covers the property or the proceeds from the sale property proposed to be used in another way. </P>
                                <P>(c) If the new use of the property is under the authority of another Administrator, the other Administrator will be consulted on whether the new use will meet the criteria of the other program. Since the new project or activity must be carried out in the same area as the original project or activity, a new rural area determination will not be necessary. </P>
                                <P>(d) Borrowers and grantees that wish to take advantage of this option may make their request through the appropriate Rural Development State Office. Permission to use this option will be exercised on a case-by-case-basis on applications submitted through the State Office to the Administrator for consideration. If the proposal is approved, the Administrator will issue a memorandum to the State Director outlining the conditions necessary to complete the transaction. </P>
                            </SECTION>
                            <SUBPART>
                                <HD SOURCE="HED">Subpart F—Analyzing Credit Needs and Graduation of Borrowers </HD>
                            </SUBPART>
                            <P>6. Revise § 1951.251 to read as follows: </P>
                            <SECTION>
                                <SECTNO>§ 1951.251 </SECTNO>
                                <SUBJECT>Purpose. </SUBJECT>
                                <P>This subpart prescribes the policies to be followed when analyzing a direct borrower's need for continued Agency supervision, further credit, and graduation. All loan accounts will be reviewed for graduation in accordance with this subpart, with the exception of Guaranteed, Rural Development Loan Funds, and Rural Rental Housing loans made to build or acquire new units pursuant to contracts entered into on or after December 15, 1989, and Intermediary Relending Program loans. The term “Agency” used in this subpart refers to the Farm Service Agency (FSA) (including its county and State committees and their personnel), Rural Housing Service (RHS), or Rural Business-Cooperative Service (RBS), depending upon the loan program discussed herein. This subpart does not apply to RHS direct single family housing (SFH) customers. In addition, this subpart does not apply to Water and Waste Programs of the Rural Utilities Service, Watershed loans, Resource Conservation and Development loans, which are serviced under part 1782 of this title. </P>
                            </SECTION>
                            <SUBPART>
                                <HD SOURCE="HED">Subpart O—Servicing Cases Where Unauthorized Loan(s) or Other Financial Assistance Was Received—Community and Insured Business Programs </HD>
                            </SUBPART>
                            <P>7. Revise § 1951.701 to read as follows: </P>
                            <SECTION>
                                <SECTNO>§ 1951.701 </SECTNO>
                                <SUBJECT>Purpose. </SUBJECT>
                                <P>This subpart prescribes the policies and procedures for servicing Community and Business Program loans and/or grants made by Rural Development when it is determined that the borrower or grantee was not eligible for all or part of the financial assistance received in the form of a loan, grant, or subsidy granted, or any other direct financial assistance. It does not apply to guaranteed loans. Loans sold without insurance by the Rural Development to the private sector will be serviced in the private sector and will not be serviced under this subpart. The provisions of this subpart are not applicable to such loans. Future changes to this subpart will not be made applicable to such loans. This subpart does not apply to Water and Waste Programs of the Rural Utilities Service, Watershed loans, and Resource Conservation and Development Loans, which are serviced under part 1782 of this title. </P>
                            </SECTION>
                        </PART>
                        <PART>
                            <HD SOURCE="HED">PART 1955—PROPERTY MANAGEMENT </HD>
                            <P>8. The authority citation for part 1955 continues to read as follows: </P>
                            <AUTH>
                                <HD SOURCE="HED">Authority:</HD>
                                <P>5 U.S.C. 301; 7 U.S.C. 1989; and 42 U.S.C. 1480. </P>
                            </AUTH>
                            <SUBPART>
                                <HD SOURCE="HED">Subpart A—Liquidation of Loans Secured by Real Estate and Acquisition of Real and Chattel Property </HD>
                            </SUBPART>
                            <P>9. Revise § 1955.1 to read as follows: </P>
                            <SECTION>
                                <PRTPAGE P="65554"/>
                                <SECTNO>§ 1955.1 </SECTNO>
                                <SUBJECT>Purpose. </SUBJECT>
                                <P>This subpart delegates authority and prescribes procedures for the liquidation of loans to individuals and to organizations as identified in § 1955.3. It pertains to the Farm Credit programs of the Farm Service Agency (FSA), Multi-Family Housing (MFH) and Community Facilities (CF) programs of the Rural Housing Service (RHS), and direct programs of the Rural Business-Cooperative Service (RBS). Guaranteed RBS loans are liquidated upon direction from the Deputy Administrator, Business Programs, RBS. This subpart does not apply to RHS single family housing loans or to CF loans sold without insurance in the private sector. These CF loans will be serviced in the private sector and future revisions to this subpart no longer apply to such loans. In addition, this subpart does not apply to Water and Waste Programs of the Rural Utilities Service, Watershed loans, Resource Conservation and Development loans, which are serviced under part 1782 of this title. </P>
                            </SECTION>
                            <SUBPART>
                                <HD SOURCE="HED">Subpart B—Management of Property </HD>
                            </SUBPART>
                            <P>10. Revise the introductory text of § 1955.51 to read as follows: </P>
                            <SECTION>
                                <SECTNO>§ 1955.51 </SECTNO>
                                <SUBJECT>Purpose. </SUBJECT>
                                <P>This subpart delegates authority and prescribes policies and procedures for the Rural Housing Service (RHS), Rural Business-Cooperative Service (RBS), and Farm Service Agency (FSA), herein referred to as “Agency,” and references contained in this subpart to the Farmers Home Administration (FmHA) are synonymous with “Agency.” This subpart does not apply to RHS single family housing loans or community program loans sold without insurance to the private sector. These community program loans will be serviced by the private sector and future revisions and this subpart no longer apply to such loans. In addition, this subpart does not apply to Water and Waste Programs of the Rural Utilities Service, Watershed loans, Resource Conservation and Development loans, which are serviced under part 1782 of this title. This subpart does cover: </P>
                                <STARS/>
                            </SECTION>
                            <SUBPART>
                                <HD SOURCE="HED">Subpart C—Disposal of Inventory Property </HD>
                            </SUBPART>
                            <P>11. Revise § 1955.101 to read as follows: </P>
                            <SECTION>
                                <SECTNO>§ 1955.101 </SECTNO>
                                <SUBJECT>Purpose. </SUBJECT>
                                <P>This subpart delegates program authority and prescribes policies and procedures for the sale of inventory property including real estate, related real estate rights and chattels. It also covers the granting of easements and rights-of-way on inventory property. Credit sales of inventory property to ineligible (nonprogram (NP)) purchasers will be handled in accordance with subpart J of part 1951 of this chapter, except Community and Business Programs (C&amp;BP) and Multi-Family Housing (MFH) which will be handled in accordance with this subpart. In addition, credit sales of Single-Family Housing (SFH) properties converted to MFH will be handled in accordance with this subpart. This subpart does not apply to SFH inventory property. In addition, this subpart does not apply to Water and Waste Programs of the Rural Utilities Service, Watershed loans, Resource Conservation and Development loans, which are serviced under part 1782 of this title. </P>
                            </SECTION>
                        </PART>
                    </CHAPTER>
                </REGTEXT>
                <REGTEXT TITLE="2" PART="1956">
                    <PART>
                        <HD SOURCE="HED">PART 1956—DEBT SETTLEMENT </HD>
                        <P>12. The authority citation for part 1956 continues to read as follows: </P>
                        <AUTH>
                            <HD SOURCE="HED">Authority:</HD>
                            <P>5 U.S.C. 301; 7 U.S.C. 1981; 31 U.S.C 3711; 42 U.S.C. 1480. </P>
                        </AUTH>
                        <SUBPART>
                            <HD SOURCE="HED">Subpart C—Debt Settlement—Community and Business Programs </HD>
                        </SUBPART>
                        <P>13. Amend § 1956.101 by adding the following sentence to the end of the section: </P>
                        <SECTION>
                            <SECTNO>§ 1956.101 </SECTNO>
                            <SUBJECT>Purpose. </SUBJECT>
                            <P>* * * In addition, this subpart does not apply to Water and Waste Programs of the Rural Utilities Service, Watershed loans, Resource Conservation and Development loans, which are serviced under part 1782 of this title. </P>
                        </SECTION>
                    </PART>
                </REGTEXT>
                <SIG>
                    <DATED>Dated: October 7, 2004. </DATED>
                    <NAME>Gilbert Gonzalez, </NAME>
                    <TITLE>Acting Under Secretary, Rural Development. </TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 04-25247 Filed 11-12-04; 8:45 am] </FRDOC>
            <BILCOD>BILLING CODE 3410-15-P </BILCOD>
        </PRORULE>
        <PRORULE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF AGRICULTURE </AGENCY>
                <SUBAGY>Rural Business-Cooperative Service </SUBAGY>
                <CFR>7 CFR Part 4280 </CFR>
                <RIN>RIN 0570-AA50 </RIN>
                <SUBJECT>Renewable Energy Systems and Energy Efficiency Improvements Grant, Guaranteed Loan, and Direct Loan Program </SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Rural Business-Cooperative Service, USDA. </P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Proposed rule: extension of comment period. </P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>
                        The Rural Business-Cooperative Service (RBS) is extending the deadline of November 4, 2004, for submitting comments regarding the proposed Renewable Energy Systems and Energy Efficiency Improvements Grant, Guaranteed Loan, and Direct Loan Program. The program will assist farmers, ranchers, and small rural businesses to purchase renewable energy systems and make energy efficiency improvements. The proposed rule was published in the 
                        <E T="04">Federal Register</E>
                         on October 5, 2004 (69 FR 59650). This extension will allow additional time for the public to submit comments. 
                    </P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Comments must be submitted by December 15, 2004. </P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>You may submit comments to this rule by any of the following methods: </P>
                    <P>
                        Agency Web Site: 
                        <E T="03">http://rdinit.usda.gov/regs/</E>
                        . Follow instructions for submitting comments on the Web site. 
                    </P>
                    <P>
                        E-Mail: 
                        <E T="03">comments@usda.gov</E>
                        . Include the RIN No. 0570-AA50 in the subject line of the message. 
                    </P>
                    <P>
                        Federal eRulemaking Portal: 
                        <E T="03">http://www.regulations.gov</E>
                        . Follow the instructions for submitting comments. 
                    </P>
                    <P>Mail: Submit written comments via the U.S. Postal Service to the Branch Chief, Regulations and Paperwork Management Branch, U.S. Department of Agriculture, STOP 0742, 1400 Independence Avenue, SW., Washington, DC 20250-0742. </P>
                    <P>Hand Delivery/Courier: Submit written comments via Federal Express Mail or another courier service requiring a street address to the Branch Chief, Regulations and Paperwork Management Branch, U.S. Department of Agriculture, 300 7th Street, SW., 7th Floor, Washington, DC 20024. </P>
                    <P>All written comments will be available for public inspection during regular working hours at 300 7th Street, SW., 7th Floor, address listed above. </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>Georg A. Shultz, Special Advisor for Renewable Energy Policy and Programs, Office of the Deputy Administrator Business Programs, U.S. Department of Agriculture, Mail Stop 3220, 1400 Independence Ave., SW., Washington, DC 20250-3220, telephone: (202) 720-2976. </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>
                    RBS published the notice of proposed rule making with a 30-day comment period. The reason for this limited time for comments was based primarily on the need to have a published final rule in time for the implementation of the program in fiscal year (FY) 2005. The Agency felt that since the program outlined in the proposed rule is similar 
                    <PRTPAGE P="65555"/>
                    in scope as the Notices of Funds Availability (NOFA) for the grant program published in FY 2003 and FY 2004 and the Agency's current Business and Industry Guaranteed Loan Program forms the basis of the proposed guaranteed loan program, that a 30-day period would be sufficient. The additional 30-day comment period will delay publication of the final rule a commensurate time. The delay in publication will create additional time constraints on applicants. It will also constrain the time for processing the applications, including meeting environmental assessment requirements. RBS is extending the comment period in response to numerous requests from the public for additional time to comment. 
                </P>
                <SIG>
                    <DATED>Dated: November 5, 2004. </DATED>
                    <NAME>Gilbert Gonzalez, </NAME>
                    <TITLE>Acting Under Secretary, Rural Development. </TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 04-25239 Filed 11-12-04; 8:45 am] </FRDOC>
            <BILCOD>BILLING CODE 3410-XY-P</BILCOD>
        </PRORULE>
        <PRORULE>
            <PREAMB>
                <AGENCY TYPE="N">DEPARTMENT OF COMMERCE</AGENCY>
                <SUBAGY>Bureau of Industry and Security</SUBAGY>
                <CFR>15 CFR Parts 732, 736, 740, 744, 752, 764, and 772</CFR>
                <DEPDOC>[Docket No. 040915266-4313-02]</DEPDOC>
                <RIN>RIN 0694-AC94</RIN>
                <SUBJECT>Revised “Knowledge”  Definition, Revision of “Red Flags” Guidance and Safe Harbor</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Bureau of Industry and Security, Commerce.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Proposed rule; reopening of comment period. </P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>This notice reopens the comment period on a proposed rule that would revise the knowledge definition and the “red flags” guidance as well as create a safe harbor from knowledge based violations in the Export Administration Regulations.</P>
                </SUM>
                <EFFDATE>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Comments must be received by December 15, 2004.</P>
                </EFFDATE>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        Send comments on this proposed rule to: The Federal eRulemaking Portal: 
                        <E T="03">http://www.regulations.gov,</E>
                         via e-mail to 
                        <E T="03">rpd2@bis.doc.gov,</E>
                         fax them to 202-482-3355, or on paper to Regulatory Policy Division, Office of Exporter Services, Room 2705, U.S. Department of Commerce, Washington, DC 20230. Refer to Regulation Identification Number 0694-AC94 in all comments.
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        For further information regarding this proposed rule, contact: William Arvin, Office of Exporter Services, at 
                        <E T="03">warvin@bis.doc.gov,</E>
                         fax 202-482-3355 or telephone 202-482-2440.
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>On October 13, 2004, the Bureau of Industry and Security published a proposed rule that would revise the Export Administration Regulations in three ways: Revise the knowledge definition, revise the “red flags” guidance; and create a safe harbor from certain knowledge based violations. The deadline for public comments was November 12, 2004 (69 FR 60829). The Bureau is now reopening the comment period until December 15, 2004, to allow the public more time to comment on this proposed rule.</P>
                <SIG>
                    <DATED>Dated: November 9, 2004.</DATED>
                    <NAME>Eileen Albanese,</NAME>
                    <TITLE>Director, Office of Exporter Services.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 04-25309 Filed 11-12-04; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 3510-33-M</BILCOD>
        </PRORULE>
        <PRORULE>
            <PREAMB>
                <AGENCY TYPE="N">DEPARTMENT OF THE TREASURY</AGENCY>
                <SUBAGY>Internal Revenue Service</SUBAGY>
                <CFR>26 CFR Part 1</CFR>
                <DEPDOC>[REG-129771-04]</DEPDOC>
                <RIN>RIN 1545-BD49</RIN>
                <SUBJECT>Guidance Under Section 951 for Determining Pro Rata Share; Hearing Cancellation</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Internal Revenue Service (IRS), Treasury.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Cancellation of notice of public hearing on proposed rulemaking.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>This document cancels a public hearing on proposed regulations under section 951(a) of the Internal Revenue Code (Code) that provide guidance for determining a United States shareholder's pro rata share of a controlled foreign corporation's (CFC's) subpart F income, previously excluded subpart F income withdrawn from investment in less developed countries, previously excluded subpart F income withdrawn from foreign base company shipping operations, and amounts determined under section 956.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>The public hearing originally scheduled for November 18, 2004, at 10 a.m., is cancelled.</P>
                </DATES>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>Sonya M. Cruse of the Publications and Regulations Branch, Legal Processing Division, Associate Chief Counsel (Procedures and Administration), at (202) 622-4693 (not a toll-free number).</P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>
                    A notice of proposed rulemaking and notice of public hearing that appeared in 
                    <E T="04">Federal Register</E>
                     on Friday, August 6, 2004, (69 FR 47822), announced that a public hearing was scheduled for November 18, 2004, at 10 a.m., in the IRS Auditorium, Internal Revenue Service Building, 1111 Constitution Avenue, NW., Washington, DC. The subject of the public hearing is under section 951(a) of the Internal Revenue Code.
                </P>
                <P>The public comment period for these regulations expired on November 4, 2004. The notice of proposed rulemaking and notice of public hearing, instructed those interested in testifying at the public hearing to submit a request to speak and an outline of the topics to be addressed. As of Tuesday, November 9, 2004, no one has requested to speak. Therefore, the public hearing scheduled for November 18, 2004, is cancelled.</P>
                <SIG>
                    <NAME>Cynthia E. Grigsby,</NAME>
                    <TITLE>Acting Chief, Publications and Regulations Branch, Legal Processing Division, Associate Chief Counsel, (Procedures and Administration).</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 04-25324 Filed 11-9-04; 3:46 pm]</FRDOC>
            <BILCOD>BILLING CODE 4830-01-P</BILCOD>
        </PRORULE>
        <PRORULE>
            <PREAMB>
                <AGENCY TYPE="N">DEPARTMENT OF HOMELAND SECURITY </AGENCY>
                <SUBAGY>Coast Guard </SUBAGY>
                <CFR>33 CFR Chapter I </CFR>
                <DEPDOC>[USCG-2004-19615] </DEPDOC>
                <SUBJECT>Exclusion Zones for Marine LNG Spills </SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Coast Guard, DHS. </P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Request for public comments; correction. </P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>
                        The Coast Guard published a document in the 
                        <E T="04">Federal Register</E>
                         on November 3, 2004, requesting comments on a petition for rulemaking from the City of Fall River. That document contained an incorrect docket number for the submission of comments. 
                    </P>
                </SUM>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        If you have questions on this notice, please call Commander John Cushing at 202-267-1043, or e-mail 
                        <E T="03">JCushing@comdt.uscg.mil.</E>
                         If you have questions on viewing or submitting material to the docket, please call Ms. Andrea M. Jenkins, Program Manager, Docket Operations, telephone 202-366-0271. 
                    </P>
                    <HD SOURCE="HD1">Correction </HD>
                    <P>
                        In the 
                        <E T="04">Federal Register</E>
                         of November 3, 2004, in FR Doc. 04-24454, on page 
                        <PRTPAGE P="65556"/>
                        63979, the docket number is incorrect. The docket number is corrected to read (USCG-2004-19615) each place that it appears. 
                    </P>
                    <SIG>
                        <DATED>Dated: November 8, 2004. </DATED>
                        <NAME>David L. Nichols, </NAME>
                        <TITLE>Commander, U.S. Coast Guard, Acting Chief, Office of Regulations, and Administrative Law. </TITLE>
                    </SIG>
                </FURINF>
            </PREAMB>
            <FRDOC>[FR Doc. 04-25254 Filed 11-12-04; 8:45 am] </FRDOC>
            <BILCOD>BILLING CODE 4910-15-P</BILCOD>
        </PRORULE>
        <PRORULE>
            <PREAMB>
                <AGENCY TYPE="N">DEPARTMENT OF THE INTERIOR </AGENCY>
                <SUBAGY>National Park Service </SUBAGY>
                <CFR>36 CFR Part 7 </CFR>
                <RIN>RIN 1024-AC93 </RIN>
                <SUBJECT>Pictured Rocks National Lakeshore, Personal Watercraft Use </SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>National Park Service, Interior. </P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Proposed Rule.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>
                        The National Park Service (NPS) is proposing to designate areas where personal watercraft (PWC) may be used in Pictured Rocks National Lakeshore, Michigan. This proposed rule implements the provisions of the NPS general regulations authorizing park areas to allow the use of PWC by promulgating a special regulation. The NPS 
                        <E T="03">Management Policies 2001</E>
                         require individual parks to determine whether PWC use is appropriate for a specific park area based on an evaluation of that area's enabling legislation, resources and values, other visitor uses, and overall management objectives. 
                    </P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Comments must be received by January 14, 2005. </P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        Comments on the proposed rule should be mailed to N8391 Sand Point Road, P.O. Box 40 Munising, Michigan 49862-0040. Comments may also be sent by e-mail to 
                        <E T="03">PIRO@den.nps.gov.</E>
                         If you comment by e-mail, please include “PWC rule” in the subject line and your name and return address in the body of your Internet message. 
                    </P>
                    <P>
                        For additional information see “Public Participation” under 
                        <E T="02">SUPPLEMENTARY INFORMATION</E>
                         below. 
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Kym Hall, Special Assistant, National Park Service, 1849 C Street, NW., Room 3145, Washington, DC 20240. Phone: (202) 208-4206. E-mail: 
                        <E T="03">Kym_Hall@nps.gov.</E>
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <HD SOURCE="HD1">Background </HD>
                <HD SOURCE="HD2">Additional Alternatives </HD>
                <P>The information contained in this proposed rule supports implementation of the modified preferred alternative for Pictured Rocks National Lakeshore in the Environmental Assessment (EA) published July, 2002, and the errata sheet published October, 2003. The errata sheet corrects factual information in the EA as well as provides the analysis of the modified preferred alternative. The public should be aware that two other alternatives including a no-PWC alternative were presented in the EA and one alternative was modified in the subsequent errata sheet. Those alternatives should also be reviewed and considered when making comments on this proposed rule. </P>
                <HD SOURCE="HD2">Personal Watercraft Regulation </HD>
                <P>On March 21, 2000, the National Park Service published a regulation (36 CFR 3.24) on the management of personal watercraft (PWC) use within all units of the national park system (65 FR 15077). This regulation prohibits PWC use in all national park units unless the NPS determines that this type of water-based recreational activity is appropriate for the specific park unit based on the legislation establishing that park, the park's resources and values, other visitor uses of the area, and overall management objectives. The regulation prohibits PWC use in all park units effective April 20, 2000, except a limited exception was provided for 21 parks, lakeshores, seashores, and recreation areas. The regulation established a 2-year grace period following the final rule publication to give these 21 park units time to consider whether PWC use should be allowed. Accordingly, on April 22, 2002, Pictured Rocks National Lakeshore closed for PWC use. </P>
                <HD SOURCE="HD2">Description of Pictured Rocks National Lakeshore </HD>
                <P>Pictured Rocks National Lakeshore is situated in the north-central section of Michigan's Upper Peninsula, along the southern shore of Lake Superior. The eastern half of the Upper Peninsula is bounded by Lakes Superior, Michigan, and Huron. There are a variety of other national parks in the upper Great Lakes, including Apostle Islands National Lakeshore and Isle Royal National Park on Lake Superior, and Sleeping Bear Dunes and Indiana Dunes National Lakeshores on Lake Michigan. Canadian provincial parks are also located on Lake Superior. </P>
                <P>The national lakeshore stretches from Munising to Grand Marais, approximately 40 miles to the northeast. The shoreline consists of narrow sandy beaches, sandstone cliffs, and a perched sand dune system. The sandy shoreline is susceptible to erosion from natural weather conditions. </P>
                <P>Pictured Rocks National Lakeshore was authorized in 1966. The lakeshore is noted for its multicolored sandstone cliffs, beaches, sand dunes, waterfalls, inland lakes, wildlife, and forested shoreline. Attractions include a lighthouse and former Coast Guard life-saving stations, along with old farmsteads and orchards. The lakeshore is a year-round recreational destination where hiking, camping, hunting, nature study, and winter activities abound. </P>
                <HD SOURCE="HD2">Purpose of Pictured Rocks National Lakeshore </HD>
                <P>As formulated during the Pictured Rocks general management planning process, the purpose of the national lakeshore includes the following: </P>
                <P>Preserve a portion of the Great Lakes shoreline for its geographic, scientific, scenic, and historic features, and its associated ecological processes. </P>
                <P>Provide opportunities for public benefit in recreation, education, enjoyment, and inspiration. </P>
                <P>Protect the character and use of the shoreline zone while allowing economic utilization of the inland buffer zone's renewable resources. </P>
                <HD SOURCE="HD2">Significance of Pictured Rocks National Lakeshore </HD>
                <P>As stated in the national lakeshore's Draft General Management Plan / Wilderness Study/Environmental Impact Statement, Pictured Rocks National Lakeshore is significant because: </P>
                <P>Pictured Rocks National Lakeshore preserves and affords public access to a spectacular and diverse segment of the Lake Superior shoreline. </P>
                <P>Unmatched in their scenic value, the 200-foot high Pictured Rocks cliffs rise perpendicularly from Lake Superior, creating a rock mosaic of form, color, and texture, which is enhanced by cascading waterfalls. </P>
                <P>Grand Sable Dunes, perched atop 300-foot-high sand banks above Lake Superior, is one of two perched dune systems on the Great Lakes; within these dunes live unique plant communities resulting from geomorphic processes. </P>
                <P>Twelve miles of unspoiled and undeveloped Lake Superior beach contrast with the Pictured Rocks cliffs and Grand Sable Dunes. </P>
                <P>Bedrock geology and glacial landforms provide significant topographic relief marked by streams, inland lakes, and a diversity of associated vegetation. </P>
                <P>
                    The shoreline offers extraordinary and inspirational scenic vistas of Lake 
                    <PRTPAGE P="65557"/>
                    Superior, which has the largest surface area of any fresh water lake on earth. 
                </P>
                <P>Pictured Rocks National Lakeshore offers a variety of affordable year-round recreational opportunities for appropriate public use. </P>
                <P>Within a distinct area, the lakeshore contains a spectrum of cultural resources focused on the human use of Lake Superior and its shoreline. </P>
                <P>Lying in a transition zone between boreal and eastern hardwood forest, the lakeshore's scientifically recognized assemblage of flora and fauna is representative of associations unique to the Lake Superior Basin. </P>
                <P>Pictured Rocks is the only national park system area with a legislated buffer zone. </P>
                <HD SOURCE="HD2">Authority and Jurisdiction </HD>
                <P>
                    Under the National Park Service's Organic Act of 1916 (Organic Act) (16 U.S.C. 1 
                    <E T="03">et seq.</E>
                    ) Congress granted the NPS broad authority to regulate the use of the Federal areas known as national parks. In addition, the Organic Act (16 U.S.C. 3) allows the NPS, through the Secretary of the Interior, to “make and publish such rules and regulations as he may deem necessary or proper for the use and management of the parks * * *”. 
                </P>
                <P>16 U.S.C. 1a-1 states, “The authorization of activities shall be conducted in light of the high public value and integrity of the National Park System and shall not be exercised in derogation of the values and purposes for which these various areas have been established * * *”. </P>
                <P>As with the United States Coast Guard, NPS's regulatory authority over waters subject to the jurisdiction of the United States, including navigable waters and areas within their ordinary reach, is based upon the Property and Commerce Clauses of the U.S. Constitution. In regard to the NPS, Congress in 1976 directed the NPS to “promulgate and enforce regulations concerning boating and other activities on or relating to waters within areas of the National Park System, including waters subject to the jurisdiction of the United States * * *” (16 U.S.C. 1a-2(h)). In 1996 the NPS published a final rule (61 FR 35136, July 5, 1996) amending 36 CFR 1.2(a)(3) to clarify its authority to regulate activities within the National Park System boundaries occurring on waters subject to the jurisdiction of the United States. </P>
                <HD SOURCE="HD2">PWC Use at Pictured Rocks National Lakeshore </HD>
                <P>PWC use in Pictured Rocks National Lakeshore began around 1990. Before the ban, use was only allowed on Lake Superior, and it was relatively low. Restrictions on inland lakes precluded PWC use on those lakes. Pictured Rocks National Lakeshore has jurisdiction on the surface water of Lake Superior extending 0.25 mile from the shoreline. This proposed rule would only apply to the waters under the lakeshore's jurisdiction. In addition, Michigan's Personal Watercraft Safety Act of 1998 (Public Act 116) stipulates regulations for PWC use. One of the regulations is that personal watercraft cannot operate within 200 feet of the shoreline unless traveling perpendicular to shoreline at no-wake speed. </P>
                <P>Before the ban, PWC operation on Lake Superior was concentrated between Sand Point and Chapel Beach, along the Lake Superior shoreline. The eastern side of the park had little PWC use. Rivers and streams within Pictured Rocks National Lakeshore are not accessible to personal watercraft due to extremely small size, shallow depths, and rocky bottoms. On inland lakes within the Lakeshore boundaries, the size of powerboat engines is restricted to two- and four-stroke internal combustion engines of 50 hp or less, essentially eliminating PWC use. </P>
                <P>Before the ban was imposed, most PWC users at the park were from within 100 miles of the lakeshore. Based on staff observations, some users come from other parts of Michigan, Wisconsin, and Minnesota, and perhaps Ohio and Illinois. There are many other areas for water-based recreation in this portion of the Upper Peninsula, including State parks, national forests, and other lakes with public access. Such areas include other portions of Lake Superior (excluding the shore of Grand Island), many lakes within the Escanaba River and Lake Superior State Forests, several lakes within the Hiawatha National Forest, Manistique Lake, South Manistique Lake, and Lake Michigan. </P>
                <P>To document actual PWC use and to provide peak usage information, staff conducted a survey at the Sand Point launch July 4-8, 2001. During the five-day survey, small craft warnings prohibited personal watercraft on two days. PWC use for the remaining three days ranged from 8 to 13 personal watercraft each day. Thus, the peak number of personal watercraft that were operating before the ban in the lakeshore was 13 per day—6.6 from the Sand Point launch and 6.6 from the Munising boat ramp. </P>
                <P>Before the ban, because personal watercraft were also launched from the Munising boat ramp on the west end of the lakeshore, the city was contacted to determine launch numbers. However, specific data were not available. Based on discussions with lakeshore staff, the number of personal watercraft launched from Munising was assumed to be the same as the number launched from Sand Point. Based on the analysis of the survey and assumptions, 6.6 personal watercraft would be launched from the Munising boat ramp each day during July and August weekends. All of these personal watercraft would likely travel within the lakeshore's jurisdiction. </P>
                <P>Grand Marais, on the east end of the lakeshore, also has boat launch facilities. According to city staff, very few personal watercraft are launched—perhaps 12 all summer, for an average of 1 personal watercraft every seven days. This analysis assumes that on average no personal watercraft would be launched from Grand Marais during July and August. </P>
                <P>The low PWC numbers are primarily a result of the cold water temperature, cool ambient air temperature, changeable weather conditions, and heavy winds and wave action. The average PWC trip within Pictured Rocks National Lakeshore lasted between three and five hours, from mid morning to mid or late afternoon. State regulations restrict operations to the hours of 8 a.m. to one hour before sunset. Most PWC users cruised and sometimes raced along the shoreline, explored the rock cliffs up close, jumped the wakes of tour boats (which make 4-5 foot swells), and traveled to beach destinations and spent the day or afternoon on the beach. Fewer PWC users assembled in pontoons and did short trips or went to beach areas. A very small number may have done day trips between Munising and Grand Marais (40+ miles). Only a few users asked about PWC camping opportunities. </P>
                <P>Before the ban, PWC users were distributed throughout the lakeshore. According to NPS staff, most personal watercraft were operated on the west end of the lakeshore. This is consistent with the launch locations and predicted launch numbers. Few PWC operators traveled the entire length of the lakeshore due to the long distance, rough waters, and potential for changing weather. </P>
                <P>
                    Generally, there is very little information specific to visitor concerns about PWC use. Visitor surveys were conducted for the winter of 1999-2000 and for the summer of 2000 (with questions specific to PWC use in the national lakeshore). A majority of the respondents to the survey supported or strongly supported restricting PWC use to designated areas. No PWC accidents have been observed or reported to NPS staff. Five incident reports have been documented, one for operating too close 
                    <PRTPAGE P="65558"/>
                    to other motorcraft, two for operating too close to swimmers, and two for operating illegally on inland lakes. There are no observations or reports related to natural resource concerns. 
                </P>
                <HD SOURCE="HD1">Resource Protection and Public Use Issues </HD>
                <HD SOURCE="HD1">Pictured Rocks National Lakeshore Environmental Assessment </HD>
                <P>
                    The environmental assessment was available for public review and comment for the period August 1 through November 15, 2004. An errata sheet was prepared to address the changes to alternative B, the preferred alternative. To request a copy of the document and the errata sheet contact Superintendent, Pictured Rocks National Lakeshore, N8391 Sand Point Road, P.O. box 40, Munising, MI 49862-0040. A copy of the Environmental Assessment and the errata sheet may also be found at 
                    <E T="03">http://www.nps.gov/piro.</E>
                </P>
                <P>The purpose of the environmental assessment was to evaluate a range of alternatives and strategies for the management of PWC use at Pictured Rocks to ensure the protection of park resources and values while offering recreational opportunities as provided for in the National Lakeshore's enabling legislation, purpose, mission, and goals. The assessment assumed alternatives would be implemented beginning in 2002 and considered a 10-year period, from 2002 to 2012. In addition, the environmental assessment defines such terms as “negligible” and “adverse.” In this document, these terms are used to describe the environmental impact. Refer to the EA for complete definitions. </P>
                <P>The environmental assessment evaluates three alternatives addressing the use of personal watercraft at Pictured Rocks National Lakeshore. The errata sheet modifies one of the alternatives, Alternative B. Each alternative is described below: </P>
                <P>Alternative A—Under alternative A, PWC use would continue as was provided and managed within Pictured Rocks National Lakeshore before the ban. PWC use would be unrestricted on Lake Superior from the lakeshore's 0.25-mile jurisdictional boundary to the lakeshore's shoreline. Launch and retrieval of personal watercraft would be permitted only at the Sand Point boat ramp on Lake Superior. PWC users would be able to land anywhere along the shoreline. PWC users would continue to abide by Michigan's Personal Watercraft Safety Act of 1998 (Public Act 116) and related regulations. </P>
                <P>Alternative B—Alternative B was modified by the errata dated October 2003. Under the modified alternative B, PWC use would be allowed to operate on the waters of Lake Superior within the boundaries of Pictured Rocks National Lakeshore from the western boundary of the lakeshore up to the east end of Miners Beach. </P>
                <P>PWC use would be allowed under the following conditions: Personal watercraft may only be launched from a designated launch site at Sand Point, PWC users may beach their craft only on Miners Beach, and PWC users may not launch or operate in any other area of the lakeshore. The superintendent of the park may temporarily limit, restrict, or terminate access to areas designated for PWC use after taking into consideration public health and safety, natural and cultural resource protection, and other management activities and objectives. PWC use would be restricted at specific locations during the permitted use of ethnographic resources. Boat patrols would be conducted in the vicinity of the ethnographic resource use in order to reduce the potential for PWC-related intrusion into the ceremonial activity. PWC users would continue to abide by Michigan's Personal Watercraft Safety Act of 1998 (Public Act 116) and related regulations, as identified in alternative A. This alternative would allow PWC use along the Lake Superior shoreline within the western end of the park, covering approximately 8 miles of shoreline. The numbers of personal watercraft would not be restricted. </P>
                <P>No-Action Alternative—Under the no-action alternative, the National Park Service would take no action to reinstate the use of personal watercraft at Pictured Rocks National Lakeshore and no special rule would be promulgated to continue personal watercraft use. Under this alternative, NPS would continue to prohibit personal watercraft use at Pictured Rocks begun on April 22, 2002. </P>
                <P>Alternative B is the park's preferred alternative because it would best fulfill the park responsibilities as trustee of the sensitive habitat; ensure safe, healthful, productive, and aesthetically and culturally pleasing surroundings; and attain a wider range of beneficial uses of the environment without degradation, risk of health or safety, or other undesirable and unintended consequences. </P>
                <P>As previously noted, NPS will consider the comments received on this proposal, as well as the comments previously received on the Environmental Assessment [as modified by the errata sheet]. In the final rule, the NPS will implement one of these alternatives as proposed, or choose a different alternative or combination of alternatives. Therefore, the public should review and consider the other alternatives contained in the Environmental Assessment [as modified by the errata sheet] when making comments on this proposed rule. </P>
                <P>
                    The following summarizes the predominant resource protection and public use issues associated with reinstating PWC use at Pictured Rocks National Lakeshore. Each of these issues is analyzed in the 
                    <E T="03">Pictured Rocks National Lakeshore, Personal Watercraft Use Environmental Assessment</E>
                     as modified by the errata sheet. 
                </P>
                <HD SOURCE="HD2">Water Quality </HD>
                <P>Most research on the effects of personal watercraft on water quality focuses on the impacts of two-stroke engines, and it is assumed that any impacts caused by these engines also apply to the personal watercraft powered by them. There is general agreement that two-stroke engines discharge a gas-oil mixture into the water. Fuel used in PWC engines contains many hydrocarbons, including benzene, toluene, ethylbenzene, and xylene (collectively referred to as BTEX) and polyaromatic hydrocarbons (PAH). PAH also are released from boat engines, including those in personal watercraft. These compounds are not found appreciably in the unburned fuel mixture, but rather are products of combustion. Discharges of these compounds—BTEX and PAH—have potential adverse effects on water quality. A common gasoline additive, methyl tertiary butyl ether (MTBE) is not used in Michigan. </P>
                <P>
                    A typical conventional (
                    <E T="03">i.e.</E>
                    , carbureted) two-stroke PWC engine discharges as much as 30% of the unburned fuel mixture directly into the water. At common fuel consumption rates, an average two-hour ride on a personal watercraft may discharge 3 gallons of fuel into the water. According to the California Air Resources Board, an average personal watercraft can discharge between 1.2 and 3.3 gallons of fuel during one hour at full throttle. However, hydrocarbon (HC) discharges to water are expected to decrease substantially over the next 10 years due to mandated improvements in engine technology. 
                </P>
                <P>
                    PWC use would continue within the lakeshore, with a shift in location due to restrictions east of Miners Beach. Overall numbers of personal watercraft would remain similar to the number before the ban, with maximum use projected to increase from 13 per day in 2002 to 16 per day in 2012. For example, the estimated use in 2002 if PWC were allowed would have been 52 
                    <PRTPAGE P="65559"/>
                    PWC-hours per day in the designated use area. Daily peak operation times would increase in 2012 to 64 PWC-hours in the designated use area. Water quality impacts east of Miners Beach would be reduced compared to before the ban, since PWC use would not be allowed in this area. 
                </P>
                <P>PWC users would operate within the designated use area because of the closure of other areas to the east and proximity to the launch facility at Sand Point. The Sand Point area would have the highest use and highest pollutant loads. This location also tends to have shallower waters that extend for some distance offshore. Over the next 10 years PWC use in this area is projected to increase from 13 to 16 machines per day. </P>
                <P>The calculated threshold volumes for pollutants emitted by personal watercraft and boats would range from 0 to 240 acre-feet for the ecological criteria. The 1-methyl naphthalene volume for Sand Point (240 acre-feet) would be less than 1% of the volume available. These pollutant concentrations are well below the water quality benchmarks and would likely not be detectable. Cumulative ecological impacts under this proposal would be negligible. </P>
                <P>Threshold volumes for the human health criteria range from 0 to 10,800 acre-feet. Benzene emissions in the Sand Point area would have the highest concentrations and would require 45% of the total water volume available within the 0.25-mile jurisdictional boundary for dilution. Benzene levels would be below the human health criterion. Similar to before the ban, dilution with adjacent waters and volatilization would occur and therefore cumulative human health based impacts would be negligible to minor. If the State water quality standard for benzene was used in place of the EPA criterion, estimated human health impacts from benzene would be even lower. </P>
                <P>Total PAH concentrations in the designated use area with boating activity would equal or exceed 0.1 μg/L in 2002 and 2012. Although the calculated levels are well below aquatic life benchmarks, the concentrations could have a minor to moderate adverse impact to aquatic life due to phototoxic effects. </P>
                <P>Future (2012) pollutant loads would decrease, despite increased boating traffic, due to reductions in engine emissions. Impact levels for cumulative actions would be negligible to moderate, depending on the location and pollutant type. All effects would be short term and would occur during the times of heaviest use. </P>
                <P>In conclusion, based on analyses for individual pollutants, this proposal would have negligible to minor adverse effects on water quality due to continued PWC use. No impacts would occur east of Miners Beach where PWC use would be restricted under this proposed rule. While all pollutant loads would be well below benchmarks and criteria, PAH concentrations in the Sand Point segment and the western Cliffs segment could have negligible to moderate adverse phototoxic effects on aquatic life. </P>
                <P>Cumulative impacts from PWC and motorized boat use would range from negligible to moderate. No impacts would occur in the Beaver Basin segment. Total PAH concentrations could be a concern for aquatic life, due to potential phototoxicity. Benzene concentrations could be detectable, but are expected to remain below the human health criterion. By 2012 impacts would be reduced substantially through improved emission controls. </P>
                <HD SOURCE="HD2">Air Quality </HD>
                <P>
                    Personal watercraft emit various compounds that pollute the air. In the two-stroke engines commonly used in personal watercraft, the lubricating oil is used once and is expelled as part of the exhaust; and the combustion process results in emissions of air pollutants such as volatile organic compounds (VOC), nitrogen oxides (NO
                    <E T="52">X</E>
                    ), particulate matter (PM), and carbon monoxide (CO). Personal watercraft also emit fuel components such as benzene that are known to cause adverse health effects. Even though PWC engine exhaust is usually routed below the waterline, a portion of the exhaust gases go into the air. These air pollutants may adversely impact park visitor and employee health, as well as sensitive park resources. 
                </P>
                <P>
                    For example, in the presence of sunlight VOC and NO
                    <E T="52">X</E>
                     emissions combine to form ozone. Ozone causes respiratory problems in humans, including cough, airway irritation, and chest pain during inhalations. Ozone is also toxic to sensitive species of vegetation. It causes visible foliar injury, decreases plant growth, and increases plant susceptibility to insects and disease. Carbon monoxide can affect humans as well. It interferes with the oxygen carrying capacity of blood, resulting in lack of oxygen to tissues. NO
                    <E T="52">X</E>
                     and PM emissions associated with PWC use can also degrade visibility. NO
                    <E T="52">X</E>
                     can also contribute to acid deposition effects on plants, water, and soil. However, because emission estimates show that NO
                    <E T="52">X</E>
                     from personal watercraft are minimal (less than 5 tons per year), acid deposition effects attributable to personal watercraft use are expected to be minimal. 
                </P>
                <P>Under this proposed rule the number of personal watercraft used daily in the lakeshore would follow similar trends as before the ban, ranging from 13 in 2002 to 16 in 2012. The impacts of continued PWC use within the lakeshore, but with restrictions east of Miners Beach, would be the negligible, since the emissions would all be less than 50 tons/year. All pollutant loads would be less than 20 tons/year, with negligible to moderate impact levels. </P>
                <P>As stated above, the number of personal watercraft operating within Pictured Rocks National Lakeshore would be similar to the number before the ban, except that PWC use would be prohibited east of Miners Beach. Therefore, PWC-related activities would result in negligible adverse impacts for all pollutants and would range from negligible to moderate adverse for air quality impact levels. </P>
                <HD SOURCE="HD2">Soundscapes </HD>
                <P>Daily PWC use levels would be similar to the number before the ban, with a slight change in the area of use. Under this proposal there would be an estimated 13 personal watercraft per day in the designated use area. No PWC use would be allowed east of Miners Beach. </P>
                <P>In most cases, personal watercraft would be dispersed along 8 miles of the lakeshore so that operating craft would be infrequent at any given location. At the areas that have the highest visitor use, such as Sand Point, PWC noise would be diluted by the sounds from wind, waves, other visitors, and motorboats. In general, the use of personal watercraft would result in negligible adverse impacts where other users are concentrated, such as at overlooks and beaches. Within the designated PWC use area, PWC noise would be heard frequently but would not be overly disruptive to visitors because of the high degree of activity that occurs within the area. Thus, PWC noise would have a moderate adverse impact on the soundscapes in the area of designated use. </P>
                <P>
                    Backcountry users, particularly in the Beaver Basin segment and along the North Country National Scenic Trail, tend to be more sensitive to sound levels and PWC activity. The intolerance to PWC noise by backcountry users was documented in the summer 2000 visitor survey. Under this proposed rule personal watercraft would be prohibited east of Miners Beach. Backcountry users in this area might still hear infrequent PWC noise since personal watercraft could still 
                    <PRTPAGE P="65560"/>
                    operate outside the 0.25-mile boundary. Thus, eliminating PWC use from the eastern portions of the lakeshore would have minor beneficial impacts to the soundscape because related noise would be less frequent and at a greater distance from shore. 
                </P>
                <P>Overall, this proposed rule would have a minor beneficial effect east of Miners Beach and a moderate adverse effect near Sand Point and Miners Beach on days when PWC use was relatively heavy. Negligible impacts would occur when use was occasional and distanced from other park users, for example, PWC users operating far from shore. Moderate adverse impacts would occur mainly where PWC use would conflict with other quieter uses, such as fishing, beach uses, or backcountry camping. In general, the impact to those seeking a quiet visitor experience would most likely be short-term and minor because PWC use would not be constant throughout the day and because the enjoyment of the typical visitor activities in the area would not be compromised. Overall, this proposal would result in a net minor beneficial to moderate adverse impact on the soundscape of Pictured Rocks National Lakeshore. All impacts would be temporary, since noise would usually be for limited times. </P>
                <P>Therefore, noise from personal watercraft would continue to have short- and long-term, moderate adverse impacts in the area of designated use. Impact levels would be related to the number of personal watercraft operating, as well as the sensitivity of other visitors. Eliminating PWC use east of Miners Beach would have minor beneficial impacts. </P>
                <HD SOURCE="HD2">Wildlife and Wildlife Habitat </HD>
                <P>Some research suggests that personal watercraft affect wildlife by interrupting normal activities. This is thought to be caused by PWC speed, noise, and access. Flight response is the most likely impact of PWC use; the most likely occurrence of PWC-induced flight would be on Lake Superior. Impacts to sensitive species at Pictured Rocks, such as loons, peregrine falcons, and piping plovers, are documented under “Threatened, Endangered, or Special Concern Species.” </P>
                <P>The number of PWC users in the lakeshore would be similar to the number before the ban, except use would be prohibited east of Miners Beach. Wildlife impacts under this proposal would be similar to those that existed before the ban on PWC use. Due to the low habitat productivity and lack of colonial wildlife along the lakeshore, as well as the low number of personal watercraft in use, impacts to wildlife and wildlife habitat due to PWC activity would be negligible at most locations. Closing eastern portions of the lakeshore to PWC use would have negligible beneficial impacts. Over the next 10 years impacts would continue to be negligible since PWC numbers would not increase substantially. All wildlife impacts would be temporary. </P>
                <P>Therefore, due to the 200′ distance that PWC users are required to operate at flat wake speed in proximity to the shoreline, impacts on wildlife and wildlife habitat would be negligible at most locations. Prohibiting PWC use east of Miners Beach would have negligible beneficial impacts. </P>
                <HD SOURCE="HD2">Threatened, Endangered, or Special Concern Species </HD>
                <P>The same issues described for PWC use and general wildlife also pertain to special concern species. Potential impacts from personal watercraft include inducing flight and alarm responses, disrupting normal behaviors and causing stress, degrading habitat quality, and potentially affecting reproductive success. Special status species at the recreation area include Federal or State listed threatened, endangered, or candidate species. </P>
                <P>
                    The Endangered Species Act (16 U.S.C 1531 
                    <E T="03">et seq.</E>
                    ) mandates that all Federal agencies consider the potential effects of their actions on species that are listed as threatened or endangered. If the National Park Service determines that an action may adversely affect a Federally listed species, consultation with the U.S. Fish and Wildlife Service is required to ensure that the action will not jeopardize the species' continued existence or result in the destruction or adverse modification of critical habitat. The animal species at Pictured Rocks National Lakeshore that have the potential to be affected by this proposed rule include the federally listed piping plover and the State listed peregrine falcon and common loon. Plant species include the federally listed pitcher's thistle and the State listed Lake Huron tansy. 
                </P>
                <P>This proposal would allow continued PWC use from the western park boundary to the east end of Miners Beach. PWC use would be prohibited east of Miners Beach. Potential effects would be similar to those that existed before the ban and would be limited to interactions with wildlife farther than 200 feet from shore or to personal watercraft landing on shore. </P>
                <P>Piping Plover—PWC use would not be allowed within the Grand Sable segment, where potential habitat exists, and there would be no effect on the piping plover. If plovers ever became established in the western end of the lakeshore, then mitigating actions could be required to minimize any adverse effect from PWC use. </P>
                <P>Common Loon and Peregrine Falcon—Interactions between personal watercraft and loons or falcons would have the same impacts as before the ban and would not likely adversely affect peregrine falcons or loons. Interactions between personal watercraft and loons or falcons would have the same impacts as before the ban and would not likely adversely affect peregrine falcons or loons. </P>
                <P>Pitcher's Thistle and Lake Huron Tansy—PWC use would not be allowed within the Grand Sable segment, where these plants are known to exist. Therefore, this proposal would affect the pitcher's thistle or the Lake Huron tansy. Restoration activities proposed for 2002 would have a beneficial effect on the thistle and the tansy. </P>
                <P>Overall, PWC use would have no effect on the piping plover, the pitcher's thistle, or the Lake Huron tansy, and would not be likely to adversely affect the common loon or the peregrine falcon since interactions would be extremely limited. </P>
                <P>Cumulative effects for PWC users and other visitors would be similar to before the ban on PWC use and would not likely adversely affect concerned species or their habitat. PWC use would have no effect in the eastern portions of the lakeshore. </P>
                <P>Piping Plover—There has been no evidence of plover use in the national lakeshore since 1992. PWC use or motorized boating would not be allowed in areas where critical plover habitat has been designated in the eastern end of the lakeshore. No direct effect on the piping plover is anticipated. If plovers started using habitat within Pictured Rocks National Lakeshore, then PWC and visitor activity would have the potential for adverse effects, and mitigating measures would be taken. </P>
                <P>Therefore, PWC use would have no cumulative effect on the piping plover, the pitcher's thistle, or the Lake Huron tansy and would not be likely to adversely affect the common loon or the peregrine falcon since interactions would be extremely limited. </P>
                <HD SOURCE="HD2">Shoreline Vegetation </HD>
                <P>
                    PWC are able to access areas that other types of watercraft may not, which may cause direct disturbance to vegetation. Indirect impact on shoreline vegetation may occur through trampling if operators disembark and engage in activities on shore. In addition, wakes created by personal watercraft may 
                    <PRTPAGE P="65561"/>
                    affect shorelines through erosion by wave action. The proposed rule aims to limit these disturbances to the shoreline areas. 
                </P>
                <P>PWC use under the proposed rule would continue to be allowed in the designated use area but use would be prohibited east of Miners Beach. PWC impacts to shoreline vegetation would be similar to those before the ban, since the number of PWC users would be comparable, although use areas would be modified. Impacts to vegetation east of Miners Beach would be negligible and beneficial since users would no longer have access to shoreline areas. Continued PWC use in other areas would have negligible adverse impacts to sensitive shoreline vegetation over the short and long term, with no perceptible changes in plant community size, integrity, or continuity. </P>
                <P>Therefore, PWC use would have negligible adverse impacts in the designated uea area over the short and long term because there have been no perceptible changes to plant community size, integrity or continuity, and none are expected in the future (2012). PWC restrictions east of Miners Beach would result in negligible beneficial impacts to shoreline vegetation. </P>
                <HD SOURCE="HD2">Visitor Experience </HD>
                <P>The proposed rule would provide park visitors with a high-quality experience and manage potential conflicts between PWC use and other park visitors. PWC use under this proposal would continue to be allowed in the designated use area and PWC use would be prohibited east of Miners Beach. Of the 13 to 16 personal watercraft operating in the lakeshore during peak use, these restrictions would affect an estimated five to six PWC operators by changing their location of use. Additionally, PWC operation would be restricted at certain locations during the permitted use of ethnographic resources. </P>
                <P>Impact on PWC Users—By prohibiting PWC use east of Miners Beach, there would be no use at Twelvemile Beach. Additionally, more PWC riders would stay within the west end of the park, between Munising and Miners Beach. Most PWC users (estimated at 60%) would have little or no noticeable change in their location of operation. They could, however, notice more personal watercraft operating within the 8 miles of the shoreline open to PWC use. Voluntarily extending operations farther from shore would likely offset this increase in density. Under this proposal PWC users would be limited in their location of operation and could be affected by a slight increase in density of use. As a result, visitors who use personal watercraft at Pictured Rocks National Lakeshore would experience moderate adverse impacts. </P>
                <P>Impact on Frontcountry Visitors—Swimmers, hikers, and other visitors to the Sand Point, Miners Beach, and Miners Castle areas would have slightly more contact with PWC operators than before the ban because PWC use would only be allowed along this stretch of the lakeshore and would be prohibited east of Miners Beach. The increased amount of contact would not be noticeable in comparison to existing conditions since most activities occur in this stretch of the lakeshore. PWC activity near Sand Point, Miners Beach, and Miners Castle would have negligible adverse impacts on the experiences of swimmers, hikers, and other visitors because under State regulations personal watercraft must be operated at no-wake speed within 200 feet of the shore and may only travel perpendicular to the shore. </P>
                <P>Visitors east of Miners Beach would no longer have contact with PWC users within the lakeshore's 0.25-mile jurisdiction. Visitors to Chapel Beach and Twelvemile Beach, in particular, tend to look for quieter experiences. Therefore, this proposal would have a negligible beneficial impact to visitors east of Miners Beach. </P>
                <P>Impact on Backcountry Visitors—Backcountry visitors east of Miners Beach would have decreased contact with PWC users, resulting in a moderate beneficial impact to their experiences. PWC restrictions would particularly enhance the experiences of wilderness visitors in the Beaver Basin segment. Visitors along the North Country National Scenic Trail within the Sand Point segment and the western one mile of the Cliffs segment would continue to be occasionally affected by PWC use, with a moderate adverse impact. </P>
                <P>Motorized boats and other visitors would continue to interact, with impacts the same as before the ban on PWC use. Cumulative impacts related to the use of personal watercraft, motorized boats, and other visitor activities would be negligible over the short and long term because there would be little noticeable change in the visitor experience for most visitors. Backcountry visitors east of Miners Beach would have moderate beneficial impacts because of decreased impacts from PWC use. Most visitors would continue to be satisfied with their experiences at Pictured Rocks National Lakeshore. </P>
                <P>Therefore, PWC users would be limited in their location of operation within the national lakeshore and could notice a slight increase in the density of use in the vicinity of Sand Point. As a result, they would experience moderate adverse impacts. Restricting PWC use east of Miners Beach would have negligible beneficial impacts on the experiences of most other visitors in the short and long term, and it would have long-term, moderate, beneficial impacts on those visitors desiring backcountry experiences with natural “quiet.” The level of PWC use would remain relatively low at lakeshore locations. When related to other visitor activities, PWC use would not appreciably limit the critical characteristics of visitor experiences. </P>
                <HD SOURCE="HD2">Visitor Conflict and Safety </HD>
                <P>The proposed rule would minimize or reduce the potential for PWC user accidents and improve safety between PWC users and other water recreationists. This proposed rule assumes that PWC operations would be similar to before the ban, except that PWC use would be discontinued east of Miners Beach. As a result, the watercraft that normally operate in the eastern portions of the national lakeshore would be relocated to the western portion of the lakeshore. </P>
                <P>Personal Watercraft/Swimmer Conflicts—Impacts would be similar to before the PWC ban since the overall number of personal watercraft operating within the lakeshore would not change. PWC user/swimmer interactions would increase slightly in the Sand Point segment and the western one mile of the Cliffs segment because of a shift in PWC use from other locations. However, under State regulations PWC operators must travel at no-wake speed within 200 feet of the shore and only perpendicular to the shore. The change in location for PWC operation would not be noticeable to other visitors and would continue to result in minor adverse impacts. In the remaining lakeshore locations there would be little or no conflict between PWC users and swimmers. No conflicts would occur east of Miners Beach, resulting in a negligible beneficial impact to these visitors. </P>
                <P>Overall, PWC use would continue to have negligible to minor adverse impacts on most swimmers at Pictured Rocks National Lakeshore. Beneficial impacts would occur east of Miners Beach. Impacts would be perceptible to a relatively small number of visitors at localized areas, primarily at Sand Point and Miners Beach. </P>
                <P>
                    Personal Watercraft/Other Boat Conflicts—Impacts would be similar to before the ban. Overall, PWC use would continue to have minor adverse impacts on other motorized boat users at Pictured Rocks National Lakeshore. 
                    <PRTPAGE P="65562"/>
                    Impacts would be perceptible to a relatively small number of visitors at localized areas, primarily at the Sand Point launch. 
                </P>
                <P>Cumulative impacts would be similar to before the ban on PWC use. The natural separation of use between the various lakeshore visitors reduces the potential for conflicts. For this reason, the cumulative impact of the various user groups on visitor conflicts and safety would be negligible to minor over the short and long term. Beneficial impacts would occur east of Miners Beach. Impacts would be perceptible to a relatively small number of visitors at localized areas, primarily at the Sand Point beach. </P>
                <P>Therefore, continued PWC use would have short- and long-term, minor, adverse impacts on visitor conflicts and safety, particularly in the Sand Point area, due to the number of visitors and boats present on high use days. Conflicts at other locations would remain negligible because use is lower and conflicts would be less likely to occur. Conflicts would be eliminated east of Miners Beach, resulting in negligible, beneficial impacts. </P>
                <HD SOURCE="HD2">The Proposed Rule </HD>
                <P>Under the proposed rule in § 7.32 PWC use would be allowed to operate on the waters of Lake Superior within the boundaries of Pictured Rocks National Lakeshore from the western boundary of the lakeshore up to the east end of Miners Beach. This proposed rule would allow PWC use along the Lake Superior shoreline within the western end of the park, covering approximately 8 miles of shoreline. PWC use would be allowed under the following conditions: </P>
                <P>Personal watercraft may only be launched from a designated launch site at Sand Point. </P>
                <P>PWC users may beach their craft on Miners Beach, however no launching or retrieving of the craft may occur at Miners Beach. </P>
                <P>PWC users may not launch or operate in any other area of the lakeshore. </P>
                <P>The superintendent may temporarily limit, restrict, or terminate access to areas designated for PWC use after taking into consideration public health and safety, natural and cultural resource protection, and other management activities and objectives. </P>
                <P>PWC use would be restricted at specific locations during the permitted use of ethnographic resources. Boat patrols would be conducted in the vicinity of the ethnographic resource use in order to reduce the potential for PWC-related intrusion into the ceremonial activity. </P>
                <P>PWC users must comply with the requirements of the Michigan Personal Watercraft Safety Act of 1998 (Public Act 116), including the requirement to operate at flat wake speed within 200′ of the shoreline, and related regulations. </P>
                <HD SOURCE="HD1">Compliance with Other Laws </HD>
                <HD SOURCE="HD1">Regulatory Planning and Review (Executive Order 12866) </HD>
                <P>This document is a significant rule and has been reviewed by the Office of Management and Budget under Executive Order 12866. </P>
                <P>(1) This rule will not have an effect of $100 million or more on the economy. It will not adversely affect in a material way the economy, productivity, competition, jobs, the environment, public health or safety, or State, local, or tribal governments or communities. The National Park Service has completed the report “Economic Analysis of Personal Watercraft Regulations in Pictured Rocks National Lakeshore” (RTI, International, November 2004). </P>
                <P>(2) This rule will not create a serious inconsistency or otherwise interfere with an action taken or planned by another agency. Actions taken under this rule will not interfere with other agencies or local government plans, policies or controls. This rule is an agency specific rule. </P>
                <P>(3) This rule does not alter the budgetary effects of entitlements, grants, user fees, or loan programs or the rights or obligations of their recipients. This rule will have no effects on entitlements, grants, user fees, or loan programs or the rights or obligations of their recipients. No grants or other forms of monetary supplements are involved. </P>
                <P>(4) This rule does raise novel legal or policy issues. This rule is one of the special regulations being issued for managing PWC use in National Park Units. The National Park Service published general regulations (36 CFR 3.24) in March 2000, requiring individual park areas to adopt special regulations to authorize PWC use. The implementation of the requirement of the general regulation continues to generate interest and discussion from the public concerning the overall effect of authorizing PWC use and National Park Service policy and park management. </P>
                <HD SOURCE="HD1">Regulatory Flexibility Act </HD>
                <P>
                    The Department of the Interior certifies that this rulemaking will not have a significant economic effect on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 
                    <E T="03">et seq.</E>
                    ). This certification is based on a report entitled report “Economic Analysis of Personal Watercraft Regulations in Pictured Rocks National Lakeshore” (RTI, International, November 2004). 
                </P>
                <HD SOURCE="HD1">Small Business Regulatory Enforcement Fairness Act (SBREFA) </HD>
                <P>This rule is not a major rule under 5 U.S.C. 804(2), the Small Business Regulatory Enforcement Fairness Act. This proposed rule: </P>
                <P>a. Does not have an annual effect on the economy of $100 million or more. </P>
                <P>b. Will not cause a major increase in costs or prices for consumers, individual industries, Federal, State, or local government agencies, or geographic regions. </P>
                <P>c. Does not have significant adverse effects on competition, employment, investment, productivity, innovation, or the ability of U.S.-based enterprises to compete with foreign-based enterprises. </P>
                <HD SOURCE="HD1">Unfunded Mandates Reform Act </HD>
                <P>This rule does not impose an unfunded mandate on State, local, or tribal governments or the private sector of more than $100 million per year. The rule does not have a significant or unique effect on State, local or tribal governments or the private sector. This rule is an agency specific rule and does not impose any other requirements on other agencies, governments, or the private sector. </P>
                <HD SOURCE="HD1">Takings (Executive Order 12630) </HD>
                <P>In accordance with Executive Order 12630, the rule does not have significant takings implications. A taking implication assessment is not required. No taking of personal property will occur as a result of this rule. </P>
                <HD SOURCE="HD1">Federalism (Executive Order 13132) </HD>
                <P>In accordance with Executive Order 13132, the rule does not have sufficient Federalism implications to warrant the preparation of a Federalism Assessment. This proposed rule only affects use of NPS administered lands and waters. It has no outside effects on other areas by allowing PWC use in specific areas of the park. </P>
                <HD SOURCE="HD1">Civil Justice Reform (Executive Order 12988) </HD>
                <P>In accordance with Executive Order 12988, the Office of the Solicitor has determined that this rule does not unduly burden the judicial system and meets the requirements of sections 3(a) and 3(b)(2) of the Order. </P>
                <HD SOURCE="HD1">Paperwork Reduction Act </HD>
                <P>
                    This regulation does not require an information collection from 10 or more 
                    <PRTPAGE P="65563"/>
                    parties and a submission under the Paperwork Reduction Act is not required. An OMB Form 83-I is not required. 
                </P>
                <HD SOURCE="HD1">National Environmental Policy Act </HD>
                <P>
                    As a companion document to this NPRM, NPS has issued the 
                    <E T="03">Personal Watercraft Use Environmental Assessment for Pictured Rocks National Lakeshore</E>
                     and subsequent errata sheet. The environmental assessment was available for public review and comment for the period August 1 through November 15, 2004. To request a copy of the document and errata sheet contact Superintendent, Pictured Rocks National Lakeshore, N8391 Sand Point Road, P.O. Box 40, Munising, MI 49862-0040. A copy of the Environmental Assessment and errata sheet may also be found at www.nps.gov/piro. 
                </P>
                <HD SOURCE="HD1">Government-to-Government Relationship With Tribes </HD>
                <P>In accordance with the President's memorandum of April 29, 1994, “Government to Government Relations with Native American Tribal Governments” (59 FR 22951) and 512 DM 2, we have evaluated potential effects on Federally recognized Indian tribes and have determined that there are no potential effects. </P>
                <HD SOURCE="HD1">Clarity of Rule </HD>
                <P>
                    Executive Order 12866 requires each agency to write regulations that are easy to understand. We invite your comments on how to make this rule easier to understand, including answers to questions such as the following: (1) Are the requirements in the rule clearly stated? (2) Does the rule contain technical language or jargon that interferes with its clarity? (3) Does the format of the rule (grouping and order of sections, use of headings, paragraphing, 
                    <E T="03">etc.</E>
                    ) aid or reduce its clarity? (4) Would the rule be easier to read if it were divided into more (but shorter) sections? (A “section” appears in bold type and is preceded by the symbol “§ ” and a numbered heading; for example [§ 7.32 Pictured Rocks National Lakeshore] (5) Is the description of the rule in the “Supplementary Information” section of the preamble helpful in understanding the proposed rule? What else could we do to make the rule easier to understand? 
                </P>
                <P>
                    Send a copy of any comments that concern how we could make this rule easier to understand to: Office of Regulatory Affairs, Department of the Interior, Room 7229, 1849 C Street, NW., Washington, DC 20240. You may also e-mail the comments to this address: 
                    <E T="03">Exsec@ios.doi.gov.</E>
                </P>
                <P>
                    <E T="03">Drafting Information:</E>
                     The primary authors of this regulation are: Larry Hach, Chief Ranger, Pictured Rocks National Lakeshore; Sarah Bransom, Environmental Quality Division; and Kym Hall, Special Assistant. 
                </P>
                <HD SOURCE="HD1">Public Participation </HD>
                <P>
                    Comments on the proposed rule should be mailed to N8391 Sand Point Road, P.O. Box 40, Munising, MI 49862-0040. Comments may also be sent by e-mail to 
                    <E T="03">PIRO@den.nps.gov.</E>
                     If you comment by e-mail, please include “PWC rule” in the subject line and your name and return address in the body of your Internet message. 
                </P>
                <P>Our practice is to make comments, including names and addresses of respondents, available for public review during regular business hours. Individual respondents may request that we withhold their home address from the rulemaking record, which we will honor to the extent allowable by law. If you wish us to withhold your name and/or address, you must state this prominently at the beginning of your comment. However, we will not consider anonymous comments. We will make all submissions from organizations or businesses, and from individuals identifying themselves as representatives or officials or organizations or businesses, available for public inspection in their entirety. </P>
                <LSTSUB>
                    <HD SOURCE="HED">List of Subjects in 36 CFR Part 7 </HD>
                    <P>District of Columbia, National Parks, Reporting and recordkeeping requirements. </P>
                </LSTSUB>
                <P>In consideration of the foregoing, the National Park Service proposes to amend 36 CFR part 7 as follows: </P>
                <PART>
                    <HD SOURCE="HED">PART 7—SPECIAL REGULATIONS, AREAS OF THE NATIONAL PARK SYSTEM </HD>
                    <P>1. The authority for Part 7 continues to read as follows: </P>
                    <AUTH>
                        <HD SOURCE="HED">Authority:</HD>
                        <P>16 U.S.C. 1, 3, 9a, 460(q), 462(k); Sec. 7.96 also issued under DC Code 8-137(1981) and DC Code 40-721 (1981).</P>
                    </AUTH>
                    <P>2. Amend § 7.32 by adding paragraph (d) to read as follows: </P>
                    <SECTION>
                        <SECTNO>§ 7.32 </SECTNO>
                        <SUBJECT>Pictured Rocks National Lakeshore. </SUBJECT>
                        <STARS/>
                        <P>
                            (d) 
                            <E T="03">Personal Watercraft (PWC).</E>
                             (1) PWC are allowed on the waters within Pictured Rocks National Lakeshore, from the western boundary of the lakeshore to the east end of Miners Beach. 
                        </P>
                        <P>(2) PWC may only be launched from a designated launch site at Sand Point. </P>
                        <P>(3) At Sand Point Beach and Miners Beach, PWC users may only beach their craft. </P>
                        <P>(4) The Superintendent may temporarily limit, restrict, or terminate access to the areas designated for PWC use after taking into consideration public health and safety, natural and cultural resource protection, and other management activities and objectives. </P>
                    </SECTION>
                    <SIG>
                        <DATED>Dated: November 4, 2004. </DATED>
                        <NAME>Paul Hoffman, </NAME>
                        <TITLE>Deputy Assistant Secretary, Fish and Wildlife and Parks. </TITLE>
                    </SIG>
                </PART>
            </SUPLINF>
            <FRDOC>[FR Doc. 04-25318 Filed 11-12-04; 8:45 am] </FRDOC>
            <BILCOD>BILLING CODE 4310-70-P </BILCOD>
        </PRORULE>
        <PRORULE>
            <PREAMB>
                <AGENCY TYPE="N">POSTAL RATE COMMISSION </AGENCY>
                <CFR>39 CFR Part 3001 </CFR>
                <DEPDOC>[Docket No. RM2005-1; Order No. 1423] </DEPDOC>
                <SUBJECT>Periodic Reporting Rule </SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Postal Rate Commission. </P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Advance notice of proposed rulemaking. </P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>This document addresses a dispute that has arisen over the Postal Service's compliance with certain periodic reporting rules. These rules are intended to facilitate participation in Commission proceedings by providing the public with data and information on cost methodologies and other matters. This notice describes the dispute and invites comments on this development, including suggestions on possible rule changes. </P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>
                        <E T="03">Initial Comments:</E>
                         December 6, 2004; 
                        <E T="03">Reply Comments:</E>
                         January 6, 2005. 
                    </P>
                </DATES>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>Stephen L. Sharfman, General Counsel, (202) 789-6818. </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <HD SOURCE="HD1">Regulatory History </HD>
                <P>68 FR 2272, January 16, 2003. </P>
                <P>68 FR 65348, November 19, 2003. </P>
                <HD SOURCE="HD1">Summary </HD>
                <P>The Postal Rate Commission amended its Rules Applicable to the Filing of Reports by the U.S. Postal Service in its Order No. 1386, issued November 3, 2003. That order updated the rules to reflect new data systems and methodologies, and increased the amount of information the Postal Service was to submit to assist the Commission and foster effective public participation in Administrative Procedure Act (APA) hearings pursuant to 39 U.S.C. 3624. </P>
                <P>
                    The Postal Service opposed expansion of its obligations under 39 CFR 
                    <PRTPAGE P="65564"/>
                    3001.102, Filing of Reports, in the rulemaking docket leading to the adoption of Order No. 1386. Although it initially complied with some of its new obligations, the Postal Service has now informed the Commission that after consideration at the “highest level” of postal management, it has determined that it will not comply with Commission rules that require the reporting of new methodologies and data used in the preparation of its annual Cost and Revenue Analysis (CRA) report. 
                </P>
                <P>In support of its action, the Postal Service reiterated several legal contentions fully considered and rejected by the Commission in its rulemaking. However, the primary motivating factor leading to the Postal Service announcement that it would not comply with the rules seems to be the Commission practice of making materials filed in compliance with its rules available to the public. </P>
                <P>The Commission requests that interested persons provide comments on this controversy, including suggestions for adjustments to Commission rules designed to reconcile the conflicting interests outlined in this Notice. Comments should be provided by December 6, 2004. Reply comments may be submitted by January 6, 2005. </P>
                <HD SOURCE="HD1">Background </HD>
                <P>Over the years, postal ratemaking has become increasingly complex. The ability to computerize information and apply econometrics to large data bases has led to more sophisticated analyses of postal costs, volumes, and revenues. The Commission, and to an even greater extent mailers and other interested participants in Postal Rate Commission proceedings, have had growing difficulty in reviewing multiple new complex analyses in the context of proceedings that must, by statute, be completed in 10 months. 39 U.S.C. 3624(c)(1). </P>
                <P>The Postal Service supports its requests for rate increases with testimony from 40+ witnesses, a number of whom sponsor technical analyses that have been in preparation for many months. Participants must review this material, develop their criticisms, and present any suggested alternative analyses approximately half way through a case to allow other participants and the Commission to evaluate their views. The Commission is charged with reviewing every analysis presented, getting clarifications as needed, and preparing a technically sound, comprehensive decision. </P>
                <P>Commission conclusions must be confined to materials in the evidentiary record. Participants have complained that the process becomes ineffective and one-sided if only the Postal Service has time sufficient to analyze data and prepare persuasive evidence. </P>
                <P>Following the most recent rate case, the Postal Service and Postal Rate Commission jointly sponsored a Ratemaking Summit to obtain public input on ways to make the ratemaking process more streamlined and less burdensome for all involved. The Summit took place in May and June, 2002, and involved written comments followed by two, separate full day discussion sessions. </P>
                <P>Attention was given both to how the Postal Service planned and implemented rate changes, and how to improve the current rate case process. The majority of comments addressing the rate case process focused on the difficulty of responding adequately to multiple new complex technical presentations within the 10-month timeframe. Participants emphasized they do not have the resources to address several major technical studies simultaneously. </P>
                <P>The most widely supported solution was to find a way to provide participants with more timely access to annual cost and volume data, as well as any changes in the methodologies the Postal Service uses to aggregate and distribute that data in preparing its annual reports. It has been the Postal Service's consistent practice to withhold from the public both the basic cost and volume data underlying its aggregate results, and any changes to its analytic methodologies, until it submits an omnibus rate request. </P>
                <HD SOURCE="HD1">Recent Amendments to the Periodic Reporting Rules </HD>
                <P>A short time after the Ratemaking Summit, the Commission issued a notice of proposed rulemaking, in which it sought comments on whether to update and expand its Rules Applicable to the Filing of Reports by the U.S. Postal Service. These rules had not been revised for over a decade and no longer fully reflected existing operating and data collection practices. The Commission is directed by 39 U.S.C. 3603 to implement such rules as it finds necessary and proper to enable it to carry out its statutory functions. That section specifically provides such rules “shall not be subject to any change or supervision by the Postal Service.” </P>
                <P>All those who submitted either comments or reply comments, with the exception of the Postal Service, urged the Commission to amend its periodic reporting rules to facilitate analysis between rate cases. The Postal Service has opposed parts of these proposals, raising legal arguments (set forth below) and expressing concern that compliance would be burdensome, and that it might face time-consuming questions about new analytic methods underlying its published summary reports. </P>
                <P>The Commission followed APA processes, resolving every issue raised. It narrowed its initial proposal somewhat in light of the Postal Service's burden arguments, but it retained several proposed amendments to the periodic reporting rules providing access to new data collection systems and estimating methods. The Commission found that updating the periodic reporting rules would result in favor of key improvements: </P>
                <P>(1) Help the Commission and the public to evaluate the soundness of the cost, volume and revenue estimates on which existing rates were based; </P>
                <P>(2) Inform the Commission and the public about new data sets and estimation techniques incorporated by the Postal Service each year into the Cost and Revenue Analysis (CRA) report it currently provides; </P>
                <P>(3) Allow the public to participate more meaningfully in Commission cases; and </P>
                <P>(4) Enable the Commission to expedite the processing of rate, classification, and complaint cases. </P>
                <P>In November 2003 the Commission amended its periodic reporting rules. The Postal Service has complied with some parts of the new rule, but it now has refused to provide data and methodologies used to develop the majority of the cost attributions reported in its Cost and Revenue analysis. The Attachment to this Order lists the information the Postal Service has not provided. </P>
                <HD SOURCE="HD1">The Postal Service Position </HD>
                <P>
                    The Postal Service explained its views in detailed filings in Docket RM2003-3. All of these filings may be accessed on the Commission Web site, 
                    <E T="03">http://www.prc.gov.</E>
                     The most recent Postal Service statement, in which it announced it would not provide required information, may also be found there on the “Daily Listing” for September 17, 2004. 
                </P>
                <P>
                    The Postal Service advances two main arguments in support of its position that the Commission is not authorized to require periodic reports of this nature. First, it contends that Commission authority is limited to acting in response to Postal Service requests for rate or classification decisions, and other strictly limited specific functions set forth in the Act. The Postal Service argues that the Commission does not 
                    <PRTPAGE P="65565"/>
                    have broad investigative or oversight authority, and the Service has implied that the amended rules are an attempt by the Commission to expand its authority and oversee operations in a manner not contemplated by the statute. 
                </P>
                <P>Second, the Postal Service contends that Congress does not want it to have to make information of this nature public “indiscriminately.” The Act includes a special test applicable to Freedom of Information Act (FOIA) requests. The Postal Service does not have to provide “information of a commercial nature” which “under good business practice would not be publicly disclosed” in response to a FOIA request. 39 U.S.C. 410(c)(2). The Postal Service correctly observes that private businesses in the United States seldom disclose detailed information about their operating costs. </P>
                <P>The Postal Service argues that because it is standard Commission practice to post public documents on its Web site, including data received as periodic reports, the Service should not provide such detailed information to the Commission. The Postal Service seems to concede that the Commission might have use for these materials, and for explanations of changes since the most recent rate case, but it contends that allowing internet access to this information would be contrary to Congress' vision of the Postal Service following good business practices. </P>
                <HD SOURCE="HD1">The Current Commission Position </HD>
                <P>The Commission has not found either Postal Service argument persuasive, as explained fully in Order No. 1386. The Commission has concluded that its responsibility under section 3603 to establish rules to carry out its functions under the Act does provide the authority to assure that sufficient information is available in a timely fashion to facilitate meaningful public participation and to enable the Commission to provide informed recommendations in response to Postal Service rate and classification requests. </P>
                <P>The Commission also has concluded that information required by its rules is not equivalent to a citizen's FOIA request. While citizens can file a FOIA request seeking information on any topic without any showing of need, the Commission's rules focus on information needed to carry out its statutory functions. The Act requires public participation in all Commission proceedings, and thus contemplates public access to relevant data. In past rate cases, the Postal Service has made all of the contested information available without suggesting that there was any need to restrict public access to it. </P>
                <P>The Commission always has recognized that when the Postal Service or any other participant provides items for use in a Commission proceeding that it shows to be trade secrets or other sensitive business information, and that disclosure of this information could result in commercial harm, such items should be made subject to appropriate protective conditions. Similarly, the Commission has been willing to accommodate in its periodic reporting rules, Postal Service requests that specific information be protected as commercially sensitive, after balancing the asserted risk of harm against the needs of the public to remain informed. See Docket No. RM89-3, Order No. 839, at 7-8 (deferring filing dates for billing determinants of competitive products). </P>
                <HD SOURCE="HD1">Comments </HD>
                <P>The Postal Service has indicated its interest in further exploring the possibility of ways to refine procedures for controlling dissemination of information provided as periodic reports. This might be accomplished through additions to rule 102. Those responding to this notice are invited to advise on the most important policies and principles that should guide the Commission in evaluating potential action in regard to this situation. Commenters also may suggest procedures for obtaining a desired outcome or specific proposals for changes to Commission rules. </P>
                <HD SOURCE="HD1">Ordering Paragraphs </HD>
                <P>It is ordered:</P>
                <P>1. Interested persons are invited to submit comments on the Commission's Advance Notice of Proposed Rulemaking on or before December 6, 2004. Any reply comments should be submitted by January 6, 2005. </P>
                <P>
                    2. The Secretary shall cause this Advance Notice of Proposed Rulemaking to be published in the 
                    <E T="04">Federal Register</E>
                    . 
                </P>
                <HD SOURCE="HD1">Attachment </HD>
                <HD SOURCE="HD3">Materials Required by Rule 102 That the Postal Service Has Not Provided</HD>
                <P>1. The In-Office Cost System (IOCS) data for FY 2003 used to distribute attributable mail processing and in-office carrier costs to classes of mail in the Cost and Revenue Analysis (CRA) report. </P>
                <P>2. The City Carrier Cost System (CCCS) data for FY 2003 used to distribute attributable city carrier costs to classes of mail in the CRA. </P>
                <P>3. The Rural Carrier Cost System (RCCS) data for 2003 used to distribute attributable rural carrier costs to classes of mail in the CRA. </P>
                <P>4. The National Mail Count data for 2003. These data are used to determine attributable rural carrier costs. </P>
                <P>5. MODS input data used to estimate mail processing cost variabilities by activity. </P>
                <P>6. SAS computer programs showing how FY 2003 attributable mail processing costs were estimated and distributed to mail classes in the CRA. </P>
                <P>7. Revenue, Pieces, and Weight reports by rate category for the first three quarters of FY 2004. </P>
                <SIG>
                    <P>By the Commission.</P>
                    <DATED>Issued: November 8, 2004. </DATED>
                    <NAME>Steven W. Williams,</NAME>
                    <TITLE>Secretary. </TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 04-25298 Filed 11-12-04; 8:45 am] </FRDOC>
            <BILCOD>BILLING CODE 7710-FW-P </BILCOD>
        </PRORULE>
        <PRORULE>
            <PREAMB>
                <AGENCY TYPE="N">ENVIRONMENTAL PROTECTION AGENCY</AGENCY>
                <CFR>40 CFR Part 720</CFR>
                <DEPDOC>[OPPT-2003-0058; FRL-7342-2]</DEPDOC>
                <RIN>RIN 2070-AJ04</RIN>
                <SUBJECT>TSCA Inventory Nomenclature for Enzymes and Proteins</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Environmental Protection Agency (EPA).</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Advance Notice of Proposed Rulemaking (ANPRM).</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>This ANPRM alerts interested parties that EPA is considering new procedures and regulations for naming enzymes and proteins when listing such substances on the Toxic Substances Control Act (TSCA) Chemical Substances Inventory (Inventory). More specifically, this ANPRM outlines four identification elements that EPA currently believes are appropriate for use in developing unique TSCA Inventory nomenclature for proteinaceous enzymes. This ANPRM also solicits public comment on several specific questions relating to this initiative.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Comments must be received on or before December 15, 2004.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>Submit your comments, identified by  docket ID number OPPT-2003-0058, by one of the following methods:</P>
                    <P>
                        • 
                        <E T="03">Federal eRulemaking Portal</E>
                        : 
                        <E T="03">http://www.regulations.gov/</E>
                        .  Follow the on-line instructions for submitting comments.
                    </P>
                    <P>
                        • 
                        <E T="03">Agency Website</E>
                        : 
                        <E T="03">http://www.epa.gov/edocket/</E>
                        .  EDOCKET, EPA's electronic public docket and 
                        <PRTPAGE P="65566"/>
                        comment system, is EPA's preferred method for receiving comments.  Follow the on-line instructions for submitting comments.
                    </P>
                    <P>
                        • 
                        <E T="03">E-mail:</E>
                          
                        <E T="03">oppt.ncic@epa.gov</E>
                        .
                    </P>
                    <P>
                        • 
                        <E T="03">Mail:</E>
                         Document Control Office (7407M), Office of Pollution Prevention and Toxics (OPPT), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001.
                    </P>
                    <P>
                        • 
                        <E T="03">Hand delivery/courier</E>
                        :  OPPT Document Control Office (DCO), EPA East Bldg., Rm. 6428, 1201 Constitution Ave., NW., Washington, DC, Attention: Docket ID number OPPT-2003-0058. The DCO is open from 8 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The telephone number for the DCO is (202) 564-8930. Such deliveries are only accepted during the Docket's normal hours of operation, and special arrangements should be made for deliveries of boxed information.
                    </P>
                    <P>
                        <E T="03">Instructions</E>
                        :  Direct your comments to docket ID number OPPT-2003-0058.  EPA's policy is that all comments received will be included in the public docket without change and may be made available on-line at 
                        <E T="03">http://www.epa.gov/edocket/</E>
                        , including any personal information provided, unless the comment includes information claimed to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Do not submit information that you consider to be CBI or otherwise protected through EDOCKET, regulations.gov, or e-mail.  The EPA EDOCKET and the Federal regulations.gov websites are “anonymous access” systems, which means EPA will not know your identity or contact information unless you provide it in the body of your comment.  If you send an e-mail comment directly to EPA without going through EDOCKET or regulations.gov, your e-mail address will be automatically captured and included as part of the comment that is placed in the public docket and made available on the Internet.  If you submit an electronic comment, EPA recommends that you include your name and other contact information in the body of your comment and with any disk or CD-ROM you submit.  If EPA cannot read your comment due to technical difficulties and cannot contact you for clarification, EPA may not be able to consider your comment.  Electronic files should avoid the use of special characters, any form of encryption, and be free of any defects or viruses. For additional information about EPA's public docket visit EDOCKET on-line or see the 
                        <E T="04">Federal Register</E>
                         of May 31, 2002 (67 FR 38102) (FRL-7181-7).
                    </P>
                    <P>
                        <E T="03">Docket</E>
                        : All documents in the docket are listed in the EDOCKET index at 
                        <E T="03">http://www.epa.gov/edocket/</E>
                        .  Although listed in the index, some information is not publicly available, i.e., CBI or other information whose disclosure is restricted by statute.  Certain other material, such as copyrighted material, is not placed on the Internet and will be publicly available only in hard copy form.  Publicly available docket materials are available either electronically in EDOCKET or in hard copy at the OPPT Docket, EPA Docket Center (EPA/DC), EPA West, Rm. B102, 1301 Constitution Ave., NW., Washington, DC.  The Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The EPA Docket Center Reading Room telephone number is (202) 566-1744, and the telephone number for the OPPT Docket, which is located in the EPA Docket Center, is (202) 566-0280.
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        <E T="03">For general information contact</E>
                        : Colby Lintner, Regulatory Coordinator, Environmental Assistance Division (7408M), Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number: (202) 554-1404; e-mail address: 
                        <E T="03">TSCA-Hotline@epa.gov</E>
                        .
                    </P>
                    <P>
                        <E T="03">For technical information contact</E>
                        : James Alwood, Chemical Control Division, (7405M), Office Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number: (202) 564-8974; e-mail address: 
                        <E T="03">alwood.jim@epa.gov</E>
                        .
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <HD SOURCE="HD1">I. General Information</HD>
                <HD SOURCE="HD2">A. Does this Action Apply to Me?</HD>
                <P>You may be potentially affected by this action if you manufacture, import, process, or use chemical substances which are subject to TSCA jurisdiction. Potentially affected entities may include, but are not limited to:</P>
                <P>• Chemical manufacturers (NAICS 325), e.g., persons manufacturing, importing, processing, or using chemicals for commercial purposes.</P>
                  
                <P>• Petroleum and coal product industries (NAICS 324), e.g., persons manufacturing, importing, processing, or using chemicals for commercial purposes.</P>
                <P>
                    This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in this unit could also be affected. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether this action might apply to certain entities. To determine whether you or your business may be affected by this action, you should carefully examine the applicability provisions in title 40 of the Code of Federal Regulations (CFR) at 40 CFR 720.22. If you have any questions regarding the applicability of this action to a particular entity, consult the technical person listed under 
                    <E T="02">FOR FURTHER INFORMATION CONTACT</E>
                    .
                </P>
                <HD SOURCE="HD2">B. How Can I Access Electronic Copies of this Document and Other Related Information?</HD>
                <P>
                    In addition to EDOCKET (
                    <E T="03">http://www.epa.gov/edocket/</E>
                    ), you may access this 
                    <E T="04">Federal Register</E>
                     document electronically through the EPA Internet under the “
                    <E T="04">Federal Register</E>
                    ” listings at 
                    <E T="03">http://www.epa.gov/fedrgstr/</E>
                    . A frequently updated electronic version of 40 CFR part 720 is available on E-CFR Beta Site Two at 
                    <E T="03">http://www.gpoaccess.gov/ecfr/</E>
                    .
                </P>
                <HD SOURCE="HD2">C. What Should I Consider as I Prepare My Comments for EPA?</HD>
                <P>
                    1. 
                    <E T="03">Submitting CBI</E>
                    . Do not submit this information to EPA through EDOCKET, regulations.gov, or e-mail.  Clearly mark the part or all of the information that you claim to be CBI.  For CBI information in a disk or CD ROM that you mail to EPA, mark the outside of the disk or CD ROM as CBI and then identify electronically within the disk or CD ROM the specific information that is claimed as CBI.  In addition to one complete version of the comment that includes information claimed as CBI, a copy of the comment that does not contain the information claimed as CBI must be submitted for inclusion in the public docket.  Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2.
                </P>
                <P>
                    2. 
                    <E T="03">Tips for preparing your comments</E>
                    . When submitting comments, remember to:
                </P>
                <P>
                    i. Identify the rulemaking by docket ID number and other identifying information (subject heading, 
                    <E T="04">Federal Register</E>
                     date and page number).
                </P>
                <P>ii. Follow directions—The Agency may ask you to respond to specific questions or organize comments by referencing a CFR part or section number.</P>
                <PRTPAGE P="65567"/>
                <P>iii. Explain why you agree or disagree; suggest alternatives and substitute language for your requested changes.</P>
                <P>iv. Describe any assumptions and provide any technical information and/or data that you used.</P>
                <P>v. If you estimate potential costs or burdens, explain how you arrived at your estimate in sufficient detail to allow for it to be reproduced.</P>
                <P>vi. Provide specific examples to illustrate your concerns, and suggest alternatives.</P>
                <P>vii. Explain your views as clearly as possible, avoiding the use of profanity or personal threats.</P>
                <P>viii. Make sure to submit your comments by the comment period deadline identified.</P>
                <HD SOURCE="HD1">II. Background</HD>
                <HD SOURCE="HD2">A. What Action is the Agency Taking?</HD>
                <P>This ANPRM is alerting stakeholders that EPA is considering changing procedures and requirements for naming enzymes and proteins for the purpose of listing those substances on the TSCA Inventory. Specifically, EPA has identified four elements that it currently believes are appropriate for use in creating unique and unambiguous identities for proteinaceous enzymes on the TSCA Inventory. Through this ANPRM, EPA is also soliciting public comment on the scientific appropriateness and technical feasibility of using the identification elements summarized herein.</P>
                <HD SOURCE="HD2">B. What is the Agency's Authority for Taking this Action?</HD>
                <P>Section 8(b) of TSCA requires EPA to “compile, keep current, and publish a list of each chemical substance which is manufactured or processed in the United States” (the TSCA Inventory). In order to fulfill this requirement, EPA must continuously update and keep current various types of information, including, but not limited to, the information used to identify any new chemical substance that is reported to be manufactured or processed in the United States. EPA also makes corrections, when necessary, of previously reported information on the TSCA Inventory.</P>
                <HD SOURCE="HD2">C. TSCA Inventory Background</HD>
                <P>As stated above, TSCA section 8(b) requires EPA to compile, keep current, and publish a list of chemical substances which are manufactured (including imported) or processed in the United States. This listing, known as the “TSCA Inventory,” informs the public of which chemical substances are being manufactured, imported, or processed in the United States for commercial purposes. For the TSCA Inventory to accurately inform the public, it must be continuously and accurately updated as new information becomes available. The updating process includes adding to the Inventory the identities of new chemical substances that are being introduced into U.S. commerce and corrections when necessary of the identities of previously reported substances. The Agency has developed policies regarding the identification of chemical substances for the purpose of assigning a unique description of each substance on the TSCA Inventory. Published nomenclature guidance is currently available for polymeric substances, substances containing varying carbon chain lengths, complex reaction products, mixtures, and chemical substances of unknown or variable compositions. Approximately 81,500 chemical substances, as defined in section 3 of TSCA, are on the TSCA Inventory at this time.</P>
                <P>In its implementation of TSCA, EPA defines chemical substances as either “existing” chemicals or “new” chemicals. The only way to determine if a substance is new or existing is by consulting the TSCA Inventory. Any substance that is listed on the TSCA Inventory is an existing chemical, otherwise it is a new chemical. If a substance is a new chemical, generally it can be manufactured or imported for non-exempt commercial purposes only when a Premanufacture Notice (PMN) is submitted at least 90 days before the manufacture or import of such substance begins (see section 5(a) of TSCA and 40 CFR part 720). During this 90-day review period EPA will evaluate the proposed manufacture, processing, use, distribution in commerce, and disposal of the substance, and if necessary, prohibit or limit any activity that may result in an unreasonable risk of injury to human health or the environment. A new chemical substance also can be manufactured or imported if it is subject to an exemption from full premanufacture reporting, for example a Low Volume Exemption or a Test Marketing Exemption (see 40 CFR part 723 and 40 CFR 720.38). In addition a new chemical substance is excluded from premanufacture reporting under certain conditions such as manufacture or import of small quantities for research and development or if the substance does not meet the TSCA definition of chemical substance as defined in 40 CFR part 720.3(e) (see 40 CFR 720.30).</P>
                <HD SOURCE="HD2">D. Inventory Listings of Enzymes</HD>
                <P>When EPA promulgated the TSCA Inventory Reporting Regulations of 1977 (42 FR 64572, December 23, 1977), the Agency did not provide specific guidance regarding how complex biological compounds should be identified. However, EPA did publish the TSCA Candidates List to provide examples of the types of substances that would be reportable for the Inventory. That list included enzymes. As a result, approximately 150 enzymes were reported and listed on the TSCA Inventory without specific agency guidance regarding how they should be unambiguously identified. The original Inventory listings for non-enzymatic proteins and other complex biological compounds are based on information originally reported to EPA that varies widely in the type and specificity of information included.</P>
                <P>
                    The enzymes currently on the TSCA Inventory are identified by a Chemical Abstract Services (CAS) Registry Number and Chemical Abstracts 9
                    <SU>th</SU>
                     Collective Index Name. The names assigned to these enzymes by EPA vary in the type and specificity of information included due to wide variation in the type and amount of information originally reported to EPA. For some enzymes, the name is broad, defining only the most generic catalytic activity of the enzyme (e.g., proteinase).
                </P>
                <P>As a result of the existing broad and generic TSCA Inventory enzyme listings, it has been difficult for EPA to determine whether enzyme substances are new and distinct, or covered under existing listings. In most cases, newly developed enzymes appear to be subsumed under one of the current broad and generic TSCA Inventory enzyme listings, which means that, although they are newly developed, they appear to be existing chemicals. This, in turn, means that EPA is reviewing very few new enzymes under section 5 of TSCA, despite the ongoing innovation in this field as to the specificity and functions of commercially available enzymes. Under the existing nomenclature system, therefore, EPA may not be addressing all of the newly developed enzymes and considering the potential risks that may be associated with these substances under section 5 of TSCA. A more specific nomenclature system would allow EPA to assess newly developed enzymes and take actions needed to prevent potential unreasonable risks to health and the environment that may be associated with these substances under section 5 of TSCA before they occur.</P>
                <PRTPAGE P="65568"/>
                <P>
                    In addition, the broad TSCA Inventory enzyme listings, the lack of clear reporting guidelines, and the absence of policy concerning what structural variation or changes trigger reporting, also make it difficult for manufacturers to determine whether enzyme substances are new or covered under existing listings. Recognizing that enzyme listings on the Inventory were broad, EPA developed an interim policy that manufacturers of enzymes should contact EPA regarding submission of a 
                    <E T="03">bona fide</E>
                     intent to manufacture before producing any enzyme. EPA also routinely advised submitters of a Notice of Bona Fide Intent to Manufacture that the Agency may modify the method of listing enzymes on the Inventory and that this could require reporting at a higher level of detail than is required at present. This case-by-case determination creates uncertainty and an unnecessary burden for both the Agency and PMN submitters. More specific guidelines for identifying enzymes on the TSCA Inventory would make the process of deciding whether an  enzyme is new or existing more predictable and transparent.
                </P>
                <P>In order to more effectively meet its statutory obligation under TSCA to prevent unreasonable risk to human health and the environment and to maintain a complete and accurate list of all chemical substances manufactured, imported, or processed, EPA believes it is necessary to refine its policies with regard to enzyme identification reporting requirements. The timely development of identification reporting guidelines for enzymes is essential, given the increasing use of enzymes in commerce, the wide variety of enzymes that are being produced, and the development of new and different manufacturing techniques.</P>
                <HD SOURCE="HD1">III. Identification Elements</HD>
                <HD SOURCE="HD2">A. Description of Identification Elements</HD>
                <P>EPA has identified four elements that it currently believes are appropriate to use in combination to create unambiguous listings for proteinaceous enzymes on the TSCA Inventory:</P>
                <P>1. Function.</P>
                <P>2. Source.</P>
                <P>3. Processing.</P>
                <P>4. Amino acid sequence.</P>
                <FP>EPA believes that no individual element provides sufficient identification information by itself. Rather, EPA anticipates that all four elements will provide useful and necessary information for the unambiguous identification of proteinaceous enzymes and that some combination of these and/or additional identification elements may be appropriate for other enzymes and proteins.</FP>
                <P>The function of an enzyme refers to its catalytic activity. The internationally accepted nomenclature conventions of the Nomenclature Committee of the International Union of Biochemistry and Molecular Biology (NC-IUBMB) describe and differentiate enzymes based on catalytic activity. Function, or catalytic activity, could be incorporated as an element of chemical identity of an enzyme on the TSCA Inventory using this standard enzyme nomenclature.</P>
                <P>Source refers to the organism from which the gene encoding the enzyme was derived and the organism or manufacturing platform (e.g., tissue culture) in which the enzyme is produced. The two sources may be the same or differ when the enzyme gene from one organism is introduced through genetic engineering into a different organism or through the use of a synthetic sequence.</P>
                <P>Processing refers to procedures used to isolate the enzyme from the production organism or manufacturing platform, procedures used to purify it, or any chemical reactions to which the enzyme is subjected to produce the final product.</P>
                <P>The amino acid sequence of an enzyme or protein is known as its primary structure. The amino acid sequence is a systematic representation of the linear chain of amino acids connected via amide bonds that produce a polypeptide.</P>
                <FP>
                    An example of enzyme nomenclature using these identification elements would be neopullulanase (
                    <E T="03">Enzyme Commission</E>
                     3.2.1.135), produced by 
                    <E T="03">Bacillus stearothermophilus</E>
                    , treated with acetic acid, with amino acid sequence:
                </FP>
                <BILCOD>BILLING CODE 6560-50-S</BILCOD>
                <GPH SPAN="3" DEEP="311">
                    <PRTPAGE P="65569"/>
                    <GID>EP15no04a.055</GID>
                </GPH>
                <BILCOD>BILLING CODE 6560-50-C</BILCOD>
                <FP>This is one version of enzyme nomenclature using these four identification elements. Actual nomenclature would vary widely depending on use of all four elements, nomenclature used for each element, and the level of detail ultimately used for each element.</FP>
                <HD SOURCE="HD2">B. Issues for Public Comment</HD>
                <P>EPA is soliciting comments on all aspects of the discussion presented in this document regarding nomenclature issues for enzymes and proteins, for purposes of listing these chemical substances on the TSCA Inventory. EPA is particularly interested in receiving comments on the following topics.</P>
                <P>EPA has identified four elements (listed in Unit III.A.), that it currently believes are appropriate to derive unique nomenclature for the purpose of unambiguously listing proteinaceous enzymes on the TSCA Inventory. EPA is seeking comments on the scientific appropriateness of using these identification elements, the level of detail necessary to create specific, unambiguous TSCA Inventory listings, the technical feasibility of providing such information, and any additional or alternative elements that could be used to identify proteinaceous enzymes on the TSCA Inventory.</P>
                <P>Are the identification elements proposed for proteinaceous enzymes scientifically appropriate and sufficiently comprehensive for non-proteinaceous enzymes and non-enzymatic proteins? Are there additional or alternative identification elements that should be used in creating TSCA Inventory listings for non-proteinaceous enzymes and non-enzymatic proteins?If so, what are these alternatives, and why is it believed that these alternatives are preferable.</P>
                <HD SOURCE="HD1">IV. Do Any Statutory or Executive Order Reviews Apply to this Action?</HD>
                <P>
                    Under Executive Order 12866, entitled 
                    <E T="03">Regulatory Planning and Review</E>
                     (58 FR 51735, October 4, 1993), it has been determined that this ANPRM is a “significant regulatory action” under section 3(f) of the Executive order.  The Agency therefore submitted this document to OMB for the 10-day review period afforded under this Executive order.  Any changes made in response to OMB comments during that review have been documented in the docket as required by the Executive order.
                </P>
                <P>Since this ANPRM does not impose or propose any requirements, and instead seeks comments and suggestions for the Agency to consider in developing a subsequent notice of proposed rulemaking, the various other review requirements that apply when an agency imposes requirements do not apply to this action.</P>
                <P>
                    As part of your comments on this ANPRM you may include any comments or information that you have regarding these requirements.  In particular, any comments or information that would help the Agency to assess the potential impact of a rule on small entities pursuant to the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 
                    <E T="03">et seq</E>
                    .); to consider voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note); or to consider environmental health or safety effects on children pursuant to Executive Order 13045, entitled 
                    <E T="03">Protection of Children from Environmental Health Risks and Safety Risks</E>
                     (62 FR 19885, April 23, 1997).  The Agency will consider such comments during the development of any subsequent notice of proposed rulemaking as it takes appropriate steps to address any applicable requirements.
                </P>
                <LSTSUB>
                    <HD SOURCE="HED">List of Subjects in 40 CFR Part 720</HD>
                    <P>Environmental protection, Chemicals, Hazardous substances, Reporting and recordkeeping requirements.</P>
                </LSTSUB>
                <SIG>
                    <PRTPAGE P="65570"/>
                    <DATED>Dated: November 1, 2004.</DATED>
                    <NAME>Michael O. Leavitt,</NAME>
                    <TITLE>Administrator.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 04-25307 Filed 11-12-04; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 6560-50-S</BILCOD>
        </PRORULE>
        <PRORULE>
            <PREAMB>
                <AGENCY TYPE="N">FEDERAL COMMUNICATIONS COMMISSION </AGENCY>
                <CFR>47 CFR Parts 2 and 80 </CFR>
                <DEPDOC>[WT Docket No. 04-344; RM-10821; FCC 04-207] </DEPDOC>
                <SUBJECT>Maritime Communications </SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Federal Communications Commission. </P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Proposed rule. </P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>In this document, the Commission initiates a rulemaking proceeding to identify the electromagnetic spectrum that should be used for maritime Automatic Identification Systems (AIS) in the United States and its territorial waters. AIS is an important tool for enhancing maritime safety and homeland security, and the Commission is concerned that recent developments may have created uncertainty in the maritime community regarding the very high frequency (VHF) channels to be used for AIS, and that this in turn could impede efforts to expedite the broad deployment of AIS. The Commission has received conflicting petitions and other pleadings on this subject from the National Telecommunications and Information Administration (NTIA), which is representing the interests of the Federal Government, including the United States Coast Guard (USCG or Coast Guard) and the Department of Transportation (including the Saint Lawrence Seaway Development Corporation) in this matter, and from MariTEL, Inc. (MariTEL), the licensee of all nine of the maritime VHF Public Coast (VPC) station service areas. Based on these petitions and pleadings, as well as responsive comments from other stakeholders in the maritime community, the Commission proposes to designate VHF maritime Channels 87B and 88B for exclusive AIS use domestically, in keeping with the international allocation of those channels for AIS, because the Commission tentatively concludes that the use of those channels will best secure to the United States the maritime safety and homeland security benefits of AIS. In addition, the Commission tentatively concludes that it should deny MariTEL's pending petitions that conflict with this proposal. </P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Submit comments on or before December 30, 2004, and reply comments are due on or before January 31, 2005. </P>
                </DATES>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Jeffrey Tobias, 
                        <E T="03">Jeff.Tobias@FCC.gov</E>
                        , Public Safety and Critical Infrastructure Division, Wireless Telecommunications Bureau, (202) 418-0680, or TTY (202) 418-7233. 
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>
                    This is a summary of the Federal Communications Commission's Notice of Proposed Rulemaking (“NPRM”) in WT Docket No. 04-344, FCC 04-207, adopted on August 26, 2004, and released on October 15, 2004. The full text of this document is available for inspection and copying during normal business hours in the FCC Reference Center, 445 12th Street, SW., Washington, DC 20554. The complete text may be purchased from the Commission's copy contractor, Best Copy and Printing, Inc., 445 12th Street, SW., Room CY-B402, Washington, DC 20554. The full text may also be downloaded at: 
                    <E T="03">http://www.fcc.gov.</E>
                     Alternative formats are available to persons with disabilities by contacting Brian Millin at (202) 418-7426 or TTY (202) 418-7365 or at 
                    <E T="03">bmillin@fcc.gov.</E>
                </P>
                <P>
                    1. Section 80.371(c)(3) of the Commission's Rules, 47 CFR 80.371(c)(3), directs the licensee of VHF Public Coast Service Areas (VPCSAs) 1-9, 
                    <E T="03">i.e.</E>
                    , MariTEL, and the Coast Guard to negotiate in good faith to select two narrowband offset channel pairs to be dedicated to AIS use, and specifies that if an agreement cannot be reached, the Coast Guard may petition the Commission to select the channel pairs. Although MariTEL and the Coast Guard did in fact reach an agreement to designate frequencies 157.375 MHz and 161.975 MHz for AIS and executed a Memorandum of Agreement (MOA) to that effect, MariTEL later exercised its right to terminate the MOA. Following termination of the MOA, NTIA petitioned the Commission on behalf of the Coast Guard to select Channels 87B and 88B for AIS and to work with NTIA to reallocate the channels for exclusive AIS use nationwide on a shared Federal Government/non-Federal Government basis. After reviewing various proposals submitted by MariTEL and NTIA, including their technical submissions, and the comments filed in response to a number of public notices relating to this matter, the Commission tentatively agrees with NTIA and the Coast Guard, as well as the vast majority of commenters, that the public interest would be served by designating Channels 87B and 88B for exclusive AIS use in the nine maritime VPCSAs. The Commission therefore grants the petition for rulemaking filed by NTIA on October 24, 2003, RM-10821 to the extent that it seeks initiation of a rulemaking proceeding to consider this issue, denies the Emergency Petition for Declaratory Ruling filed by MariTEL on October 15, 2003, and adopts the instant 
                    <E T="03">Notice of Proposed Rule Making</E>
                     in which it proposes to designate Channels 87B and 88B for exclusive AIS use in the nine maritime VPCSAs. 
                </P>
                <P>2. Designating Channels 87B and 88B for AIS in the United States and its territorial waters would permit seamless worldwide AIS operations. If the United States were to designate channels other than 87B and 88B for AIS, vessels entering United States waters would have to switch to those alternative channels, instead of being able to use the same channels that were employed in international waters. Commenters indicate that requiring such switching would increase the risk of vessel collisions. If ships must switch channels as they approach and transit an AIS “fence” between international and United States waters, there is a risk that they will disappear temporarily from the screens of vessel traffic management systems as well as from the screens of AIS receivers located on the bridges of vessels. </P>
                <P>
                    3. Further, domestic use of Channels 87B and 88B for AIS would facilitate the speedy and efficient deployment of AIS, allowing the United States to take full advantage of existing AIS standards and infrastructure. Mandating the use of other channels could prolong implementation schedules for future PAWSS installations and delay full implementation of AIS as a component of homeland security because of the need for additional technical analysis, possible design changes, and conceivably more extensive shore infrastructure to accommodate AIS channel shifting. In addition, AIS operations on Channels 87B and 88B already have been deployed in, for example, the Saint Lawrence Seaway. A switch to other channels on the United States side would not only necessitate a costly reconfiguration of the AIS network on the Seaway but, more importantly, would compromise the ability of the United States to coordinate with Canada in monitoring vessel traffic on the Seaway and in other areas, since Canada uses Channels 87B and 88B for AIS. In addition to implementation delays and coordination difficulties, the use of channels other than 87B and 88B would affect the United States adversely because it would cause the U.S. Government to expend considerably more time, money and resources to 
                    <PRTPAGE P="65571"/>
                    implement a domestic AIS infrastructure. 
                </P>
                <P>4. Designating specific channels for AIS should provide greater regulatory certainty, which in turn should encourage investment in AIS technology. Calling for another round of negotiations between the Coast Guard and MariTEL to identify channels for AIS would likely result in greater delay before this critical issue could be definitively resolved, and the resultant uncertainty could retard the pace of AIS deployment in the United States. Further, a resolution premised on a new MOA between the parties would still leave open the possibility that either party would terminate that future MOA, returning us to the present predicament. Specifically designating AIS channels in the Commission's Rules, in contrast, would eliminate that possibility. Therefore, the Commission sees important public interest benefits in designating specific channels for AIS, and the record developed thus far overwhelmingly militates in favor of designating Channels 87B and 88B for this purpose rather than any other channels. </P>
                <P>5. After reviewing the parties' technical submissions, the Commission also tentatively concludes that there is no basis in public policy or equity either to forego designating Channels 87B and 88B for AIS in order to protect MariTEL's interests or to provide some mechanism to compensate MariTEL if it does so. The Commission believed that the action it proposes here is essential to public safety, a reasonable regulatory response to changed circumstances, does not limit the licensed VPC spectrum available for MariTEL's proposed data offerings to any greater degree than would the designation of four narrowband offset channels, does not unfairly undermine MariTEL's reasonable investment-backed expectations, and does not undermine the integrity of the Commission's auction process. The Commission invites comment on these tentative conclusions as well as on its overall proposal. In addition, the Commission encourages the Coast Guard and Maritel to cooperate in an effort to avoid interference to and from AIS and VPC operations, and to take reasonable measures to remedy any instances of interference that occur. Although the Commission does not propose here to mandate any particular type of cooperative interference mitigation measures, it seeks comment on whether there are specific actions it could take to facilitate such collaboration. </P>
                <P>6. The Commission also tentatively concludes that it should not adopt MariTEL's proposal to serve as the AIS frequency coordinator. MariTEL's proposed fees for providing AIS frequency coordination would create an unwarranted disincentive for voluntary carriage of AIS equipment. The effectiveness of AIS as a tool in service of maritime safety and homeland security is directly proportional to the percentage of vessels that operate with AIS. Creating a disincentive for voluntary AIS carriage should be considered only if there are equally weighty reasons in favor of it. Here, there is no apparent countervailing public interest benefit in MariTEL's proposal to act as AIS frequency coordinator that could justify a measure that would discourage fitting vessels with AIS equipment. In addition, the proposed fees would unfairly burden the owners and operators of vessels subject to mandatory AIS carriage requirements, who must already shoulder the costs of purchasing and installing AIS equipment to fulfill the requirement. </P>
                <P>7. The Commission also declines to propose adoption of MariTEL's proposal for shared use of Channels 87B and 88B, as set forth in MariTEL's submission of February 9, 2004. The public interest benefits of adopting this proposal are unclear, and do not outweigh the clear disadvantages of the proposal. First, the MariTEL sharing proposal would permit MariTEL to use on a shared basis not only Channel 87B but also the Federal Government channel 88B. The Commission is not empowered to give MariTEL any rights to use a Federal Government channel, and NTIA has not indicated any readiness to do so. Second, the MariTEL sharing proposal is premised in part on the Commission adopting regulations precluding the reception and use of AIS transmissions except by MariTEL, the Coast Guard and ship stations. However, precluding other entities from acquiring and using AIS information, or allowing such access and use only upon payment to MariTEL, could inhibit domestic implementation of AIS, could preclude beneficial public/private cooperative arrangements between the Coast Guard and private maritime associations, and could otherwise impede efficient AIS implementation. Finally, the MariTEL sharing proposal calls for the Commission to modify the technical requirements for AIS devices in order to prevent interference from AIS operations on Channels 87B and 88B to adjacent channel VPC channels. The AIS technical requirements are based on the international standards, and the Commission tentatively concludes that it should not revise those requirements unilaterally, and effectively abandon the standards-setting efforts to date, solely at the behest of and for the benefit of a single company. This is especially so because some of the mandatory AIS carriage deadlines have come into effect, and it is at best uncertain that the Commission could develop new technical requirements soon enough to give vessel operators a reasonable opportunity to come into compliance. </P>
                <HD SOURCE="HD1">I. Procedural Matters </HD>
                <HD SOURCE="HD2">A. Ex Parte Rules—Permit-But-Disclose Proceeding </HD>
                <P>8. This is a permit-but-disclose notice and comment rulemaking proceeding. Ex parte presentations are permitted, except during the Sunshine Agenda period, provided they are disclosed as provided in the Commission's rules. </P>
                <HD SOURCE="HD2">B. Comment Dates </HD>
                <P>9. Pursuant to sections 1.415 and 1.419 of the Commission's rules, 47 CFR 1.415, 1.419, interested parties may file comments on or before December 30, 2004 and reply comments on or before January 31, 2005. Comments may be filed using the Commission's Electronic Comment Filing System (ECFS) or by filing paper copies. </P>
                <P>
                    10. Comments filed through the ECFS can be sent as an electronic file via the Internet to 
                    <E T="03">http://www.fcc.gov/e-file/ecfs.html.</E>
                     Generally, only one copy of an electronic submission must be filed. If multiple docket or rulemaking numbers appear in the caption of this proceeding, however, commenters must transmit one electronic copy of the comments to each docket or rulemaking number referenced in the caption. In completing the transmittal screen, commenters should include their full name, Postal Service mailing address, and the applicable docket or rulemaking number. Parties may also submit an electronic comment by Internet e-mail. To get filing instructions for e-mail comments, commenters should send an e-mail to 
                    <E T="03">ecfs@fcc.gov,</E>
                     and should include the following words in the body of the message, “get form &lt;your e-mail address&gt;.” A sample form and directions will be sent in reply. Parties who choose to file by paper must file an original and four copies of each filing. If more than one docket or rulemaking number appears in the caption of this proceeding, commenters must submit two additional copies for each additional docket or rulemaking number. All filings must be addressed to the Commission's Secretary, Marlene H. Dortch, Office of the Secretary, Federal Communications Commission, 445 12th 
                    <PRTPAGE P="65572"/>
                    St., SW., Washington, DC 20554. Filings can be sent first class by the U.S. Postal Service, by an overnight courier or hand and message-delivered. Hand and message-delivered paper filings must be delivered to 236 Massachusetts Avenue, NE., Suite 110, Washington, DC 20002. Filings delivered by overnight courier (other than U.S. Postal Service Express Mail and Priority Mail) must be sent to 9300 East Hampton Drive, Capitol Heights, MD 20743. 
                </P>
                <P>11. Parties who choose to file by paper should also submit their comments on diskette. These diskettes should be submitted to: Jeffrey Tobias, Wireless Telecommunications Bureau, 445 12th St., SW., Room 3-A432, Washington, DC 20554. Such a submission should be on a 3.5 inch diskette formatted in an IBM compatible format using Microsoft Word or compatible software. The diskette should be accompanied by a cover letter and should be submitted in “read only” mode. The diskette should be clearly labeled with the commenter's name, proceeding (including the docket number in this case, WT Docket No. 04-344), type of pleading (comment or reply comment), date of submission, and the name of the electronic file on the diskette. The label should also include the following phrase “Disk Copy—Not an Original.” Each diskette should contain only one party's pleadings, preferably in a single electronic file. In addition, commenters should send diskette copies to the Commission's copy contractor, Best Copy and Printing, Inc., 445 12th St., SW., Room CY-B402, Washington, DC 20554. </P>
                <HD SOURCE="HD2">C. Paperwork Reduction Act </HD>
                <P>
                    12. This document does not contain proposed information collection(s) subject to the Paperwork Reduction Act of 1995 (PRA), Public Law 104-13. In addition, therefore, it does not contain any new or modified “information collection burden for small business concerns with fewer than 25 employees,” pursuant to the Small Business Paperwork Relief Act of 2002, Public Law 107-198, 
                    <E T="03">see</E>
                     44 U.S.C. 3506(c)(4). 
                </P>
                <HD SOURCE="HD1">II. Initial Regulatory Flexibility Analysis </HD>
                <P>
                    13. As required by the Regulatory Flexibility Act (RFA), the Commission has prepared this present Initial Regulatory Flexibility Analysis (IRFA) of the possible significant economic impact on small entities by the policies and rules proposed in the 
                    <E T="03">Notice of Proposed Rule Making</E>
                     in WT Docket No. 04-344 (
                    <E T="03">NPRM</E>
                    ). Written public comments are requested on this IRFA. Comments must be identified as responses to the IRFA and must be filed by the deadlines for comments on the 
                    <E T="03">NPRM</E>
                     as provided in paragraph 70, 
                    <E T="03">supra</E>
                    , of the item. The Commission will send a copy of the 
                    <E T="03">NPRM</E>
                    , including the IRFA, to the Chief Counsel for Advocacy of the U.S. Small Business Administration. In addition, the 
                    <E T="03">NPRM</E>
                     and IRFA (or summaries thereof) will be published in the 
                    <E T="04">Federal Register</E>
                    .
                </P>
                <HD SOURCE="HD2">A. Need for, and Objectives of, the Proposed Rules </HD>
                <P>
                    14. In the 
                    <E T="03">NPRM</E>
                    , we seek comment on rule amendments that are intended to identify the spectrum that should be used for maritime Automatic Identification Systems (AIS) in the United States and its territorial waters. AIS is an important tool for enhancing maritime safety and homeland security, and we are concerned that recent developments may have created uncertainty in the maritime community regarding the very high frequency (VHF) channels to be used for AIS, and that this in turn could impede efforts to expedite the broad deployment of AIS domestically. In the 
                    <E T="03">NPRM</E>
                    , we propose to designate VHF maritime Channels 87B and 88B for AIS use domestically, in keeping with the international allocation of those channels for AIS, because we believe the use of those channels will best secure to the United States the maritime safety and homeland security benefits of AIS. 
                </P>
                <HD SOURCE="HD2">B. Legal Basis for Proposed Rules </HD>
                <P>15. The proposed action is authorized under sections 1, 4(i), 302, 303(f) and (r), and 332 of the Communications Act of 1934, as amended, 47 U.S.C. 1, 154(i), 302, 303(f) and (r), and 332. </P>
                <HD SOURCE="HD2">C. Description and Estimate of the Number of Small Entities To Which the Proposed Rules Will Apply </HD>
                <P>16. The RFA directs agencies to provide a description of and, where feasible, an estimate of the number of small entities that may be affected by the proposed rules, if adopted. The RFA defines the term “small entity” as having the same meaning as the terms “small business,” “small organization,” and “small governmental jurisdiction.” In addition, the term “small business” has the same meaning as the term “small business concern” under the Small Business Act. A small business concern is one which: (1) Is independently owned and operated; (2) is not dominant in its field of operation; and (3) satisfies any additional criteria established by the Small Business Administration (SBA). </P>
                <P>17. Small businesses in the aviation and marine radio services use a very high frequency (VHF) marine or aircraft radio and, as appropriate, an emergency position-indicating radio beacon (and/or radar) or an emergency locator transmitter. The Commission has not developed a small business size standard specifically applicable to these small businesses. For purposes of this analysis, the Commission uses the SBA small business size standard for the category “Cellular and Other Telecommunications,” which is 1,500 or fewer employees. Between December 3, 1998 and December 14, 1998, the Commission held an auction of 42 VHF Public Coast (VPC) licenses in the 157.1875-157.4500 MHz (ship transmit) and 161.775-162.0125 MHz (coast transmit) bands. For purposes of the auction, the Commission defined a “small” business as an entity that, together with controlling interests and affiliates, has average gross revenues for the preceding three years not to exceed fifteen million dollars. In addition, a “very small” business is one that, together with controlling interests and affiliates, has average gross revenues for the preceding three years not to exceed three million dollars. There are approximately 10,672 licensees in the Marine Coast Service, and the Commission estimates that almost all of them qualify as “small” businesses under the above special small business size standards. </P>
                <HD SOURCE="HD2">D. Description of Projected Reporting, Recordkeeping, and Other Compliance Requirements </HD>
                <P>18. There are no projected reporting, recordkeeping or other compliance requirements. </P>
                <HD SOURCE="HD2">E. Steps Taken To Minimize Significant Economic Impact on Small Entities, and Significant Alternatives Considered </HD>
                <P>19. The RFA requires an agency to describe any significant alternatives that it has considered in reaching its proposed approach, which may include the following four alternatives: (1) The establishment of differing compliance or reporting requirements or timetables that take into account the resources available to small entities; (2) the clarification, consolidation, or simplification of compliance or reporting requirements under the rule for small entities; (3) the use of performance, rather than design standards; and (4) an exemption from coverage of the rule, or any part thereof, for small entities. </P>
                <P>
                    In the 
                    <E T="03">NPRM</E>
                    , we request comment on the proposal to designate Channels 87B and 88B for exclusive AIS use. We 
                    <PRTPAGE P="65573"/>
                    describe here, and seek comment on, possible alternatives to imposing these new rules that might minimize the economic impact on small entities. First, we ask commenters to consider the interference impact on MariTEL, Inc., licensee of the nine maritime VPC service areas, or on any incumbent site-based VPC licensees or any Economic Area (EA) VPC licensees of the proposed designation of Channels 87B and 88B for AIS exclusively. We tentatively conclude that the proposed designation of Channels 87B and 88B for AIS should not have an adverse effect on MariTEL's use of its VPC channels to a materially greater extent, if at all, than would designation of two narrowband offset channel pairs of the Commission's choosing from the 156-162 MHz VHF maritime band. We request comment on this tentative conclusion. In addition, commenters are asked if incumbent site based VPC operations can co-exist on a non-interference basis with AIS and, if not, should the Commission require that that these operations be migrated to other spectrum and/or should the licensees be compensated in some way. 
                </P>
                <P>20. Commenters are requested to identify potential means of minimizing or eliminating any adverse economic impact on any small entities, particularly VPC licensees that qualify as small entities, if Channels 87B and 88B are designated for AIS use. Such means may include, but are not limited to, exemptions, grandfathering protection, or geographic limitations on the use of Channels 87B and 88B for AIS. Additionally or alternatively, we seek comment on whether we could provide replacement spectrum for licensees who may find themselves unable to continue using their licensed VPC channels because of our proposal. For example, we might be able to modify their licenses to provide other channels in lieu of Channels 87B and 88B. We also could designate channels other than Channels 87B and 88B for AIS use in the United States as a means of minimizing any adverse economic impact on these licensee. We note, however, that mandating use of channels other than Channels 87B and 88B for AIS use in the United States may have an adverse economic impact on vessel operators and radio equipment manufacturers that qualify as small entities by, for example, increasing the cost of AIS equipment, causing premature obsolescence of AIS equipment already installed on vessels, or leaving manufacturers with stranded inventory. Accordingly, commenting parties, and particularly commenting parties who favor adopting an alternative to the Commission's proposal, are asked to address the potential economic impact of that alternative on small entities. </P>
                <P>
                    21. In Appendix D of the 
                    <E T="03">NPRM</E>
                    , we list all of the incumbent site-based licensees that currently operate within VHF Public Coast Service Areas (VPCSAs) 1-9 on the channels which we are proposing to designate for exclusive AIS use. We assume for purposes of this IRFA that some or all of these licensees qualify as small entities. We specifically invite these licensees to address the expected economic impact on them of our proposal, and to suggest alternatives or additions to our proposal that would minimize that impact, including but not limited to the methods discussed in the preceding paragraph. 
                </P>
                <P>
                    22. We also note that there are incumbent licensees operating on the specified channels in inland areas. We do not anticipate any significant adverse effect on any such licensee due to the geographic limitations of our proposal, 
                    <E T="03">i.e.</E>
                    , our limiting the AIS set-aside to areas near major navigable waterways. Commenters who believe differently are asked to describe the expected adverse economic impact on incumbent inland licensees operating on these or adjacent channels, and to provide suggested methods of minimizing any such impact. In addition, we note that, although we are proposing only to designate Channels 87B and 88B for AIS in the nine maritime VPCSAs, we have not foreclosed the possibility of designating those channels for AIS on a nationwide basis. Accordingly, inland licensees and other interested parties should address the possible economic impact on small entities if we were to designate Channels 87B and 88B for AIS in inland areas as well as the nine maritime VPCSAs. 
                </P>
                <HD SOURCE="HD2">F. Federal Rules That May Duplicate, Overlap, or Conflict With the Proposed Rules </HD>
                <P>None. </P>
                <HD SOURCE="HD1">III. Ordering Clauses </HD>
                <P>23. The Commission's Consumer Information Bureau, Reference Information Center, SHALL SEND a copy of this NPRM, including the Initial Regulatory Flexibility Analysis, to the Chief Counsel for Advocacy of the Small Business Administration. </P>
                <LSTSUB>
                    <HD SOURCE="HED">List of Subjects in 47 CFR Parts 2 and 80 </HD>
                    <P>Communications equipment, Radio.</P>
                </LSTSUB>
                <SIG>
                    <FP>Federal Communications Commission. </FP>
                    <NAME>Marlene H. Dortch, </NAME>
                    <TITLE>Secretary.</TITLE>
                </SIG>
                <HD SOURCE="HD1">Proposed Rules </HD>
                <P>For the reasons discussed in the preamble, the Federal Communications Commission proposes to amend 47 CFR parts 2 and 80 as follows: </P>
                <PART>
                    <HD SOURCE="HED">PART 2—FREQUENCY ALLOCATIONS AND RADIO TREATY MATTERS; GENERAL RULES AND REGULATIONS </HD>
                    <P>1. The authority citation for part 2 continues to read as follows: </P>
                    <AUTH>
                        <HD SOURCE="HED">Authority:</HD>
                        <P>47 U.S.C. 154, 302a, 303, and 336, unless otherwise noted. </P>
                    </AUTH>
                    <P>2. Section 2.106, the Table of Frequency Allocations, is amended as follows: </P>
                    <P>a. Revise pages 30 and 31. </P>
                    <P>b. In the list of United States (US) Notes, add note USxxx and remove note US223. </P>
                    <SECTION>
                        <SECTNO>§ 2.106 </SECTNO>
                        <SUBJECT>Table of Frequency Allocations. </SUBJECT>
                        <P>The revisions and additions read as follows:</P>
                        <STARS/>
                        <BILCOD>BILLING CODE 6712-01-P</BILCOD>
                        <GPH SPAN="3" DEEP="640">
                            <PRTPAGE P="65574"/>
                            <GID>EP15NO04A.056</GID>
                        </GPH>
                        <GPH SPAN="3" DEEP="626">
                            <PRTPAGE P="65575"/>
                            <GID>EP15NO04A.057</GID>
                        </GPH>
                        <BILCOD>BILLING CODE 6712-01-C</BILCOD>
                        <PRTPAGE P="65576"/>
                        <HD SOURCE="HD1">United States (US) Notes </HD>
                        <STARS/>
                        <P>USxxx The bands 161.9625-161.9875 MHz (AIS 1 with its center frequency at 161.975 MHz) and 162.0125-162.0375 MHz (AIS 2 with its center frequency at 162.025 MHz) are allocated to the maritime mobile service on a primary basis for Federal and non-Federal Government use in VHF Public Coast Station Areas (VPCSAs) 1-9. In these areas, the maritime mobile service shall be used exclusively for Automatic Identification Systems (AIS). In VPCSAs 10-42, the band 161.9625-161.9875 MHz is allocated to the maritime mobile service on a primary basis for exclusive non-Federal Government use and the 162.0125-162.0375 MHz is allocated to the fixed and mobile services on a primary basis for exclusive Federal Government use. See 47 CFR 80.371(c)(1)(ii) for the definitions of VPCSAs. </P>
                        <STARS/>
                    </SECTION>
                </PART>
                <PART>
                    <HD SOURCE="HED">PART 80—STATIONS IN THE MARITIME SERVICES </HD>
                    <P>3. The authority citation for part 80 continues to read as follows: </P>
                    <AUTH>
                        <HD SOURCE="HED">Authority:</HD>
                        <P>Secs. 4, 303, 307(e), 309, and 332, 48 Stat. 1066, 1082, as amended; 47 U.S.C. 154, 303, 307(e), 309, and 332, unless otherwise noted. Interpret or apply 48 Stat. 1064-1068, 1081-1105, as amended; 47 U.S.C. 151-155, 301-609; 3 UST 3450, 3 UST 4726, 12 UST 2377. </P>
                    </AUTH>
                    <P>4. Section 80.5 is amended by adding an entry for “Automatic Identification Systems (AIS)” in alphabetical order to read as follows: </P>
                    <SECTION>
                        <SECTNO>§ 80.5 </SECTNO>
                        <SUBJECT>Definitions. </SUBJECT>
                        <STARS/>
                        <P>
                            <E T="03">Automatic Identification Systems (AIS).</E>
                             A maritime navigation safety communications system standardized by the International Telecommunication Union (ITU) that provides vessel information, including the vessel's identity, type, position, course, speed, navigational status and other safety-related information automatically to appropriately equipped shore stations, other ships, and aircraft; receives automatically such information from similarly fitted ships; monitors and tracks ships; and exchanges data with shore-based facilities. 
                        </P>
                        <STARS/>
                        <P>5. Section 80.13 is amended by revising paragraph (c) to read as follows: </P>
                    </SECTION>
                    <SECTION>
                        <SECTNO>§ 80.13 </SECTNO>
                        <SUBJECT>Station license required. </SUBJECT>
                        <STARS/>
                        <P>(c) A ship station is licensed by rule and does not need an individual license issued by the FCC if the ship station is not subject to the radio equipment carriage requirements of any statute, treaty or agreement to which the United States is signatory, the ship station does not travel to foreign ports, and the ship station does not make international communications. A ship station licensed by rule is authorized to transmit radio signals using a marine radio operating in the 156-162 MHz band, any type of AIS, any type of EPIRB, and any type of radar installation. All other transmissions must be authorized under a ship station license. Even though an individual license is not required, a ship station licensed by rule must be operated in accordance with all applicable operating requirements, procedures, and technical specifications found in this part. </P>
                        <P>6. Section 80.371 is amended by revising paragraphs (c)(1)(i), (c)(2) and (c)(3) to read as follows: </P>
                    </SECTION>
                    <SECTION>
                        <SECTNO>§ 80.371 </SECTNO>
                        <SUBJECT>Public correspondence frequencies. </SUBJECT>
                        <STARS/>
                        <P>
                            (c) 
                            <E T="03">Working frequencies in the marine VHF 156-162 MHz band.</E>
                             (1)(i) The frequency pairs listed in the following table are available for assignment to public coast stations for public correspondence communications with ship stations and units on land.
                        </P>
                        <GPOTABLE COLS="3" OPTS="L2,i1" CDEF="s50,10,10">
                            <TTITLE>
                                Working Carrier Frequency Pairs in the 156-162 MHz Band 
                                <SU>1</SU>
                            </TTITLE>
                            <BOXHD>
                                <CHED H="1">Channel designator </CHED>
                                <CHED H="1">
                                    Carrier 
                                    <LI>frequency </LI>
                                    <LI>(MHz) </LI>
                                </CHED>
                                <CHED H="2">
                                    Ship 
                                    <LI>transmit </LI>
                                </CHED>
                                <CHED H="2">
                                    Coast 
                                    <LI>transmit </LI>
                                </CHED>
                            </BOXHD>
                            <ROW>
                                <ENT I="01">24 </ENT>
                                <ENT>157.200 </ENT>
                                <ENT>161.800 </ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">84 </ENT>
                                <ENT>157.225 </ENT>
                                <ENT>161.825 </ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">25 </ENT>
                                <ENT>157.250 </ENT>
                                <ENT>161.850 </ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">
                                    85 
                                    <SU>2</SU>
                                      
                                </ENT>
                                <ENT>157.275 </ENT>
                                <ENT>161.875 </ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">26 </ENT>
                                <ENT>157.300 </ENT>
                                <ENT>161.900 </ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">86 </ENT>
                                <ENT>157.325 </ENT>
                                <ENT>161.925 </ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">27 </ENT>
                                <ENT>157.350 </ENT>
                                <ENT>161.950 </ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">
                                    87 
                                    <SU>3</SU>
                                      
                                </ENT>
                                <ENT>157.375 </ENT>
                                <ENT>157.375 </ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">28 </ENT>
                                <ENT>157.400 </ENT>
                                <ENT>162.000 </ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">
                                    88 
                                    <SU>4</SU>
                                      
                                </ENT>
                                <ENT>157.425 </ENT>
                                <ENT>157.425 </ENT>
                            </ROW>
                            <TNOTE>
                                <SU>1</SU>
                                 For special assignment of frequencies in this band in certain areas of Washington State, the Great Lakes and the east coast of the United States pursuant to arrangements between the United States and Canada, 
                                <E T="03">see</E>
                                 subpart B of this part. 
                            </TNOTE>
                            <TNOTE>
                                <SU>2</SU>
                                 The frequency pair 157.275/161.875 MHz is available on a primary basis to ship and public coast stations. In Alaska it is also available on a secondary basis to private mobile repeater stations. 
                            </TNOTE>
                            <TNOTE>
                                <SU>3</SU>
                                 Within VHF Public Coast Station Areas (VPCSAs) 1 through 9 listed in the table in paragraph (c)(1)(ii) of this section, the frequency 161.975 MHz may be used only for Automatic Identification System communications. 
                            </TNOTE>
                            <TNOTE>
                                <SU>4</SU>
                                 Within that portion of VHF Public Coast Station Areas (VPCSAs) 1 through 9 listed in the table in paragraph (c)(1)(ii) of this section within 120 km (75 miles) of the United States/Canada border, in the area of the Great Lakes, the Saint Lawrence Seaway, and the Puget Sound and the Strait of Juan de Fuca and its approaches, the frequency 157.425 MHz is available for use by ship stations for public correspondence communications and the frequency 162.025 MHz is available only for Automatic Identification System communications. One hundred twenty kilometers (75 miles) from the United States/Canada border 157.425 MHz is available for intership and commercial communications. Outside the Puget Sound area and its approaches and the Great Lakes, 157.425 MHz is available for communications between commercial fishing vessels and associated aircraft while engaged in commercial fishing activities. 
                            </TNOTE>
                        </GPOTABLE>
                        <STARS/>
                        <P>(2) Any recovered channel pairs will revert automatically to the holder of the VPCSA license within which such channels are included, except the channel pairs listed in the table in paragraph (c)(1)(i) of this section. Those channel pairs, and any channel pairs recovered where there is no VPCSA licensee, will be retained by the Commission for future licensing. </P>
                        <P>(3) VPCSA licensees may not operate on Channel 228B (162.0125 MHz), which is available for use in the Coast Guard's Ports and Waterways Safety System (PAWSS). In addition, VPCSA licensees in VPCSAs 1-9 may not operate on Channel AIS 1 (161.975 MHz) or Channel AIS 2 (162.025 MHz), which are designated in those areas exclusively for Automatic Identification Systems (AIS), except to transmit and receive AIS communications to the same extent, and subject to the same limitations, as other shore stations participating in AIS. </P>
                        <STARS/>
                        <P>7. Section 80.373 is amended by revising paragraph (j) to read as follows: </P>
                    </SECTION>
                    <SECTION>
                        <SECTNO>§ 80.373 </SECTNO>
                        <SUBJECT>Private communications frequencies. </SUBJECT>
                        <STARS/>
                        <P>
                            (j) 
                            <E T="03">Frequencies for portable ship stations.</E>
                             VHF frequencies authorized for stations authorized carrier frequencies in the 156.275 MHz to 157.450 MHz and 161.575 MHz to 162.025 MHz bands may also be authorized as marine utility stations. Marine-utility stations on shore must not cause interference to any Automatic Identification System, VHF or coast station, VHF or UHF land mobile base station, or U.S. Government station. 
                        </P>
                        <P>8. Section 80.393 is added to read as follows: </P>
                    </SECTION>
                    <SECTION>
                        <SECTNO>§ 80.393 </SECTNO>
                        <SUBJECT>Frequencies for AIS stations. </SUBJECT>
                        <P>
                            Automatic Identification Systems (AIS) is a maritime broadcast service provided by both the United States 
                            <PRTPAGE P="65577"/>
                            Coast Guard and Commission licensees. The simplex channels at 161.975 MHz (AIS 1) and 162.025 MHz (AIS 2), each with a 25 kHz bandwidth, may be authorized in VHF Public Coast Station Areas 1-9 for AIS. These areas are codified at 47 CFR 80.371(c)(1)(ii). In accordance with the Maritime Transportation Security Act, the United States Coast Guard regulates AIS carriage requirements for non-Federal Government ships. These requirements are codified at 33 CFR 164.46, 401.20. 
                        </P>
                    </SECTION>
                </PART>
            </SUPLINF>
            <FRDOC>[FR Doc. 04-25289 Filed 11-12-04; 8:45 am] </FRDOC>
            <BILCOD>BILLING CODE 6712-01-P </BILCOD>
        </PRORULE>
    </PRORULES>
    <VOL>69</VOL>
    <NO>219</NO>
    <DATE>Monday, November 15, 2004</DATE>
    <UNITNAME>Notices</UNITNAME>
    <NOTICES>
        <NOTICE>
            <PREAMB>
                <PRTPAGE P="65578"/>
                <AGENCY TYPE="F">DEPARTMENT OF AGRICULTURE</AGENCY>
                <SUBAGY>Forest Service</SUBAGY>
                <SUBJECT>Bridger-Teton National Forest-Wyoming—Kemmerer and Greys River Ranger Districts; Lincoln County, WY Salt Pass Grazing Allotments Environmental Impact Statement.</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Forest Service, USDA.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice of intent to prepare an environmental impact statement.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The Department of Agriculture, Forest Service, will prepare An Environmental Impact Statement (EIS) to analyze the effects of domestic livestock grazing in the Salt Pass area. The Salt Pass Grazing Allotments (composed of Giraffe, Lower Salt, Porcupine, Smiths Fork, Buckskin Knoll, Lake Alice, North Salt River, South Salt River domestic sheep allotments and Trespass domestic cattle allotment) are located in Township 28, 29, 30 North, and Range 116, 117, 118, 119 West; Sixth Principal Meridian. The allotments are located entirely within Lincoln County. The allotments are located on two ranger districts, Kemmerer and Greys River. The Kemmerer Ranger District administers all the allotments except North Salt River and South Salt River, which are administered by the Greys River Ranger District.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Comments concerning the scope of the analysis must be received by December 17, 2005. The draft environmental impact statement is expected in April 2005 and the final environmental impact statement is expected by July 2005.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        Send written comments to: Russ Bacon, District Ranger, Kemmerer Ranger District, P.O. Box 31, Kemmerer, Wyoming 83101. For further information, mail correspondence to 
                        <E T="03">mailroom_r4_bridger_teton@fs.fed.us</E>
                         and on the subject line put only “Salt Pass Allotments”.
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>Russ Bacon, Kemmerer District Ranger, Kemmerer Ranger District, P.O. Box 31, Kemmerer, Wyoming 83101 or phone (307) 877-4415.</P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <HD SOURCE="HD1">Purpose and Need for Action</HD>
                <P>
                    This proposal, in part, is to comply with Public Law 104-19, section 504(a): establish and adhere to a schedule for the completion of National Environmental Policy Act (NEPA) of 1969 (42 U.S.C. 4321 
                    <E T="03">et seq.</E>
                    ) analysis and decision on all grazing allotments within the National Forest System unit for which NEPA is needed (Pub. L. 104-19, General Provision 1995). Upon completion of the NEPA analysis and decisions for the allotments, the terms and conditions of the existing grazing permits will be  modified, as necessary, to conform to such NEPA analysis. In addition, the purpose of the proposed action is to improve range condition and trend and achieve desired conditions within the project area through livestock grazing.
                </P>
                <HD SOURCE="HD1">Proposed Action</HD>
                <P>The proposed action is to authorize continued livestock grazing, provide analysis and data to update allotment management plans (AMPs), and allow livestock grazing that meets or moves existing resources conditions toward desired conditions on National Forest grazing allotments while complying with applicable statutes. Adaptive management, which allows flexibility during the implementation of the grazing strategy, would allow managers to make adjustments and corrections to management based on monitoring.</P>
                <HD SOURCE="HD1">Possible Alternatives</HD>
                <P>
                    <E T="03">Grazing as Currently Permitted:</E>
                     Although allotment management plans (AMP's) would be prepared for each of the nine allotments, the grazing management practices specified for the allotments with existing AMP's would not be changed. In addition, no new utilization standards would be initiated to move existing resource conditions in the project area toward the desired future conditions (DFC's) specified in the Forest Plan.
                </P>
                <P>
                    <E T="03">No Grazing by Domestic Livestock</E>
                     (No grazing alternative): This would eliminate livestock grazing in the project area. This alternative was developed to demonstrate the effects that eliminating livestock grazing would have on the environment and to more clearly illustrate the potential effects of implementing other alternatives. Under this alternative, domestic livestock grazing on all nine allotments within the project area would be phased out over several years as existing Term Grazing Permits expire.
                </P>
                <HD SOURCE="HD1">Responsible Official</HD>
                <P>Russell Bacon, District Forest Ranger, Kemmerer Ranger District, P.O. Box 31, Kemmerer, Wyoming 83101 and Charlene Bucha-Gentry, District Forest Ranger, Greys River Ranger District, P.O. Box 339, Afton, Wyoming 83110.</P>
                <HD SOURCE="HD1">Nature of Decision To Be Made</HD>
                <P>The decision, which is based on this analysis, will be to decide if livestock will be allowed to graze on the allotment complex, either through the implementation of the proposed action, or an alternative to the proposed action. The decision would include any mitigation measures needed in addition to those prescribed in the Forest Plan.</P>
                <HD SOURCE="HD1">Scoping Process</HD>
                <P>
                    Forest Service is seeking information, comments, and assistance from individuals, organizations, tribal governments, and federal, state, and local agencies interested in or affected by this project. This analysis is for nine grazing allotments. The decision will have limited environmental effects outside the allotment boundaries, and the economic impacts are localized. Public participation will be solicited by notifying in person and/or by mail known interested affected publics. News releases will be used to give the public general notice. Public participation activities would include requests for written comments. The first formal opportunity to comment is to respond to this notice of intent, which initiates the scoping process (40 CFR 1501.7). Scoping includes: (1) Identifying potential issues, (2) narrowing the potential issues and identifying significant issues of those that have been covered by prior environmental review, (3) exploring alternatives in addition to No Action, and (4) identifying potential environmental effects of the proposed action and alternatives.
                    <PRTPAGE P="65579"/>
                </P>
                <HD SOURCE="HD1">Preliminary Issues</HD>
                <P>The Forest Service has identified the following potential issues. Your input is especially valuable here. It will help us determine which of these merit detailed analysis. It will also help identify additional issues related to the proposed action that may not be listed here.</P>
                <P>• Effects of grazing on soil erosion and productivity.</P>
                <P>• Effects of grazing on watershed condition and function.</P>
                <P>• Effects of grazing on the life cycle of the Bonneville and Snake River cutthroat trout.</P>
                <HD SOURCE="HD1">Comment Requested</HD>
                <P>This notice of intent initiates the scoping process which guides the development of the environmental impact statement.</P>
                <P>
                    <E T="03">Early Notice of Importance of Public Participation in Subsequent Environmental Review:</E>
                     A draft environmental impact statement will be prepared for comment. The comment period on the draft environmental impact statement will be 45 days from the date the Environmental Protection Agency publishes the notice of availability in the 
                    <E T="04">Federal Register</E>
                    .
                </P>
                <P>
                    The Forest Service believes, at this early stage, it is important to give reviewers notice of: several court rulings related to public participation in the environmental review process. First, reviewers of draft environmental impact statements must structure their participation in the environmental review of the proposal so that it is meaningful and alerts an agency to the reviewer's position and contention. 
                    <E T="03">Vermont Yankee Nuclear Power Corp</E>
                     v. 
                    <E T="03">NRDC</E>
                    , 435 U.S. 519, 533 (1978). Also, environmental objections that could be raised at the draft environmental impact statement stage but that are not raised until after completion of the final environmental impact statement may be waived or dismissed by the courts. 
                    <E T="03">City of Angoon</E>
                     v. 
                    <E T="03">Hodel</E>
                    , 803 F.2d 1016, 1022 (9th Cir. 1986) and 
                    <E T="03">Wisconsin Heritages, Inc.</E>
                     v. 
                    <E T="03">Harris</E>
                    , 490 F. Supp. 1334, 1338 (E.D. Wis. 1980). Because of these court rulings, it is very important that those interested in this proposed action participate by the close of the 45 day comment period so that substantive comments and objections are made available to the Forest Service at a time when it can meaningully consider them and respond to them in the final environmental impact statement.
                </P>
                <P>To assist the Forest Service in identifying and considering issues and concerns on the proposed action, comments on the draft environmental impact statement should be as specific as possible. It is also helpful if comments refer to specific pages or chapters of the draft statement. Comments may also address the adequacy of the draft environmental impact statement or the merits of the alternatives formulated and discussed in the statement. Reviewers may wish to refer to the Council on Environmental Quality Regulations for implementing the procedural provisions of the National Environmental Policy Act at 40 CFR 1503.3 in addressing these points.</P>
                <P>Comments received, including the names and addresses of those who comment, will be considered part of the public record on this proposal and will be available for public inspection. </P>
                <EXTRACT>
                    <FP>(Authority: 40 CFR 1501.7 and 1508.22; Forest Service Handbook 1909.15, Section 21.)</FP>
                </EXTRACT>
                <SIG>
                    <DATED>Dated: November 4, 2004.</DATED>
                    <NAME>Fred Fouse,</NAME>
                    <TITLE>Acting District Ranger.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 04-25249  Filed 11-12-04; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 3410-11-M</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF AGRICULTURE</AGENCY>
                <SUBAGY>Natural Resources Conservation Service</SUBAGY>
                <SUBJECT>Notice of Proposed Change to the Natural Resources Conservation Service's National Handbook of Conservation Practices</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Natural Resources Conservation Service (NRCS), U.S. Department of Agriculture, Maine State Office.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>
                        Notice of availability of proposed changes in the NRCS National Handbook of Conservation Practices, Section IV of the Maine State NRCS Field Office Technical Guide (FOTG) located at 
                        <E T="03">http://www.me.nrcs.usda.gov</E>
                         under “Draft Standards for Comments” for review and comment.
                    </P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>It is the intention of NRCS to issue revised conservation practice standards in its National Handbook of Conservation Practices. These revised standards are the following:</P>
                    <P>314 Brush Management; 329 Residue Management, Ridge-Till; 340 Cover Crop; 342 Critical Area Planting; 344 Residue Management, Seasonal; 386 Field Border; 511 Forage Harvest Management; 512 Pasture and Hay Planting; 528 Animal Trails and Walkways; 590 Nutrient Management; 557 Row Arrangement.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Comments will be received for a 30-day period commencing with this date of publication.</P>
                </DATES>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>Inquire in writing to Christopher R. Jones, State Resource Conservationist, Natural Resources Conservation Service (NRCS), 967 Illinois Avenue, Suite #3, Bangor, Maine 04401.</P>
                    <P>A copy of these standards are available from the above individual.</P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>Section 343 of the Federal Agricultural Improvement and Reform Act of 1966 states that revisions made after enactment of the law to NRCS State Technical Guides used to carry out highly erodible land and wetland provisions of the law shall be made available for public review and comment. For the next 30 days the NRCS will receive comments relative to the proposed changes. Following that period a determination will be made by the NRCS regarding disposition of those comments and a final determination of change will be made.</P>
                <SIG>
                    <DATED>Dated: November 4, 2004.</DATED>
                    <NAME>Christopher R. Jones,</NAME>
                    <TITLE>State Resource Conservationist.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 04-25246 Filed 11-12-04; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 3410-16-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="N">COMMISSION ON CIVIL RIGHTS</AGENCY>
                <SUBJECT>Agenda and Notice of Public Meeting of the Vermont Advisory Committee</SUBJECT>
                <P>Notice is hereby given, pursuant to the provisions of the rules and regulations of the U.S. Commission on Civil Rights that a conference call of the Vermont Advisory Committee will convene at 10:30 a.m. and adjourn at 11 a.m., Tuesday, November, 16, 2004. The purpose of the conference call is to discuss juvenile justice issues in Vermont.</P>
                <P>This conference call is available to the public through the following call-in number: 1-800-659-8294, access code: 30141003. Any interested member of the public may call this number and listen to the meeting. Callers can expect to incur charges for calls not initiated using the supplied call-in number or over wireless lines, and the Commission will not refund any incurred charges. Callers will incur no charge for calls using the call-in number over land-line connections. Persons with hearing impairments may also follow the proceedings by first calling the Federal Relay Service at 1-800-977-8339 and providing the Service with the conference call number and access code.</P>
                <P>
                    To ensure that the Commission secures an appropriate number of lines for the public, persons are asked to register by contacting Barbara de La 
                    <PRTPAGE P="65580"/>
                    Viez of the Eastern Regional Office at 202-376-7533 by 4 p.m. on Monday, November 15, 2004.
                </P>
                <P>The meeting will be conducted pursuant to the provisions of the rules and regulations of the Commission.</P>
                <SIG>
                    <DATED>Dated in Washington, DC, November 8, 2004.</DATED>
                    <NAME>Ivy L. Davis,</NAME>
                    <TITLE>Chief, Regional Programs Coordination Unit.</TITLE>
                </SIG>
            </PREAMB>
            <FRDOC>[FR Doc. 04-25248 Filed 11-12-04; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 6335-01-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="N">DEPARTMENT OF COMMERCE</AGENCY>
                <SUBAGY>Foreign-Trade Zones Board</SUBAGY>
                <DEPDOC>[Docket 47-2004]</DEPDOC>
                <SUBJECT>Foreign-Trade 243—Victorville, CA; Application for Expansion</SUBJECT>
                <P>An application has been submitted to the Foreign-Trade Zones (FTZ) Board (the Board) by the Southern California Logistics Airport Authority, grantee of Foreign-Trade Zone 243, requesting authority to expand its zone to include additional sites in the Victorville area, within and adjacent to the Victorville Customs user fee airport and the Los Angeles-Long Beach Customs port of entry. The application was submitted pursuant to the provisions of the Foreign-Trade Zones Act, as amended (19 U.S.C. 81a-81u), and the regulations of the Board (15 CFR Part 400). It was formally filed on October 29, 2004.</P>
                <P>
                    FTZ 243 was approved on July 26, 2000 (Board Order 1097, 65 FR 47953, 8/4/00). The general-purpose zone project currently consists of the following site: 
                    <E T="03">Site 1</E>
                     (1,954 acres) consists of: Parcel 1 (1,943 acres)—Southern California Logistics Airport complex located at 18374 Phantom, Victorville; Parcel 2 (7 acres, 287,060 sq. ft.)—located at 19317 Arenth Avenue, Industry (expires 1/31/05); Parcel 3 (1 acre, 35,283 sq. ft.)—located at 13731 Proctor Avenue, Industry (expires 1/31/05); and, Parcel 4 (3 acres, 156,816 sq. ft.)—located at 3525 Walnut Avenue, Chino (expires 1/31/05).
                </P>
                <P>The applicant is now requesting authority for a major expansion of the zone as described below. The proposal requests authority to expand the zone to include nine additional sites in the cities of Industry, Whittier, Chino and Rialto, California.</P>
                <P>
                    <E T="03">Proposed Site 2</E>
                     (7 acres)—Golden State Foods warehouse located at 19317 Arenth Avenue, Industry (this site will include Site 1-Parcel 2 on a permanent basis); 
                </P>
                <P>
                    <E T="03">Proposed Site 3</E>
                     (4 acres)—Proctor Warehouse located at 13731 Proctor Avenue, Industry (this site will include Site 1-Parcel 3 on a permanent basis); 
                </P>
                <P>
                    <E T="03">Proposed Site 4</E>
                     (179 acres, 13 parcels)—located within the 186-acre Fairway Business Center in the City of Industry; 
                </P>
                <P>
                    <E T="03">Proposed Site 5</E>
                     (318 acres)—Grand Crossing Industrial Park located at the intersection of the Pomona (60) and Orange (57) Freeways in the City of Industry; 
                </P>
                <P>
                    <E T="03">Proposed Site 6</E>
                     (70 acres)—Gateway Pointe Industrial Park located at the intersection of the Pomona (60) and San Gabriel River (605) Freeways in the City of Whittier; 
                </P>
                <P>
                    <E T="03">Proposed Site 7</E>
                     (4 acres)—FBC Industries warehouse facility located at 3525 Walnut Avenue, Chino (this site will include Site 1-Parcel 4 on a permanent basis); 
                </P>
                <P>
                    <E T="03">Proposed Site 8</E>
                     (14 acres, 2 parcels)—Schaefer Warehouse (Parcel 1, 7 acres) located at 5125 Schaefer Avenue and Pacific Warehouse (Parcel 2, 7 acres) located at 5085 Schaefer Avenue, Chino; 
                </P>
                <P>
                    <E T="03">Proposed Site 9</E>
                     (8 acres)—Eucalyptus Warehouse located at 4340 Eucalyptus Avenue, Chino; and,
                </P>
                <P>
                    <E T="03">Proposed Site 10</E>
                     (91 acres)—located within the 138-acre ProLogis Park I-210 at the Alder Interchange and Interstate 210 extension in the City of Rialto.
                </P>
                <P>
                    The applicant is also requesting that 11 acres at 
                    <E T="03">Site 1</E>
                     (Southern California Logistics Airport) be restored to zone status and that Parcels 2, 3 and 4 be granted zone status on a permanent basis as noted above. (A minor boundary modification was approved in December 2003 (A(27f)-60-2003), removing 11 acres from Site 1 (Southern California Logistics Airport) to establish the temporary parcels.) No specific manufacturing requests are being made at this time. Such requests would be made to the Board on a case-by-case basis.
                </P>
                <P>In accordance with the Board's regulations, a member of the FTZ Staff has been designated examiner to investigate the application and report to the Board.</P>
                <P>Public comment on the application is invited from interested parties. Submissions (original and 3 copies) shall be addressed to the Board's Executive Secretary at one of the addresses below:</P>
                <P>
                    1. 
                    <E T="03">Submissions via Express/Package Delivery Services:</E>
                     Foreign-Trade Zones Board, U.S. Department of Commerce, Franklin Court Building—Suite 4100W, 1099 14th Street NW., Washington, DC 20005; or
                </P>
                <P>
                    2. 
                    <E T="03">Submissions via the U.S. Postal Service:</E>
                     Foreign-Trade Zones Board, U.S. Department of Commerce, FCB—Suite 4100W, 1401 Constitution Avenue, NW., Washington, DC 20230.
                </P>
                <P>The closing period for their receipt is January 14, 2005. Rebuttal comments in response to material submitted during the foregoing period may be submitted during the subsequent 15-day period (to January 31, 2005).</P>
                <P>A copy of the application and accompanying exhibits will be available for public inspection at the Office of the Foreign-Trade Zones Board's Executive Secretary at the first address listed above, and at the U.S. Department of Commerce, Export Assistance Center, 2940 Inland Empire Boulevard, Suite 121, Ontario, CA 91764.</P>
                <SIG>
                    <DATED>Dated: November 4, 2004.</DATED>
                    <NAME>Dennis Puccinelli,</NAME>
                    <TITLE>Executive Secretary.</TITLE>
                </SIG>
            </PREAMB>
            <FRDOC>[FR Doc. 04-25294 Filed 11-12-04; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 3510-D5-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF COMMERCE</AGENCY>
                <SUBAGY>National Oceanic and Atmospheric Administration</SUBAGY>
                <DEPDOC>[I.D. 110904C]</DEPDOC>
                <SUBJECT>Re-Initiation of Request for Nominations to the Marine Fisheries Advisory Committee (MAFAC)</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice of request for nominations.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The Marine Fisheries Advisory Committee (the “Committee) is the only Federal Advisory committee with the responsibility to advise the Secretary of Commerce (Secretary) on all matters concerning living marine resources that are the responsibility of the Department of Commerce.  The Committee makes recommendations to the Secretary to assist in the development and implementation of Departmental regulations, policies and programs critical to the mission and goals of the National Marine Fisheries Service.  The Committee is composed of leaders in the commercial, recreational, environmental, academic, state, tribal, and consumer interests from the nation's coastal regions.</P>
                    <P>
                        On June 14, NMFS published a Notice requesting nominees for four vacancies on the Committee.  The nomination ran through July 15, 2004, and resulted in the appointment of only two of the vacancies.  Therefore, in keeping with the Administration's policy to ensure the Committee reflect a balanced 
                        <PRTPAGE P="65581"/>
                        composition of national interests, expertise and geographic representation, the Administration has decided to reinitiate a request for additional nominations in the hopes of receiving a more diverse selection of qualified candidates to fill the remaining two vacancies in time for the Committee's next meeting in January 2005.  The Department of Commerce is seeking up to two highly qualified individuals knowledgeable about fisheries and living marine resources to serve on the Committee.
                    </P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Nominations must be postmarked on or before November 30, 2004.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>Nominations should be sent to Laurel Bryant, Executive Director, MAFAC, Office of Constituent Services, NMFS, 1315 East-West Highway #9508, Silver Spring, Maryland 20910.</P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Laurel Bryant, Executive Director; (301) 713-2379 x171.  E-mail: 
                        <E T="03">Laurel.Bryant@noaa.gov</E>
                        .
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>The establishment of MAFAC was approved by the Secretary on December 28, 1970, and initially chartered under the Federal Advisory Committee Act, 5, U.S.C. App.2, on February 17, 1971.  The Committee meets twice a year with supplementary subcommittee meetings as determined necessary by the Secretary.  Individuals serve for a term of three years for no more than two consecutive terms if re-appointed.  No less that 15 and no more than 21 individuals may serve on the Committee.  Membership is comprised of highly qualified individuals representing commercial and recreational fisheries interests, environmental organizations, academic institutions, governmental, tribal and consumer groups from a balance of geographical regions, including the Hawaiian and the Pacific Islands, and the U.S. Virgin Islands. Nominations are encouraged from all interested parties involved with or representing interests affected by Agency actions in managing living marine resources.  Nominees should possess demonstrable expertise in a field related to the management of living marine resources and be able to fulfill the time commitments required for two meetings annually.</P>
                <P>A MAFAC member cannot be a Federal agency employee or a member of a Regional Fishery Management Council.  Selected candidates must have security checks and complete financial disclosure forms.  Membership is voluntary, and except for reimbursable travel and related expenses, service is without pay.</P>
                <P>Each submission should include the submitting person's or organization's name and affiliation, a cover letter describing the nominee's qualifications and interest in serving on the Committee, a curriculum vitae or resume of nominee, and no more than three supporting letters describing the nominee's qualifications and interest in serving on the Committee.  Self-nominations are acceptable.  The following contact information should accompany each nominee's submission: name, address, phone number, fax number, and e-mail address if available.</P>
                <P>
                    Nominations should be sent to (see 
                    <E T="02">ADDRESSES</E>
                    ) and nominations must be received by (see 
                    <E T="02">DATES</E>
                    ).  The full text of the Committee Charter and its current membership can be viewed at the Agency's web page at 
                    <E T="03">www.nmfs.noaa.gov/mafac.htm</E>
                    .
                </P>
                <SIG>
                    <DATED>Dated: November 9, 2004.</DATED>
                    <NAME>Alan D. Risenhoover,</NAME>
                    <TITLE>Deputy Director, Office of Sustainable Fisheries, National Marine Fisheries Service.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 04-25314 Filed 11-12-04; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 3510-22-S</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF COMMERCE</AGENCY>
                <SUBAGY>National Oceanic and Atmospheric Administration</SUBAGY>
                <DEPDOC>[I.D. 102904C]</DEPDOC>
                <SUBJECT>Endangered and Threatened Species; Take of Anadromous Fish</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Receipt of applications to renew and modify permit 1166 and request for comment.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>Notice is hereby given that NMFS has received an application to renew a permit for scientific research from A.A. Rich and Associates (AAR) in San Anselmo, California (1166).  The permit would affect federally endangered Sacramento River winter-run Chinook salmon and Southern California steelhead, and threatened Central Valley steelhead, Central California Coast steelhead, and Central California Coast coho salmon.  This document serves to notify the public of the availability of the permit applications for review and comment.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Written comments on the permit applications must be received no later than 5 p.m. Pacific Standard Time on December 15, 2004.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>E-mailed comments on the permit applications must be sent to FRNpermits.SR@noaa.gov.  The applications and related documents are available for review by appointment, for permit 1166: Protected Resources Division, NMFS, 777 Sonoma Avenue, Room 315, Santa Rosa, CA 95404 (ph: 707-575-6097, fax: 707-5783-435).</P>
                </ADD>
                  
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Jeffrey Jahn at phone number 707-575-6097, or e-mail: 
                        <E T="03">Jeffrey.Jahn@noaa.gov</E>
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <HD SOURCE="HD1">Authority</HD>
                <P>Issuance of permits and permit modifications, as required by the Endangered Species Act of 1973 (16 U.S.C. 1531 1543) (ESA), is based on a finding that such permits/modifications:  (1) are applied for in good faith; (2) would not operate to the disadvantage of the listed species which are the subject of the permits; and (3) are consistent with the purposes and policies set forth in section 2 of the ESA.  Authority to take listed species is subject to conditions set forth in the permits.  Permits and modifications are issued in accordance with and are subject to the ESA and NMFS regulations governing listed fish and wildlife permits (50 CFR parts 222-226).</P>
                <P>Those individuals requesting a hearing on an application listed in this notice should set out the specific reasons why a hearing on that application would be appropriate (see ADDRESSES).  The holding of such a hearing is at the discretion of the Assistant Administrator for Fisheries, NOAA.  All statements and opinions contained in the permit action summaries are those of the applicant and do not necessarily reflect the views of NMFS.</P>
                <HD SOURCE="HD1">Species Covered in This Notice</HD>
                <P>
                    This notice is relevant to federally endangered Sacramento River winter-run Chinook salmon (
                    <E T="03">Oncorhynchus tshawytscha</E>
                    ) and Southern California steelhead (
                    <E T="03">O. mykiss</E>
                    ), threatened Central Valley steelhead (
                    <E T="03">O. mykiss</E>
                    ), Central California Coast steelhead (
                    <E T="03">O. mykiss</E>
                    ), and Central California Coast coho salmon (
                    <E T="03">O. kisutch</E>
                    ).
                </P>
                 Application Received
                <P>
                    AAR requests to renew and modify a 5-year permit (1166) for take of juvenile Sacramento River winter-run Chinook salmon and Central Valley steelhead to conduct pre-project fish surveys on the San Joaquin River and Old River in California.  AAR requests authorization for an estimated annual take of 30 juvenile Sacramento River winter-run Chinook salmon and 80 juvenile Central Valley steelhead, with no more than 5 percent unintentional mortality to result 
                    <PRTPAGE P="65582"/>
                    from capture by beach seine, scale samples, and release of fish.
                </P>
                <P>AAR also requests take of juvenile Central California Coast steelhead and juvenile Central California Coast coho salmon to conduct pre- and post-project fish surveys, relocation activities, and fish monitoring activities in various streams in Marin, Sonoma and Mendocino counties.  AAR requests authorization for an estimated annual take of 450 juvenile Central California Coast steelhead, and 50 juvenile Central California Coast coho salmon, with no more than 5 percent unintentional mortality to result from capture (dip net, seine, electrofishing) and release of fish.</P>
                <P>In addition, AAR requests take of juvenile Southern California steelhead to conduct fish monitoring activities in Hilton Creek, tributary to the Santa Ynez River in Santa Barbara County. AAR requests authorization for an estimated annual take of 2 juvenile Southern California Coast steelhead with no more than 5 percent unintentional mortality to result from capture (dip net, seine, electrofishing) and release of fish.</P>
                <SIG>
                    <DATED>Dated:  November 9, 2004.</DATED>
                    <NAME>Phil Williams,</NAME>
                    <TITLE>Chief, Endangered Species Division, Office of Protected Resources, National Marine Fisheries Service.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 04-25316 Filed 11-12-04; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 3510-22-S</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF COMMERCE</AGENCY>
                <SUBAGY>National Oceanic and Atmospheric Administration</SUBAGY>
                <DEPDOC>[I.D. 052104F]</DEPDOC>
                <SUBJECT>Endangered and Threatened Species:  Take of Threatened West Coast Salmonids</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice of Availability of Draft Environmental Assessment (EA) and Request for Comments.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>
                        Notice is hereby given of the availability of a draft EA for NMFS' June 2004 proposed amendments to the Endangered Species Act (ESA) protective regulations for West Coast threatened salmon and steelhead (
                        <E T="03">Oncorhynchus</E>
                         spp.)   The ESA protective regulations provide for “limits” on ESA prohibitions for specified categories of activities determined to contribute to conserving listed salmonids.  The draft EA analyzes the impacts of:   (1) revising and simplifying existing protective regulations so that all threatened West Coast salmon and steelhead are subject to the same limits, and (2) revising the current protective regulations so that the section 9 take prohibitions do not apply to adipose-fin-clipped hatchery fish and resident O. mykiss (rainbow trout).  NMFS is furnishing this notification to allow other agencies and the public an opportunity to review and comment on the draft EA.  All comments received will become part of the public record and will be available for review.
                    </P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>All comments on the draft EA must be received no later than 5 p.m. Pacific Standard Time on December 15, 2004.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        Copies of the draft EA are available on the Internet at 
                        <E T="03">http://www.nwr.noaa.gov/1salmon/salmesa/draft4dEA.html</E>
                        , or upon request (see 
                        <E T="02">FOR FURTHER INFORMATION CONTACT</E>
                        ).
                    </P>
                    <P>You may submit comments on the draft EA by any of the following methods:</P>
                    <P>E-mail:  The mailbox address for submitting e-mail comments on the draft EA is salmon.draft4dEA@nwr.noaa.gov.  Please include in the subject line of the e-mail comment the document identifier “Draft 4(d) EA”</P>
                    <P>Mail:  Submit written comments and information to Chief, NMFS, Protected Resources Division, 525 NE Oregon Street, Suite 500, Portland, Oregon, 97232-2737.  Please identify the comment as regarding the “Draft 4(d) EA.”  You may hand-deliver written comments to our office at the street address below.  Business hours are 8 a.m. to 5 p.m., Monday through Friday, except Federal holidays.</P>
                    <P>Hand Delivery/Courier:  NMFS, Protected Resources Division, 525 NE Oregon Street, Suite 210, Portland, Oregon, 97232-2737.  Business hours are noted above.</P>
                    <P>Fax:   503-230-5435. Please identify the fax comment as regarding the “Draft 4(d) EA.”</P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        NMFS, Northwest Region, Protected Resources Division by phone at (503) 872-2791.  Copies of the 
                        <E T="04">Federal Register</E>
                         notices cited herein and additional salmon-related materials are available on the Internet at 
                        <E T="03">http://www.nwr.noaa.gov</E>
                        .
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <HD SOURCE="HD1">Species Covered in This Notice</HD>
                <P>The following species and Evolutionarily Significant Units (ESUs) are covered in this notice:</P>
                <P>
                    Chinook salmon (
                    <E T="03">O. tshawytscha</E>
                    ):  the Sacramento River winter-run, Central Valley spring-run, California Coastal, Upper Willamette River, Lower Columbia River, Puget Sound, Snake River fall-run, and Snake River spring/summer-run chinook ESUs;
                </P>
                <P>
                    <E T="03">Coho salmon</E>
                     (
                    <E T="03">O. kisutch</E>
                    ):  Southern Oregon/Northern California Coast, Oregon coast, and Lower Columbia River coho ESUs;
                </P>
                <P>
                    <E T="03">Sockeye salmon</E>
                     (
                    <E T="03">O. nerka</E>
                    ):  the Ozette Lake sockeye ESU;
                </P>
                <P>
                    <E T="03">Chum salmon</E>
                     (
                    <E T="03">O. keta</E>
                    ):  the Columbia River and Hood Canal summer-run chum ESUs;
                </P>
                <P>
                    <E T="03">Steelhead and rainbow trout</E>
                     (
                    <E T="03">O. mykiss</E>
                    ):  South-Central California Coast, Central California Coast, California Central Valley, Northern California, Upper Willamette River, Lower Columbia River, Middle Columbia River, Snake River Basin, and Upper Columbia River 
                    <E T="03">O. mykiss</E>
                     ESUs.
                </P>
                <HD SOURCE="HD1">Background</HD>
                <P>
                    On June 14, 2004, NMFS published proposed ESA listing determinations for 27 ESUs of salmon and 
                    <E T="03">O. mykiss</E>
                     (69 FR 33101).  NMFS proposed threatened status for 23 ESUs in California, Oregon, Washington, and Idaho, and as part of that rulemaking also proposed amendments to the existing 4(d) protective regulations for threatened salmon and steelhead ESUs.  The National Environmental Policy Act (NEPA) requires that Federal agencies conduct an environmental analysis of their actions to determine if the actions may affect the human environment.  Accordingly, NMFS has prepared a draft EA that analyzes the impacts of the proposed amendments to the 4(d) protective regulations for West Coast salmonids, and is making it available for public review and comment.
                </P>
                <P>This draft EA analyzes two alternatives:   (1) No Action (no revision to the current 4(d) protective regulations); and (2) the Proposed Action Alternative (revision and simplification of existing 4(d) protective regulations).  The Proposed Action Alternative includes the following amendments:</P>
                <P>
                    Apply the 4(d) protections and 14 limits promulgated in 2000 (as modified in the proposed amendments) to three ESUs being newly proposed for threatened status; Apply the same 4(d) protections and 14 limits promulgated in 2000 (as modified in proposed amendments) to all threatened ESUs; Amend an expired 4(d) limit which provided a temporary exemption for ongoing research with pending permit applications during the 2000 4(d) rulemaking, to temporarily exempt ongoing research during the current rulemaking process; Move the 
                    <PRTPAGE P="65583"/>
                    description of the limit for Tribal Resource Management Plans (§ 223.209) so that the text would appear next to the 4(d) rule in the Code of Federal Regulations, improving the clarity of the 4(d) regulations; and Amend the current 4(d) rule so that the section 9(a) take prohibitions apply to anadromous fish with an intact adipose fin only (that is, the take prohibitions and 4(d) protective regulations would not apply to unclipped hatchery fish or resident O. mykiss included in the subject ESUs).
                </P>
                <P>Because the proposed action creates an optional ESA process, the effects that it may generate are limited to those associated with amending the 4(d) protective regulations.  The proposed action does not address the potential effects of individual activities or programs that may seek coverage under one of the 4(d) “limits.”  It is impossible to anticipate the specific impacts of such programs that may be submitted to and approved by NMFS.  NMFS will conduct further NEPA analyses as necessary when a specific program is submitted to NMFS for coverage under one of the 4(d) limits for West Coast salmonids.</P>
                <P>This notice is provided pursuant to the NEPA regulations (40 CFR 1506.6).  The final NEPA determinations will not be completed until after the end of the 30-day comment period and after NMFS has fully considered all comments received during the public comment period.</P>
                <AUTH>
                    <HD SOURCE="HED">Authority:</HD>
                    <P>
                        16 U.S.C. 1531 
                        <E T="03">et seq.</E>
                    </P>
                </AUTH>
                <SIG>
                    <DATED>Dated:  November 9, 2004.</DATED>
                    <NAME>Laurie K. Allen,</NAME>
                    <TITLE>Director, Office of Protected Resources, National Marine Fisheries Service.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 04-25313  Filed 11-12-04; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 3510-22-S</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF COMMERCE</AGENCY>
                <SUBAGY>National Oceanic and Atmospheric Administration</SUBAGY>
                <DEPDOC>[I.D. 102704]</DEPDOC>
                <SUBJECT>Taking and Importing of Marine Mammals</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice of affirmative finding renewal.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The Assistant Administrator for Fisheries, NMFS, (Assistant Administrator) renewed the affirmative finding for the Republic of Ecuador under the Marine Mammal Protection Act (MMPA).  This affirmative finding renewal will allow yellowfin tuna and yellowfin tuna products harvested in the eastern tropical Pacific Ocean (ETP), in compliance with the International Dolphin Conservation Program (IDCP) by Ecuadorian-flag purse seine vessels or vessels operating under Ecuadorian jurisdiction, to continue to be imported into the United States.  The affirmative finding renewal was based on review of documentary evidence submitted by the Republic of Ecuador and obtained from the Inter-American Tropical Tuna Commission (IATTC) and the Department of State.  This finding remains in effect through March 31, 2005.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Effective April 1, 2004, through March 31, 2005.</P>
                </DATES>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>Regional Administrator, Southwest Region, NMFS, 501 West Ocean Boulevard, Suite 4200, Long Beach, California, 90802-4213; Phone 562-980-4000; Fax 562-980-4018.</P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>The MMPA, 16 U.S.C. 1361 et seq., allows entry into the United States of yellowfin tuna harvested by purse seine vessels in the ETP under certain conditions.  Under implementing regulations at 50 CFR 216.24, a nation with purse seine vessels greater than 400 short tons (362.8 metric tons) carrying capacity fishing for tuna in the ETP must have an affirmative finding in order to export such tuna and tuna products to the United States.  If requested by the harvesting nation, the Assistant Administrator will determine whether to make an affirmative finding based upon documentary evidence provided by the government of the harvesting nation, the IATTC, or the Department of State.  The finding will be reviewed annually to ensure that the nation continues to meet the requirements for an affirmative finding.  The requirements must be met in order for the finding to remain valid for the following 12-month period: April 1 through March 31, or for such other period as the Assistant Administrator may determine.</P>
                <P>The affirmative finding process requires that the harvesting nation meet several conditions related to compliance with the IDCP.   Every 5 years, the government of the harvesting nation must request an affirmative finding and submit the required documentary evidence directly to the Assistant Administrator.  A nation may opt to provide information regarding compliance with the IDCP directly to NMFS on an annual basis or to authorize the IATTC to release the information to NMFS in years when NMFS will review and consider whether to issue an affirmative finding determination without an application from the harvesting nation.</P>
                <P>An affirmative finding will be terminated, in consultation with the Secretary of State, if the Assistant Administrator determines that the requirements of 50 CFR 216.24(f) are no longer being met or that a nation is consistently failing to take enforcement actions on violations which diminish the effectiveness of the IDCP.  Every 5 years, the government of the harvesting nation must request an affirmative finding and submit the required documentary evidence directly to the Assistant Administrator.</P>
                <P>As a part of the annual review process set forth in 50 CFR 216.24(f), the Assistant Administrator considered documentary evidence submitted by the Republic of Ecuador and obtained from the IATTC and the Department of State and determined that Ecuador has met the MMPA's requirements to receive an affirmative finding.</P>
                <P>After consultation with the Department of State, NMFS renewed the Republic of Ecuador's affirmative finding allowing the continued importation into the United States of yellowfin tuna and products derived from yellowfin tuna harvested in the ETP by Ecuadorian-flag purse seine vessels or vessels operating under Ecuadorian jurisdiction.</P>
                <P>The Republic of Ecuador must submit a new application no later than January 2005 for an affirmative finding to be effective for the period April 1, 2005, through March 31, 2006, and the subsequent 4 years.</P>
                <SIG>
                    <DATED>Dated:  November 9, 2004.</DATED>
                    <NAME>Rebecca Lent,</NAME>
                    <TITLE>Deputy Assistant Administrator for Regulatory Programs, National Marine Fisheries Service.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 04-25315  Filed 11-12-04; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 3510-22-S</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF COMMERCE</AGENCY>
                <SUBAGY>National Oceanic and Atmospheric Administration</SUBAGY>
                <DEPDOC>[I.D. 101304E]</DEPDOC>
                <SUBJECT>Issuance of Permit 1493</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration, Commerce.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>
                        Notice of decision and availability of decision documents on the issuance of ESA research/
                        <PRTPAGE P="65584"/>
                        enhancement permit 1493 for takes of endangered species.
                    </P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>This notice advises the public that a scientific research permit to the Bonneville Power Administration (BPA) and the Confederated Tribes and Bands of the Yakama Nation, as their agent, pursuant to the Endangered Species Act of 1973 (ESA), has been issued and that the decision documents are available upon request.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Permit 1493 was issued on September 15, 2004, subject to certain conditions set forth therein.  The permit expires on September 15, 2009.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        Requests for copies of the decision documents or any of the other associated documents should be directed to the Salmon Recovery Division, NOAA Fisheries, 525 NE Oregon Street, Suite 510, Portland, Oregon 97232.  The documents are also available on the Internet at 
                        <E T="03">www.nwr.noaa.gov</E>
                        .
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Kristine Petersen, Portland, OR, at phone number:  (503) 230-5409, e-mail: 
                        <E T="03">Kristine.Petersen@noaa.gov</E>
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>The following species and evolutionarily significant units (ESUs) are covered in the permit:</P>
                <P>
                    Steelhead (
                    <E T="03">Oncorhynchus mykiss</E>
                    ): endangered Upper Columbia River.
                </P>
                <P>
                    Chinook salmon (
                    <E T="03">O. tshawytscha</E>
                    ): endangered Upper Columbia River spring run.
                </P>
                <P>Issuance of this permit, as required by the ESA, was based on a finding that such permits: (1) were applied for in good faith; (2) will not operate to the disadvantage of the listed species which are the subject of the permits; and (3) is consistent with the purposes and policies set forth in section 2 of the ESA. This permit was issued in accordance with, and is subject to, 50 CFR part 222, the NMFS regulations governing listed species permits.</P>
                <SIG>
                    <DATED>Dated:  November 9, 2004.</DATED>
                    <NAME>Phil Williams,</NAME>
                    <TITLE>Chief, Endangered Species Division,  Office of Protected Resources, National Marine Fisheries Service.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 04-25317 Filed 11-12-04; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 3510-22-S</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="N">COMMODITY FUTURES TRADING COMMISSION </AGENCY>
                <SUBJECT>In the Matter of the Intercontinental Exchange, Inc. Petition for Expansion of the Definition of an Eligible Commercial Entity Under Section 1a(11)(C) of the Commodity Exchange Act </SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Commodity Futures Trading Commission. </P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Order. </P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>
                        In response to a petition from the Intercontinental Exchange, Inc. (“Intercontinental”), the Commodity Futures Trading Commission (“Commission” or “CFTC”), pursuant to section 1a(11)(C) of the Commodity Exchange Act (“Act”), is issuing an order that deems, subject to certain conditions, brokers and traders associated with the International Petroleum Exchange (“IPE”), a recognized investment exchange (“RIE”) located in the United Kingdom (“U.K.”), who are either authorized by the Financial Services Authority (“FSA”) or registered with the IPE,
                        <SU>1</SU>
                        <FTREF/>
                         when acting in a proprietary trading capacity, to be an “eligible commercial entity” as defined in section 1a(11) of the Act.
                        <SU>2</SU>
                        <FTREF/>
                         Accordingly, subject to certain conditions as set forth in the Commission's order, IPE members authorized as commodity brokers by FSA or registered as local traders with IPE, when acting for their own accounts, are permitted to enter into transactions in exempt commodities on exempt commercial markets pursuant to section 2(h)(3) of the Act. In order to participate, the FSA-authorized broker or IPE-registered trader must either be an eligible contract participant, as that term is defined in section 1a(12) of the Act, or have its trades on the exempt commercial market guaranteed by a clearing member that is both a member of an FSA-recognized derivatives clearing organization and is an eligible contract participant. 
                    </P>
                    <FTNT>
                        <P>
                            <SU>1</SU>
                             Registration with IPE is not registration with FSA or any other government entity. Criteria and procedures for obtaining membership or trading privileges on IPE are discussed below.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>2</SU>
                             The Commission previously determined to expand ECE eligibility to include, subject to certain conditions, Commission-registered floor brokers and floor traders. 
                            <E T="03">See</E>
                             68 FR 2319 (January 16, 2003). That action applied to Commission-registered floor brokers and floor traders conducting business on electronic or open outcry markets. Similarly, this action applies to IPE brokers and local traders conducting business on IPE in either electronic or open outcry trading environments. As used in this 
                            <E T="04">Federal Register</E>
                             notice and in the prior 
                            <E T="04">Federal Register</E>
                             notice, the term proprietary trading means trading for one's own account.
                        </P>
                    </FTNT>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">EFFECTIVE DATE:</HD>
                    <P>This order is effective November 15, 2004. </P>
                </DATES>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Clarence Sanders, Special Counsel, Division of Market Oversight, Commodity Futures Trading Commission, Three Lafayette Centre, 1155 21st Street, NW., Washington, DC 20581. Telephone: (202) 418-5068. Electronic mail: 
                        <E T="03">csanders@cftc.gov.</E>
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <HD SOURCE="HD1">I. Statutory Background </HD>
                <P>
                    The Commodity Futures Modernization Act of 2000 (“CFMA”), Public Law No. 106-554, was signed into law on December 21, 2000. Under amendments implemented by the CFMA, section 2(h)(3) of the Act authorizes trading in an “exempt commodity” 
                    <SU>3</SU>
                    <FTREF/>
                     on an exempt commercial market (“ECM”) meeting the requirements of section 2(h) (3)-(5). Under those provisions, transactions between an eligible commercial entity (“ECE”) in an exempt commodity on an ECM are exempt from all but certain limited requirements of the Act.
                    <SU>4</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>3</SU>
                         Section 1a(14) of the Act defines the term “exempt commodity” to mean a commodity that is not an excluded commodity or an agricultural commodity. Section 1a(13) defines the term “excluded commodity” to mean, among other things, an interest rate, exchange rate, currency, credit risk or measure, debt instrument, measure of inflation, or other macroeconomic index or measure. Although the term “agricultural commodity” is not defined in the Act, section 1a(4) enumerates a non-exclusive list of several agricultural-based commodities and products. The broadest type of commodities that fall into the exempt category are energy and metals products.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>4</SU>
                         Under section 2(h)(3), ECMs are markets that meet the requirements of section 2(h)(3)-(5) by notifying the Commission of their intention to operate a trading facility in reliance on the exemption and by limiting themselves to transactions: (1) In exempt commodities, (2) entered into on a principal-to-principal basis by ECEs, and (3) executed or traded on an electronic trading facility. An ECM is not a registered entity, but is required to notify the Commission of its intention to operate an electronic trading facility in reliance on the exemption set forth in section 2(h)(3). The notification of operation as an ECM must include several certifications and, pursuant to Commission regulation 36.3(c)(3), a representation that it will require each participant to comply with all applicable law and that it has a reasonable basis for believing that authorized participants are ECEs. Section 2(h)(4) reserves, with respect to transactions eligible for the 2(h)(3) exemption, certain provisions of the Act, including certain anti-fraud and anti-manipulation provisions.
                    </P>
                </FTNT>
                <P>
                    Section 1a(11) of the Act lists those eligible contract participants (“ECP”) 
                    <SU>5</SU>
                    <FTREF/>
                      
                    <PRTPAGE P="65585"/>
                    that are qualified to be ECEs.
                    <SU>6</SU>
                    <FTREF/>
                     As defined under section 1a(11), floor brokers and floor traders, even if determined to fall within the definition of an ECP, do not, as a category, fall within the statutory definition of an ECE. Thus, commodity brokers and traders, whether conducting business in either electronic or open outcry trading environments, are prohibited from entering into transactions on ECMs.
                </P>
                <FTNT>
                    <P>
                        <SU>5</SU>
                         Section 1a(12) lists those entities and individuals included within the ECP category. Included generally as ECPs are financial institutions; insurance companies; and investment companies subject to regulation; commodity pools and employee benefit plans subject to regulation and asset requirements; other entities subject to asset requirements or whose obligations are guaranteed by an ECP that meets a net worth requirement; governmental entities; brokers, 
                        <PRTPAGE/>
                        dealers, and futures commission merchants (“FCM”) subject to regulation and organized as other than natural persons or proprietorships; brokers, dealers, and FCMs subject to regulation and organized as natural persons or proprietorships subject to total asset requirements or whose obligations are guaranteed by an ECP that meets a net worth requirement; floor brokers or floor traders subject to regulation in connection with transactions that take place on or through the facilities of a registered entity or an exempt board of trade; individuals subject to total asset requirements; an investment adviser or commodity trading adviser acting as an investment manager or fiduciary for another ECP, and any other person that the Commission deems eligible in light of the financial or other qualifications of the person.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>6</SU>
                         Section 1a(11) defines the term ECE by listing those entities and individuals considered to be ECEs. Generally, an ECE is an ECP that (1) in connection with its business, demonstrates the ability to make or take delivery of the underlying commodity; incurs risk, in addition to price risk related to the commodity; or is a dealer that regularly provides risk management or hedging services to, or engages in market-making activities with, the foregoing entities with respect to the commodity or derivatives transactions in the commodity; or (2) is other than a natural person or government entity and regularly enters into transactions with respect to the commodity, subject to certain qualification or total asset requirements; or (3) such other persons as the Commission shall determine appropriate.
                    </P>
                </FTNT>
                <P>Section 1a(11)(C) of the Act, however, vests the Commission with discretion to expand the list of entities qualifying as an ECE. Specifically, under that provision, the definition of an ECE shall include “such other persons as the Commission shall determine appropriate and shall designate by rule, regulation, or order.” Therefore, a Commission-determination recognizing that IPE brokers and traders, either authorized by FSA or registered with IPE, are considered to be ECEs would permit these entities to enter into exempt commodity transactions on ECMs pursuant to section 2(h)(3) of the Act. </P>
                <HD SOURCE="HD1">II. The Petition </HD>
                <HD SOURCE="HD2">A. Scope of Request </HD>
                <P>
                    By letter dated February 9, 2004, Intercontinental requested that the Commission issue an order pursuant to section 1a(11) of the Act that would expand the ECE category to include certain IPE brokers and local traders, who are either authorized by FSA or registered with IPE, thus permitting them to trade on ECMs.
                    <SU>7</SU>
                    <FTREF/>
                     Intercontinental operates a commodities trading platform for energy and metals (the “Intercontinental electronic platform”) and is itself an ECM. Intercontinental also owns IPE, a U.K. futures exchange that trades energy futures products. The Intercontinental electronic platform is used by IPE for its electronic trading system. Intercontinental stated that including IPE brokers and local traders as ECEs would be consistent with the CFMA and would recognize their value as both liquidity providers and market makers. 
                </P>
                <FTNT>
                    <P>
                        <SU>7</SU>
                         Intercontinental submitted its notice of operation as an ECM to the Commission on December 27, 2001. Intercontinental is one of 11 ECMs that have submitted notices to the Commission to date.
                    </P>
                </FTNT>
                <P>
                    As more fully described below, Intercontinental's request applies to certain IPE brokers and local traders conducting business on IPE in either electronic or open outcry trading environments.
                    <SU>8</SU>
                    <FTREF/>
                     Specifically, Intercontinental proposed that eligible IPE brokers must be located in the U.K., be authorized and regulated by the FSA, and be a member of the IPE. For IPE local traders, Intercontinental proposed that eligible local traders be located in the U.K., be outside the scope of the Financial Services and Markets Act of 2000 (“FSMA”), and be a member of, or registered to, the IPE. Additionally, for both brokers and local traders, Intercontinental proposed that they have, as a part of their business activities, the business of acting as a broker or local trader but need not have any connection or experience in the underlying physical commodity. Finally, Intercontinental proposed that an eligible IPE broker or local trader must be an ECP or, if not an ECP, then the IPE broker or local trader must have its trades on the ECM guaranteed by an entity that is both an ECP and a clearing member of a U.K. recognized clearing organization. 
                </P>
                <FTNT>
                    <P>
                        <SU>8</SU>
                         The two classes denominated as brokers or local traders encompass four separate types of holders of trading privileges on IPE. Within the broker class there are Floor Members and General Participants. Floor Members hold privileges to trade on the IPE floor, whereas General Participants may trade only through the IPE electronic trading system. After establishment by IPE of the General Participant class, Floor Members were eligible to be grandfathered as General Participants. Also new Floor Members can elect to qualify as General Participants. The class denominated as local traders by IPE can similarly be broken down into two separate trader types. These are called Local Members and Individual Participants. Local Members may trade on the IPE floor, but Individual Participants may trade solely through the IPE electronic trading system. During July 2003 IPE introduced a new “electronic” membership structure. FSA recognizes all four classes as “members,” irrespective of whether the individual class is vested with equity or voting rights. See FSA Handbook Glossary at M8, 01/10/04, which defines a member as “a person who is entitled, under an arrangement or agreement between him and that body, to use that body's facilities.”
                    </P>
                </FTNT>
                <P>
                    In its petition, Intercontinental noted that the Commission has previously expanded the eligibility criteria for ECE status to include Commission-registered floor brokers and floor traders when acting in a proprietary trading capacity. In this respect, Intercontinental commented that the relief it seeks for IPE brokers and local traders is an appropriate extension of the Commission's previous expansion of the ECE definition. Moreover, Intercontinental contends that the IPE brokers and local traders, much as the CFTC registered floor brokers and floor traders qualifying under the Commission's prior action, are commodity professionals supervised by a central regulator, the FSA, or the IPE. Intercontinental also notes that the IPE brokers and local traders regularly trade on the IPE as part of their business and would utilize ECMs in connection with their trading activities. Intercontinental also observes that the Commission's prior action effectively acknowledges that floor brokers and floor traders are sophisticated market participants who are subject to a comprehensive regulatory scheme, such as that provided under FSA and IPE regulations. Intercontinental concludes that IPE brokers and local traders satisfy similar criteria, including that of having their trades guaranteed by the arrangements put in place by an RIE, and should therefore be eligible for the same type of relief.
                    <SU>9</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>9</SU>
                         FSA recognition requirements place obligations on an RIE to put in place satisfactory arrangements for securing clearing and settlement services, which generally will be carried out by a Recognized Clearing House.
                    </P>
                </FTNT>
                <HD SOURCE="HD2">B. IPE Brokers </HD>
                <P>The petition requests that the ECE definition be expanded to include IPE brokers that are located in the UK when acting in a proprietary capacity. The IPE brokers include IPE Floor Members and IPE General Participants. IPE Floor Members may trade in either the open outcry or electronic markets; General Participants are restricted to the electronic market only. </P>
                <P>
                    As the petition describes, IPE brokers are firms authorized to transact business on behalf of customers or for the firm's proprietary account.
                    <SU>10</SU>
                    <FTREF/>
                     When acting on behalf of customers, the firm's business activities fall within the scope of the FSMA. Thus, a firm conducting such 
                    <PRTPAGE P="65586"/>
                    activities in the UK is subject to regulation by the FSA. Among other qualifying criteria, such firms must obtain FSA authorization prior to engaging in the commodity brokerage business.
                    <SU>11</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>10</SU>
                         Although IPE brokers have FSA authorization to conduct transactions on behalf of customers, any relief granted in response to the Intercontinental petition would be solely for their proprietary trading activities.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>11</SU>
                         Under the U.K. regulatory regime, FSA also is responsible for approving persons who perform certain “controlled functions” for an authorized person. The FSA has specified 27 separate controlled functions, which fall into two main groups. The first of these two groups is the “significant influence functions” group, which includes activities carried out by persons in positions having a significant influence over conduct of the firm, such as governing functions (a Board Director or Chief Executive) or required functions (Compliance Officer or Money-Laundering Reporting Officer). The other group is the “customer functions” group, which includes persons performing advisory functions or customer trading and investment management functions.
                    </P>
                </FTNT>
                <P>
                    As there are two separate trading venues at IPE, conduct of business by IPE brokers may take two different forms. Each IPE floor-based broker (
                    <E T="03">i.e.</E>
                    , Floor Members) is represented on the trading floor by one or more individual traders.
                    <SU>12</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>12</SU>
                         In order to qualify for membership as a Floor member on IPE, an applicant also must meet a schedule of IPE eligibility requirements. Under this schedule, an applicant must (1) be a firm or company, (2) meet IPE requirements on record-keeping, training and fitness of staff and directors, and implement internal procedures to ensure compliance with regulations, (3) meet minimum IPE-established net worth requirements, (4) maintain a properly established office in an IPE-approved location for the conduct of business, (5) have a continuing interest in trading and maintain trading staff on the IPE floor, (6) be a clearing member of LCH.Clearnet or be a party to a clearing agreement with another firm that is a member of LCH.Clearnet, and (7) hold at least one seat on IPE, where the applicant wishes to self-execute transactions on the IPE floor.
                    </P>
                </FTNT>
                <P>
                    General Participants are IPE brokers authorized to conduct business solely on the electronic trading platform. IPE-established eligibility requirements for this class of membership differ from those applicable to floor members. However, both classes of IPE brokers are authorized by FSA and therefore under FSA oversight. When operating on the IPE electronic trading platform, representatives of IPE General Participants are registered with the IPE as a Responsible Individual (“RI”) or, alternatively, are registered with the FSA as an Approved Person linked to a particular General Participant.
                    <SU>13</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>13</SU>
                         Under the applicable schedule of requirements, the applicant must (1) demonstrate fitness to be a member, (2) demonstrate sufficiency of controls and procedures to ensure that employees, agents, and representatives are fit and proper, suitably qualified and experienced, adequately trained, and properly supervised, (3) maintain a properly established office in an IPE-approved location for the conduct of business, (4) meet minimum IPE-established financial standing requirements, (5) be a party to an IPE-prescribed Platform User Agreement, (6) maintain access to the Trading Server via a front end application meeting IPE criteria, (7) be a clearing member of LCH.Clearnet or be a party to a clearing agreement with another firm that is a member of LCH.Clearnet, (8) hold all necessary licenses, authorizations, and consents or qualifies for an exclusion permitting the conduct of business on the Platform in accordance with applicable law and regulation, and (9) identify the location of all RIs, along with related details and information on order routing, upon request from IPE.
                    </P>
                </FTNT>
                <HD SOURCE="HD2">C. IPE Local Traders </HD>
                <P>
                    The petition also requests that the ECE definition be expanded to include IPE local traders located in the UK. Under IPE rules, local traders are authorized to trade for their own account but are prohibited from engaging in customer brokerage. As noted above, IPE local traders as a class are composed of two separate types of holders of trading privileges. These are Local Members and Individual Participants.
                    <SU>14</SU>
                    <FTREF/>
                     Qualifying criteria for these two trader classes differ in some respects. Local Members hold privileges to trade on the IPE floor.
                    <SU>15</SU>
                    <FTREF/>
                     Individual Participants are authorized to trade solely on the electronic trading platform.
                    <SU>16</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>14</SU>
                         A third local trader class, Trade Participant membership, also exists but relief is not being sought for this class. Trade Participants are companies limited to trading for their own account.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>15</SU>
                         To qualify as an IPE Local Member an applicant must (1) demonstrate fitness as a member and an intention to comply with IPE regulations, (2) register with IPE and successfully pass the Registered Floor Trader examination, (3) demonstrate that the applicant will become a party to a clearing agreement with a clearing member of LCH.Clearnet, (4) demonstrate that the applicant is entitled, upon admission to membership, to acquire or lease a minimum of one seat on IPE, (5) demonstrate that the applicant is either a sole trader or a company where 90 percent of issued share capital is owned by the sole trader or 90 percent of voting rights of a non-share capital company is held by the sole trader, and (6) provide any other information or documents requested by IPE.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>16</SU>
                         To demonstrate eligibility an applicant as an Individual Participant must (1) demonstrate fitness as a member and an intention to comply with IPE regulations, (2) register with IPE as an RI and successfully pass the Registered Trader examination, (3) be a party to an IPE-prescribed Platform User Agreement, (4) maintain access to the Trading Server via a front end application meeting IPE criteria, (5) demonstrate that the applicant will become a party to a clearing agreement with a clearing member of LCH.Clearnet, and (6) demonstrate substantial experience trading on a UK futures exchanges, or otherwise meet the Intermediate Customer Standards found in FSA Conduct of Business Rule 4.1.9R.
                    </P>
                </FTNT>
                <P>
                    Notably, both Local Members and Individual Participants are outside the scope of the FSMA and therefore need not be authorized by the FSA—either when trading on IPE on behalf of their own account or on behalf of other IPE members.
                    <SU>17</SU>
                    <FTREF/>
                     However, both Local Members and Individual Participants must be members of, or registered with, the IPE, and must meet independent qualifying criteria established by IPE under an FSA-recognized regime.
                    <SU>18</SU>
                    <FTREF/>
                     The IPE actively monitors Local Member and Individual Participant trading activity, and has authority to impose sanctions for improper trading conduct.
                    <SU>19</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>17</SU>
                         IPE Local Members and Individual Participants were determined to be outside the scope of FSMA by Order 2001. Local Members and Individual Participants may be individuals or corporations, although in the case of a corporation, 90 percent of the share capital or voting rights must be held by a single member.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>18</SU>
                         FSA confirms that IPE regulations appear to meet the requirements in the FSA sourcebook on Recognized Investment Exchanges and Recognized Clearing Houses.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>19</SU>
                         All IPE members and holders of trading privileges must execute an IPE-prescribed agreement consenting to be bound by IPE rules. 
                        <E T="03">See</E>
                         IPE Rule B.1.4.
                    </P>
                </FTNT>
                <HD SOURCE="HD1">D. Qualifying Experience for Individual Participants </HD>
                <P>IPE affirms that it will determine whether an applicant has substantial qualifying experience by applying the standards set out under the definition of an Intermediate Customer contained in FSA regulations. In particular, IPE represents that the standards defining an expert private client as an Intermediate Customer found in Rule 4.1.9R of the FSA Conduct of Business (“COB”) sourcebook will be applied as the primary guide in determining the adequacy of an applicant's experience for this purpose. </P>
                <P>
                    COB Rule 4.1.9R imposes a two-tiered regulatory structure on financial services firms servicing accounts of expert private clients. This structure is divided between (1) procedural steps in establishing a client relationship with an expert private client and (2) objective steps in determining the adequacy of the expert private client's trading and business experience. More specifically, under FSA regulations, a financial intermediary is required to classify a client in one of three classifications: these are private (“retail”) customer, intermediate customer, or market counterparty.
                    <SU>20</SU>
                    <FTREF/>
                     Provisions under COB Rule 4.1.9R, permit a financial services firm to classify a client who would otherwise be a private, or retail, customer as an Intermediate Customer only upon a determination that the client is an “expert” private client. 
                </P>
                <FTNT>
                    <P>
                        <SU>20</SU>
                         See COB Rule 4.1.4, FSA Handbook, Release 034, September 2004.
                    </P>
                </FTNT>
                <P>
                    COB 4.1.9R requires a firm to assess the adequacy of a client's experience and knowledge as an expert private client.
                    <SU>21</SU>
                    <FTREF/>
                     In this respect, COB Rule 
                    <PRTPAGE P="65587"/>
                    4.1.9R requires that a firm inquire about the client's knowledge, understanding, and awareness of risks in the applicable investments and markets. The rule also requires a firm to consider the length of time the client has been active in the applicable markets, the frequency of dealings, and the extent to which the client has relied on advice. Finally, the rule instructs a firm to inquire about or consider the size and nature of any transactions undertaken for the client, and the client's financial standing, including where appropriate an assessment of the client's net worth and portfolio holdings. 
                </P>
                <FTNT>
                    <P>
                        <SU>21</SU>
                         Under the first tier, which concerns the establishment of a client relationship, COB Rule 4.1.9R requires that a firm take reasonable care to determine that the client has sufficient experience and understanding, disclose in writing the regulatory protections waived by such classification, provide the client sufficient time to consider the determination, and obtain the client's written consent or otherwise demonstrate that informed consent has been given by the client.
                    </P>
                </FTNT>
                <P>Essentially, IPE has determined to adopt the COB Rule 4.1.9R standards as qualifying criteria for applicants as IPE Individual Participants. Thus, these standards, otherwise imposed upon financial services firms regulated by FSA, will also be part of IPE procedures and serve as a screening device for determining the sufficiency of an applicant's experience and knowledge for admission on the IPE as an Individual Participant. In this respect, IPE confirms that its application of the criteria found in Rule 4.1.9R, to assess experience and knowledge of Individual Participant applicants, will be part of an independent determination made by IPE management. Moreover, IPE represents that any prior status an applicant may have attained as a customer of a financial services firm would not be determinative of eligibility, but that IPE would undertake an independent assessment of the applicant's experience and knowledge under the standards of COB Rule 4.1.9R. </P>
                <HD SOURCE="HD1">E. Comments </HD>
                <P>
                    The Intercontinental petition was published in the 
                    <E T="04">Federal Register</E>
                     for a 15-day public comment period on March 22, 2004.
                    <SU>22</SU>
                    <FTREF/>
                     In addition, the 
                    <E T="04">Federal Register</E>
                     release includes a series of questions posed by the Commission regarding the petition. Those questions focus on whether the petition should be granted; what conditions if any should apply; whether any grant of the petition should be specifically tailored to the Intercontinental ECM or be more broadly applied to other ECMs as well; whether relief should extend to IPE traders with rights to trade only on the IPE electronic platform, or to IPE locals not registered with the FSA and, if so, what standards should apply to evaluate the qualifications of such persons. 
                </P>
                <FTNT>
                    <P>
                        <SU>22</SU>
                         69 FR 13286 (March 22, 2004).
                    </P>
                </FTNT>
                <P>
                    In total, the Commission received three comment letters responding to the 
                    <E T="04">Federal Register</E>
                     notice, two of which were submitted by the New York Mercantile Exchange (“NYMEX”) in letters dated April 7, and May 27, 2004. The other comment was submitted by Intercontinental in a letter dated April 28, 2004. The Intercontinental comment letter primarily responded to issues critically raised in the NYMEX letter of April 7, 2004. 
                </P>
                <HD SOURCE="HD3">1. NYMEX Comment Letters </HD>
                <P>The NYMEX comment letters include a generalized critical assessment of the petition. In so doing, the letters characterize the relief being sought as “broad and unrestricted,” and argue against the grant of the petition. In arriving at this conclusion, NYMEX emphasizes several different aspects of the IPE institutional and regulatory environment. </P>
                <P>In particular, NYMEX sets out its view of the regulatory landscape governing ECMs as one in which statutory exemption is conditioned on the commercial nature of the market. Following this line of reasoning, NYMEX asserts that the IPE electronic traders are best characterized as representing a retail rather than a commercial interest and, on that basis, concludes they should be denied eligibility to obtain trading privileges on ECMs. </P>
                <P>In amplifying its objection to a grant of access for IPE electronic traders, NYMEX asserts that granting the petition for IPE electronic traders would open ECM access to a “potentially large group of unschooled and unsophisticated electronic traders who are not required to be registered here or in the U.K.” NYMEX further concludes that granting such regulatory relief could impose risks to the integrity of trading on an ECM. Thus, NYMEX concludes that a grant of relief sought by Intercontinental would be contrary to statutory intent and the public interest. </P>
                <P>Along a similar line of reasoning, NYMEX questions whether the IPE local traders (both Local Members and Individual Participants) could meet commercial standards justifying access to an ECM. NYYMEX supports this conclusion by arguing that the lack of FSA registration for IPE local traders, combined with a lack of express qualifying and trading participation requirements, raises a question as to whether such traders could serve as effective “liquidity providers” on an ECM. </P>
                <P>NYMEX also questions whether the petition is imbued with a full understanding of the meaning of “trading for one's own account” within the context of obtaining trading access to an ECM. </P>
                <P>The NYMEX comments also respond to the Commission's inquiry whether any regulatory response to the petition should be tailored specifically to permit IPE members to trade solely on Intercontinental or should be more broadly designed to permit IPE members to trade on other ECMs as well. Although more generally opposing the grant of the petition, NYMEX, in response to this question, comments that it is unable to identify any factual circumstances that would be unique to Intercontinental's ECM. On this basis, NYMEX concludes there is no need to tailor any hypothetical relief to the specific factual circumstances of the Intercontinental ECM and, in this respect, questions the wisdom of “creating private definitions for public statutory categories.” In summary, although NYMEX argues against granting the petition, NYMEX suggests that in any grant of relief the Commission “may wish to consider allowing such IPE members to trade on other ECMs.” </P>
                <HD SOURCE="HD3">2. Intercontinental Letter </HD>
                <P>
                    As noted, Intercontinental submitted a comment letter dated April 28, 2004. That letter generally responds to the issues raised in the NYMEX letter of April 7, 2004. At the outset, Intercontinental notes that the IPE, as an RIE regulated by FSA, is subject to a panoply of FSA requirements, which, according to Intercontinental, are designed to protect the functioning of the market and the interests of users.
                    <SU>23</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>23</SU>
                         Recognized Investment Exchanges and Recognized Clearing Houses, FSA Handbook, Release 033, July 2004. More specifically, Intercontinental represents that Part 2.7 of the RIE Sourcebook imposes obligations requiring an RIE to restrict membership to applicants (1) over whom it can with reasonable certainty enforce its rules contractually, (2) who have sufficient technical competence to use its facilities, (3) who it is appropriate to admit to membership having regard to the size and sophistication of users of its facilities and the nature of the business effected by means of or cleared through its facilities, and (4) if appropriate who have adequate financial resources in relation to their exposure to the UK recognized body or its central counterparty. See also FSA Handbook Glossary at M8, 01/10/04, which defines a member as “a person who is entitled, under an arrangement or agreement between him and that body, to use that body's facilities.” Thus, all holders of IPE trading privileges are deemed “members,” and are regulated as such under FSA regulations, irrespective of whether individuals within a particular class of traders hold any equity or voting rights in IPE.
                    </P>
                </FTNT>
                <P>
                    Intercontinental also comments that these FSA requirements on member access to an RIE should also be read in conjunction with the rules and requirements independently applied by 
                    <PRTPAGE P="65588"/>
                    IPE.
                    <SU>24</SU>
                    <FTREF/>
                     As a supplement to these rules and requirements, Intercontinental comments that IPE also applies a membership due diligence screening process in which the IPE inquiry seeks information on an applicant's personal history including, but not limited to, the applicant's experience and knowledge of derivatives trading, whether an individual applicant has been registered by another regulatory body, has ever been disciplined by another regulatory body, or been insolvent. Additionally, Intercontinental comments that, as part of the due diligence screening, IPE conducts an identification inquiry under anti-money laundering standards and reviews or confirms all information obtained with appropriate agencies. 
                </P>
                <FTNT>
                    <P>
                        <SU>24</SU>
                         These are the same rules and requirements outlined above in Section II.
                    </P>
                </FTNT>
                <P>With respect to IPE contracts traded on the electric platform, Intercontinental comments that IPE makes available two different training programs for new members before they can access the system. As a consequence of these requirements, Intercontinental maintains that the characterization by NYMEX that IPE electronic traders are “unschooled and unsophisticated,” or of a retail nature, is not accurate. On this basis, Intercontinental concludes that the IPE members should be viewed as eligible to access the over-the-counter contracts traded on Intercontinental's ECM. </P>
                <P>Intercontinental's comment letter also notes that it is not seeking relief solely for its own ECM, but rather does not oppose broad ECM access for the IPE membership. Intercontinental also acknowledges that relief is being sought solely for “principal-to-principal” trading. </P>
                <P>While not responding to any aspect of NYMEX's comment letter, Intercontinental did add several clarifications with respect to its relief request. For instance, Intercontinental remarks that its systems are adequate to enforce the requirement that IPE members eligible for relief must be located in the U.K., as it inquires into a participant's physical location by collecting information on a participant's principal business address. Intercontinental also comments that it conducts an anti-money laundering inquiry for privately-owned companies in which the participant must present the company's registered address, as well as collecting the address and telephone number for each user as part of its process for new market users. </P>
                <HD SOURCE="HD1">III. Discussion </HD>
                <P>Under the CEA, ECMs are commercial markets executing principal-to-principal transactions. In view of the unregulated nature of these markets, Congress intended that access should be confined to professional traders—either ECEs as defined in section 1a(11) or other traders that have an interest in the underlying commodity as part of their business operations, perform a market-making role, or otherwise provide a similar trading function that improves market liquidity. </P>
                <P>
                    As noted above the Commission has previously acted to expand the ECE definition to include floor brokers and floor traders registered with the Commission and acting in a proprietary capacity, since these persons operate as knowledgeable, experienced professional traders who historically have provided a trading function that improves market liquidity.
                    <SU>25</SU>
                    <FTREF/>
                     The Commission stated in the 
                    <E T="04">Federal Register</E>
                     notice accompanying that action that in order to qualify as an ECE under the Order, the “CFTC-registered floor broker or floor trader must be a member of a DCM or otherwise have trading privileges on a DCM * * * [and act] as a floor broker or floor trader, either on a DCM's open outcry market or [perform] an equivalent function on the DCM's electronic market.” In the 
                    <E T="04">Federal Register</E>
                     notice, the Commission also acknowledged, as professional traders providing market-making type activities, that the floor broker or floor trader “need not have any connection to or experience in the underlying physical commodity.” Finally, the Commission stated that the “floor broker or floor trader must either be an ECP or have its trades on the ECM guaranteed by a clearing member that is both a member of a CFTC-registered derivatives clearing organization and an ECP.” 
                </P>
                <FTNT>
                    <P>
                        <SU>25</SU>
                         68 FR 2319 (January 16, 2003). The Commission also incorporated floor brokers and floor traders in the definition of an ECE as it relates to trading on a Derivatives Transaction Execution Facility. 
                        <E T="03">See</E>
                         Commission Regulation 37.1(b), and the discussion thereunder at 66 FR 42256.
                    </P>
                </FTNT>
                <P>Underlying the Commission's prior action was the notion that registration was a proxy for the aforementioned knowledge, experience, and professionalism, and for the provision of a market-making or similar trading function that improves market liquidity. </P>
                <P>As outlined above in Section II.A, Intercontinental maintains that its petition seeks relief of a similar nature, and further represents that granting its request would constitute an appropriate extension of the Commission's prior action. Although NYMEX supported the Commission's prior action, NYMEX now opposes the Intercontinental petition for IPE traders. In contrast to Intercontinental's declaration, the comment letters submitted by NYMEX argue that the Intercontinental petition fails to satisfy standards established under the Commission's prior action to include CFTC-registered floor brokers and floor traders in the definition of an ECE. </P>
                <P>The Commission believes that granting relief for IPE brokers would comply with the Commission's prior action to expand the ECE category to include CFTC-registered floor brokers and floor traders. IPE brokers, by virtue of having received FSA authorization as a prerequisite to engaging in the conduct of commodity brokerage on IPE, conform to that part of the standards enunciated in the Commission's prior action. The Commission also has entered into an information-sharing arrangement with the FSA.</P>
                <P>
                    With respect to IPE floor and electronic local traders, NYMEX correctly concludes that these traders are neither authorized nor approved by FSA, the U.K. regulator with jurisdiction over commodity futures exchanges and other instrumentalities operating in the U.K. financial services industry. Nonetheless, the Commission believes that it is appropriate to include these traders under the ECE category since, as identified above, IPE floor and electronic local traders do have to meet a schedule of criteria in order to establish eligibility as an IPE Local Member or Individual Participant. In order to demonstrate fitness, both IPE Local Members and Individual Participants must, among other things, successfully pass the Registered Trader examination that is administered by IPE.
                    <SU>26</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>26</SU>
                         
                        <E T="03">See</E>
                         IPE Rule G.10(c). The Registered Floor Trader exam tests knowledge of trading behavior and of the rules and regulations of IPE.
                    </P>
                </FTNT>
                <P>As either an applicant or an IPE-approved trader, Local Members and Individual Participants must meet a schedule of fees that is essentially the same for both classes of membership. Each applicant is required to pay an application fee of 500 pounds. If accepted to membership, each applicant would then be required to pay an annual subscription fee of 350 pounds per seat or membership. Additionally, each applicant would be subject to an annual minimum activity charge of 1000 pounds, if the applicant failed to trade at least 4000 lots per year. </P>
                <P>
                    Other applicable criteria differ for each of these two trader classes, most 
                    <PRTPAGE P="65589"/>
                    notably with respect to evidencing an adequate level of experience and knowledge. Local Members are required to either purchase or lease a seat on IPE and to serve both a trainee and probationary period. While in trainee status, an applicant may only enter a trading pit as an observer.
                    <SU>27</SU>
                    <FTREF/>
                     In order to achieve probationary status, an applicant must pass the Registered Trader exam. During the probationary period, an applicant may execute transactions on the exchange, but only under the supervision of another IPE member.
                    <SU>28</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>27</SU>
                         
                        <E T="03">See</E>
                         IPE Rule 1.3.2.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>28</SU>
                         
                        <E T="03">See</E>
                         IPE Rule 1.6.7(f).
                    </P>
                </FTNT>
                <P>
                    After completion of the probationary period, the applicant's performance is subjected to peer review by other IPE members and the IPE Trading Committee.
                    <SU>29</SU>
                    <FTREF/>
                     Final acceptance or denial of membership is conditioned on confirmation of the IPE Trading Committee. Thus, the trainee and probationary periods required of Local Members appear to serve as a training period or apprenticeship preparatory to a new member receiving full floor trading privileges.
                </P>
                <FTNT>
                    <P>
                        <SU>29</SU>
                         Under IPE Rule 1.6.7, the probationary period runs for a period of 90 days unless terminated earlier at the discretion of the IPE Trading Committee.
                    </P>
                </FTNT>
                <P>For Individual Participants, who only have trading privileges for the IPE electronic system, IPE has implemented other requirements that differ from those applicable to Local Members. Under IPE requirements, as in the case of Local Members, Individual Participants must also show fitness to be a member. However, as outlined above in Section II.C, in addition to successfully passing the Registered Trader Exam, applicants for Individual Participant membership must demonstrate substantial experience trading on a U.K. futures exchange, or otherwise satisfy the standards defining an Intermediate Customer under FSA Conduct of Business Rule 4.1.9R. </P>
                <P>According to Intercontinental, electronic trader eligibility is limited to existing IPE-registered traders, to traders at other U.K. exchanges, to other individuals with substantial trading experience on U.K. futures exchanges, or to traders who have successfully passed the Registered Trader exam. Thus, according to Intercontinental, FSA-developed standards under COB Rule 4.1.9R, which define an intermediate customer, are used by IPE as a screening device to differentiate professional from retail experience among applicants. </P>
                <P>As the above suggests, criteria set out under COB Rule 4.1.9R are intended for use in determining whether a client would have experience meeting or qualifying at the intermediate customer level. Thus COB Rule 4.1.9R instructs that, in determining a client's experience and knowledge, a firm should inquire about: </P>
                <P>1. The client's knowledge, understanding, and awareness of risks in the applicable investments and markets, </P>
                <P>2. The length of time the client has been active in these markets, the frequency of dealings, and the extent to which client relied on advice, </P>
                <P>3. The size and nature of the transactions undertaken for the client, and </P>
                <P>4. The client's financial standing, which may include an assessment of net worth and portfolio. </P>
                <P>As a practice that is functionally parallel to that required of financial firms under COB Rule 4.1.9R, Intercontinental has represented that IPE will confine eligibility for admission as an electronic trader to applicants with: </P>
                <P>1. Sufficient knowledge and understanding of market and risks, </P>
                <P>2. Who were active on such markets for a reasonable length of time, </P>
                <P>3. Who have traded in appropriate size and quantity, and </P>
                <P>4. Who have appropriate financial standing. </P>
                <P>
                    In this respect, IPE confirms that it will apply the criteria found in Rule 4.1.9R applicable to assessing experience and knowledge of an expert private customer as part of an independent determination made by IPE management. Moreover, IPE represents that the prior status an applicant may have attained as a customer of a financial services firm would not be determinative of eligibility, but that IPE would undertake an independent assessment of the applicant's experience and knowledge under the standards of COB Rule 4.1.9R.
                    <SU>30</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>30</SU>
                         IPE is posting the Individual Participant application form on its Web site. The application form includes an eligibility requirement in reference to the Intermediate Customer standards under FSA COB 4.1.9R. There are no specific FSA regulations governing an RIE's record-keeping obligations regarding membership applications or documents relating thereto. However, IPE maintains that Money Laundering Regulations 1993 require IPE retention of new client records, including IPE members, for a five-year period following the termination of the business relationship. In the case of an IPE member or holder of trading privileges, the five-year period would run from the date of rejection or resignation from membership.
                    </P>
                </FTNT>
                <P>
                    As a general matter, IPE also maintains that as an RIE it is organized as a wholesale market and is not open to retail membership. In this regard, IPE points out that FSA rules and standards found in the Recognized Investment Exchange and Clearing House sourcebook (“REC”) impose requirements on types of applicants eligible for membership. Among other things, REC Rule 2.7.3 states that FSA may conduct assessments of whether access to a UK recognized body's facilities is based on criteria designed to protect the orderly functioning of the market and the interests of investors. Further, Rule 2.7.3 states that FSA, in conducting any such assessments, may consider: (a) Whether the RIE limits access as a member to persons over whom it can with reasonable certainty enforce its rules, (b) who have sufficient technical competence to use the market's facilities, (c) whom it is appropriate to admit to membership having regard for the size and sophistication of users of its facilities and the nature of business thereon, and (d) where appropriate, the adequacy of financial resources in relation to a member's exposure to the UK recognized body or central counterparty.
                    <SU>31</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>31</SU>
                         Administratively, REC Rule 2.7.3 also seeks to ensure that an RIE's membership criteria are objective in their scope and are applied in an objective, non-discriminatory manner. Specifically, for access to electronic markets, REC Rule 2.7.4 provides that the FSA may review an RIE's rules and practices concerning procedures, controls, and security for inputting instructions into the system; the facilities provided and restrictions imposed on clients inputting instructions into the system; practices used to detect, identify, and prevent instructions to the system that breach any relevant restrictions; the quality and completeness of the audit trail; and procedures governing the determination to suspend system trading or member access.
                    </P>
                </FTNT>
                <P>
                    As noted, IPE local traders need not be authorized or approved by FSA as a pre-condition in obtaining trading privileges on IPE. The U.K. approach therefore differs somewhat from that applied under U.S. regulation, where Commission requirements mandate registration with a government body for both floor brokers and floor traders. However, even though qualifying determinations for local traders are reserved to IPE, those procedures are subject to FSA supervision. Thus, notwithstanding the formalistic differences in the treatment of local traders in the U.S. and U.K. regulatory systems, the Commission believes that the U.K. regulatory structure facilitates and enforces a level of regulation for the IPE local traders that meets applicable standards of professionalism established under the Commission's prior action expanding the ECE category to include 
                    <PRTPAGE P="65590"/>
                    CFTC-registered floor brokers and floor traders.
                    <SU>32</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>32</SU>
                         The Commission has found the U.K. regulatory program generally comparable to the U.S. framework pursuant to a grant of relief under CFTC regulation 30.10. The review for this determination focused generally upon firms acting in the capacity of futures commission merchants for U.S. customers trading on U.K. exchanges, rather than on proprietary trading by brokers and traders. 
                        <E T="03">See</E>
                         68 FR 58583 (October 10, 2003).
                    </P>
                </FTNT>
                <HD SOURCE="HD1">IV. Conclusion </HD>
                <P>
                    After consideration of the Intercontinental petition, and the additional material submitted by Intercontinental to accompany the petition, and the comment letters submitted in response to the 
                    <E T="04">Federal Register</E>
                     notice, the Commission has determined, consistent with the Intercontinental petition, that it is appropriate to issue an order, pursuant to Section 1a(11)(c) of the Act, that includes certain IPE floor and electronic brokers and traders, subject to certain conditions, within the definition of an ECE for eligibility to trade on an ECM.
                    <SU>33</SU>
                    <FTREF/>
                     As in the prior action to expand the ECE definition to include CFTC-registered floor brokers and floor traders, either in open outcry or electronic markets, the Commission believes that expanding the definition to include IPE floor and electronic brokers and traders is consistent with the purposes of the CFMA.
                    <SU>34</SU>
                    <FTREF/>
                     Moreover, and again as in the prior action, the Commission believes that inclusion of IPE floor and electronic brokers and traders in the definition of an ECE could potentially increase competition and efficiency, and reduce liquidity risk, on ECMs. 
                </P>
                <FTNT>
                    <P>
                        <SU>33</SU>
                         As noted, Intercontinental seeks to include in the definition of an ECE four separate types of holders of trading privileges on IPE: the broker class is composed of Floor Members and General Participants and the local trader class is composed of Local Members and Individual Participants.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>34</SU>
                         The Commission's prior action to include CFTC-registered floor brokers and floor traders in the ECE definition specifically acknowledged that the prior action would reach a “floor broker or floor trader, either on a DCM's open outcry market or [when] performing an equivalent function on the DCM's electronic market.” 
                        <E T="03">See</E>
                         68 FR 2323 (January 16, 2003).
                    </P>
                </FTNT>
                <P>As noted above, underlying the Commission's prior action was the notion that registration serves as a proxy for the aforementioned knowledge, experience and professionalism, and for the provision of a market-making or similar trading function that improves market liquidity. Commission action taken here makes a similar finding for IPE floor and electronic brokers and traders with respect to their knowledge, experience and professionalism, and their ability to provide market-making or similar trading functions that improve market liquidity. </P>
                <P>The Commission also notes that IPE registration of electronic local traders is based on eligibility pursuant to the Intermediate Customer standards under FSA COB 4.1.9R. The Commission considers the inclusion of this process in IPE registration as a reasonable proxy for an electronic local trader's knowledge, experience, professionalism, and ability to provide a market-making or similar trading function that improves market liquidity. Moreover, the Commission believes that the IPE has the experience and ability to apply the standards in an efficient and prudent manner. The Commission points out that these determinations are based on materials provided by, and/or representations made by, IPE and FSA and, as such, are particular to IPE. If another market or governmental regulator petitioned the Commission for a similar expansion of the ECE definition, an analogous showing to the Commission would be necessary. </P>
                <P>
                    The Commission also notes that it has previously expanded the ECE definition for purposes of trading on a DTEF.
                    <SU>35</SU>
                    <FTREF/>
                     That action incorporated within the ECE definition registered floor brokers and floor traders, whose trading obligations are guaranteed by a registered FCM, when trading for their own accounts on a DTEF. 
                </P>
                <FTNT>
                    <P>
                        <SU>35</SU>
                         Commission regulation 37.1(b).
                    </P>
                </FTNT>
                <P>In order to qualify as an ECE under the Commission's order, an IPE floor or electronic broker or trader must be a member of IPE or otherwise have trading privileges on IPE and be located in the U.K. Pursuant to those requirements, the qualifying IPE floor or electronic broker or trader also must be authorized by FSA or registered with IPE. The IPE floor or electronic broker or trader must have as a part of its business the business of acting as a commodity broker or local trader, either on IPE's open outcry or electronic market, but need not have any connection to or experience in the underlying physical commodity. The Commission believes that the trading expertise of IPE floor or electronic brokers or traders would be applicable to trading in any commodity product traded on an ECM. Among other things, the ability of an IPE floor or electronic broker or trader to interpret market momentum, and facilitate the adjustment of market prices to new information, is more a function of trading expertise than of experience in the underlying physical commodity. </P>
                <P>A qualifying IPE floor or electronic broker or trader must be either an ECP or have its trades on the ECM guaranteed by a clearing member that is both a member of an FSA-recognized derivatives clearing organization and an ECP. The Commission believes that requiring either the IPE floor or electronic broker or trader, or the guarantor thereof, to be an ECP provides sufficient financial backing for the IPE floor or electronic broker or trader and mitigates any credit and collection risk that might otherwise arise. The Commission notes that the guarantor of an IPE floor or electronic broker or trader would be placing its own money at risk, and expects that such guarantor would carefully consider the risk involved in the provision of the guarantee for that particular broker or trader. </P>
                <HD SOURCE="HD1">V. Cost Benefit Analysis </HD>
                <P>Section 15 of the Act, as amended by section 119 of the CFMA, requires the Commission to consider the costs and benefits of its action before issuing a new order under the Act. By its terms, section 15 does not require the Commission to quantify the costs and benefits of its action or to determine whether the benefits of the action outweigh the costs. Rather, section 15 simply requires the Commission to “consider the costs and benefits” of its order. </P>
                <P>Section 15(a) further specifies that the costs and benefits of the proposed order shall be evaluated in light of five broad areas of market and public concern: (1) Protection of market participants and the public; (2) efficiency competitiveness and financial integrity of futures markets; (3) price discovery; (4) sound risk management practices; and (5) other public interest considerations. The Commission may, in its discretion, give greater weight to any one of the five enumerated areas of concern and may, in its discretion, determine that, notwithstanding its costs, a particular order is necessary or appropriate to protect the public interest or to effectuate any of the provisions or to accomplish any of the purposes of the Act. </P>
                <P>
                    The subject order is intended to reduce regulatory barriers to permit certain IPE floor or electronic brokers or traders, when acting in a proprietary capacity, to enter into transactions in exempt commodities on ECMs pursuant to section 2(h)(3) of the Act if such entities are either ECPs or have obtained a financial guarantee for such transactions from a clearing member that is both a member of a FSA-registered derivatives clearing organization and an ECP. The Commission has considered the costs and benefits of the order in light of the 
                    <PRTPAGE P="65591"/>
                    specific provisions of section 15(a) of the Act. 
                </P>
                <HD SOURCE="HD2">A. Protection of Market Participants and the Public </HD>
                <P>The order would deem certain professional IPE floor or electronic brokers or traders meeting the required conditions who are ECPs, or who have guarantees from clearing members that are members of FSA-registered derivatives clearing organizations and are ECPs, to be ECEs under section 1a(11)(c) and thus permit them to enter into proprietary transactions in exempt commodities on ECMs. Under the Act, ECEs are sophisticated investors who have the financial wherewithal or trading expertise to participate in these markets. Accordingly, there should be no effect on the Commission's ability to protect market participants and the public. </P>
                <HD SOURCE="HD2">B. Efficiency and Competition </HD>
                <P>The order is expected to benefit efficiency and competition by, among other things, providing essential trading expertise to the market that enhances price discovery through both the speed and efficiency of market adjustment to new fundamentals and by generally increasing the pool of potential counterparties for participants trading on exempt commercial markets. </P>
                <HD SOURCE="HD2">C. Financial Integrity of Futures Markets and Price Discovery </HD>
                <P>The order should have no effect, from the standpoint of imposing costs or creating benefits, on the financial integrity of the futures and options markets. The order should enhance the price discovery function of such markets. </P>
                <HD SOURCE="HD2">D. Sound Risk Management Practices </HD>
                <P>The order should have no effect, from the standpoint of imposing costs, on the risk management practices of the futures and options industry. Where an individual or entity is qualified as an ECP, the individual or entity has been deemed under the Act to be sufficiently responsible to execute trades in certain excluded or exempt commodity transactions, and no further mitigation of credit risk is necessary. Moreover, where an individual or entity does not qualify as an ECP, the order requires that a clearing member of an FSA-recognized derivatives clearing organization that is itself an ECP guarantee the trades in order to mitigate the credit and collection risk. </P>
                <HD SOURCE="HD2">E. Other Public Interest Considerations </HD>
                <P>The order is consistent with one of the purposes of the Act as articulated in section 3 in that it would promote responsible innovation and fair competition among boards of trade, other markets, and market participants. </P>
                <HD SOURCE="HD1">VI. Order </HD>
                <P>Upon due consideration, and pursuant to its authority under section 1a(11)(C) of the Act, the Commission hereby determines that certain professional International Petroleum Exchange (“IPE”) floor or electronic brokers or local traders, who are authorized by the Financial Services Authority (“FSA”) or registered with the IPE, when acting in a proprietary capacity, are appropriate persons as defined in section 1a(11)(C) and, thus, are deemed to be eligible commercial entities and may enter into contracts, agreements or transactions in an exempt commodity on an exempt commercial market under the following conditions: </P>
                <P>1. The contracts, agreements, or transactions must be executed on an exempt commercial market that meets the requirements of section 2(h)(3)-(5) of the Act. </P>
                <P>2. The IPE floor or electronic broker, denominated as either a Floor Member or General Participant pursuant to IPE membership rules, must be a member of IPE or otherwise have trading privileges on IPE, be located in the U.K., and be subject to the rules of IPE. </P>
                <P>3. The IPE local trader, denominated as a Local Member or Individual Participant pursuant to IPE membership rules, must be a member of IPE or otherwise have trading privileges on IPE, be located in the U.K., and be subject to the rules of IPE. </P>
                <P>4. The IPE Floor Member or General Participant must be authorized and regulated by the FSA. </P>
                <P>5. The IPE Local Member or Individual Participant must be registered with the IPE. </P>
                <P>6. The IPE Floor Member, General Participant, Local Member, or Individual Participant must have as a part of its business the business of acting as a professional commodity broker or trader on either the IPE open outcry or electronic markets. </P>
                <P>7. The IPE Individual Participant must meet and satisfy the current qualifying standards of an Intermediate Customer pursuant to FSA Conduct of Business (“COB”) Rule 4.1.9R. IPE must notify the Commission of any changes to the standards included in FSA COB Rule 4.1.9R. </P>
                <P>8. The IPE Floor Member, General Participant, Local Member, or Individual Participant must be either an eligible contract participant, as that term is defined in section 1a(12) of the Act, or have its trades on the exempt commercial market guaranteed by a clearing member that is a member of an FSA-recognized derivatives clearing organization and is an eligible contract participant. </P>
                <SIG>
                    <DATED>Issued by the Commission this 8th day of November, 2004, in Washington, DC. </DATED>
                    <NAME>Jean A. Webb, </NAME>
                    <TITLE>Secretary of the Commission.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 04-25282 Filed 11-12-04; 8:45 am] </FRDOC>
            <BILCOD>BILLING CODE 6351-01-P </BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="N">DEPARTMENT OF DEFENSE</AGENCY>
                <AGENCY TYPE="O">GENERAL SERVICES ADMINISTRATION</AGENCY>
                <AGENCY TYPE="O">NATIONAL AERONAUTICS AND SPACE ADMINISTRATION</AGENCY>
                <DEPDOC>[OMB Control No. 9000-0078]</DEPDOC>
                <SUBJECT>Federal Acquisition Regulation; Submission for OMB Review; Make-or-Buy Program</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCIES:</HD>
                    <P>Department of Defense (DOD), General Services Administration (GSA), and National Aeronautics and Space Administration (NASA).</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice of request for comments regarding an extension to an existing OMB clearance (9000-0078).</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>Under the provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35), the Federal Acquisition Regulation (FAR) Secretariat has submitted to the Office of Management and Budget (OMB) a request to review and approve an extension of a currently approved information collection requirement concerning make-or-buy programs. A request for public comments was published at 69 FR 44645, July 27, 2004. No comments were received.</P>
                </SUM>
                <P>Public comments are particularly invited on:  Whether this collection of information is necessary for the proper performance of functions of the FAR, and whether it will have practical utility; whether our estimate of the public burden of this collection of information is accurate, and based on valid assumptions and methodology; ways to enhance the quality, utility, and clarity of the information to be collected; and ways in which we can minimize the burden of the collection of information on those who are to respond, through the use of appropriate technological collection techniques or other forms of information technology.</P>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Submit comments on or before December 15, 2004.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        Submit comments regarding this burden estimate or any other aspect 
                        <PRTPAGE P="65592"/>
                        of this collection of information, including suggestions for reducing this burden, to the General Services Administration, FAR Secretariat (VR),
                    </P>
                </ADD>
                1800 F Street, NW, Room 4035, Washington, DC 20405. Please cite OMB Control No. 9000-0078, Make-or-Buy Program, in all correspondence. 
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT</HD>
                    <P>Jerry Zaffos, Contract Policy Division, GSA (202) 208-6091</P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <HD SOURCE="HD1">A.  Purpose</HD>
                <P>Price, performance, and/or implementation of socio-economic policies may be affected by make-or-buy decisions under certain Government prime contracts.  Accordingly, FAR 15.407-2, Make-or-Buy Programs (i) Sets forth circumstances under which a Government contractor must submit for approval by the contracting officer a make-or-buy program, i.e., a written plan identifying major items to be produced or work efforts to be performed in the prime contractor's facilities and those to be subcontracted;</P>
                <P>(ii) Provides guidance to contracting officers concerning the review and approval of the make-or-buy programs; and</P>
                <P>(iii) Prescribes the contract clause at FAR 52.215-9, Changes or Additions to Make-or-Buy Programs, which specifies the circumstances under which the contractor is required to submit for the contracting officer's advance approval a notification and justification of any proposed change in the approved make-or-buy program.</P>
                <P>The information is used to assure the lowest overall cost to the Government for required supplies and services.</P>
                <HD SOURCE="HD1">B.  Annual Reporting Burden</HD>
                <P>
                    <E T="03">Respondents:</E>
                     150.
                </P>
                <P>
                    <E T="03">Responses Per Respondent:</E>
                     3.
                </P>
                <P>
                    <E T="03">Total Responses: 450.</E>
                </P>
                <P>
                    <E T="03">Hours Per Response:</E>
                     8.
                </P>
                <P>
                    <E T="03">Total Burden Hours:</E>
                     3,600.
                </P>
                <P>
                    <E T="03">Obtaining Copies of Proposals:</E>
                     Requesters may obtain a copy of the information collection documents from the General Services Administration, FAR Secretariat (VR), Room 4035, Washington, DC  20405, telephone (202) 501-4755.  Please cite OMB Control No. 9000-0078, Make-or-Buy Program, in all correspondence.
                </P>
                <SIG>
                    <DATED>Dated: November 4, 2004</DATED>
                    <NAME>Laura Auletta,</NAME>
                    <TITLE>Director, Contract Policy Division.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 04-25291 Filed 11-12-04; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 6820-EP-S</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF DEFENSE</AGENCY>
                <AGENCY TYPE="O">GENERAL SERVICES ADMINISTRATION</AGENCY>
                <AGENCY TYPE="O">NATIONAL AERONAUTICS AND SPACE ADMINISTRATION</AGENCY>
                <DEPDOC>[OMB Control No. 9000-0155]</DEPDOC>
                <SUBJECT>Submission for OMB Review; Prohibition on Acquisition of Products Produced by Forced or Indentured Child Labor</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCIES:</HD>
                    <P>Department of Defense (DOD), General Services Administration (GSA), and National Aeronautics and Space Administration (NASA).</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice of request for comments regarding an extension to an existing OMB clearance.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>Under the provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35), the Federal Acquisition Regulation (FAR) Secretariat will be submitting to the Office of Management and Budget (OMB) a request to review and approve an extension of a currently approved information collection requirement regarding prohibition on acquisition of products produced by forced or indentured child labor.  A request for public comments was published at 69 FR 54767 on September 10, 2004. No comments were received.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Submit comments on or before: December 15, 2004.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>Submit comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden to the Regulatory Secretariat (VR), General Services Administration, Room 4035, 1800 F Street, NW., Washington, DC  20405.  Please cite OMB Control No. 9000-0155, Prohibition on Acquisition of Products Produced by Forced or Indentured Child Labor, in all correspondence.</P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT</HD>
                    <P>Craig R. Goral, Contract Policy Division, GSA (202) 501-3856.</P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <HD SOURCE="HD1">A.  Purpose</HD>
                <P>This information collection complies with Executive Order 13126, Prohibition on Acquisition of Products Produced by Forced or Indentured Child Labor, signed by the President on June 12, 1999.  Executive Order 13126 requires that this prohibition be enforced within the federal acquisition system by means of: (1) A provision that requires the contractor to certify to the contracting officer that the contractor or, in the case of an incorporated contractor, a responsible official of the contractor has made a good faith effort to determine whether forced or indentured child labor was used to mine, produce, or manufacture any product furnished under the contract and that, on the basis of those efforts, the contractor is unaware of any such use of child labor; and (2) A provision that obligates the contractor to cooperate fully in providing reasonable access to the contractor's records, documents, persons, or premises if reasonably requested by authorized officials of the contracting agency, the Department of the Treasury, or the Department of Justice, for the purpose of determining whether forced or indentured child labor was used to mine, produce, or manufacture any product furnished under the contract.</P>
                <P>The information collection requirements of the Executive Order are evidenced via the certification requirements delineated at FAR 22.1505, 52.212-3, 52.222-18, and 52.222-19.</P>
                <P>To eliminate some of the administrative burden on offerors who must submit the same information to various contracting offices, the Civilian Agency Acquisition Council and the Defense Acquisition Regulations Council (Councils) decided to amend the Federal Acquisition Regulation (FAR) to require offerors to submit representations and certifications electronically via the Business Partner Network (BPN), unless certain exceptions apply.  Online Representations and Certifications Application (ORCA) is the specific application on the BPN to replace the paper based Representations and Certifications (Reps and Certs) process.  The change to the FAR is being accomplished by FAR Case 2002-024.  The clearance associated with this case referenced this OMB Control No. 9000-0155 and reduced the hours of burden by 35%—attributable to mandated use of ORCA.  This reduction is already reflected in the figures below.</P>
                <HD SOURCE="HD1">B.  Annual Reporting Burden</HD>
                <P>
                    <E T="03">Respondents:</E>
                     500.
                </P>
                <P>
                    <E T="03">Responses Per Respondent:</E>
                     1.
                </P>
                <P>
                    <E T="03">Hours Per Response:</E>
                     0.325.
                </P>
                <P>
                    <E T="03">Total Burden Hours:</E>
                     162.
                </P>
                <P>
                    <E T="03">Obtaining Copies of Proposals:</E>
                     Requesters may obtain a copy of the information collection documents from the General Services Administration, Regulatory Secretariat (VR), 1800 F Street, NW, Room 4035, Washington, DC 20405, telephone (202) 501-4755.  Please cite OMB Control No. 9000-0155, Prohibition on Acquisition of Products 
                    <PRTPAGE P="65593"/>
                    Produced by Forced or Indentured Child Labor, in all correspondence.
                </P>
                <SIG>
                    <DATED>Dated: September 10, 2004</DATED>
                    <NAME>Laura Auletta,</NAME>
                    <TITLE> Director, Contract Policy Division.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 04-25292  Filed 11-12-04; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 6820-EP-S</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF DEFENSE</AGENCY>
                <AGENCY TYPE="O">GENERAL SERVICES ADMINISTRATION</AGENCY>
                <AGENCY TYPE="O">NATIONAL AERONAUTICS AND SPACE ADMINISTRATION</AGENCY>
                <DEPDOC>[OMB Control No. 9000-0014]</DEPDOC>
                <SUBJECT>Federal Acquisition Regulation; Submission for OMB Review; Statement and Acknowledgment (Standard Form 1413)</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCIES:</HD>
                    <P>Department of Defense (DOD), General Services Administration (GSA), and National Aeronautics and Space Administration (NASA).</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice of request for public comments regarding an extension of an existing OMB clearance (9000-0014).</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>
                        Under the provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35), the Federal Acquisition Regulation (FAR) Secretariat has submitted to the Office of Management and Budget (OMB) a request to review and approve an extension of a currently approved information collection requirement concerning statement and acknowledgment (Standard Form 1413).  A request for public comments was published in the 
                        <E T="04">Federal Register</E>
                         at 69 FR 54135 on September 1, 2004.  No comments were received.
                    </P>
                    <P>Public comments are particularly invited on:  Whether this collection of information is necessary for the proper performance of functions of the FAR, and whether it will have practical utility; whether our estimate of the public burden of this collection of information is accurate, and based on valid assumptions and methodology; ways to enhance the quality, utility, and clarity of the information to be collected; and ways in which we can minimize the burden of the collection of information on those who are to respond, through the use of appropriate technological collection techniques or other forms of information technology.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Comments may be submitted on or before December 15, 2004.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>Submit comments, including suggestions for reducing this burden to the General Services Administration, FAR Secretariat (VR), 1800 F Street, NW, Room 4035, Washington, DC  20405. Please cite OMB Control No. 9000-0014, Statement and Acknowledgment, Standard Form 1413, in all correspondence.</P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT</HD>
                    <P>Craig Goral, Contract Policy Division, GSA (202) 501-3856.</P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <HD SOURCE="HD1">A. Purpose</HD>
                <P>Standard Form 1413, Statement and Acknowledgment, is used by all Executive Agencies, including the Department of Defense, to obtain a statement from contractors that the proper clauses have been included in subcontracts.  The form includes a signed contractor acknowledgment of the inclusion of those clause in the subcontract.</P>
                <HD SOURCE="HD1">B. Annual Reporting Burden</HD>
                <P>
                    <E T="03">Respondents:</E>
                     31,500.
                </P>
                <P>
                    <E T="03">Responses Per Respondent:</E>
                     2.
                </P>
                <P>
                    <E T="03">Total Responses: 63,000</E>
                </P>
                .
                <P>
                    <E T="03">Hours Per Response:</E>
                     .05.
                </P>
                <P>
                    <E T="03">Total Burden Hours:</E>
                     3,150.
                </P>
                <P>
                    <E T="03">Obtaining Copies of Proposals:</E>
                     Requesters may obtain a copy of the information collection documents from the General Services Administration, FAR Secretariat (VR), 1800 F Street, NW, Room 4035, Washington, DC 20405, telephone (202) 501-4755.  Please cite OMB Control No. 9000-0014, Statement and Acknowledgment, Standard Form 1413, in all correspondence.
                </P>
                <SIG>
                    <DATED>Dated: October 28, 2004</DATED>
                    <NAME>Laura Auletta,</NAME>
                    <TITLE>Director, Contract Policy Division.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 04-25293  Filed 11-12-04; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 6820-EP-S</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF DEFENSE</AGENCY>
                <AGENCY TYPE="O">GENERAL SERVICES ADMINISTRATION</AGENCY>
                <AGENCY TYPE="O">NATIONAL AERONAUTICS AND SPACE ADMINISTRATION</AGENCY>
                <DEPDOC>[OMB Control No. 9000-0018]</DEPDOC>
                <SUBJECT>Federal Acquisition Regulation; Submission for OMB Review; Certification of Independent Price Determination and Parent Company and Identifying Data</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCIES:</HD>
                    <P>Department of Defense (DOD), General Services Administration (GSA), and National Aeronautics and Space Administration (NASA).</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice of request for comments regarding an extension to an existing OMB clearance (9000-0018).</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>Under the provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35), the Federal Acquisition Regulation (FAR) Secretariat has submitted to the Office of Management and Budget (OMB) a request to review and approve an extension of a currently approved information collection requirement concerning certification of independent price determination and parent company and identifying data.  A request for public comments was published in the Federal Register at 69 FR 53685 on September 2, 2004. No comments were received.</P>
                </SUM>
                <P>Public comments are particularly invited on:  Whether this collection of information is necessary for the proper performance of functions of the FAR, and whether it will have practical utility; whether our estimate of the public burden of this collection of information is accurate, and based on valid assumptions and methodology; ways to enhance the quality, utility, and clarity of the information to be collected; and ways in which we can minimize the burden of the collection of information on those who are to respond, through the use of appropriate technological collection techniques or other forms of information technology.</P>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Submit comments on or before December 15, 2004.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>Submit comments regarding this burden or any other aspect of this collection of information, including suggestions for reducing this burden to the General Services Administration, FAR Secretariat (VR), 1800 F Street, NW, Room 4035, Washington, DC 20405.</P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>Craig Goral, Contract Policy Division, GSA (202) 501-3856.</P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <HD SOURCE="HD1">A.  Purpose</HD>
                <P>
                    Agencies are required to report under 41 U.S.C. 252(d) and 10 U.S.C. 2305(d) suspected violations of the antitrust laws (e.g., collusive bidding, identical bids, uniform estimating systems, etc.) to the Attorney General. As a first step in assuring that Government contracts are not awarded to firms violating such laws, offerors on Government contracts must complete the certificate of independent price determination.  An offer will not be considered for award where the certificate has been deleted or modified.  Deletions or modifications of the certificate and suspected false 
                    <PRTPAGE P="65594"/>
                    certificates are reported to the Attorney General.
                </P>
                <HD SOURCE="HD1">B.  Annual Reporting Burden</HD>
                <P>
                    <E T="03">Respondents:</E>
                     64,250.
                </P>
                <P>
                    <E T="03">Responses Per Respondent:</E>
                     20.
                </P>
                <P>
                    <E T="03">Total Responses</E>
                    : 1,285,000.
                </P>
                <P>
                    <E T="03">Hours Per Response:</E>
                     .0065.
                </P>
                <P>
                    <E T="03">Total Burden hours:</E>
                     8,352.
                </P>
                <P>
                    <E T="03">Obtaining Copies of Proposals:</E>
                     Requesters may obtain a copy of the information collection documents from the General Services Administration, FAR Secretariat (VR), Room 4035, 1800 F Street, Washington, DC  20405, telephone (202) 501-4755.  Please cite OMB Control No. 9000-0018, Certification of Independent Price Determination and Parent Company and Identifying Data, in all correspondence.
                </P>
                <SIG>
                    <DATED>Dated: October 28, 2004</DATED>
                    <NAME>Laura Auletta,</NAME>
                    <TITLE>Acting Director, Contract Policy Division.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 04-25295 Filed 11-12-04; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 6820-EP-S</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="N">DEPARTMENT OF EDUCATION</AGENCY>
                <SUBJECT>Submission for OMB Review; Comment Request</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Department of Education.</P>
                </AGY>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The Director, Regulatory Information Management Services, Office of the Chief Information Officer invites comments on the submission for OMB review as required by the Paperwork Reduction Act of 1995.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Interested persons are invited to submit comments on or before December 15, 2004.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>Written comments should be addressed to the Office of Information and Regulatory Affairs, Attention: Carolyn Lovett, Desk Officer, Department of Education, Office of Management and Budget, 725 17th Street, NW., Room 10235, New Executive Office Building, Washington, DC 20503, or faxed to (202) 395-6974. </P>
                </ADD>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>
                    Section 3506 of the Paperwork Reduction Act of 1995 (44 U.S.C. chapter 35) requires that the Office of Management and Budget (OMB) provide interested Federal agencies and the public an early opportunity to comment on information collection requests. OMB may amend or waive the requirement for public consultation to the extent that public participation in the approval process would defeat the purpose of the information collection, violate State or Federal law, or substantially interfere with any agency's ability to perform its statutory obligations. The Director, Regulatory Information Management Services, Office of the Chief Information Officer, publishes that notice containing proposed information collection requests prior to submission of these requests to OMB. Each proposed information collection, grouped by office, contains the following: (1) Type of review requested, 
                    <E T="03">e.g.,</E>
                     new, revision, extension, existing or reinstatement; (2) title; (3) summary of the collection; (4) description of the need for, and proposed use of, the information; (5) respondents and frequency of collection; and (6) reporting and/or recordkeeping burden. OMB invites public comment.
                </P>
                <SIG>
                    <DATED>Dated: November 5, 2004.</DATED>
                    <NAME>Jeanne Van Vlandren, </NAME>
                    <TITLE>Director, Regulatory Information Management Services, Office of the Chief Information Officer.</TITLE>
                </SIG>
                <HD SOURCE="HD1">Federal Student Aid</HD>
                <P>
                    <E T="03">Type of Review:</E>
                     Extension.
                </P>
                <P>
                    <E T="03">Title:</E>
                     Guaranty Agency Financial Report.
                </P>
                <P>
                    <E T="03">Frequency:</E>
                     Monthly, annually.
                </P>
                <P>
                    <E T="03">Affected Public:</E>
                     State, local, or tribal gov't, SEAs or LEAs; businesses or other for-profit.
                </P>
                <P>
                    <E T="03">Reporting and Recordkeeping Hour Burden:</E>
                </P>
                <P> Responses: 612.</P>
                <P> Burden Hours: 33,660.</P>
                <P>
                    <E T="03">Abstract:</E>
                     The Guaranty Agency Financial Report is used to request payments from and make payments to the Department of Education under the Federal Family Education Loan (FFEL) program authorized by Title IV, Part B of the Higher Education Act (HEA) of 1965, as amended. The report is also used to monitor the agency's financial activities, including activities concerning its Federal fund, operating fund and the agency's restricted account.
                </P>
                <P>
                    Requests for copies of the submission for OMB review; comment request may be accessed from 
                    <E T="03">http://edicsweb.ed.gov,</E>
                     by selecting the “Browse Pending Collections” link and by clicking on link number 2641. When you access the information collection, click on “Download Attachments” to view. Written requests for information should be addressed to U.S. Department of Education, 400 Maryland Avenue, SW., Potomac Center, 9th Floor, Washington, DC 20202-4700. Requests may also be electronically mailed to the Internet address 
                    <E T="03">OCIO_RIMG@ed.gov</E>
                     or faxed to 202-245-6621. Please specify the complete title of the information collection when making your request.
                </P>
                <P>
                    Comments regarding burden and/or the collection activity requirements should be directed to Sheila Carey at her e-mail address 
                    <E T="03">Sheila.Carey@ed.gov.</E>
                     Individuals who use a telecommunications device for the deaf (TDD) may call the Federal Information Relay Service (FIRS) at 1-800-877-8339.
                </P>
            </SUPLINF>
            <FRDOC>[FR Doc. 04-25256  Filed 11-12-04; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4000-01-M</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="N">ENVIRONMENTAL PROTECTION AGENCY </AGENCY>
                <DEPDOC>[AMS-FRL-7837-7] </DEPDOC>
                <SUBJECT>California State Motor Vehicle Pollution Control Standards; Request for Waiver of Federal Preemption; Opportunity for Public Hearing </SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Environmental Protection Agency (EPA). </P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice of opportunity for public hearing and comment. </P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The California Air Resources Board (CARB) has notified EPA that it has adopted amendments to the California heavy-duty diesel regulations for 2007 and subsequent model year vehicles and engines (“2007 California Heavy Duty Diesel Engine Standards”) and related test procedures including the not-to-exceed (NTE) and supplemental steady-state tests (“supplemental test procedures”) to determine compliance with applicable standards. By letter dated July 16, 2004, CARB submitted a request that EPA grant a waiver of preemption under section 209(b) of the Clean Air Act (CAA), 42 U.S.C. 7543(b) for these amendments. This notice announces that EPA has tentatively scheduled a public hearing concerning California's request and that EPA is accepting written comment on the request. </P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>EPA has tentatively scheduled a public hearing concerning CARB's request on December 15, 2004 beginning at 10 a.m. EPA will hold a hearing only if a party notifies EPA by December 6, 2004, expressing its interest in presenting oral testimony. By December 10, 2004, any person who plans to attend the hearing should call David Dickinson at (202) 343-9256 to learn if a hearing will be held. If EPA does not receive a request for a public hearing, then EPA will not hold a hearing, and instead consider CARB's request based on written submissions to the docket. Any party may submit written comments by January 24, 2005. </P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        EPA will make available for public inspection at the Air and Radiation Docket and Information Center written comments received from interested parties, in addition to any 
                        <PRTPAGE P="65595"/>
                        testimony given at the public hearing. The official public docket is the collection of materials that is available for public viewing at the Air and Radiation Docket in the EPA Docket Center, (EPA/DC) EPA West, Room B102, 1301 Constitution Ave., NW., Washington, DC. The EPA Docket Center Public Reading Room is open from 8:30 to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Public Reading Room is (202) 566-1744, and the telephone number for the Air and Radiation Docket is (202) 566-1743. The reference number for this docket is OAR-2004-0132. Parties wishing to present oral testimony at the public hearing should provide written notice to David Dickinson at the address noted below. If EPA receives a request for a public hearing, EPA will hold the public hearing at 1310 L St, NW., Washington, DC 20005. 
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        David Dickinson, Certification and Compliance Division (6405J), U.S. Environmental Protection Agency, 1200 Pennsylvania Ave, NW., Washington, DC 20460. Telephone: (202) 343-9256, Fax: (202) 343-2804, e-mail address: 
                        <E T="03">Dickinson.David@EPA.GOV.</E>
                         EPA will make available an electronic copy of this Notice on the Office of Transportation and Air Quality's (OTAQ's) homepage (
                        <E T="03">http://www.epa.gov/otaq/</E>
                        ). Users can find this document by accessing the OTAQ homepage and looking at the path entitled “Regulations.” This service is free of charge, except any cost you already incur for Internet connectivity. Users can also get the official 
                        <E T="04">Federal Register</E>
                         version of the Notice on the day of publication on the primary Web site: (
                        <E T="03">http://www.epa.gov/docs/fedrgstr/EPA-AIR/</E>
                        ). 
                    </P>
                    <P>Please note that due to differences between the software used to develop the documents and the software into which the documents may be downloaded, changes in format, page length, etc., may occur. Parties wishing to present oral testimony at the public hearing should provide written notice to David Dickinson at: U.S. Environmental Protection Agency, 1200 Pennsylvania Ave., NW., (6405J), Washington, DC 20460. Telephone: (202) 343-9256. </P>
                    <P>
                        <E T="03">Docket:</E>
                         An electronic version of the public docket is available through EPA's electronic public docket and comment system. You may use EPA dockets at 
                        <E T="03">http://www.epa.gov/edocket/</E>
                         to submit or view public comments, access the index listing of the contents of the official public docket, and to access those documents in the public docket that are available electronically. Although a part of the official docket, the public docket, the public docket does not include Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Once in the edocket system, select “search,” then key in the appropriate docket ID number. 
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P/>
                <HD SOURCE="HD1">(A) Background and Discussion </HD>
                <P>Section 209(a) of the Clean Air Act, as amended (“Act”), 42 U.S.C. 7543(a), provides: </P>
                <EXTRACT>
                    <P>No State or any political subdivision thereof shall adopt or attempt to enforce any standard relating to the control of emissions from new motor vehicles or new motor vehicle engines subject to this part. No state shall require certification, inspection or any other approval relating to the control of emissions from any new motor vehicle or new motor vehicle engine as condition precedent to the initial retail sale, titling (if any), or registration of such motor vehicle, motor vehicle engine, or equipment. </P>
                </EXTRACT>
                <P>Section 209(b)(1) of the Act requires the Administrator, after notice and opportunity for public hearing, to waive application of the prohibitions of section 209(a) for any state that has adopted standards (other than crankcase emission standards) for the control of emissions from new motor vehicles or new motor vehicle engines prior to March 30, 1966, if the state determines that the state standards will be, in the aggregate, at least as protective of public health and welfare as applicable federal standards. California is the only state that is qualified to seek and receive a waiver under section 209(b). The Administrator must grant a waiver unless he finds that (A) the determination of the state is arbitrary and capricious, (B) the state does not need the state standards to meet compelling and extraordinary conditions, or (C ) the state standards and accompanying enforcement procedures are not consistent with section 202(a) of the Act. </P>
                <P>CARB's July 16, 2004, letter to the Administrator notified EPA that it had adopted amendments to its heavy-duty diesel vehicle and engine program. These amendments are to title 13, California Code of Regulations (CCR), section 1958.8. The specific regulatory text and the incorporated document covered by CARB's rulemaking are: section 1956.8, Title 13, CCR as shown in attachment 2 to CARB's July 16, 2004 letter; and the amendments to the related test procedures incorporated in section 1956.8(b), “California Exhaust Emission Standards and Test Procedures for 1985 and Subsequent Model Heavy-Duty Diesel Engines and Vehicles,” also shown in attachment 2. </P>
                <P>Please provide comment as to whether (a) California's determination that its amendments as referenced in its July 16, 2004, request letter, are at least as protective of public health and welfare as applicable federal standards is arbitrary and capricious, (b) California needs separate standards to meet compelling and extraordinary conditions, and (c) California's standards and accompanying enforcement procedures are consistent with section 202(a) of the Clean Air Act. </P>
                <HD SOURCE="HD2">Procedures for Public Participation </HD>
                <P>In recognition that public hearings are designed to give interested parties an opportunity to participate in this proceeding, there are no adverse parties as such. Statements by participants will not be subject to cross-examination by other participants without special approval by the presiding officer. The presiding officer is authorized to strike from the record statements that he or she deems irrelevant or repetitious and to impose reasonable time limits on the duration of the statement of any participant. </P>
                <P>If hearing(s) are held, the Agency will make a verbatim record of the proceedings. Interested parties may arrange with the reporter at the hearing(s) to obtain a copy of the transcript at their own expense. Regardless of whether public hearing(s) are held, EPA will keep the record open until January 24, 2005. Upon expiration of the comment period, the Administrator will render a decision on CARB's request based on the record of the public hearing(s), if any, relevant written submissions, and other information that he deems pertinent. All information will be available for inspection at EPA Air Docket. (OAR-2004-0132). </P>
                <P>
                    Persons with comments containing proprietary information must distinguish such information from other comments to the greatest possible extent and label it as “Confidential Business Information” (CBI). If a person making comments wants EPA to base its decision in part on a submission labeled CBI, then a nonconfidential version of the document that summarizes the key data or information should be submitted for the public docket. To ensure that proprietary information is not inadvertently placed in the docket, submissions containing such information should be sent directly to the contact person listed above and not to the public docket. Information covered by a claim of confidentiality will be disclosed by EPA only to the 
                    <PRTPAGE P="65596"/>
                    extent allowed and by the procedures set forth in 40 CFR part 2. If no claim of confidentiality accompanies the submission when EPA receives it, EPA will make it available to the public without further notice to the person making comments. 
                </P>
                <SIG>
                    <DATED>Dated: November 8, 2004. </DATED>
                    <NAME>Jeffrey R. Holmstead, </NAME>
                    <TITLE>Assistant Administrator, Office of Air and Radiation. </TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 04-25304 Filed 11-12-04; 8:45 am] </FRDOC>
            <BILCOD>BILLING CODE 6560-50-P </BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">ENVIRONMENTAL PROTECTION AGENCY</AGENCY>
                <DEPDOC>[OPPT-2003-0004; FRL-7687-3]</DEPDOC>
                <SUBJECT>Access to Confidential Business Information by Science Applications International Corporation</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Environmental Protection Agency (EPA).</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>EPA has authorized its contractor Science Applications International Corporation (SAIC), of Reston, Virginia, access to information which has been submitted to EPA under sections 4, 5, 6, 8, 12, and 13 of the Toxic Substances Control Act (TSCA). Some of the information may be claimed or determined to be Confidential Business Information (CBI).</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Access to the confidential data will occur no sooner than November 22, 2004.</P>
                </DATES>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Colby Lintner, Regulatory Coordinator, Environmental Assistance Division (7408M), Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone number: (202) 554-1404; e-mail address: 
                        <E T="03">TSCA-Hotline@epa.gov.</E>
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <HD SOURCE="HD1">I.  General Information</HD>
                <HD SOURCE="HD2">A.  Does this Notice Apply to Me?</HD>
                <P>
                    This action is directed to the public in general.  This action may, however, be of interest to those persons who are or may be required to conduct testing of chemical substances under TSCA.  Since other entities may also be interested, the Agency has not attempted to describe all the specific entities that may be affected by this action.  If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under 
                    <E T="02">FOR FURTHER INFORMATION CONTACT</E>
                    .
                </P>
                <HD SOURCE="HD2">B. How Can I Get Copies of this Document and Other Related Documents?</HD>
                <P>
                    1. 
                    <E T="03">Docket.</E>
                     EPA has established an official public docket for this action under docket identification (ID) number OPPT-2003-0004. The official public docket consists of the documents specifically referenced in this action, any public comments received, and other information related to this action.  Although a part of the official docket, the public docket does not include CBI or other information whose disclosure is restricted by statute.  The official public docket is the collection of materials that is available for public viewing at the EPA Docket Center, Rm. B102-Reading Room, EPA West, 1301 Constitution Ave., NW., Washington, DC.  The EPA Docket Center is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The EPA Docket Center Reading Room telephone number is (202) 566-1744 and the telephone number for the OPPT Docket, which is located in EPA Docket Center, is (202) 566-0280.
                </P>
                <P>
                    2. 
                    <E T="03">Electronic access</E>
                    .  You may access this 
                    <E T="04">Federal Register</E>
                     document electronically through the EPA Internet under the “
                    <E T="04">Federal Register</E>
                    ” listings at 
                    <E T="03">http://www.epa.gov/fedrgstr/</E>
                    .
                </P>
                <P>
                    An electronic version of the public docket is available through EPA's electronic public docket and comment system, EPA Dockets.  You may use EPA Dockets at 
                    <E T="03">http://www.epa.gov/edocket/</E>
                     to submit or view public comments, access the index listing of the contents of the official public docket, and to access those documents in the public docket that are available electronically.  Although not all docket materials may be available electronically, you may still access any of the publicly available docket materials through the docket facility identified in Unit I.B.1.  Once in the system, select “search,”  then key in the appropriate docket ID number.
                </P>
                <HD SOURCE="HD1">II. What Action is the Agency Taking?</HD>
                <P>Under Contract Number EP-W-04-046, SAIC of 11251 Roger Bacon Drive, Reston, VA, will  assist EPA by providing expert witness support for a civil administrative hearing, administer the Core TSCA Enforcement Center (CTEC) automated tracking system for TSCA CBI, and perform enforcement inspections.  SAIC will also assist in the review and/or collection of information from businesses and could potentially access documents subjects to TSCA CBI claim.</P>
                <P>In accordance with 40 CFR 2.306(j), EPA has determined that under Contract  Number EP-W-04-046, SAIC  will require access to CBI submitted to EPA under  sections 4, 5, 6, 8, 12, and 13 of TSCA, to perform successfully the duties specified under the contract.</P>
                <P>SAIC personnel will be given information submitted to EPA under sections 4, 5, 6, 8, 12, and 13 of TSCA.   Some of the information may be claimed or determined to be CBI.</P>
                <P>EPA is issuing this notice to inform all submitters of information under  sections 4, 5, 6, 8, 12, and 13 of TSCA, that the Agency may provide SAIC   access to these CBI materials on a need-to-know basis only.  All access to TSCA CBI under this contract will take place at EPA Headquarters only.</P>
                <P>Clearance for access to TSCA CBI under Contract Number EP-W-04-046 may continue until September 30, 2009.  Access will commence no sooner than November 22, 2004.</P>
                <P>SAIC personnel have signed nondisclosure agreements and will be briefed on appropriate security procedures before they are permitted access to TSCA CBI.</P>
                <LSTSUB>
                    <HD SOURCE="HED">List of Subjects</HD>
                    <P>Environmental protection, Confidential business information.</P>
                </LSTSUB>
                <SIG>
                    <DATED>Dated: November 4, 2004.</DATED>
                    <NAME>Brion Cook,</NAME>
                    <TITLE>Director, Information Management Division, Office of Pollution Prevention and Toxics.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 04-25306 Filed 11-12-04; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 6560-50-S</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">ENVIRONMENTAL PROTECTION AGENCY</AGENCY>
                <DEPDOC>[FRL-7837-6]</DEPDOC>
                <SUBJECT>Notice of Availability of the “Model Application/Information Request for CERCLA Service Station Dealer Exemption” Under Section 114(c) of the Comprehensive Environmental Response, Compensation and Liability Act (CERCLA)</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Environmental Protection Agency.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice of availability.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The U.S. Environmental Protection Agency (EPA) is announcing the availability of the “Model Application/Information Request for CERCLA Service Station Dealer Exemption.”</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>The model was issued on November 8, 2004.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        The model will be available on EPA's Web site at 
                        <E T="03">http://www.epa.gov/compliance/resources/policies/cleanup/superfund/ssde-mod-appinfo.pdf.</E>
                    </P>
                </ADD>
                <FURINF>
                    <PRTPAGE P="65597"/>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Susan Boushell, EPA's Office of Site Remediation Enforcement, (202) 564-2173 or 
                        <E T="03">boushell.susan@epa.gov.</E>
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>
                    On February 3, 2004 (69 FR 5147), EPA published a notice of availability for public comment on the “Draft Model CERCLA Application/Information Request for Service Station Dealers.” On July 20, 2004 (69 FR 43412), EPA published a notice of availability for public comment on a revised draft model, entitled “Draft Model Application/Information Request for CERCLA Service Station Dealer Exemption.” After careful consideration of the comments received, EPA revised and finalized the model application/ information request. The final model is available on EPA's Web site at 
                    <E T="03">http://www.epa.gov/ compliance/resources/policies/cleanup/superfund/ssde-mod-appinfo.pdf.</E>
                </P>
                <SIG>
                    <DATED>Dated: November 8, 2004.</DATED>
                    <NAME>Susan E. Bromm,</NAME>
                    <TITLE>Director, Office of Site Remediation Enforcement.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 04-25305 Filed 11-12-04; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 6560-50-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="N">FEDERAL COMMUNICATIONS COMMISSION</AGENCY>
                <SUBJECT>Notice of Public Information Collection(s) Being Submitted to OMB for Review and Approval</SUBJECT>
                <DATE>November 4, 2004.</DATE>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The Federal Communications Commissions, as part of its continuing effort to reduce paperwork burden invites the general public and other Federal agencies to take this opportunity to comment on the following information collection, as required by the Paperwork Reduction Act of 1995, Public Law 104-13. An agency may not conduct or sponsor a collection of information unless it displays a currently valid control number. No person shall be subject to any penalty for failing to comply with a collection of information subject to the Paperwork Reduction Act (PRA) that does not display a valid control number. Comments are requested concerning (a) whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information shall have practical utility; (b) the accuracy of the Commission's burden estimate; (c) ways to enhance the quality, utility, and clarity of the information collected; and (d) ways to minimize the burden of the collection of information on the respondents, including the use of automated collection techniques or other forms of information technology.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Written comments should be submitted on or before December 15, 2004. If you anticipate that you will be submitting comments, but find it difficult to do so within the period of time allowed by this notice, you should advise the contact listed below as soon as possible.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        Direct all comments to Les Smith, Federal Communications Commission, Room 1-A804, 445 12th Street, SW., Washington, DC 20554 or via the Internet to Leslie.Smith@fcc.gov or Kristy L. LaLonde, Office of Management and Budget (OMB), Room 10236 NEOB, Washington, DC 20503, (202) 395-3087 or via the Internet at 
                        <E T="03">Kristy_L._LaLonde@omb.eop.gov.</E>
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        For additional information or copy of the information collection(s) contact Les Smith at (202) 418-0217 or via the Internet at 
                        <E T="03">Leslie.Smith@fcc.gov.</E>
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P SOURCE="NPAR">
                    <E T="03">OMB Control Number:</E>
                     3060-0788.
                </P>
                <P>
                    <E T="03">Title:</E>
                     DTV Showings/Interference Agreements.
                </P>
                <P>
                    <E T="03">Form Number:</E>
                     FCC Form 301 and FCC Form 340.
                </P>
                <P>
                    <E T="03">Type of Review:</E>
                     Revision of a currently approved collection.
                </P>
                <P>
                    <E T="03">Respondents:</E>
                     Business or other for-profit entities; and Not-for-profit institutions.
                </P>
                <P>
                    <E T="03">Number of Respondents:</E>
                     300.
                </P>
                <P>
                    <E T="03">Estimated Time per Response:</E>
                     5 hours.
                </P>
                <P>
                    <E T="03">Frequency of Response:</E>
                     On occasion reporting requirement; and Third party disclosure.
                </P>
                <P>
                    <E T="03">Total Annual Burden:</E>
                     1,500 hours.
                </P>
                <P>
                    <E T="03">Total Annual Cost:</E>
                     $2,400,000.
                </P>
                <P>
                    <E T="03">Privacy Act Impact Assessment:</E>
                     No impact(s).
                </P>
                <P>
                    <E T="03">Needs and Uses:</E>
                     Section III-D of the FCC Form 301 and Section VII of the FCC Form 340 begin with a “Certification Checklist.” This checklist contains a series of questions by which applicants may certify compliance with key processing requirements. The first certification requires conformance with the DTV Table of Allotments. The Commission allows flexibility for DTV facilities to be constructed at locations within five kilometers of the reference allotment sites without consideration of additional interference to analog or DTV service, provided the DTV service does not exceed the allotment reference height above average terrain or effective radiated power. In order for the Commission to process applications that cannot certify affirmatively, 47 CFR Section 73.623(c) requires applicants to submit a technical showing to establish that their proposed facilities will not result in additional interference to TV broadcast and DTV operations. Additionally, the Commission permits broadcasters to agree to proposed DTV facilities that do not conform to the initial allotment parameters, even though they might be affected by potential new interference. The Commission will consider granting applications on the basis of interference agreements if it finds that such grants will serve the public interest. These agreements must be signed by all parties to the agreement. In addition, the Commission needs the following information to enable such public interest determinations: A list of parties predicted to receive additional interference from the proposed facility, a showing as to why a grant based on the agreements would serve the public interest, and technical studies depicting the additional interference.
                </P>
                <P>In 2001, the Commission removed from this collection all references to industry frequency coordination committees. These committees did not evolve. Respondents have been using consulting engineers and attorneys to prepare the technical showings and interference agreements.</P>
                <P>
                    <E T="03">OMB Control Number:</E>
                     3060-0685.
                </P>
                <P>
                    <E T="03">Title:</E>
                     Annual Updating of Maximum Permitted Rates for Regulated Cable Services, FCC Form 1240.
                </P>
                <P>
                    <E T="03">Form Number:</E>
                     FCC 1240.
                </P>
                <P>
                    <E T="03">Type of Review:</E>
                     Revision of currently approved collection.
                </P>
                <P>
                    <E T="03">Respondents:</E>
                     Business or other for-profit entities; and State, local, or tribal government.
                </P>
                <P>
                    <E T="03">Number of Respondents:</E>
                     3,000.
                </P>
                <P>
                    <E T="03">Estimated Time per Response:</E>
                     10 hour (avg.).
                </P>
                <P>
                    <E T="03">Frequency of Response:</E>
                     Annual reporting requirement.
                </P>
                <P>
                    <E T="03">Total Annual Burden:</E>
                     30,000 hours.
                </P>
                <P>
                    <E T="03">Total Annual Cost:</E>
                     $562,500.
                </P>
                <P>
                    <E T="03">Privacy Impact Assessment:</E>
                     No impact(s).
                </P>
                <P>
                    <E T="03">Needs and Uses:</E>
                     The FCC Form 1240 is filed with the local franchising authorities (“LFAs”) by cable operators seeking to adjust maximum permitted rates to reflect changes in external costs. The Commission authored the Form 1240 to enable local franchising authorities to adjudicate permitted rates for regulated cable rates, services, and equipment; for the addition and/or deletion of channels; and for allowance for pass through of external costs due to inflation.
                </P>
                <SIG>
                    <PRTPAGE P="65598"/>
                    <FP>Federal Communications Commission.</FP>
                    <NAME>Marlene H. Dortch,</NAME>
                    <TITLE>Secretary.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 04-25286 Filed 11-12-04; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 6712-01-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">FEDERAL COMMUNICATIONS COMMISSION</AGENCY>
                <DEPDOC>[IB Docket No. 04-398; FCC 04-247]</DEPDOC>
                <SUBJECT>The Effect of Foreign Mobile Termination Rates on U.S. Customers</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Federal Communications Commission.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Proposed rule.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>
                        This document is a summary of the 
                        <E T="03">Notice of Inquiry</E>
                         that was adopted by the Commission on October 14, 2004. The 
                        <E T="03">Notice of Inquiry</E>
                         seeks to develop a record on foreign mobile termination rates and inquires whether U.S. customers have adequate information and alternatives with regard to foreign mobile termination rates and surcharges, and whether such charges raise consumer concerns.
                    </P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Comments are due January 14, 2005, and reply comments are due by February 14, 2005.</P>
                </DATES>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>Peggy Reitzel or Francis Gutierrez, Policy Division, International Bureau, (202) 418-1460.</P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>
                    This is a summary of the Commission's 
                    <E T="03">Notice of Inquiry</E>
                     in IB Docket No. 04-398, FCC 04-247, which was adopted on October 14, 2004. The full text of this Commission decision is available for inspection and copying during normal business hours in the FCC Reference Center (Room CY-A257), 445 12th Street, SW., Washington, DC 20554. The document may also be downloaded from the Commission's Web site at 
                    <E T="03">http://hraunfoss.fcc.gov/edocs_public/attachmatch/FCC-04-247A1.pdf.</E>
                     The complete text may also be purchased from the Commission's copy contractor, Best Copy and Printing, Inc., in person at 445 12th Street, SW., Room CY-B402, Washington, DC 20554, via telephone at (202) 488-5300, via facsimile at (202) 488-5563, or via e-mail at 
                    <E T="03">FCC@BCPIWEB.COM.</E>
                </P>
                <HD SOURCE="HD1">Summary of the Notice of Inquiry</HD>
                <P>
                    On October 14, 2004, the Commission adopted a 
                    <E T="03">Notice of Inquiry</E>
                     on the Effect of Foreign Mobile Termination Rates on U.S. Customers. By this 
                    <E T="03">Notice of Inquiry,</E>
                     the Commission seeks to develop a record on foreign mobile termination rates that will enable the Commission to assess properly the effects of foreign mobile termination rates on U.S. customers and competition in the U.S.-international services market.
                </P>
                <P>
                    In the 
                    <E T="03">Notice of Inquiry,</E>
                     the Commission seeks comment on foreign mobile termination rate payment flows and the relevant regulatory regimes. The Commission seeks input, analyses, and comments on the concerns raised by parties in the 
                    <E T="03">ISP Reform Order,</E>
                     FCC 04-53, 69 FR 23151, April 28, 2004, and on actions taken by foreign national regulatory authorities to address mobile termination rates within their respective jurisdictions. In addition, the Commission asks for factual information and data on foreign mobile termination rates. Finally, the Commission seeks comment on the appropriate framework by which the Commission can analyze whether foreign mobile termination rates are unreasonably high.
                </P>
                <P>
                    The Commission encourages all interested parties to respond to the questions and requests set forth in the 
                    <E T="03">Notice of Inquiry.</E>
                </P>
                <HD SOURCE="HD1">Ordering Clauses</HD>
                <P>
                    Pursuant to the authority contained in 47 U.S.C. Sections 151, 4(i), 201, 202, 203, 204, 205, 211, 218, 303(r), 403 this 
                    <E T="03">Notice of Inquiry</E>
                     is 
                    <E T="03">adopted.</E>
                </P>
                <SIG>
                    <FP>Federal Communications Commission.</FP>
                    <NAME>Marlene H. Dortch,</NAME>
                    <TITLE>Secretary.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 04-25287 Filed 11-12-04; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 6712-01-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="N">FEDERAL HOUSING FINANCE BOARD </AGENCY>
                <SUBJECT>Sunshine Act Meeting Notice; Announcing a Closed Meeting of the Board of Directors </SUBJECT>
                <DATES>
                    <HD SOURCE="HED">TIME AND DATE:</HD>
                    <P>The meeting of the Board of Directors is scheduled to begin at 10 a.m. on Wednesday, November 17, 2004. </P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">PLACE:</HD>
                    <P>Board Room, Second Floor, Federal Housing Finance Board, 1777 F Street, NW., Washington, DC 20006. </P>
                </ADD>
                <PREAMHD>
                    <HD SOURCE="HED">STATUS:</HD>
                    <P>The entire meeting will be closed to the public. </P>
                </PREAMHD>
                <PREAMHD>
                    <HD SOURCE="HED">MATTER TO BE CONSIDERED AT THE MEETING:</HD>
                    <P>  </P>
                </PREAMHD>
                <FP SOURCE="FP-1">Periodic Update of Examination Program Development and Supervisory Findings. </FP>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Shelia S. Willis, Paralegal Specialist, Office of General Counsel, by telephone at (202) 408-2876 or by electronic mail at 
                        <E T="03">williss@fhfb.gov</E>
                        . 
                    </P>
                    <SIG>
                        <DATED>Dated: November 10, 2004. </DATED>
                        <P>By the Federal Housing Finance Board.</P>
                        <NAME>Mark J. Tenhundfeld, </NAME>
                        <TITLE>General Counsel. </TITLE>
                    </SIG>
                </FURINF>
            </PREAMB>
            <FRDOC>[FR Doc. 04-25404 Filed 11-10-04; 12:41 pm] </FRDOC>
            <BILCOD>BILLING CODE 6725-01-P </BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="N">FEDERAL RESERVE SYSTEM</AGENCY>
                <SUBJECT>Change in Bank Control Notices; Acquisition of Shares of Bank or Bank Holding Companies</SUBJECT>
                <P>The notificants listed below have applied under the Change in Bank Control Act (12 U.S.C. 1817(j)) and § 225.41 of the Board’s Regulation Y (12 CFR 225.41) to acquire a bank or bank holding company.  The factors that are considered in acting on the notices are set forth in paragraph 7 of the Act (12 U.S.C. 1817(j)(7)).</P>
                <P>The notices are available for immediate inspection at the Federal Reserve Bank indicated.  The notices also will be available for inspection at the office of the Board of Governors. Interested persons may express their views in writing to the Reserve Bank indicated for that notice or to the offices of the Board of Governors.  Comments must be received not later than November 29, 2004.</P>
                <P>
                    <E T="04">A.  Federal Reserve Bank of Minneapolis</E>
                     (Jacqueline G. Nicholas, Community Affairs Officer) 90 Hennepin Avenue, Minneapolis, Minnesota 55480-0291:
                </P>
                <P>
                    <E T="03">1.  Todd L. Johnson, Nancy S. Johnson, Hillary K. Johnson, and Matthew S. Johnson</E>
                    , all of Duluth, Minnesota; to acquire voting shares of NATCOM Bancshares, Inc., Superior, Wisconsin, and thereby indirectly acquire voting shares of National Bank of Commerce, Superior, Wisconsin.
                </P>
                <P>
                    <E T="04">2.  Federal Reserve Bank of Kansas City</E>
                     (Donna J. Ward, Assistant Vice President) 925 Grand Avenue, Kansas City, Missouri 64198-0001:
                </P>
                <P>
                    <E T="03">1.  Walter David Scott, Amy Scott, Sandra Parker</E>
                    , all of Omaha, Nebraska, and Karen Dixon, Leawood, Kansas; to acquire voting shares of DB Holding Company, Inc., Omaha, Nebraska, and thereby indirectly acquire voting shares of Omaha State Bank, Omaha, Nebraska.
                </P>
                <SIG>
                    <P>Board of Governors of the Federal Reserve System, November 8, 2004.</P>
                    <NAME>Robert deV. Frierson,</NAME>
                    <TITLE>Deputy Secretary of the Board.</TITLE>
                </SIG>
            </PREAMB>
            <FRDOC>[FR Doc. 04-25269 Filed 11-12-04; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 6210-01-S</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <PRTPAGE P="65599"/>
                <AGENCY TYPE="S">FEDERAL RESERVE SYSTEM</AGENCY>
                <SUBJECT>Formations of, Acquisitions by, and Mergers of Bank Holding Companies</SUBJECT>
                <P>
                    The companies listed in this notice have applied to the Board for approval, pursuant to the Bank Holding Company Act of 1956 (12 U.S.C. 1841 
                    <E T="03">et seq.</E>
                    ) (BHC Act), Regulation Y (12 CFR Part 225), and all other applicable statutes and regulations to become a bank holding company and/or to acquire the assets or the ownership of, control of, or the power to vote shares of a bank or bank holding company and all of the banks and nonbanking companies owned by the bank holding company, including the companies listed below.
                </P>
                <P>
                    The applications listed below, as well as other related filings required by the Board, are available for immediate inspection at the Federal Reserve Bank indicated.  The application also will be available for inspection at the offices of the Board of Governors.  Interested persons may express their views in writing on the standards enumerated in the BHC Act (12 U.S.C. 1842(c)).  If the proposal also involves the acquisition of a nonbanking company, the review also includes whether the acquisition of the nonbanking company complies with the standards in section 4 of the BHC Act (12 U.S.C. 1843).  Unless otherwise noted, nonbanking activities will be conducted throughout the United States.  Additional information on all bank holding companies may be obtained from the National Information Center website at 
                    <E T="03">www.ffiec.gov/nic/</E>
                    .
                </P>
                <P>Unless otherwise noted, comments regarding each of these applications must be received at the Reserve Bank indicated or the offices of the Board of Governors not later than December 6, 2004.</P>
                <P>
                    <E T="04">A.  Federal Reserve Bank of Atlanta</E>
                     (Sue Costello, Vice President) 1000 Peachtree Street, N.E., Atlanta, Georgia 30303:
                </P>
                <P>
                    <E T="03">1.  CBS Financial Corporation</E>
                    , Smyrna, Georgia; to become a bank holding company by acquiring 100 percent of the voting shares of Community Bank of the South, Smyrna, Georgia.
                </P>
                <P>
                    <E T="04">B.  Federal Reserve Bank of St. Louis</E>
                     (Randall C. Sumner, Vice President) 411 Locust Street, St. Louis, Missouri 63166-2034:
                </P>
                <P>
                    <E T="03">1.  Centennial Bancshares, Inc.</E>
                    , Little Rock, Arkansas; to become a bank holding company by acquiring 100 percent of the voting shares of Pine State Bancshares, Inc., Kingsland, Arkansas, and thereby indirectly acquire Pine State Bank, Kingsland, Arkansas.
                </P>
                <SIG>
                    <P>Board of Governors of the Federal Reserve System, November 8, 2004.</P>
                    <NAME>Robert deV. Frierson,</NAME>
                    <TITLE>Deputy Secretary of the Board.</TITLE>
                </SIG>
            </PREAMB>
            <FRDOC>[FR Doc. 04-25268 Filed 11-12-04; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 6210-01-S</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="N">DEPARTMENT OF HEALTH AND HUMAN SERVICES </AGENCY>
                <SUBJECT>National Coordinator for Health Information Technology; Development and Adoption of a National Health Information Network </SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Department of Health and Human Services. </P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Request for information. </P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>
                        Public comment is sought regarding considerations in implementing the President's call for widespread adoption of interoperable electronic health records (EHRs) within 10 years. On April 27, 2004, President Bush established the position of the National Health Information Technology Coordinator. On May 6, 2004, Secretary Tommy G. Thompson appointed David J. Brailer, MD, PhD to serve as National Coordinator for Health Information Technology. The Executive Order signed by the President required the National Coordinator to report within 90 days of operation on the development and implementation of a strategic plan. This Framework for Strategic Action entitled: “The Decade of Health Information Technology: Delivering Consumer-centric and Information-rich Health Care” (the Framework), was presented at the Health Information Technology Secretarial Summit II on July 21, 2004. The Framework is posted for reference at: 
                        <E T="03">[http://www.hhs.gov/onchit/framework/]</E>
                        . The Framework outlines an approach toward the nationwide implementation of interoperable health information technology in both the public and the private sectors. 
                    </P>
                    <P>In order to realize a new vision for health care through the use of information technology, the report called for a sustained set of strategic actions, embraced by the public and the private health sectors, which will be taken over many years. The Framework outlined four major goals: inform clinical practice with use of EHRs, interconnect clinicians so that they can exchange health information using advanced and secure electronic communication, personalize care with consumer-based health records and better information for consumers, and improve public health through advanced biosurveillance methods and streamlined collection of data for quality measurement and research. </P>
                    <P>This Request for Information (RFI) addresses the goal of interconnecting clinicians by seeking public comment and input regarding how widespread interoperability of health information technologies and health information exchange can be achieved. This RFI is intended to inform policy discussions about possible methods by which widespread interoperability and health information exchange could be deployed and operated on a sustainable basis. </P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Responses should be submitted to the Department of Health and Human Services (HHS), Office of the National Coordinator for Health Information Technology (ONCHIT), on or before 5 p.m. e.s.t. on January 18, 2005. </P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        Electronic responses are preferred and should be addressed to: 
                        <E T="03">NHINRFI@hhs.gov</E>
                         in the Office of the National Coordinator for Health Information Technology, Department of Health and Human Services. Include NHIN RFI Responses in the subject line. Non-electronic responses will also be accepted. Please send to:  Office of the National Coordinator Health Information Technology, Department of Health and Human Services, Attention: NHIN RFI Responses, Hubert H. Humphrey Building, Room 517D, 200 Independence Avenue, SW., Washington, DC 20201. 
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        On December 6, 2004, there will be a technical assistance conference call to answer questions from potential responders. More details will be provided on how to participate in this call on the ONCHIT Web site 
                        <E T="03">[http://www.hhs.gov/onchit/]</E>
                        . Additionally, a public, online Frequently Asked Question (FAQ) page will be provided to answer questions throughout the response period on ONCHIT's Web site. 
                    </P>
                    <P>
                        Please direct e-mail inquiries and responses to 
                        <E T="03">NHINRFI@hhs.gov</E>
                        . For additional information, contact Lee Jones or Lori Evans, in the Office of the National Coordinator for Health Information Technology at toll free (877) 474-3918. 
                    </P>
                    <P>
                        <E T="03">Background:</E>
                         As the nation embarks on the widespread deployment of EHRs, a variety of concomitant challenges and barriers must be addressed. One of these is interoperability, or the ability to exchange patient health information among disparate clinicians and other authorized entities in real time and under stringent security, privacy and other protections. Interoperability is an essential factor in using health information technology to improve the 
                        <PRTPAGE P="65600"/>
                        quality and efficiency of care in the United States. Interoperability is necessary for compiling the complete experience of a patient's care, for maintaining a patient's personal health records and for ensuring that complete health information is accessible to clinicians as the patient moves through various healthcare settings. Interoperability is needed for clinicians to make fact-based decisions so medical errors and redundant tests can be reduced. Interoperability is also critical to cost-effective and timely data collection for biosurveillance, quality measurement and clinical research. In short, interoperability is essential for realizing the key goals that are desired from health information technology. 
                    </P>
                    <P>With the exception of a few isolated regional projects, the United States does not currently have meaningful health information interoperability capabilities. Moreover, the broad set of actions and tasks that are needed to achieve interoperability are not well-defined. It is known that interoperability requires a set of common standards that specify how information can be communicated and in what format. On this, there has been considerable effort and progress achieved by private sector organizations such as Health Level 7 (HL7), and by the American National Standards Institute (ANSI), both of which are voluntary consensus standards setting organizations. Also, HHS and other Federal agencies have advanced the adoption of standards through the Consolidated Health Informatics (CHI) initiative, as well as the Public Health Information Network (PHIN) and National Electronic Disease Surveillance System (NEDSS) under the leadership of the Centers for Disease Control and Prevention (CDC). With HHS participation, HL7 has also created a functional model and standards for electronic health records. </P>
                    <P>However more remains to be done to achieve interoperability and to determine the process by which these tasks should be pursued in the public and private sectors. Clearly needed are interconnection tools such as mobile authentication, identification management, common web services architecture and security technologies. Also needed are precisely defined implementation regimens that are specified at the level of software code. There is also a need for common networking and communication tools to unify access and security. Aside from this, mechanisms for ensuring the sustainable operation of these components on a widespread and publicly available basis must be defined. There are potentially other components that may not be known at this time. The collective array of components that underlie nationwide interoperability is referred to as a National Health Information Network (NHIN) in the Framework. </P>
                    <P>The NHIN could be developed and operated in many ways. It could include state-of-the-art web technologies or more traditional clearinghouse architectures. It could be highly decentralized or somewhat centrally brokered. It could be a nationwide service, a collection of regional services or a set of tools that share common components. It could be overseen by public organizations, by private organizations, or by public-private consortia. Regardless of how it is developed, overseen or operated, there is a compelling public interest for a NHIN to exist. </P>
                    <P>
                        Therefore, the National Coordinator for Health Information Technology is seeking comments on and ideas for how a NHIN can be deployed for widespread use. To begin this process, the National Coordinator is inviting responses about the questions in this RFI. We intend to explore the role of the federal government in facilitating deployment of a NHIN, how it could be coordinated with the Federal Health Architecture (FHA), and how it could be supported and coordinated by Regional Health Information Organizations (RHIOs). (For additional information on the FHA and the RHIOs, please refer to the report: “The Decade of Health Information Technology: Delivering Consumer-centric and Information-rich Health Care,” at: 
                        <E T="03">[http://www.hhs.gov/onchit/framework/]</E>
                        ). 
                    </P>
                    <P>There are many perspectives that can be brought to bear on this important topic. Health information technology organizations, healthcare providers, industry associations and other stakeholders all have important insights that will inform future deliberation. In the interest of having the most compelling, complete and thorough responses possible, we encourage interested parties to collaborate and submit unified responses to this RFI wherever possible. Comments from the public at large are also invited.</P>
                    <HD SOURCE="HD1">Request for Information </HD>
                    <P>General 1. The primary impetus for considering a NHIN is to achieve interoperability of health information technologies used in the mainstream delivery of health care in America. Please provide your working definition of a NHIN as completely as possible, particularly as it pertains to the information contained in or used by electronic health records. Please include key barriers to this interoperability that exist or are envisioned, and key enablers that exist or are envisioned. This description will allow reviewers of your submission to better interpret your responses to subsequent questions in this RFI regarding interoperability. </P>
                    <P>2. What type of model could be needed to have a NHIN that: Allows widely available access to information as it is produced and used across the health care continuum; enables interoperability and clinical health information exchange broadly across most/all HIT solutions; protects patients' individually identifiable health information; and allows vendors and other technology partners to be able to use the NHIN in the pursuit of their business objectives? Please include considerations such as roles of various private- and public-sector entities in your response. </P>
                    <P>
                        3. What aspects of a NHIN could be national in scope (
                        <E T="03">i.e.</E>
                        , centralized commonality or controlled at the national level), versus those that are local or regional in scope (
                        <E T="03">i.e.</E>
                        , decentralized commonality or controlled at the regional level)? Please describe the roles of entities at those levels. (Note: “national” and “regional” are 
                        <E T="03">not</E>
                         meant to imply Federal or local governments in this context.) 
                    </P>
                    <HD SOURCE="HD2">Organizational and Business Framework </HD>
                    <P>4. What type of framework could be needed to develop, set policies and standards for, operate, and adopt a NHIN? Please describe the kinds of entities and stakeholders that could compose the framework and address the following components: </P>
                    <P>a. How could a NHIN be developed? What could be key considerations in constructing a NHIN? What could be a feasible model for accomplishing its construction? </P>
                    <P>b. How could policies and standards be set for the development, use and operation of a NHIN? </P>
                    <P>c. How could the adoption and use of the NHIN be accelerated for the mainstream delivery of care? </P>
                    <P>d. How could the NHIN be operated? What are key considerations in operating a NHIN? </P>
                    <P>5. What kind of financial model could be required to build a NHIN? Please describe potential sources of initial funding, relative levels of contribution among sources and the implications of various funding models. </P>
                    <P>
                        6. What kind of financial model could be required to operate and sustain a functioning NHIN? Please describe the 
                        <PRTPAGE P="65601"/>
                        implications of various financing models. 
                    </P>
                    <P>7. What privacy and security considerations, including compliance with relevant rules of the Health Insurance Portability and Accountability Act of 1996 (HIPAA), are implicated by the NHIN, and how could they be addressed? </P>
                    <P>8. How could the framework for a NHIN address public policy objectives for broad participation, responsiveness, open and non-proprietary interoperable infrastructure? </P>
                    <HD SOURCE="HD2">Management and Operational Considerations </HD>
                    <P>9. How could private sector competition be appropriately addressed and/or encouraged in the construction and implementation of a NHIN? </P>
                    <P>10. How could the NHIN be established to maintain a health information infrastructure that: </P>
                    <P>a. Evolves appropriately from private investment; </P>
                    <P>b. Is non-proprietary and available in the public domain; </P>
                    <P>c. Achieves country-wide interoperability; and </P>
                    <P>d. Fosters market innovation. </P>
                    <P>11. How could a NHIN be established so that it will be utilized in the delivery of care by healthcare providers, regardless of their size and location, and also achieve enough national coverage to ensure that lower income rural and urban areas could be sufficiently served? </P>
                    <P>12. How could community and regional health information exchange projects be affected by the development and implementation of a NHIN? What issues might arise and how could they be addressed? </P>
                    <P>13. What effect could the implementation and broad adoption of a NHIN have on the health information technology market at large? Could the ensuing market opportunities be significant enough to merit the investment in a NHIN by the industry? To what entities could the benefits of these market opportunities accrue, and what implication (if any) does that have for the level of investment and/or role required from those beneficiaries in the establishment and perpetuation of a NHIN? </P>
                    <HD SOURCE="HD2">Standards and Policies To Achieve Interoperability </HD>
                    <P>(Question 4b above asks how standards and policy setting for a NHIN could be considered and achieved. The questions below focus more specifically on standards and policy requirements.) </P>
                    <P>14. What kinds of entity or entities could be needed to develop and diffuse interoperability standards and policies? What could be the characteristics of these entities? Do they exist today? </P>
                    <P>15. How should the development and diffusion of technically sound, fully informed interoperability standards and policies be established and managed for a NHIN, initially and on an ongoing basis, that effectively address privacy and security issues and fully comply with HIPAA? How can these standards be protected from proprietary bias so that no vendors or organizations have undue influence or advantage? Examples of such standards and policies include: secure connectivity, mobile authentication, patient identification management and information exchange. </P>
                    <P>16. How could the efforts to develop and diffuse interoperability standards and policy relate to existing Standards Development Organizations (SDOs) to ensure maximum coordination and participation? </P>
                    <P>17. What type of management and business rules could be required to promote and produce widespread adoption of interoperability standards and the diffusion of such standards into practice? </P>
                    <P>18. What roles and relationships should the federal government take in relation to how interoperability standards and policies are developed, and what roles and relationships should it refrain from taking? </P>
                    <HD SOURCE="HD2">Financial and/or Regulatory Incentives and Legal Considerations </HD>
                    <P>19. Are financial incentives required to drive the development of a marketplace for interoperable health information, so that relevant private industry companies will participate in the development of a broadly available, open and interoperable NHIN? If so, what types of incentives could gain the maximum benefit for the least investment? What restrictions or limitation should these incentives carry to ensure that the public interest is advanced? </P>
                    <P>
                        20.What kind of incentives should be available to regional stakeholders (
                        <E T="03">e.g.</E>
                        , health care providers, physicians, employers that purchase health insurance, payers) to use a health information exchange architecture based on a NHIN? 
                    </P>
                    <P>21. Are there statutory or regulatory requirements or prohibitions that might be perceived as barriers to the formation and operation of a NHIN, or to support it with critical functions? </P>
                    <P>
                        22. How could proposed organizational mechanisms or approaches address statutory and regulatory requirements (
                        <E T="03">e.g.</E>
                        , data privacy and security, antitrust constraints and tax issues)? 
                    </P>
                    <HD SOURCE="HD2">Other </HD>
                    <P>23. Describe the major design principles/elements of a potential technical architecture for a NHIN. This description should be suitable for public discussion. </P>
                    <P>24. How could success be measured in achieving an interoperable health information infrastructure for the public sector, private sector and health care community or region? </P>
                    <SIG>
                        <DATED>Dated: November 9, 2004. </DATED>
                        <NAME>David J. Brailer, </NAME>
                        <TITLE>National Coordinator, Office of the National Coordinator for Health Information Technology. </TITLE>
                    </SIG>
                </FURINF>
            </PREAMB>
            <FRDOC>[FR Doc. 04-25382 Filed 11-10-04; 11:30 am] </FRDOC>
            <BILCOD>BILLING CODE 4150-24-P </BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF HEALTH AND HUMAN SERVICES</AGENCY>
                <SUBAGY>Administration on Aging</SUBAGY>
                <SUBJECT>Agency Information Collection Activities; Proposed Collection; Comment Request; Senior Medicare Patrol Program Outcome Measurement</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Administration on Aging, HHS.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>
                        The Administration on Aging (AoA) is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish notice in the 
                        <E T="04">Federal Register</E>
                         concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the information collection requirements relating to Senior Medicare Patrol (SMP) program outcome measurement.
                    </P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Submit written or electronic comments on the collection of information by January 14, 2005.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        Submit electronic comments on the collection of information to: 
                        <E T="03">Barbara.dieker@aoa.gov.</E>
                         Submit written comments on the collection of information to Barbara Dieker, Administration on Aging, Washington, DC 20201 or by fax at (202) 357-3558.
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Barbara Dieker at (202) 357-0139 or 
                        <E T="03">Barbara.dieker@aoa.gov.</E>
                        <PRTPAGE P="65602"/>
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>
                    Under the PRA (44 U.S.C. 3501-3520), Federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. “Collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes agency request or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal agencies to provide a 60-day notice in the 
                    <E T="04">Federal Register</E>
                     concerning each proposed collection of information, including each proposed extension of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, AoA is publishing notice of the proposed collection of information set forth in this document. With respect to the following collection of information, AoA invites comments on: (1) Whether the proposed collection of information is necessary for the proper performance of AoA's functions, including whether the information will have practical utility; (2) the accuracy of AoA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques when appropriate, and other forms of information technology. AoA estimates the burden of this collection of information as follows:
                </P>
                <P>
                    <E T="03">Frequency:</E>
                     Annually.
                </P>
                <P>
                    <E T="03">Respondents:</E>
                     Medicare beneficiaries after SMP education/training on fraud prevention; administered by staff or senior volunteers in 57 SMP projects nationwide.
                </P>
                <P>
                    <E T="03">Estimated number of responses:</E>
                     21,000.
                </P>
                <P>
                    <E T="03">Total Estimated Burden Hours:</E>
                     2,300.
                </P>
                <SIG>
                    <NAME>Josefina G. Carbonell,</NAME>
                    <TITLE>Assistant Secretary for Aging.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 04-25241 Filed 11-12-04; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4154-01-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF HEALTH AND HUMAN SERVICES </AGENCY>
                <SUBAGY>Centers for Medicare and Medicaid Services </SUBAGY>
                <DEPDOC>[Document Identifier: CMS-R-185, CMS 10131, CMS-10054 and CMS-R-50] </DEPDOC>
                <SUBJECT>Agency Information Collection Activities: Proposed Collection; Comment Request </SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Centers for Medicare and Medicaid Services. </P>
                    <P>In compliance with the requirement of section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Centers for Medicare and Medicaid Services (CMS) (formerly known as the Health Care Financing Administration (HCFA)), Department of Health and Human Services, is publishing the following summary of proposed collections for public comment. Interested persons are invited to send comments regarding this burden estimate or any other aspect of this collection of information, including any of the following subjects: (1) The necessity and utility of the proposed information collection for the proper performance of the agency's functions; (2) the accuracy of the estimated burden; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden. </P>
                    <P>
                        1. 
                        <E T="03">Type of Information Collection Request:</E>
                         Extension of a currently approved collection; 
                        <E T="03">Title of Information Collection:</E>
                         Granting and Withdrawal of Deeming Authority to Private Nonprofit Accreditation Organizations and of State Exemption Under State Laboratory Programs and Supporting Regulations in 42 CFR 493.551-493.557; 
                        <E T="03">Use:</E>
                         The information required is necessary to determine whether a private accreditation organization's or State licensure program's standards and accreditation/licensure process is equal to or more stringent than those of CLIA. 
                        <E T="03">Form Number:</E>
                         CMS-R-185 (OMB#: 0938-0686); 
                        <E T="03">Frequency:</E>
                         Initial application and as needed; 
                        <E T="03">Affected Public:</E>
                         Not-for-profit institutions, Business or other for-profit and State, Local, or Tribal Government; 
                        <E T="03">Number of Respondents:</E>
                         8; 
                        <E T="03">Total Annual Responses:</E>
                         76; 
                        <E T="03">Total Annual Hours:</E>
                         768. 
                    </P>
                    <P>
                        2. 
                        <E T="03">Type of Information Collection Request:</E>
                         New Collection; 
                        <E T="03">Title of Information Collection:</E>
                         Evaluation of Medicare Disease Management Demonstrations; 
                        <E T="03">Form No.:</E>
                         CMS-10131 (OMB# 0938-NEW); 
                        <E T="03">Use:</E>
                         CMS contracted with Mathematic Policy Research, Inc. (MPR) for the evaluation of disease management programs. The purpose of the patient survey is to assess the impact of disease management and prescription drug benefits on patient health, functioning status, care satisfaction, health behaviors and knowledge of condition. Data from the physician survey will be used to assess physician satisfaction with disease management services, physician perceptions of the impact of disease management on patient outcomes, education and service use, and the impact of disease management programs on physician practices and office workload.; 
                        <E T="03">Frequency:</E>
                         On Occasion; 
                        <E T="03">Affected Public:</E>
                         Individuals or households, Business or other for-profit; 
                        <E T="03">Number of Respondents:</E>
                         5000; 
                        <E T="03">Total Annual Responses:</E>
                         2500; 
                        <E T="03">Total Annual Hours:</E>
                         1625.
                    </P>
                    <P>
                        3. 
                        <E T="03">Type of Information Collection Request:</E>
                         Extension of a currently approved collection; 
                        <E T="03">Title of Information Collection:</E>
                         Recognition of Payment for New Technology Services for Ambulatory Payment Classifications (APCs) under the Outpatient Prospective Payment System and Supporting Regulations in 42 CFR, 413.65 and 419.42; 
                        <E T="03">Form No.:</E>
                         CMS-10054 (OMB# 0938-0860); 
                        <E T="03">Use:</E>
                         Information is necessary to determine services eligible for payment in new technology ambulatory payment classifications (APCs) in the outpatient prospective payment system; 
                        <E T="03">Frequency:</E>
                         On Occasion; 
                        <E T="03">Affected Public:</E>
                         Business or other for-profit; 
                        <E T="03">Number of Respondents:</E>
                         15; 
                        <E T="03">Total Annual Responses:</E>
                         15; 
                        <E T="03">Total Annual Hours:</E>
                         180. 
                    </P>
                    <P>
                        4. 
                        <E T="03">Type of Information Collection Request:</E>
                         Extension of a currently approved collection; 
                        <E T="03">Title of Information Collection:</E>
                         Medical Records Review under PPS and Supporting Regulations in 42 CFR, Sections 412.40-412.52; 
                        <E T="03">Form No.:</E>
                         CMS-R-50 (OMB# 0938-0359); 
                        <E T="03">Use:</E>
                         The Quality Improvement Organizations (QIOs) are authorized to conduct medical review activities under the Prospective Payment System (PPS) . In order to conduct these review activites, the agency depends upon hospitals to make available specific records regarding care provided to Medicare beneficiaries. The Clinical Data Abstraction Centers (CDACs) obtain copies of medical records from which they abstract data to analyze patterns of care and outcomes for heart failure/myocardial infarction, pneumonia, diabetes and surgical infection.; 
                        <E T="03">Frequency:</E>
                         Other: when records are reviewed; 
                        <E T="03">Affected Public:</E>
                          
                        <PRTPAGE P="65603"/>
                        Business or other for-profit, Not-for-profit institutions, Federal Government, and State, Local or Tribal Govt.; 
                        <E T="03">Number of Respondents:</E>
                         6,100; 
                        <E T="03">Total Annual Responses:</E>
                         397,500; 
                        <E T="03">Total Annual Hours:</E>
                         11,925. 
                    </P>
                    <P>
                        To obtain copies of the supporting statement and any related forms for the proposed paperwork collections referenced above, access CMS' Web site address at 
                        <E T="03">http://www.cms.hhs.gov/regulations/pra/</E>
                        , or e-mail your request, including your address, phone number, OMB number, and CMS document identifier, to 
                        <E T="03">Paperwork@cms.hhs.gov</E>
                        , or call the Reports Clearance Office on (410) 786-1326. 
                    </P>
                    <P>Written comments and recommendations for the proposed information collections must be mailed within 60 days of this notice directly to the CMS Paperwork Clearance Officer designated at the following address: CMS, Office of Strategic Operations and Regulatory Affairs, Division of Regulations Development and Issuances, Attention: Melissa Musotto, Room C5-14-03, 7500 Security Boulevard, Baltimore, Maryland 21244-1850. </P>
                </AGY>
                <SIG>
                    <DATED>Dated: November 5, 2004. </DATED>
                    <NAME>John P. Burke, III, </NAME>
                    <TITLE>Paperwork Reduction Act Team Leader, Office of Strategic Operations and Strategic Affairs, Division of Regulations Development and Issuances. </TITLE>
                </SIG>
            </PREAMB>
            <FRDOC>[FR Doc. 04-25250 Filed 11-12-04; 8:45 am] </FRDOC>
            <BILCOD>BILLING CODE 4120-03-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF HEALTH AND HUMAN SERVICES</AGENCY>
                <SUBAGY>Indian Health Service</SUBAGY>
                <SUBJECT>SES Executive Review Board/Performance Review Board</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Indian Health Service.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>Notice is hereby given of the appointment of members of the Indian Health Service (IHS) Senior Executive Service (SES) Executive Review Board/SES Performance Review Board.</P>
                </SUM>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>Phyllis Eddy, Acting Director, Office of Management Services, 801 Thompson Avenue, Suite 120, Rockville, Maryland 20852, (301) 443-6290.</P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>Section 4314(c) (1) through (5) of Title 5, U.S.C., requires each agency to establish, in accordance with regulations prescribed by the Office of Personnel Management, one or more SES performance review boards. The board reviews and evaluates the initial appraisal of a senior executive's performance by the supervisor and considers recommendations to the appointing authority regarding the performance of the senior executive.</P>
                <P>The following have been designated as regular members of the Senior Executive Service (SES) Executive Review Board/SES Performance Review Board for IHS: Phyllis Eddy, Chair; Elaine Perry, Deputy Director, Office of the Administrator, Substance Abuse and Mental Health Services Administration; Robert G. McSwain, Acting Deputy Director, Management Operations; Gary Hartz, Acting Deputy Director, IHS; Chris Mandregan, Jr., Director, Alaska Area IHS; Doni Wilder, Director, Portland Area IHS; John Hubbard, Director, Navajo Area IHS.</P>
                <SIG>
                    <DATED>Dated: November 5, 2004.</DATED>
                    <NAME>Charles W. Grim, </NAME>
                    <TITLE>Assistant Surgeon General, Director.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 04-25244  Filed 11-12-04; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4160-16-M</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF HEALTH AND HUMAN SERVICES </AGENCY>
                <SUBAGY>Office of Inspector General </SUBAGY>
                <SUBJECT>Program Exclusions: October 2004 </SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Office of Inspector General, HHS. </P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice of program exclusions. </P>
                </ACT>
                <P>
                    During the month of October 2004, the HHS Office of Inspector General imposed exclusions in the cases set forth below. When an exclusions is imposed, no program payment is made to anyone for any items or services (other than an emergency item or service not provided in a hospital emergency room) furnished, ordered or prescribed by an excluded party under the Medicare, Medicaid, and all Federal Health Care programs. In addition, no program payment is made to any business or facility, 
                    <E T="03">e.g.</E>
                    , a hospital, that submits bills for payment for items or services provided by an excluded party. Program beneficiaries remain free to decide for themselves whether they will continue to use the services of an excluded party even though no program payments will be made for items and services provided by that excluded party. The exclusions have national effect and also apply to all Executive Branch procurement and non-procurement programs and activities.
                </P>
                <GPOTABLE COLS="3" OPTS="L2,tp0,i1" CDEF="s100,r100,14">
                    <TTITLE>  </TTITLE>
                    <BOXHD>
                        <CHED H="1">Subject name </CHED>
                        <CHED H="1">Address </CHED>
                        <CHED H="1">Effective date </CHED>
                    </BOXHD>
                    <ROW EXPSTB="02" RUL="s">
                        <ENT I="21">
                            <E T="02">PROGRAM-RELATED CONVICTIONS</E>
                        </ENT>
                    </ROW>
                    <ROW EXPSTB="00">
                        <ENT I="01">ARMON, BOBBY </ENT>
                        <ENT>MILWAUKEE, WI</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">ARNOLD, RODELL </ENT>
                        <ENT>TOLEDO, OH</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">ARRUDA, CARMEN </ENT>
                        <ENT>ISSAQUAH, WA</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">BAUMAN, DAVID</ENT>
                        <ENT>HOUSTON, TX</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">BROWN, AUWANA</ENT>
                        <ENT>FRESNO, CA</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">CABRERA, MARCO</ENT>
                        <ENT>MIAMI, FL</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">CARTER, JERRY</ENT>
                        <ENT>DYERSBURG, TN</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">CASIANO, ROSARIO</ENT>
                        <ENT>ROSEMEAD, CA</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">CORBETT, KERMIS</ENT>
                        <ENT>ELGIN, SC</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">CORTES, FRANCISCO</ENT>
                        <ENT>HIALEAH, FL</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">DAY, APRIL</ENT>
                        <ENT>LOS ANGELES, CA</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">DELEON, VANESSA</ENT>
                        <ENT>HAWTHORNE, CA</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">ELBAGDADI, HAZEM</ENT>
                        <ENT>PETERSBURG, VA</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">ENCINAS, BENJAMIN</ENT>
                        <ENT>TUCSON, AZ</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">FATEMI, MOHAMMAD</ENT>
                        <ENT>DUNKIRK, MD</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">FINDLEY, KATHERINE</ENT>
                        <ENT>LAKEWOOD, CO</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">FORD, FRED</ENT>
                        <ENT>EGLIN AFB, FL</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">FREITAS, JOHN</ENT>
                        <ENT>CARTNEGE, MO</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">GONZALEZ, GIORDY</ENT>
                        <ENT>MIAMI, FL</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">GONZALEZ, MILAGROS</ENT>
                        <ENT>MIAMI, FL</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <PRTPAGE P="65604"/>
                        <ENT I="01">GROCE, TINA</ENT>
                        <ENT>GRANVIEW, OH</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">HARRIS, THOMAS</ENT>
                        <ENT>POTEAU, OK</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">HEDRINGTON, HERBERT</ENT>
                        <ENT>FRESNO, CA</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">HOLTHAUS, CHARLES</ENT>
                        <ENT>NEW ORLEANS, LA</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">JACOBS, ROZA</ENT>
                        <ENT>COLUMBUS, OH</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">JULIUS, RYAN</ENT>
                        <ENT>YORK, PA</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">KERSEY-THOMAS, CHRISTINE</ENT>
                        <ENT>N AUGUSTA, SC</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">LEUTTERS, FLORENCE</ENT>
                        <ENT>HICKSVILLE, NY</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">LOZANO, CARRIE</ENT>
                        <ENT>FRESNO, CA</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">MALDONADO, MARIA</ENT>
                        <ENT>LOS ANGELES, CA</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">NEIL, TAMMY</ENT>
                        <ENT>CARTHAGE, MO</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">OSSEI, HARRY</ENT>
                        <ENT>DULUTH, MN</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">OYENUSI, ADEBOWALE</ENT>
                        <ENT>MAPLEWOOD, NJ</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">PARKER, MARILYN</ENT>
                        <ENT>MESA, AZ</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">PARTON, BRENDA</ENT>
                        <ENT>LAKEWOOD, WA</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">PATEL, DIPAKKUMAR</ENT>
                        <ENT>MIDLAND, TX</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">PETRILLO, LOUIS</ENT>
                        <ENT>MIAMI, FL</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">HILLIPS, KAWAII</ENT>
                        <ENT>MARKS, MS</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">RECAIDO, BERT</ENT>
                        <ENT>CARSON, CA</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">RECAIDO, EVELYN</ENT>
                        <ENT>CARSON, CA</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">ROBISON, TROY</ENT>
                        <ENT>ORANGE PARK, FL </ENT>
                        <ENT>5/3/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">SALINAS, CARLOS</ENT>
                        <ENT>DENVER, CO</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">SCHULTZ, DENISE</ENT>
                        <ENT>GROVE CITY, OH</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">SHELHAMMER, PAUL</ENT>
                        <ENT>PITTSBURGH, PA</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">SMITH, RANDALL</ENT>
                        <ENT>OREGON CITY, OR</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">STECKLER, SCOTT</ENT>
                        <ENT>ROCKVILLE, MD</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">STRICKMAN, IRA</ENT>
                        <ENT>PENSACOLA, FL</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">TITH, LAURA</ENT>
                        <ENT>MESA, AZ </ENT>
                        <ENT>8/9/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">TUCKER, DAVID</ENT>
                        <ENT>BRONX, NY</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">VELEZ, SAMUEL</ENT>
                        <ENT>BROOKLYN, NY</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">WALBORN, TODD</ENT>
                        <ENT>BIRMINGHAM, AL</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">WATERHOUSE, DEA</ENT>
                        <ENT>FAIRHAVEN, VT</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">WATTS, WILLIAM</ENT>
                        <ENT>SEMINOLE, OK</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">WEISS, BETH </ENT>
                        <ENT>COLLINGSWOOD, NJ</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW RUL="s">
                        <ENT I="01">WELCH, DARRYL</ENT>
                        <ENT>FOX LAKE, WI</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW EXPSTB="02" RUL="s">
                        <ENT I="21">
                            <E T="02">FELONY CONVICTION FOR HEALTH CARE FRAUD</E>
                        </ENT>
                    </ROW>
                    <ROW EXPSTB="00">
                        <ENT I="01">DORRIN, ROBIN</ENT>
                        <ENT>ST LOUIS, MO</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">GUTIERREZ, JEREMY</ENT>
                        <ENT>HOUSTON, TX</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">KREUTZER, DONALD</ENT>
                        <ENT>CLARKSVILLE, MO</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">LAWTON, JANICE</ENT>
                        <ENT>WARREN, OH</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">MORAN, KELLIE </ENT>
                        <ENT>W. MONROE, NY</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">MURGATROYD, ROBERT</ENT>
                        <ENT>ATLANTA, GA</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">SAVAGE, LORI</ENT>
                        <ENT>STRONG, ME</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">STUBBS, PAMELA</ENT>
                        <ENT>RICHMOND, IN</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">TORRES, TIA</ENT>
                        <ENT>PELLA, IA</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">WINTERS, MARIANNE</ENT>
                        <ENT>TUMWATER, WA</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW RUL="s">
                        <ENT I="01">YEX, ANITA</ENT>
                        <ENT>BRUNSWICK HILLS, OH </ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW EXPSTB="02" RUL="s">
                        <ENT I="21">
                            <E T="02">FELONY CONTROL SUBSTANCE CONVICTION</E>
                        </ENT>
                    </ROW>
                    <ROW EXPSTB="00">
                        <ENT I="01">ATKINSON, TAMMY</ENT>
                        <ENT>ANTHONY, FL</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">BARTOLO, KATHRYN</ENT>
                        <ENT>SANFORD, MI</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">BRILL, LAURA</ENT>
                        <ENT>DECATUR, GA</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">ENNIS, LORI</ENT>
                        <ENT>SPARTA, MO</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">HOSKINS, TAMMY</ENT>
                        <ENT>SPRINGFIELD, IL</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">JUMPER, DONNA</ENT>
                        <ENT>BOONEVILLE, MS</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">MARTIN, TRAVIS</ENT>
                        <ENT>INDEPENDENCE, WV</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">OTINIANO, JOSHUA</ENT>
                        <ENT>ORLANDO, FL</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">PATTERSON, BARBARA</ENT>
                        <ENT>WINSTON, GA</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">ROBERSON, ELLICK</ENT>
                        <ENT>PHOENIX, AZ </ENT>
                        <ENT>5/3/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">SIGNORINE, LOUIS</ENT>
                        <ENT>GILFORD, NH</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">SUGGS, WINDY</ENT>
                        <ENT>LORIS, SC</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">TALBERT, TONY</ENT>
                        <ENT>ORLANDO, FL</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">VANDALL, TAMMY</ENT>
                        <ENT>BELTON, TX</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW RUL="s">
                        <ENT I="01">WILDE, LONA</ENT>
                        <ENT>PORT ST LUCIE, FL </ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW EXPSTB="02" RUL="s">
                        <ENT I="21">
                            <E T="02">PATIENT ABUSE/NEGLECT CONVICTIONS</E>
                        </ENT>
                    </ROW>
                    <ROW EXPSTB="00">
                        <ENT I="01">BRYANT, THOMAS</ENT>
                        <ENT>HIBBING, MN</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">FINKEL, BRIAN</ENT>
                        <ENT>FLORENCE, AZ</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">FLORES, FELIX</ENT>
                        <ENT>MORENO VALLEY, CA</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">FRAZIER, WILLIAM</ENT>
                        <ENT>PETAL, MS</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <PRTPAGE P="65605"/>
                        <ENT I="01">GONDREZ, JACKIE</ENT>
                        <ENT>ST CLOUD, MN</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">HARMON, WAYNE</ENT>
                        <ENT>NEW WATERFORD, OH</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">HOFFART, JAMES</ENT>
                        <ENT>LONG BEACH, CA</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">HOWARD, COLIN</ENT>
                        <ENT>SAN FRANCISCO, CA</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">HOWARD, LILLIE</ENT>
                        <ENT>SHREVEPORT, LA</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">JOHNSTON, WENDELL</ENT>
                        <ENT>SARDIS, MS</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">LAMM, TAMARA</ENT>
                        <ENT>PANAMA CITY, FL</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">MCCARTY-ROSARIO, DONNA</ENT>
                        <ENT>VALLEJO, CA</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">PALKO, DEBORAH</ENT>
                        <ENT>SURGOINSVILLE, TN</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">PLOURDE, STEVEN</ENT>
                        <ENT>EUREKA, CA</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">SEARL, PENNY</ENT>
                        <ENT>ONEIDA, NY</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">SHUKLA, PARAM</ENT>
                        <ENT>WAKEFIELD, MA</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">SMITH, KEYONNA</ENT>
                        <ENT>FLINT, MI</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">STANTON, JOSEPH</ENT>
                        <ENT>THORNTON, CO</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">TAMBER, SATWINDER</ENT>
                        <ENT>COVINA, CA</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">TARDAGUILA, GREGORY</ENT>
                        <ENT>TORRANCE, CA</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">VAN OORT, CHRISTINE</ENT>
                        <ENT>MT PLEASANT, IA</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">WHITEHEAD, LYNN</ENT>
                        <ENT>SMITHVILLE, TN</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">WISEMAN, RUSSELL</ENT>
                        <ENT>MEMPHIS, TN</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW RUL="s">
                        <ENT I="01">ZAIDI, MOSHIN</ENT>
                        <ENT>HOFFMAN ESTATES, IL </ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW EXPSTB="02" RUL="s">
                        <ENT I="21">
                            <E T="02">CONVICTION FOR HEALTH CARE FRAUD</E>
                        </ENT>
                    </ROW>
                    <ROW EXPSTB="00" RUL="s">
                        <ENT I="01">WHEELER, ROBERT</ENT>
                        <ENT>WATERLOO, IA</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW EXPSTB="02" RUL="s">
                        <ENT I="21">
                            <E T="02">LICENSE REVOCATION/SUSPENSION/SURRENDERED</E>
                        </ENT>
                    </ROW>
                    <ROW EXPSTB="00">
                        <ENT I="01">A HEALTH &amp; STRESS FREE</ENT>
                        <ENT>AVENTURA, FL</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">ABBOTT, KARA</ENT>
                        <ENT>CYPRESS, TX</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">AIMONE, CONNIE</ENT>
                        <ENT>BENTON CITY, WA</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">AL-GHRAOUI, FADI</ENT>
                        <ENT>FORT LAUDERDALE, FL</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">ALLEN, TOBIE</ENT>
                        <ENT>COLUMBIA, TN</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">AMENS, JOHN</ENT>
                        <ENT>TACOMA, WA</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">ANAST, SUSAN</ENT>
                        <ENT>LAKE HAVASU, AZ</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">ARMSTRONG, SHAWN</ENT>
                        <ENT>BONIFAY, FL</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">BAKER, CYNDIE</ENT>
                        <ENT>ORANGE PARK, FL</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">BAKER, JOHN</ENT>
                        <ENT>LARGO, FL</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">BARBANELL, JOANNE</ENT>
                        <ENT>PRESCOTT, AZ</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">BARNETT, BELINDA</ENT>
                        <ENT>ALMO, KY</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">BEGALLIA, DEBI</ENT>
                        <ENT>TACOMA, WA</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">BENDERS, CLARA</ENT>
                        <ENT>DORCHESTER, MA</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">BLALOCK, KERRY</ENT>
                        <ENT>TOONE, TN</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">BLENKLE, ELIZABETH</ENT>
                        <ENT>INDIAN ROCKS BEACH, FL </ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">BOESE, DEBORAH</ENT>
                        <ENT>CAPE CORAL, FL</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">BRASWELL, KATHRYN</ENT>
                        <ENT>PORT CHARLOTTE, FL</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">BRIDGES, CONNIE</ENT>
                        <ENT>COLVILLE, WA</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">BUMGARDNER, CHRISTIE</ENT>
                        <ENT>BAXTER, KY</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">BURKS, LAUREN</ENT>
                        <ENT>LOUISVILLE, KY</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">CALDWELL, PATRICIA</ENT>
                        <ENT>LEHIGH ACRES, FL</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">CAMPOSTRINI, KATHERINE</ENT>
                        <ENT>OROVILLE, CA</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">CATALANELLO, MARK</ENT>
                        <ENT>MISSOULA, MT</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">CHANDRA, PEGGY</ENT>
                        <ENT>MELBOURNE, FL</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">CLAGHORN, PEGGY</ENT>
                        <ENT>WEST RICHLAND, WA</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">COBB, KAREN</ENT>
                        <ENT>OCALA, FL</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">COCHRANE, CATHERINE</ENT>
                        <ENT>DELAND, FL</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">COMPTON, TERRI</ENT>
                        <ENT>MONTEVALLO, AL</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">CONNER, FREDERICK</ENT>
                        <ENT>YAKIMA, WA</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">COPLEY, CRYSTAL</ENT>
                        <ENT>LOUISVILLE, KY</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">COTTENGAIN, TONY</ENT>
                        <ENT>LAKELAND, FL</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">CURRY, DAVID</ENT>
                        <ENT>PARKVILLE, MD</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">CWALINA, CHARLENE</ENT>
                        <ENT>ATHOL, MA</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">DANIEL, JEAN</ENT>
                        <ENT>LEHIGH ACRES, FL</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">DECKER, MARIA</ENT>
                        <ENT>STOCKTON, CA</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">DECKER, RICHARD</ENT>
                        <ENT>JONESBOROUGH, TN</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">DESTEFANO, LISA</ENT>
                        <ENT>WEST MIFFLIN, PA</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">DICKINSON, HELEN</ENT>
                        <ENT>SARASOTA, FL</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">DIONISIO, RENATO</ENT>
                        <ENT>LOS ANGELES, CA</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">DORSEY, LARRY</ENT>
                        <ENT>AUBURN, CA</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">DWYER, DAN</ENT>
                        <ENT>BOISE, ID</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">EARLY, JAMES</ENT>
                        <ENT>NEW MILFORD, CT</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">EDWARDS, CYNTHIA</ENT>
                        <ENT>JONESVILLE, VA</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">ELMEER, GORDON</ENT>
                        <ENT>DERRY, NH</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">ENNIS, ANNA-DALE</ENT>
                        <ENT>YULEE, FL</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">ESGUERRA, CORNELIO</ENT>
                        <ENT>MESA, AZ</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <PRTPAGE P="65606"/>
                        <ENT I="01">FARIN, ANNA </ENT>
                        <ENT>MIAMI BEACH, FL</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">FINLEY, JANE</ENT>
                        <ENT>PADUCAH, KY</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">FINNIE, AMANDA</ENT>
                        <ENT>MADISONVILLE, KY</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">FOUGHTZ, ROBIN</ENT>
                        <ENT>ELK GROVE, CA</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">FULGHUM, ROBERTA</ENT>
                        <ENT>BAILEY, NC</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">GALLIEN, MAUDIE</ENT>
                        <ENT>NORTHPORT, AL</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">GEORGE, GINGER</ENT>
                        <ENT>BIRMINGHAM, AL</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">GERKIN, VICKI</ENT>
                        <ENT>MITCHELL, IN</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">GERVAIS, TINA</ENT>
                        <ENT>OWENS CROSS RDS, AL</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">GOLDSMITH, WILLIAM</ENT>
                        <ENT>LEXINGTON, KY</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">GOULD, CAROL</ENT>
                        <ENT>NEW IPSWITCH, NH</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">GREEN, AARON</ENT>
                        <ENT>SPOKANE, WA</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">GUINN, LISA</ENT>
                        <ENT>SPRINGFIELD, IL</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">HANSHEW, EVELYN</ENT>
                        <ENT>RENTON, WA</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">HARKONEN, JOHN</ENT>
                        <ENT>LOUISVILLE, KY</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">HARRIS, FITZ</ENT>
                        <ENT>MIAMI, FL</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">HART-TOWN, RAGEN</ENT>
                        <ENT>SNOHOMISH, WA</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">HERMOSURA, RICARDO</ENT>
                        <ENT>SUNNYVALE, CA</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">HOGATE, MARY</ENT>
                        <ENT>MENDOTA, IL</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">HOLDEN, JEFFREY</ENT>
                        <ENT>LATROBE, PA</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">HOMME, JULIE</ENT>
                        <ENT>KENNEWICK, WA</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">HORNSBY, DARIN</ENT>
                        <ENT>LOVELAND, OH</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">JENSEN, MARGARET</ENT>
                        <ENT>KELOS, WA</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">JOHNSON, HERBERT</ENT>
                        <ENT>MAYO, FL</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">JOHNSON, JOANNE</ENT>
                        <ENT>CLEARWATER, FL</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">JOHNSTON, TERRI</ENT>
                        <ENT>TYNER, KY</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">JONES, AWANDA</ENT>
                        <ENT>WESTCHESTER, IL</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">JONES, VICKI</ENT>
                        <ENT>HARRDOSBURG, KY</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">JORDAN, LISA</ENT>
                        <ENT>SPRING HOPE, NC</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">KARTY, JACQUELIN</ENT>
                        <ENT>WAURIKA, OK</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">KENT, AMY</ENT>
                        <ENT>MIAMI, FL</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">KIDDER, CHRISTINE</ENT>
                        <ENT>GLENDALE, CA</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">KING, DORA</ENT>
                        <ENT>SEYMOUR, TN</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">KING, LISA</ENT>
                        <ENT>CAIRO, NY</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">KING, PRESTON</ENT>
                        <ENT>JENNINGS, FL</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">KINNEY, JOSEPH THOMAS</ENT>
                        <ENT>ORLAND, FL</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">KIPER, KEVIN</ENT>
                        <ENT>PAWLING, NY</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">KNOX, DENISE</ENT>
                        <ENT>MCKEESPORT, PA</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">KOTECKI, LISA</ENT>
                        <ENT>WATERFORD, CT</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">KOTLER, JOSEPH</ENT>
                        <ENT>AVENTURA, FL</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">KRUSE, OLGAELENA</ENT>
                        <ENT>BUSHNELL, FL</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">LAMBERT, MARTHA</ENT>
                        <ENT>OSWEGO, NY</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">LEMAK, MARILYN</ENT>
                        <ENT>DWIGHT, IL</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">LEMINGS, SHELLEY</ENT>
                        <ENT>CLINTON, AR</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">LEPAGE, LINDA</ENT>
                        <ENT>GLOUCESTER, MA</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">LIDDLE, KIMBERLY</ENT>
                        <ENT>BOWLING GREEN, KY</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">LITTERAL, AMY</ENT>
                        <ENT>ASHLAND, KY</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">LOUQUE, CATHERINE</ENT>
                        <ENT>HUNTSVILLE, AL</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">MAISEL, LINDA</ENT>
                        <ENT>RENO, NV</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">MANZI, DEBORAH</ENT>
                        <ENT>NORTH HAVEN, CT</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">MARLOW, JESSICA</ENT>
                        <ENT>JELLICO, TN</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">MARLOW, KATHLEEN</ENT>
                        <ENT>WELLINGTON, FL</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">MARSHALL, DONNA</ENT>
                        <ENT>NEWTON, MA</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">MARTIN, BRANT</ENT>
                        <ENT>NORTH PORT, FL</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">MARTINSON, DEBORAH</ENT>
                        <ENT>NEW MILFORD, CT</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">MASON, JEFFREY</ENT>
                        <ENT>VENTURA, CA</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">MATTE, KIMBERLY</ENT>
                        <ENT>HENDERSONVILLE, NC</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">MCELRATH, MITCHALENA</ENT>
                        <ENT>WHITEVILLE, NC</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">MEYER, MELISSA</ENT>
                        <ENT>SOMERSET, CA</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">MIDGETTE, JENNIFER</ENT>
                        <ENT>ROANOKE RAPIDS, NC</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">MIKHAIL, PETER</ENT>
                        <ENT>ELMONT, NY</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">MILLS, ANNE</ENT>
                        <ENT>PITTSBURGH, PA</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">MIMNAGH, JANICE</ENT>
                        <ENT>WINTER HAVEN, FL</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">MISHRA, RAJENDRA</ENT>
                        <ENT>DOUGLASTON, NY</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">MOODY, JACKI</ENT>
                        <ENT>LOUISVILLE, KY</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">MOORE, KEVIN</ENT>
                        <ENT>SHASTA, CA</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">MOORE, THOMAS</ENT>
                        <ENT>CORBIN, KY</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">MOSER, DIANA</ENT>
                        <ENT>TAHLEQUAH, OK</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">MOUL, MARIANNE</ENT>
                        <ENT>DOWNINGTOWN, PA</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">MUELLER, SUSAN</ENT>
                        <ENT>PHOENIX, AZ</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">MUNOZ, ESTELLA</ENT>
                        <ENT>CHANDLER, AZ</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">NELSON, PATRICIA</ENT>
                        <ENT>GAINESVILLE, FL</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">NESTER, SHANE</ENT>
                        <ENT>MESA, AZ</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">NICHOLS, JOHN</ENT>
                        <ENT>TACOMA, WA</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <PRTPAGE P="65607"/>
                        <ENT I="01">NUNN, AMY </ENT>
                        <ENT>NEW TAZEWELL, TN</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">O'NEILL, LISA</ENT>
                        <ENT>WAKEFIELD, MA</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">OLSEN, PAM</ENT>
                        <ENT>PHILADELPHIA, PA</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">ORT, CHARLES</ENT>
                        <ENT>HACKETTSTOWN, NJ</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">OSTROM, MARSHA</ENT>
                        <ENT>MILFORD, MA</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">PACE, MIMI</ENT>
                        <ENT>BRADENTON, FL</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">PADGETT, LISA</ENT>
                        <ENT>BONIFAY, FL</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">PANICO, BARBARA</ENT>
                        <ENT>SYRACUSE, NY</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">PANTALL, CARL</ENT>
                        <ENT>SUMMERFIELD, FL</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">PASSER, ANNETTE</ENT>
                        <ENT>SCOTTSDALE, AZ</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">PECK, CHRISTINE</ENT>
                        <ENT>HEMET, CA</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">PELCZARSKI, JUDITH</ENT>
                        <ENT>HOLYOKE, MA</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">PENDZICK, RICK</ENT>
                        <ENT>DANBURY, CT</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">PEREZ, LUIS </ENT>
                        <ENT>CHULA VISTA, CA</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">PETERSON, CHERYL</ENT>
                        <ENT>FARRAGUT, IA</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">PETROCELLI, LORRAINE</ENT>
                        <ENT>BRISTOL, CT</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">PHILLIPS, SHERRY</ENT>
                        <ENT>TUBA CITY, CA</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">PITTMAN, SHANNON</ENT>
                        <ENT>WAYNESBORO, PA</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">POLITIS, JOANNA</ENT>
                        <ENT>CHARLOTTE, NC</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">RAM, RISHI</ENT>
                        <ENT>MODESTO, CA</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">REDDING, JENIFER</ENT>
                        <ENT>CONESUS, NY</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">REEVES, JENNIFER</ENT>
                        <ENT>TROUTMAN, NC</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">RHODES, MICHELLE</ENT>
                        <ENT>BUTLER, PA</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">RILEY, DONNA</ENT>
                        <ENT>NEW BEDFORD, MA</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">RODERICK, PAULA</ENT>
                        <ENT>NORTON, MA</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">RONEY, MICHELE</ENT>
                        <ENT>NORTH VERSAILLES, PA</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">SANTANA, NANCY</ENT>
                        <ENT>MIAMI, FL</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">SARMIENTO, BENJAMIN</ENT>
                        <ENT>VALLEJO, CA</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">SAYRE, DEIDRE</ENT>
                        <ENT>LUCEDALE, MS</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">SEBASTIAN-GUANDOLO, CYNTHIA</ENT>
                        <ENT>HOLLYWOOD, FL</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">SELBERG, CAROL</ENT>
                        <ENT>YAKIMA, WA</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">SHAMP, ANNMARIE</ENT>
                        <ENT>W PALM BEACH, FL</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">SHEFFIELD, ALTON</ENT>
                        <ENT>PORT ORANGE, FL</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">SIC-CUA, KAREN</ENT>
                        <ENT>BALTIMORE, MD</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">SIMAY, DOUGLAS</ENT>
                        <ENT>LA JOLLA, CA</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">SLOAN, ELLA</ENT>
                        <ENT>SHARPSBURG, KY</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">SMITH, CHAD</ENT>
                        <ENT>ALTAMONTE SPRINGS, FL</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">SPENCER, LASHAWNDA</ENT>
                        <ENT>COCOA, FL</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">STAINBACK, PAMELA</ENT>
                        <ENT>OXFORD, NC</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">STANDARD, TAMMY</ENT>
                        <ENT>SALISBURY, NC</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">STECHER, KARL</ENT>
                        <ENT>GREENWOOD VILLAGE, CO</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">STEEL, SAMUEL</ENT>
                        <ENT>ELPASO, TX</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">STEINBERG, ANDREA</ENT>
                        <ENT>BROCKTON, MA</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">STEPHENSON, JEFFREY</ENT>
                        <ENT>S POINT, OH</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">STEPHENSON, SHARON</ENT>
                        <ENT>CLAYTON, NC</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">STODDARD, TAMMY</ENT>
                        <ENT>REW, PA</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">SUMMERS, PATSY</ENT>
                        <ENT>STEVENSON, AL</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">TEBEAU, HOLLY</ENT>
                        <ENT>SAVANNAH, GA</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">THIEL, GREGORY</ENT>
                        <ENT>HENDERSON, NV</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">TRANELL, DENISE</ENT>
                        <ENT>HUNLOCK CREEK, PA</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">TUCKER, ANGELA</ENT>
                        <ENT>NEW CITY, NY</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">TUCKER, LISA</ENT>
                        <ENT>BROOKLET, GA</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">TURNER, FRANK</ENT>
                        <ENT>WARRENTON, VA</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">VANCE, DEBRAH</ENT>
                        <ENT>FAYETTEVILLE, NC</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">VASQUEZ, ANGELA</ENT>
                        <ENT>FRESNO, CA</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">VAUGHAN, DARA</ENT>
                        <ENT>SEDALIA, KY</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">VERBECK, MELISSA</ENT>
                        <ENT>TAYLORSVILLE, KY</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">VILLAFANE, KATHRYN</ENT>
                        <ENT>SNOW CAMP, NC</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">WALSTON, DENNIS</ENT>
                        <ENT>LAS VEGAS, NV</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">WESTLAKE, LAURIE</ENT>
                        <ENT>PORT ANGELES, WA</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">WHITE, CHARLIETTE</ENT>
                        <ENT>LAKE CITY, FL</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">WILLIAMS, JEROME</ENT>
                        <ENT>GRANADA HILLS, CA</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">WOOD, JOSHUA</ENT>
                        <ENT>COLLEGE PLACE, WA</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">WOOLSON, SUSAN</ENT>
                        <ENT>WORCESTER, MA</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">YOST, DAVID</ENT>
                        <ENT>SPARKS, NV</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">YOUNG, KIMBERLY</ENT>
                        <ENT>BOWLING GREEN, KY</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW RUL="s">
                        <ENT I="01">ZHAO, CHUN</ENT>
                        <ENT>EUREKA, CA</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW EXPSTB="02" RUL="s">
                        <ENT I="21">
                            <E T="02">FEDERAL/STATE EXCLUSION/SUSPENSION</E>
                        </ENT>
                    </ROW>
                    <ROW EXPSTB="00">
                        <ENT I="01">KUMAR, DAVID</ENT>
                        <ENT>UNION, NJ</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">PARIVAN INVALID COACH SERVICES</ENT>
                        <ENT>EDISON, NJ</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">PATEL, ASHOK</ENT>
                        <ENT>EDISON, NJ</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW RUL="s">
                        <ENT I="01">TULSANIA, NITAN</ENT>
                        <ENT>BASKING RIDGE, NJ </ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW EXPSTB="02" RUL="s">
                        <PRTPAGE P="65608"/>
                        <ENT I="21">
                            <E T="02">FRAUD/KICKBACKS/PROHIBITED ACTS/SETTLEMENT AGREEMENTS</E>
                        </ENT>
                    </ROW>
                    <ROW EXPSTB="00">
                        <ENT I="01">KUMAR, ANIL</ENT>
                        <ENT>MONMOUTH JUNCTION, NJ </ENT>
                        <ENT>9/21/2004 </ENT>
                    </ROW>
                    <ROW RUL="s">
                        <ENT I="01">KUMAR, SAROJ</ENT>
                        <ENT>MONMOUTH JUNCTION, NJ </ENT>
                        <ENT>9/21/2004 </ENT>
                    </ROW>
                    <ROW EXPSTB="02" RUL="s">
                        <ENT I="21">
                            <E T="02">OWNED/CONTROLLED BY CONVICTED ENTITIES</E>
                        </ENT>
                    </ROW>
                    <ROW EXPSTB="00">
                        <ENT I="01">BFK TRANSIT, INC</ENT>
                        <ENT>MILWAUKEE, WI</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">EMMETT FOOT &amp; ANKLE CLINIC</ENT>
                        <ENT>EMMETT, ID</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">KAZEM S SADATI DDS, PA</ENT>
                        <ENT>MIAMI LAKES, FL</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">MEDICAL SOUTH, INC</ENT>
                        <ENT>COLUMBUS, MS</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">ONTARIO FOOT &amp; ANKLE CLINIC</ENT>
                        <ENT>ONTARIO, OR</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">PALM BEACH TOTAL HEALTH CARE, INC</ENT>
                        <ENT>BOYNTON BEACH, FL </ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW RUL="s">
                        <ENT I="01">UNIVERSAL PLACEMENT, INC</ENT>
                        <ENT>LOS ANGELES, CA</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW EXPSTB="02" RUL="s">
                        <ENT I="21">
                            <E T="02">DEFAULT ON HEAL LOAN</E>
                        </ENT>
                    </ROW>
                    <ROW EXPSTB="00">
                        <ENT I="01">CONLEY, PAMELA</ENT>
                        <ENT>NEW ORLEANS, LA </ENT>
                        <ENT>9/14/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">FARHAT, HASSAN</ENT>
                        <ENT>STATEN ISLAND, NY </ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">LAM, THE</ENT>
                        <ENT>SAN JOSE, CA</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">SHEEHY, DANIEL</ENT>
                        <ENT>MIDDLETOWN, CA</ENT>
                        <ENT>11/18/2004 </ENT>
                    </ROW>
                </GPOTABLE>
                <SIG>
                    <DATED>Dated: November 3, 2004. </DATED>
                    <NAME>Katherine B. Petrowski, </NAME>
                    <TITLE>Director, Exclusions Staff, Office of Inspector General. </TITLE>
                </SIG>
            </PREAMB>
            <FRDOC>[FR Doc. 04-25251 Filed 11-12-04; 8:45 am] </FRDOC>
            <BILCOD>BILLING CODE 4150-04-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF HEALTH AND HUMAN SERVICES</AGENCY>
                <SUBAGY>National Institutes of Health</SUBAGY>
                <SUBJECT>Proposed Collection; Comment Request; Outcome Evaluation of the Fogarty International Center (FIC) AIDS International Training and Research Program (AITRP)</SUBJECT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the Fogarty International Center (FIC), the National Institutes of Health (NIH), will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval.</P>
                    <P>
                        <E T="03">Proposed Collection: Title:</E>
                         Outcome Evaluation of the FIC AIDS International Training and Research Program (AITRP). 
                        <E T="03">Type of Information Collection Request:</E>
                         New. 
                        <E T="03">Need and Use of Information Collection:</E>
                         This study will assess the outputs, outcomes and impacts of the AIDS International Training and Research Program (AITRP). The findings will provide valuable information concerning: (1) The research capacity development, collaboration, public health, and public policy outputs, outcomes, and impacts of AITRP at the program level and country level; (2) management and policy implications for the AITRP program based on trainee responses. 
                        <E T="03">Frequency of Response:</E>
                         Once. 
                        <E T="03">Affected Public:</E>
                         none. 
                        <E T="03">Type of Respondents:</E>
                         Trainees involved in the AITRP program. There are no Capital Costs to report. There are no Operating or Maintenance Costs to report.
                    </P>
                </SUM>
                <GPOTABLE COLS="5" OPTS="L2,i1,s50" CDEF="12,12,12,12,">
                    <TTITLE>  </TTITLE>
                    <BOXHD>
                        <CHED H="1">Type of respondents </CHED>
                        <CHED H="1">
                            Estimated number of 
                            <LI>respondents </LI>
                        </CHED>
                        <CHED H="1">
                            Estimated number of 
                            <LI>responses per respondent </LI>
                        </CHED>
                        <CHED H="1">
                            Average 
                            <LI>burden hours </LI>
                            <LI>per response </LI>
                        </CHED>
                        <CHED H="1">
                            Estimated total annual burden hours 
                            <LI>requested </LI>
                        </CHED>
                    </BOXHD>
                    <ROW RUL="n,s">
                        <ENT I="01">Trainees </ENT>
                        <ENT>300 </ENT>
                        <ENT>1 </ENT>
                        <ENT>1 </ENT>
                        <ENT>300 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="03">Total </ENT>
                        <ENT>300 </ENT>
                        <ENT>300 </ENT>
                    </ROW>
                </GPOTABLE>
                <GPOTABLE COLS="5" OPTS="L2,i1,s50" CDEF="12,12,12,12,">
                    <TTITLE>  </TTITLE>
                    <BOXHD>
                        <CHED H="1">Type of respondents </CHED>
                        <CHED H="1">
                            Estimated number of 
                            <LI>respondents </LI>
                        </CHED>
                        <CHED H="1">Frequency of response </CHED>
                        <CHED H="1">
                            Average 
                            <LI>hourly wage </LI>
                            <LI>rate </LI>
                        </CHED>
                        <CHED H="1">Respondent cost </CHED>
                    </BOXHD>
                    <ROW>
                        <ENT I="01">Trainees </ENT>
                        <ENT>300 </ENT>
                        <ENT>1 </ENT>
                        <ENT>$5.00/hr </ENT>
                        <ENT>$1500 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="03">Total Cost </ENT>
                        <ENT/>
                        <ENT/>
                        <ENT/>
                        <ENT>$1500 </ENT>
                    </ROW>
                </GPOTABLE>
                <P>
                    <E T="03">Request for Comments:</E>
                     Written comments and/or suggestions from the public and affected agencies are invited on one or more of the following points: (1) Whether the proposed collection of information is necessary for the proper performance of the function of the agency, including whether the information will have practical utility; (2) the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of 
                    <PRTPAGE P="65609"/>
                    the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on those who are to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology.
                </P>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        To request more information on the proposed project or to obtain a copy of the data collection plans and instruments, contact Dr. Linda Kupfer, Fogarty International Center, National Institutes of Health, 16 Center Drive, Building 16, Bethesda, MD 20892-6705 or call non-toll-free number 301-496-3288 or E-mail your request, including your address to: 
                        <E T="03">Kupferl@mail.nih.gov</E>
                        .
                    </P>
                    <P>
                        <E T="03">Comments Due Date:</E>
                         Comments regarding this information collection are best assured of having their full effect if received within 60-days of the date of this publication.
                    </P>
                    <SIG>
                        <DATED>Dated: November 5, 2004.</DATED>
                        <NAME>Richard Miller,</NAME>
                        <TITLE>Executive Officer, FIC, National Institutes of Health.</TITLE>
                    </SIG>
                </FURINF>
            </PREAMB>
            <FRDOC>[FR Doc. 04-25281 Filed 11-12-04; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4140-01-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF HEALTH AND HUMAN SERVICES </AGENCY>
                <SUBAGY>National Institutes of Health </SUBAGY>
                <SUBJECT>Government-Owned Inventions; Availability for Licensing </SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>National Institutes of Health, Public Health Service, DHHS. </P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 207 to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing. </P>
                </SUM>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>Licensing information and copies of the U.S. patent applications listed below may be obtained by writing to the indicated licensing contact at the Office of Technology Transfer, National Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville, Maryland 20852-3804; telephone: 301/496-7057; fax: 301/402-0220. A signed Confidential Disclosure Agreement will be required to receive copies of the patent applications. </P>
                </ADD>
                <HD SOURCE="HD1">Metal Chelators and Target-Moiety Complexes for Imaging </HD>
                <FP SOURCE="FP-1">Martin W. Brechbiel and Thomas Clifford (NCI). </FP>
                <FP SOURCE="FP-1">U.S. Provisional Application filed 23 Aug 2004 (DHHS Reference No. E-317-2004). </FP>
                <FP SOURCE="FP-1">
                    <E T="03">Licensing Contact:</E>
                     Michael Shmilovich; 301/435-5019; 
                    <E T="03">shmilovm@mail.nih.gov.</E>
                </FP>
                <P>
                    Available for licensing and commercial development are bifunctional metal chelators, metal chelator-targeting moiety complexes, metal chelator-targeting moiety-metal conjugates, kits, and methods of preparing them. These chelators are useful in diagnosing and/or treatment of cancer and thrombosis. The metal chelators may be used in conventional and solid-phase synthetic methods to form targeting moieties (
                    <E T="03">e.g.</E>
                    , peptides, and Starburst polyamidoamine dendrimers (PAMAM), capable of conjugating diagnostic and/or therapeutic metals. The formulae for two such chelators is shown below: 
                </P>
                <GPH SPAN="3" DEEP="263">
                    <GID>EN15NO04A.054</GID>
                </GPH>
                <HD SOURCE="HD1">Anti-HIV Peptide Secreting Bacteria: Therapeutics and Methods of Use </HD>
                <FP SOURCE="FP-1">Dean Hamer (NCI). </FP>
                <FP SOURCE="FP-1">U.S. Provisional Application No. 60/604,051 filed 25 Aug 2004 (DHHS Reference No. E-233-2004/0-US-01). </FP>
                <FP SOURCE="FP-1">
                    <E T="03">Licensing Contact:</E>
                     Michael Shmilovich; 301/435-5019; 
                    <E T="03">shmilovm@mail.nih.gov.</E>
                </FP>
                <P>
                    Available for licensing and commercial development are genetically 
                    <PRTPAGE P="65610"/>
                    engineered commensal bacteria compositions that secrete HIV infectivity interfering peptides with the aid of co-expressed translocation mediators such as 
                    <E T="03">HylB, HylD</E>
                     or 
                    <E T="03">tolC</E>
                     gene products. The bacteria can be, for example, 
                    <E T="03">Escherichia coli</E>
                     and are preferably those that colonize the gastrointestinal or genitourinary tracts. The secreted anti-HIV peptide can be a functional inhibitory fragment from the C-terminus of HIV, SHIV or SIV, or an inhibitory peptide derived from the N-terminus receptor-binding domain of SIV gp41, HIV-1 gp41, or HIV-2 gp41. The secreted anti-HIV peptide can also be a peptide from the allosteric domain of gp120, an extracellular loop of CCR5, an anti-CD4 immunoglobulin, a mimetic of CD4, an alpha-defensin or theta-defensin, a CD38 fragment homologous to the V3 loop of gp120, polphemusin II (a CXCR4 antagonist), a RANTES peptide that binds to CCR5 or an HIV surface binding peptide such as cyanovirin. 
                </P>
                <HD SOURCE="HD1">Method of Assessing Ischemia in a Patient </HD>
                <FP SOURCE="FP-1">Steven Warach, Lawrence Latour (NINDS). </FP>
                <FP SOURCE="FP-1">U.S. Provisional Application No. 60/381,611 filed 17 Mar 2002 (DHHS Reference No. E-082-2002/0-US-01); PCT Application No. PCT/US03/15368 filed 16 May 2003 (DHHS Reference No. E-082-2002/0-PCT-02). </FP>
                <FP SOURCE="FP-1">
                    <E T="03">Licensing Contact:</E>
                     Michael Shmilovich; 301/435-5019; 
                    <E T="03">shmilovm@mail.nih.gov.</E>
                </FP>
                <P>Hyperintense acute reperfusion marker (HARM) is well correlated with reperfusion and is a precursor to or concomitant with reperfusion injury. The inventors have developed a novel technique of assessing injuries associated with ischemia, stroke, or reperfusion injury in a patient by administering a contract agent to the patient, acquiring a fluid-attenuated inversion-recovery (FLAIR) image, and observing the presence or absence of HARM on the acquired image. The technique can also be used to determine the effectiveness of a therapeutic protocol for the treatment or prevention of reperfusion injury in a patient that has previously suffered an ischemic event. </P>
                <P>
                    This research has been described, in part, in Latour 
                    <E T="03">et al.</E>
                    , “Early Blood-Brain Barrier Disruption in Human Focal Brain Ischemia,” Ann. Neurol. 2004 56:568-477. 
                </P>
                <SIG>
                    <DATED>Dated: November 4, 2004. </DATED>
                    <NAME>Steven M. Ferguson, </NAME>
                    <TITLE>Director, Division of Technology Development and Transfer, Office of Technology Transfer, National Institutes of Health.</TITLE>
                </SIG>
            </PREAMB>
            <FRDOC>[FR Doc. 04-25278 Filed 11-12-04; 8:45 am] </FRDOC>
            <BILCOD>BILLING CODE 4140-01-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF HEALTH AND HUMAN SERVICES </AGENCY>
                <SUBAGY>National Institutes of Health </SUBAGY>
                <SUBJECT>Government-Owned Inventions; Availability for Licensing </SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>National Institutes of Health, Public Health Service, DHHS. </P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice. </P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 207 to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing. </P>
                </SUM>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>Licensing information and copies of the U.S. patent applications listed below may be obtained by writing to the indicated licensing contact at the Office of Technology Transfer, National Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville, Maryland 20852-3804; telephone: 301/496-7057; fax: 301/402-0220. A signed Confidential Disclosure Agreement will be required to receive copies of the patent applications. </P>
                </ADD>
                <HD SOURCE="HD1">Infectious Clone of Human Parvovirus B19 and Methods of Use </HD>
                <FP SOURCE="FP-1">
                    Ning Zhi 
                    <E T="03">et al.</E>
                     (NHLBI). 
                </FP>
                <FP SOURCE="FP-1">U.S. Patent Application No. 10/887,770 filed 09 Jul 2004 (DHHS Reference No.E-178-2004/0-US-01 and corresponding Canadian patent application (DHHS Reference No. E-178-2004/0-CA-02). </FP>
                <FP SOURCE="FP-1">
                    <E T="03">Licensing Contact:</E>
                     Susan Ano; 301/435-5515; 
                    <E T="03">anos@mail.nih.gov.</E>
                </FP>
                <P>This technology described in this patent application relates the first reported infectious human parvovirus B19 clone, methods of cloning the parvovirus B19 genome as well as other viral genomes that have secondary DNA structures that are unstable in bacterial cells. The infectious clone and methods of producing the same would be useful in producing infectious virus, which can in turn be used, among other things, to identify and develop therapeutic agents for treatment and/or prevention of human parvovirus B19 infections. The infectious parvovirus B19 clone is also available for licensing. Additional information about this invention can be found in Virology 2004, 318(1), 142-152. </P>
                <HD SOURCE="HD1">Immunogenic Compositions for Eradication of Latent HIV </HD>
                <FP SOURCE="FP-1">
                    Genoveffa Franchini 
                    <E T="03">et al.</E>
                     (NCI). 
                </FP>
                <FP SOURCE="FP-1">U.S. Provisional Application No. 60/536,467 filed 13 Jan 2004 (DHHS Reference No. E-072-2004/0-US-01); U.S. Provisional Application No. 60/536,976 filed 16 Jan 2004 (DHHS Reference No. E-072-2004/1-US-01). </FP>
                <FP SOURCE="FP-1">
                    <E T="03">Licensing Contact:</E>
                     Susan Ano; 301/435-5515; 
                    <E T="03">anos@mail.nih.gov.</E>
                </FP>
                <P>
                    HIV infects CD4+ cells and, after incorporation of the viral genome into the host genome, can either produce infectious virus or remain latent. HIV that is latent presents a challenge for complete removal of the virus in infected individuals and is becoming an increasingly important consideration in the identification of potential therapeutics or treatment regimens. This patent application describes immunogenic compositions based on inhibiting the function of p28
                    <E T="51">TEV</E>
                     protein, the first protein expressed during HIV infection, for treatment of latent HIV infection. Specifically, these compositions include the p28
                    <E T="51">TEV</E>
                     polypeptide, a polypeptide with significant sequence homology to p28
                    <E T="51">TEV</E>
                    , or immunogenic fragments of these polypeptides. Additional compositions include antibodies and other compounds that act to inhibit p28
                    <E T="51">TEV</E>
                     activity. This technology can also be utilized to detect latent HIV in biological samples. These compositions and methods offer a potential solution for complete virus eradication in therapeutic treatment of HIV infected individuals. 
                </P>
                <HD SOURCE="HD1">Accelerated Vaccination Strategies To Provide Protection Against Viral Infections </HD>
                <FP SOURCE="FP-1">
                    Gary J. Nabel 
                    <E T="03">et al.</E>
                     (NIAID). 
                </FP>
                <FP SOURCE="FP-1">U.S. Provisional Application No. 60/491,933 filed 01 Aug 2003 (DHHS Reference No. E-317-2003/0-US-01); PCT Application filed on 01 Aug 2004 (DHHS Reference No. E-317-2003/0-PCT-02). </FP>
                <FP SOURCE="FP-1">
                    <E T="03">Licensing Contact:</E>
                     Susan Ano; 301/435-5515; 
                    <E T="03">anos@mail.nih.gov.</E>
                </FP>
                <P>
                    The technology described in this patent application relates to recombinant viruses for use as vaccines. These viruses contain a single or plurality of sequences encoding antigens from pathogenic viruses 
                    <PRTPAGE P="65611"/>
                    heterologous to the recombinant virus. The antigenic sequences from pathogens such as influenza, RSV, measles, HPV, Epstein-Barr, Lassa, Polio, West Nile, Dengue, HIV-1 and 2, HTLV, herpes simplex virus, hepatitis viruses A, B, C, D, and E, Marburg, Ebola, and SARS are inserted into non-essential regions of either replication-competent or replication-defective adenovirus, adeno-associated virus (AAV), SV40 virus, herpes simplex virus, or vaccinia virus vectors that retain elements necessary for infectivity but are devoid of any pathogenic sequence elements. In these recombinant viruses, the antigenic sequences are operably linked to viral control elements. Thus, these recombinant viruses are capable of infecting a host and mounting an immune response specific to a given virus(es) without eliciting pathogenicity. In addition to the above, the technology also describes methods of accelerated pre-exposure or post-exposure vaccination comprising single-dose administration. The attractive features of this invention include the broad applicability of the recombinant viruses against a number of common pathogens and the potential of using them against other emergent infectious viruses; the ability of the vaccines to stimulate both cellular and humoral immune responses in humans and other hosts; and the ease of administration in single dose form via a number of routes. This technology is now available for licensing. Some fields of use may not be available. 
                </P>
                <SIG>
                    <DATED>Dated: November 9, 2004. </DATED>
                    <NAME>Steven M. Ferguson, </NAME>
                    <TITLE>Director, Division of Technology Development and Transfer, Office of Technology Transfer, National Institutes of Health. </TITLE>
                </SIG>
            </PREAMB>
            <FRDOC>[FR Doc. 04-25279 Filed 11-12-04; 8:45 am] </FRDOC>
            <BILCOD>BILLING CODE 4140-01-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF HEALTH AND HUMAN SERVICES</AGENCY>
                <SUBAGY>National Institutes of Health</SUBAGY>
                <SUBJECT>National Cancer Institute; Notice of Meeting</SUBJECT>
                <P>Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), notice is hereby given of the meeting of the National Cancer Advisory Board.</P>
                <P>The meeting will be open to the public as indicated below, with attendance limited to space available. Individuals who plan to attend and need special assistance, such as sign language interpretation or other reasonable accommodations, should notify the Contact Person listed below in advance of the meeting.</P>
                <P>A portion of the meeting will be closed to the public in accordance with the provision set forth in section 552b(6), as amended. The discussion could disclose personal information concerning NCI Staff and/or its contractors, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.</P>
                <EXTRACT>
                    <P>
                        <E T="03">Name of Committee:</E>
                         National Cancer Advisory Board.
                    </P>
                    <P>
                        <E T="03">Open:</E>
                         November 30, 2004, 8:30 a.m. to 5:30 p.m.
                    </P>
                    <P>
                        <E T="03">Agenda:</E>
                         Program reports and presentations; Business of the Board.
                    </P>
                    <P>
                        <E T="03">Place:</E>
                         Name Cancer Institute, 9000 Rockville Pike, Building 31, C Wing, 6th Floor, Conference Room 10, Bethesda, MD 20892.
                    </P>
                    <P>
                        <E T="03">Contact Person:</E>
                         Dr. Paulette S. Gray, Executive Secretary, National Cancer Institute, National Institutes of Health, 6116 Executive Boulevard, 8th Floor, Room 8001, Bethesda, MD 20892-8327, (301) 496-5147.
                    </P>
                    <P>
                        <E T="03">Name of Committee:</E>
                         National Cancer Advisory Board.
                    </P>
                    <P>
                        <E T="03">Open:</E>
                         December 1, 2004, 8:30 a.m. to 10:30 a.m.
                    </P>
                    <P>
                        <E T="03">Agenda:</E>
                         Program reports and presentations; Business of the Board.
                    </P>
                    <P>
                        <E T="03">Contact Person:</E>
                         Dr. Paulette S. Gray, Executive Secretary, National Cancer Institute, National Institutes of Health, 6116 Executive Boulevard, 8th Floor, Room 8001, Bethesda, MD 20892-8327, (301) 496-5147.
                    </P>
                    <P>
                        <E T="03">Name of Committee:</E>
                         National Cancer Advisory Board.
                    </P>
                    <P>
                        <E T="03">Closed:</E>
                         December 1, 2004, 10:30 a.m. to adjournment.
                    </P>
                    <P>
                        <E T="03">Agenda:</E>
                         Review intramural program site visit outcomes; Discussion of confidential personnel issues.
                    </P>
                    <P>
                        <E T="03">Contact Person:</E>
                         Dr. Paulette S. Gray, Executive Secretary, National Cancer Institute, National Institutes of Health, 6116 Executive Boulevard, 8th Floor, Room 8001, Bethesda, MD 20892-8327, (301) 496-5147.
                    </P>
                    <P>Any interested person may file written comments with the committee by forwarding the statement to the Contact Person listed on this notice. The statement should include the name, address, telephone number and when applicable, the business or professional affiliation of the interested person.</P>
                    <P>
                        Information is also available on the Institute's/Center's home page: 
                        <E T="03">deainfo.nci.nih.gov/advisory/ncab.htm,</E>
                         where an agenda and any additional information for the meeting will be posted when available.
                    </P>
                    <FP>(Catalogue of Federal Domestic Assistance Program Nos. 93.392, Cancer Construction; 93.393, Cancer Cause and Prevention Research; 93.394, Cancer Detection and Diagnosis Research; 93.395, Cancer Treatment Research; 93.396, Cancer Biology Research; 93.397, Cancer Centers Support; 93.398, Cancer Research Manpower; 93.399, Cancer Control, National Institutes of Health, HHS)</FP>
                </EXTRACT>
                <SIG>
                    <DATED>Dated: November 5, 2004.</DATED>
                    <NAME>LaVerne Y. Stringfield,</NAME>
                    <TITLE>Director, Office of Federal Advisory Committee Policy.</TITLE>
                </SIG>
            </PREAMB>
            <FRDOC>[FR Doc. 04-25271 Filed 11-12-04; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4140-01-M</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF HEALTH AND HUMAN SERVICES</AGENCY>
                <SUBAGY>National Institutes of Health</SUBAGY>
                <SUBJECT>National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meetings</SUBJECT>
                <P>Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), notice is hereby given of the following meetings.</P>
                <P>The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.</P>
                <EXTRACT>
                    <P>
                        <E T="03">Name of Committee:</E>
                         National Institute of Diabetes and Digestive and Kidney Diseases Special Emphasis Panel, Urinary Infection.
                    </P>
                    <P>
                        <E T="03">Date:</E>
                         December 7, 2004.
                    </P>
                    <P>
                        <E T="03">Time:</E>
                         8 a.m. to 5 p.m.
                    </P>
                    <P>
                        <E T="03">Agenda:</E>
                         To reveiw and evaluate grant applications.
                    </P>
                    <P>
                        <E T="03">Place:</E>
                         Courtyard By Marriott, 2899 Jefferson Davis Highway, Arlington, VA 22202.
                    </P>
                    <P>
                        <E T="03">Contact Person:</E>
                         Maxine A. Lesniak, MPH, Scientific Review Administrator, Review Branch, DEA, NIDDK, National Institutes of Health, Room 756, 6707 Democracy Boulevard, Bethesda, MD 20892-5452, (301) 594-7792, 
                        <E T="03">lesniakm@extra.niddk.nih.gov.</E>
                    </P>
                    <P>
                        <E T="03">Name of Committee:</E>
                         National Institute of Diabetes and Digestive and Kidney Diseases Special Emphasis Panel, Diabetes.
                    </P>
                    <P>
                        <E T="03">Date:</E>
                         December 13, 2004.
                    </P>
                    <P>
                        <E T="03">Time:</E>
                         8 a.m. to 5 p.m.
                    </P>
                    <P>
                        <E T="03">Agenda:</E>
                         To reveiw and evaluate grant applications.
                    </P>
                    <P>
                        <E T="03">Place:</E>
                         Hyatt Regency—Crystal City, 2799 Jefferson Davis Highway, Arlington, VA 22202.
                    </P>
                    <P>
                        <E T="03">Contact Person:</E>
                         Maxine A. Lesniak, MPH, Scientific Review Administrator, Review Branch, DEA, NIDDK, National Institutes of Health, Room 756, 6707 Democracy Boulevard, Bethesda, MD 20892-5452, (301) 594-7792, 
                        <E T="03">lesniakm@extra.niddk.nih.gov.</E>
                    </P>
                    <P>
                        <E T="03">Name of Committee:</E>
                         National Institute of Diabetes and Digestive and Kidney Diseases Special Emphasis Panel, Clinical Studies of Kidney Disease.
                    </P>
                    <P>
                        <E T="03">Date:</E>
                         December 16, 2004.
                        <PRTPAGE P="65612"/>
                    </P>
                    <P>
                        <E T="03">Time:</E>
                         8 a.m. to 5 p.m.
                    </P>
                    <P>
                        <E T="03">Agenda:</E>
                         To reveiw and evaluate grant applications.
                    </P>
                    <P>
                        <E T="03">Place:</E>
                         Marriott Baltimore, Washington International Airport, 1743 West Nursery Road, Baltimore, MD 21240.
                    </P>
                    <P>
                        <E T="03">Contact Person:</E>
                         Dan E. Matsumoto, PhD, Scientific Review Administrator, Review Branch, DEA, NIDDK, Room 749, 6707 Democracy Boulevard, National Institutes of Health, Bethesda, MD 20892-5452, (301) 594-8894, 
                        <E T="03">matsumotod@extra.niddk.nih.gov.</E>
                    </P>
                    <FP>(Catalogue of Federal Domestic Assistance Program Nos. 93.847, Diabetes, Endocrinology and Metabolic Research; 93.848, Digestive Diseases and Nutrition Research; 93.849, Kidney Diseases, Urology and Hematology Research, National Institutes of Health, HHS)</FP>
                </EXTRACT>
                <SIG>
                    <DATED>Dated: November 4, 2004.</DATED>
                    <NAME>LaVerne Y. Stringfield, </NAME>
                    <TITLE>Director, Office of Federal Advisory Committee Policy.</TITLE>
                </SIG>
            </PREAMB>
            <FRDOC>[FR Doc. 04-25270  Filed 11-12-04; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4140-01-M</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF HEALTH AND HUMAN SERVICES</AGENCY>
                <SUBAGY>National Institutes of Health</SUBAGY>
                <SUBJECT>National Institute of Child Health and Human Development; Notice of Closed Meeting</SUBJECT>
                <P>Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), notice is hereby given of the following meeting.</P>
                <P>The meeting will be closed to the public in accordance with the provisions set forth is sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. </P>
                <EXTRACT>
                    <P>
                        <E T="03">Name of Committee:</E>
                         National Institute of Child Health and Human Development Special Emphasis Panel, Communication of People with Mental Retardation.
                    </P>
                    <P>
                        <E T="03">Date:</E>
                         December 6, 2004.
                    </P>
                    <P>
                        <E T="03">Time:</E>
                         9 a.m. to 1 p.m.
                    </P>
                    <P>
                        <E T="03">Agenda:</E>
                         To review and evaluate grant applications.
                    </P>
                    <P>
                        <E T="03">Place:</E>
                         Embassy Suites at the Chevy Chase Pavilion, 4300 Military Road, NW., Washington, DC 20015.
                    </P>
                    <P>
                        <E T="03">Contact Person:</E>
                         Marita R. Hopmann, PhD, Scientific Review Administrator, Division of Scientific Review, National Institute of Child Health and Human Development, 6100 Building, Room 5B01, Bethesda, MD 20892, (301) 435-6911, 
                        <E T="03">hopmannm@mail.nih.gov.</E>
                    </P>
                    <FP>(Catalogue of Federal Domestic Assistance Program Nos. 93.864, Population Research; 93.865, Research for Mothers and Children; 93.929, Center for Medical Rehabilitation Research; 93.209, Contraception and Infertility Loan Repayment Program, National Institutes of Health, HHS) </FP>
                </EXTRACT>
                <SIG>
                    <DATED>Dated: November 5, 2004.</DATED>
                    <NAME>LaVerne Y. Stringfield, </NAME>
                    <TITLE>Director, Office of Federal Advisory Committee Policy.</TITLE>
                </SIG>
            </PREAMB>
            <FRDOC>[FR Doc. 04-25272  Filed 11-12-04; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4140-01-M</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF HEALTH AND HUMAN SERVICES</AGENCY>
                <SUBAGY>National Institutes of Health</SUBAGY>
                <SUBJECT>National Institute of Child Health and Human Development; Notice of Closed Meeting</SUBJECT>
                <P>Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), notice is hereby given of the following meeting.</P>
                <P>The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.</P>
                <EXTRACT>
                    <P>
                        <E T="03">Name of Committee:</E>
                         National Institute of Child Health and Human Development Special Emphasis Panel, Women's Reproductive Health Research Career Development Program.
                    </P>
                    <P>
                        <E T="03">Date:</E>
                         November 22, 2004.
                    </P>
                    <P>
                        <E T="03">Time:</E>
                         9:30 a.m. to 5 p.m.
                    </P>
                    <P>
                        <E T="03">Agenda:</E>
                         To review and evaluate grant applications.
                    </P>
                    <P>
                        <E T="03">Place:</E>
                         Holiday Inn Select Bethesda, 8120 Wisconsin Avenue, Bethesda, MD 20814.
                    </P>
                    <P>
                        <E T="03">Contact Person:</E>
                         Gopal M. Bhatnagar, PhD, Scientific Review Administrator, National Institute of Child Health and Human Development, National Institutes of Health, 6100 Bldg Rm 5B01, Rockville, MD 20852, (301) 435-6889, 
                        <E T="03">bhatnagg@mail.nih.gov.</E>
                    </P>
                    <P>This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle.</P>
                    <FP>(Catalogue of Federal Domestic Assistance Program Nos. 93.864, Population Research; 93.865, Research for Mothers and Children; 93.929, Center for Medical Rehabilitation Research; 93.209, Contraception and Infertility Loan Repayment Program, National Institutes of Health, HHS)</FP>
                </EXTRACT>
                <SIG>
                    <DATED>Dated: November 5, 2004.</DATED>
                    <NAME>LaVerne Y. Stringfield,</NAME>
                    <TITLE>Director, Office of Federal Advisory Committee Policy.</TITLE>
                </SIG>
            </PREAMB>
            <FRDOC>[FR Doc. 04-25273  Filed 11-12-04; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4140-01-M</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF HEALTH AND HUMAN SERVICES</AGENCY>
                <SUBAGY>National Institutes of Health</SUBAGY>
                <SUBJECT>National Institute of Child Health and Human Development; Notice of Closed Meeting</SUBJECT>
                <P>Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), notice is hereby given of the following meeting.</P>
                <P>The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.</P>
                <EXTRACT>
                    <P>
                        <E T="03">Name of Committee:</E>
                         National Institute of Child Health and Human Development Special Emphasis Panel, Genes, Aneuploidy and Mamalian Development.
                    </P>
                    <P>
                        <E T="03">Date:</E>
                         November 17, 2004.
                    </P>
                    <P>
                        <E T="03">Time:</E>
                         9:30 a.m. to 3 p.m.
                    </P>
                    <P>
                        <E T="03">Agenda:</E>
                         To review and evaluate grant applications.
                    </P>
                    <P>
                        <E T="03">Place:</E>
                         Ramada Inn Rockville, 1775 Rockville Pike, Rockville, MD 20852.
                    </P>
                    <P>
                        <E T="03">Contact Person:</E>
                         Gopal M. Bhatnagar, PhD, Scientific Review Administrator, National Institutes of Child Health and Human Development, National Institutes of Health, 6100 Bldg Rm 5B01, Rockville, MD 20852, (301) 435-6889, 
                        <E T="03">bhatnagg@mail.nih.gov.</E>
                    </P>
                    <P>This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle.</P>
                    <FP>(Catalogue of Federal Domestic Assistance Program Nos. 93.864, Population Research; 93.865, Research for Mothers and Children; 93.929, Center for Medical Rehabilitation Research; 93.209, Contraception and Infertility Loan Repayment Program, National Institutes of Health, HHS)</FP>
                </EXTRACT>
                <SIG>
                    <DATED>Dated: November 5, 2004.</DATED>
                    <NAME>LaVerne Y. Stringfield,</NAME>
                    <TITLE>Director, Office of Federal Advisory Committee Policy.</TITLE>
                </SIG>
            </PREAMB>
            <FRDOC>[FR Doc. 04-25274 Filed 11-12-04; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4140-01-M</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <PRTPAGE P="65613"/>
                <AGENCY TYPE="S">DEPARTMENT OF HEALTH AND HUMAN SERVICES</AGENCY>
                <SUBAGY>National Institutes of Health</SUBAGY>
                <SUBJECT>National Institute of Child Health and Human Development; Notice of Closed Meeting</SUBJECT>
                <P>Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), notice is hereby given of the following meeting.</P>
                <P>The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.</P>
                <EXTRACT>
                    <P>
                        <E T="03">Name of Committee:</E>
                         National Institute of Child Health and Human Development Special Emphasis Panel Program Project: Changing Social Contexts &amp; Family Formations.
                    </P>
                    <P>
                        <E T="03">Date:</E>
                         December 3, 2004.
                    </P>
                    <P>
                        <E T="03">Time:</E>
                         8 a.m. to 1 p.m.
                    </P>
                    <P>
                        <E T="03">Agenda:</E>
                         To review and evaluate grant applications.
                    </P>
                    <P>
                        <E T="03">Place:</E>
                         Embassy Suites at the Chevy Chase Pavilion, 4300 Military Road, NW., Washington, DC 20015.
                    </P>
                    <P>
                        <E T="03">Contact Person:</E>
                         Carla T. Walls, PhD, Scientific Review Administrator, Division of Scientific Review, National Institute of Child Health, and Human Development, NIH, 6100 Executive Blvd., Room 5B01, Bethesda, MD 20892, (301) 435-6898, 
                        <E T="03">wallsc@mail.nih.gov.</E>
                    </P>
                    <FP>(Catalogue of Federal Domestic Assistance Program Nos. 93.864, Population Research; 93.865, Research for Mothers and Children; 93.929, Center for Medical Rehabilitation Research; 93.209 Contraception and Infertility Loan Repayment Program, National Institutes of Health, HHS)</FP>
                </EXTRACT>
                <SIG>
                    <DATED>Dated: November 5, 2004.</DATED>
                    <NAME>LaVerne Y. Stringfield,</NAME>
                    <TITLE>Director, Office of Federal Advisory Committee Policy.</TITLE>
                </SIG>
            </PREAMB>
            <FRDOC>[FR Doc. 04-25275  Filed 11-12-04; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4140-01-M</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF HEALTH AND HUMAN SERVICES</AGENCY>
                <SUBAGY>National Institutes of Health</SUBAGY>
                <SUBJECT>National Institute of Child Health and Human Development; Notice of Meeting</SUBJECT>
                <P>Pursuant to section 10(a) of the Federal Advisory  Committee Act, as amended (5 U.S.C. Appendix 2), notice is hereby given of a meeting of the National Advisory Board on Medical Rehabilitation Research.</P>
                <P>The meeting will be open to the public, with attendance limited to space available. Individuals who plan to attend and need special assistance, such as sign language interpretation or other reasonable accommodations, should notify the Contact Person listed below in advance of the meeting.</P>
                <EXTRACT>
                    <P>
                        <E T="03">Name of Committee:</E>
                         National Advisory Board on Medical Rehabilitation Research.
                    </P>
                    <P>
                        <E T="03">Date:</E>
                         December 2-3, 2004.
                    </P>
                    <P>
                        <E T="03">Time:</E>
                         December 2, 2004, 8:30 a.m. to 5:30 p.m.
                    </P>
                    <P>
                        <E T="03">Agenda:</E>
                         NICHD Director's Report presentation, Regional Research Networks, and an update on the Rehabilitation Medicine Scientist Training Program.
                    </P>
                    <P>
                        <E T="03">Place:</E>
                         Holiday Inn—Silver Spring, 8777 Georgia Avenue, Silver Spring, MD 20910.
                    </P>
                    <P>
                        <E T="03">Time:</E>
                         December 3, 2004, 8:30 am. to 12 p.m.
                    </P>
                    <P>
                        <E T="03">Agenda:</E>
                         Other business dealing with the NABMRR Board.
                    </P>
                    <P>
                        <E T="03">Place:</E>
                         Holiday Inn—Silver Spring, 8777 Georgia Avenue, Silver Spring, MD 20910.
                    </P>
                    <P>
                        <E T="03">Contact Person:</E>
                         Ralph M. Nitkin, PhD, Director, BSCD, National Center for Medical Rehabilitation Research, National Institute of Child Health and Human Development, NIH, 6100 Building, Room 2A03, Bethesda, MD 20892. (301) 402-4206.
                    </P>
                    <P>Any interested person may file written comments with the committee by forwarding the statement to the Contact Person listed on this notice. The statement should include the name, address, telephone number and when applicable, the business or professional affiliation of the interested person.</P>
                    <P>
                        Information is also available on the Institute's/Center's home page: 
                        <E T="03">http://www.nichd.nih.gov/about/ncmrr.htm</E>
                        , where an agenda and any additional information for the meeting will be posted when available.
                    </P>
                    <FP>(Catalogue of Federal Domestic Assistance Program Nos. 93.864, Population Research; 93.865, Research for Mothers and Children; 93.929, Center for Medical Rehabilitation Research; 93.209, Contraception and Infertility Loan Repayment Program, National Institutes of Health, HHS)</FP>
                </EXTRACT>
                <SIG>
                    <DATED>Dated: November 5, 2004.</DATED>
                    <NAME>LaVerne Y. Stringfield,</NAME>
                    <TITLE>Director, Office of Federal Advisory Committee Policy.</TITLE>
                </SIG>
            </PREAMB>
            <FRDOC>[FR Doc. 04-25276  Filed 11-12-04; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4140-01-M</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF HEALTH AND HUMAN SERVICES</AGENCY>
                <SUBAGY>National Institutes of Health</SUBAGY>
                <SUBJECT>National Institute of General Medical Sciences; Notice of Closed Meeting</SUBJECT>
                <P>Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), notice is hereby given of the following meeting.</P>
                <P>The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.</P>
                <EXTRACT>
                    <P>
                        <E T="03">Name of Committee:</E>
                         National Institute of General Medical Sciences Special Emphasis Panel, R13 Application Review.
                    </P>
                    <P>
                        <E T="03">Date:</E>
                         November 23, 2004.
                    </P>
                    <P>
                        <E T="03">Time:</E>
                         8 a.m. to 11 a.m.
                    </P>
                    <P>
                        <E T="03">Agenda:</E>
                         To review and evaluate grant applications.
                    </P>
                    <P>
                        <E T="03">Place:</E>
                         National Institutes of Health, Natcher Building, 45 Center Drive, Bethesda, MD 20892.
                    </P>
                    <P>
                        <E T="03">Contact Person:</E>
                         Arthur L. Zachary, PhD, Office of Scientific Review, National Institutes of General Medical Sciences, National Institutes of Health, Natcher Building, Room 3AN-12, Bethesda, MD 20892. (301) 594-2886; 
                        <E T="03">zacharya@nigms.nih.gov.</E>
                    </P>
                    <P>This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle.</P>
                    <FP>(Catalogue of Federal Domestic Assistance Program Nos. 93.375, Minority Biomedical Research Support; 93.821, Cell Biology and Biophysics Research; 93.859, Pharmacology, Physiology, and Biological Chemistry Research; 93.862, Genetics and Developmental Biology Research; 93.88, Minority Access to Research Careers; 93.96, Special Minority Initiatives, National Institutes of Health, HHS.) </FP>
                </EXTRACT>
                <SIG>
                    <DATED>Dated: November 5, 2004.</DATED>
                    <NAME>LaVerne Y. Stringfield,</NAME>
                    <TITLE>Director, Office of Federal Advisory Committee Policy.</TITLE>
                </SIG>
            </PREAMB>
            <FRDOC>[FR Doc. 04-25277  Filed 11-12-04; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4140-01-M</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF HEALTH AND HUMAN SERVICES </AGENCY>
                <SUBAGY>Public Health Service </SUBAGY>
                <SUBJECT>National Toxicology Program (NTP) Board of Scientific Counselors Technical Reports Review Subcommittee Meeting; Review of Draft NTP Technical Reports </SUBJECT>
                <P>
                    Pursuant to Pub. L. 92-463, notice is hereby given of the next meeting of the NTP Board of Scientific Counselors Technical Reports Review Subcommittee (“TRR Subcommittee”) on December 9-10, 2004, in the Rodbell Auditorium, Rall Building at the 
                    <PRTPAGE P="65614"/>
                    National Institute of Environmental Health Sciences, 111 T.W. Alexander Drive, Research Triangle Park, NC 27709. The meeting will begin each day at 8:30 a.m. The meeting is open to the public with attendance limited only by the space available (see “Attendance, Registration, and Remote Access” below). 
                </P>
                <HD SOURCE="HD1">Agenda </HD>
                <P>
                    The primary agenda topic is the peer review by the TRR Subcommittee of the findings and conclusions of seven draft NTP Technical Reports (TR) of rodent toxicology and carcinogenesis studies conducted by the NTP (
                    <E T="03">see</E>
                     Preliminary Agenda below). There will also be a presentation on how the NTP handles contaminants in study materials and their impact on the interpretation of 2-year bioassays. In addition, at the request of the NTP Board of Scientific Counselors, the TRR Subcommittee will readdress the title of the Draft NTP Technical Report on Anthraquinone (see minutes from the NTP Board of Scientific Counselors meeting held June 29, 2004, available at 
                    <E T="03">http://ntp-server.niehs.nih.gov/ntpweb/index.cfm?objectid=720164E3-BDB7-CEBA-F338FA2626639D56</E>
                    ). As an introduction to the reports on the studies of polychlorinated biphenyl (PCB), a short presentation will be given on the use of Toxic Equivalency Factors (TEFs). The TEF methodology was developed as a mathematical tool that ranks the dioxin-like activity of a compound relative to 2,3,7,8-tetrachlorodibenzo-p-dioxin (TCDD), the most potent dioxin. This methodology has been applied to the NTP studies reported in TR 531: Mixture of 3,3′,4,4′,5-Pentachlorobiphenyl (PCB 126) and 2,3′,4,4′,5-Pentachlorobiphenyl (PCB 118), TR 529: 2,2′,4,4′,5,5′-Hexachlorobiphenyl (PCB 153), and TR 530: Mixture of PCB 126 and PCB 153. 
                </P>
                <P>
                    A copy of the agenda, TRR Subcommittee roster, and the draft NTP Technical Reports, as available, will be posted on the NTP Web site (
                    <E T="03">http://ntp-server.niehs.nih.gov/</E>
                     under 
                    <E T="03">Latest News</E>
                    ) and will be available upon request to the NTP Executive Secretary, Dr. Barbara S. Shane (PO Box 12233, 111 T.W. Alexander Dr., MD A3-01, Research Triangle Park, NC 27709, T: 919-541-4253; F: 919-541-0295; e-mail: 
                    <E T="03">shane@niehs.nih.gov</E>
                    ). Following the meeting, summary minutes will be available on the TRR Subcommittee Web site (see 
                    <E T="03">http://ntp-server.niehs.nih.gov/ntpweb/index.cfm?objectid=227FC084=EB0C-7E93-9DCD6F03104F0D22</E>
                    ) and in hard copy upon request to the NTP Executive Secretary. 
                </P>
                <HD SOURCE="HD1">Draft Reports Available for Public Review and Comment </HD>
                <P>
                    Approximately four weeks prior to the meeting, the draft reports will be available for public review, through the NTP Web page (
                    <E T="03">http://ntp-server.niehs.nih.gov/</E>
                     under 
                    <E T="03">Latest News</E>
                    ). Printed copies of the Draft NTP Technical Reports can be obtained, as available, from Central Data Management (NIEHS, PO Box 12233, MD EC-03, Research Triangle Park, NC 27709, T: 919-541-3419, F: 919-541-3687, e-mail: 
                    <E T="03">CDM@niehs.nih.gov</E>
                    ). 
                </P>
                <HD SOURCE="HD1">Attendance, Registration and Remote Access </HD>
                <P>
                    The meeting is open to the public with attendance limited only by the space available. Individuals who plan to attend are strongly encouraged to register with the NTP Executive Secretary by December 2, 2004 to ensure easy access to the NIEHS campus (contact information above) or online on the NTP Web site (
                    <E T="03">http://ntp.niehs.nih.gov</E>
                     under 
                    <E T="03">Latest News</E>
                    ). Please note that a photo ID is required to access the NIEHS campus. Persons needing special assistance, such as sign language interpretation or other reasonable accommodation in order to attend are asked to notify the NTP Executive Secretary at least seven business days in advance of the meeting. The NTP is also making plans to videocast the TRR Subcommittee meeting through the Internet at 
                    <E T="03">http://www.niehs.nih.gov/external/video.htm.</E>
                     The NTP cannot guarantee the technical quality of the video casting and people wishing to use this option are encouraged to test their ability to access the video cast at the above Internet address under 
                    <E T="03">Check your live video setup.</E>
                </P>
                <HD SOURCE="HD1">Public Comment </HD>
                <P>Comments on any of the Draft NTP Technical Reports are welcome. Time will be provided at the meeting for oral public comment on the reports. Persons requesting time for an oral presentation on a particular report are asked to notify the NTP Executive Secretary (contact information given above) by December 2, 2004, and to provide their contact information (name, affiliation, mailing address, phone, fax, e-mail), and supporting organization (if any). Persons registering to make comments are asked to provide a written copy of their statement to the NTP Executive Secretary on or before December 2, 2004, to enable review by the TRR Subcommittee and NTP staff prior to the meeting. These statements can supplement or expand an oral presentation. Each speaker will be allotted at least 7 minutes and, if time permits, up 10 minutes for presentation of oral comments. Each organization is allowed one time slot per report being reviewed. Registration for making public comments will also be available on-site. If registering on-site to speak and reading comments from printed text, the speaker is asked to provide 25 copies of the statement for distribution to the Subcommittee and NTP staff, and to supplement the record. </P>
                <P>
                    Written comments without an oral presentation at the meeting are also welcome. Comments should include contact information for the submitter (name, affiliation, mailing address, phone, fax, and e-mail) and supporting organization (if any). Written comments should be received by the NTP Executive Secretary on or before December 2, 2004, to enable distribution to the Subcommittee and NTP staff for their review and consideration prior to the meeting. Written comments received in response to this notice will be posted on the NTP Web site (
                    <E T="03">http://ntp.niehs.nih.gov</E>
                     under 
                    <E T="03">Latest News</E>
                    ). 
                </P>
                <HD SOURCE="HD1">Request for Additional Information </HD>
                <P>The NTP would welcome receiving toxicology and carcinogenesis information from completed, ongoing or planned studies as well as current production data, human exposure information, and use patterns for any of the chemicals listed in this announcement. Please send this information to Central Data Management at the address given above and it will be forwarded to the appropriate NTP staff. </P>
                <HD SOURCE="HD1">NTP Technical and Toxicity Report Series </HD>
                <P>
                    The NTP conducts toxicology and carcinogenesis studies of agents of public health concern. Any scientist, organization, or member of the public may nominate a chemical for NTP testing. Details about the nomination process are available on the NTP Web site (
                    <E T="03">http://ntp.niehs.nih.gov</E>
                     under 
                    <E T="03">Nominations to the Testing Program</E>
                    ). The results of short-term rodent toxicology studies are published in the NTP Toxicity Report series. Longer-term studies, generally, rodent carcinogenicity studies, are published in the NTP Technical Report series. The NTP has a new technical report series for studies conducted in genetically modified models. PDF files of completed reports are available free-of-charge at the NTP Web site (
                    <E T="03">http://ntp-server.niehs.nih.gov/index.cfm?objectid=084801F0-F43F-7B74-0BE549908B5E5C1C</E>
                    ). 
                    <PRTPAGE P="65615"/>
                </P>
                <HD SOURCE="HD1">NTP Board of Scientific Counselors </HD>
                <P>
                    The NTP Board of Scientific Counselors (“the Board”) is a technical advisory body composed of scientists from the public and private sectors who provide primary scientific oversight and peer review to the NTP. Specifically, the Board advises the NTP on matters of scientific program content, both present and future, and conducts periodic review of the program for the purpose of determining and advising on the scientific merit of its activities and overall scientific quality. The TRR Subcommittee of the Board provides scientific peer review of the findings and conclusions of NTP Technical Reports. The Report on Carcinogens Subcommittee of the Board provides scientific peer review of nominations to the Report on Carcinogens, a Congressionally mandated listing of agents 
                    <E T="03">known</E>
                     or 
                    <E T="03">reasonably anticipated to be human carcinogens.</E>
                </P>
                <P>The Board's members are selected from recognized authorities knowledgeable in fields, such as toxicology, pharmacology, pathology, biochemistry, epidemiology, risk assessment, carcinogenesis, mutagenesis, molecular biology, behavioral toxicology, neurotoxicology, immunotoxicology, reproductive toxicology or teratology, and biostatistics. The NTP strives for equitable geographic distribution and for minority and female representation on the Board. </P>
                <SIG>
                    <DATED>Dated: November 5, 2004. </DATED>
                    <NAME>Samuel H. Wilson, </NAME>
                    <TITLE>Deputy Director, National Institute of Environmental Health Sciences. </TITLE>
                </SIG>
                <HD SOURCE="HD1">Preliminary Agenda </HD>
                <HD SOURCE="HD2">National Toxicology Program (NTP) Technical Reports (TR) Scheduled for Review by the NTP Board of Scientific Counselors Technical Reports Review Subcommittee </HD>
                <HD SOURCE="HD3">December 9-10, 2004 </HD>
                <P>Rodbell Auditorium, National Institute of Environmental Health Sciences, 111 TW Alexander Drive, Research Triangle Park, NC.</P>
                <FP SOURCE="FP-2">1. Overview of Dioxin Toxic Equivalency Factors (TEFs). </FP>
                <FP SOURCE="FP-2">2. TR 531: Mixture of 3,3′,4,4′,5-Pentachlorobiphenyl (PCB 126) and 2,3′,4,4′,5-Pentachlorobiphenyl (PCB 118) (CAS Nos. 57465-28-8 and 31508-00-6, respectively). </FP>
                <FP SOURCE="FP1-2">• No longer used commercially; persistent polyhalogenated aromatic hydrocarbons present in the environment. </FP>
                <FP SOURCE="FP-2">3. TR 529: 2,2′,4,4′,5,5′-Hexachlorobiphenyl (PCB 153) (CAS No. 35065-27-1). </FP>
                <FP SOURCE="FP1-2">• No longer used commercially; persistent polyhalogenated aromatic hydrocarbon present in the environment. </FP>
                <FP SOURCE="FP-2">4. TR 530: Mixture of PCB 126 and PCB 153 (CAS No: 57465-28-8 and 835065-27-1, respectively). </FP>
                <FP SOURCE="FP1-2">• No longer used commercially; persistent polyhalogenated aromatic hydrocarbons present in the environment. </FP>
                <FP SOURCE="FP-2">5. Discussion on Contaminants in NTP Study Materials: Impact on Interpretation of 2-year Bioassays. </FP>
                <FP SOURCE="FP1-2">• Discussion of the Title of Draft NTP Technical Report on Anthraquinone (TR-494). </FP>
                <FP SOURCE="FP-2">6. TR 517: Sodium Chlorate (CAS No. 7775-09-9). </FP>
                <FP SOURCE="FP1-2">• Oxidizing agent, precursor in the synthesis of chlorine dioxide; found as byproduct in water disinfected with chlorine dioxide. </FP>
                <FP SOURCE="FP-2">7. TR 532: Bromodichloromethane (CAS No. 75-27-4). </FP>
                <FP SOURCE="FP1-2">• Water disinfectant by-product.</FP>
                <FP SOURCE="FP-2">8. TR 522: 3′-Azido-3′-thymidine (AZT) (CAS No. 30516-87-1). </FP>
                <FP SOURCE="FP1-2">• Chemotherapeutic agent for treatment of people with acquired immune deficiency syndrome (AIDS). </FP>
                <FP SOURCE="FP-2">9. TR 533: Benzophenone (CAS No. 119-61-9). </FP>
                <FP SOURCE="FP1-2">• Photoinitiator fragrance enhancer, ultraviolet curing agent, intermediate in the manufacture of agricultural chemicals. </FP>
            </PREAMB>
            <FRDOC>[FR Doc. 04-25280 Filed 11-12-04; 8:45 am] </FRDOC>
            <BILCOD>BILLING CODE 4140-01-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="N">DEPARTMENT OF HOMELAND SECURITY </AGENCY>
                <SUBAGY>Federal Emergency Management Agency </SUBAGY>
                <RIN>RIN 1660-ZA05 </RIN>
                <SUBJECT>Privacy Act Systems of Records; Amendment to Existing Routine Uses </SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Federal Emergency Management Agency (FEMA), Emergency Preparedness and Response Directorate, Department of Homeland Security (DHS). </P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice of amendment to routine uses. </P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>In compliance with the requirements of the Privacy Act of 1974, as amended, FEMA gives notice that it intends to rename its system of records notice for FEMA/REG-2, Disaster Recovery Assistance Files, to acknowledge in the nomenclature that it is now part of DHS, that it proposes to revise the existing routine uses for this system to allow information sharing with voluntary agencies actively working in the open disaster and that it proposes to add new routine uses to provide notice about routine management and oversight information sharing. In addition, to reduce the burden on the public applying for disaster assistance, FEMA has proposed to allow the registration process to be done by individuals electronically over the Internet and is therefore revising its system notice to account for electronic records. </P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">EFFECTIVE DATE:</HD>
                    <P>The amended system of records will be effective December 15, 2004, unless comments are received that result in a contrary determination. The amended system of records will be applicable to major disaster or emergencies declared on or after August 13, 2004, unless comments are received that result in a contrary determination. </P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        You may submit comments, identified by EPA DOCKET NUMBER DHS-2004-0014 and/or 1660-ZA05 by 
                        <E T="03">one</E>
                         of the following methods: 
                    </P>
                    <P>
                        • EPA Federal Partner EDOCKET Web Site: 
                        <E T="03">http://www.epa.gov/feddocket</E>
                        . Follow instructions for submitting comments on the Web site. DHS has joined the Environmental Protection Electronic Docket System (Partner EDOCKET). DHS and its agencies (excluding the United States Coast Guard (USCG) and Transportation Security Administration (TSA)) will use the EPA Federal Partner EDOCKET system. The USCG and TSA [legacy Department of Transportation (DOT) agencies] will continue to use the DOT Docket Management System until full migration to the electronic rulemaking federal docket management system occurs in 2005. 
                    </P>
                    <P>
                        • Federal e-Rulemaking Portal: 
                        <E T="03">http://www.regulations.gov</E>
                        . Follow the instructions for submitting comments. 
                    </P>
                    <P>• Fax: (202) 646-4536. </P>
                    <P>• Mail: Rules Docket Clerk, Federal Emergency Management Agency, Office of General Counsel, room 840, 500 C Street SW., Washington, DC 20472. </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Rena Y. Kim, Privacy Act Officer, Room 840, 500 C Street, SW., Washington, DC 20472; (telephone) (202) 646-3949, or (e-mail) 
                        <E T="03">Rena.Kim@dhs.gov</E>
                        . 
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>
                    Prior to March 1, 2003, FEMA was an independent agency within the Federal Government. While operating as an independent agency, FEMA published notices concerning its systems of 
                    <PRTPAGE P="65616"/>
                    records. The system at issue in this notice was last published on October 9, 2001. In compliance with the requirements of the Privacy Act of 1974, as amended, 5 U.S.C. 552a, FEMA gives notice that it intends to revise the routines uses and to add several new ones to its system of records entitled, FEMA/REG-2, Disaster Recovery Assistance Files. FEMA has amended the language in routine use (a) to allow information sharing with voluntary agencies actively working in the open disaster. FEMA also intends to add two new routine uses that allow for information sharing with other Federal and State agencies to enhance FEMA's ability to provide oversight and coordination of State activities and to ensure that the State performs and adheres to FEMA regulations and policy guidance. In addition, because FEMA became a part of DHS on March 1, 2003, FEMA is incorporating appropriate DHS routine uses as part of this system of records. 
                </P>
                <P>FEMA altered its system of records and provided a report as required by 5 U.S.C. 552a(r). This change is to amend the language of routine use (a). This amendment will not change the type or amount of information collected from individuals who apply for disaster assistance. Finally, this notice will make the public aware of routine management and oversight information sharing between FEMA and other Federal agencies, State and local governments, and contractors providing services in support of the Individual Assistance program. Routine uses (d), (e), (f), and (g) allow us to disclose information from this system of records to Federal, State, and local governments in the course of providing disaster assistance and in creating and implementing emergency evacuation plans. In addition, to reduce the burden on the public applying for disaster assistance, FEMA is now making the registration process available by an additional means—electronically via the Internet. In addition to filling out paper applications or calling in and applying over the telephone, individuals who wish to apply for disaster assistance can now also do so over the Internet. </P>
                <P>Accordingly, FEMA amends the Disaster Recovery Assistance Files of the FEMA Privacy Act system of records to read as follows: </P>
                <PRIACT>
                    <HD SOURCE="HD2">System Name: </HD>
                    <P>Disaster Recovery Assistance Files. </P>
                    <HD SOURCE="HD2">System Location: </HD>
                    <P>National Processing Service Centers (NPSC) located at FEMA MD-NPSC, 6505 Belcrest Road, Hyattsville, MD 20782; FEMA VA-NPSC, 19844 Blue Ridge Mountain Road, Bluemont, VA 20135; FEMA TX-NPSC, 3900 Karina Lane, Denton, TX 76208; and FEMA PR-NPSC, Carr 8860, KM 1.1 Bldg T-1429, Trujillo Alto, PR 00976. </P>
                    <HD SOURCE="HD2">Categories of Individuals Covered By the System: </HD>
                    <P>Individuals who apply for disaster recovery assistance through three different mediums including: (a) Electronically via the Internet, (b) by calling FEMA's toll-free number, or (c) through the submission of a paper copy of FEMA Form 90-69 following Presidentially-declared major disasters or emergencies. Our proposed additional new method will allow applicants to apply for disaster recovery assistance over the Internet, and will reduce the paperwork burden on the public. </P>
                    <HD SOURCE="HD2">Categories of Records in the System: </HD>
                    <P>(a) Records of registration for assistance (Form 90-69, Disaster Assistance Registration/Application) include individual applicants' names, addresses, telephone numbers, social security numbers, insurance coverage information, household size and composition, degree of damage incurred, income information, programs to which FEMA refers applicants for assistance, flood zones, location and height of high water level, and preliminary determinations of eligibility for disaster assistance. </P>
                    <P>(b) Inspection reports (Form 90-56, Inspection Report) contain individuals' identifying information and results of surveys of damaged real and personal property and goods, which may include individuals' homes and personal items. </P>
                    <P>(c) Temporary housing assistance eligibility determinations (Forms 90-11 through 90-13, 90-16, 90-22, 90-24 through 90-28, 90-31, 90-33, 90-41, 90-48, 90-57, 90-68 through 90-70, 90-71, 90-75 through 90-78, 90-82, 90-86, 90-87, 90-94 through 90-97, 90-99, and 90-101). These refer to approval and disapproval of temporary housing assistance and include: general correspondence, complaints, appeals and resolutions, requests for disbursement of payments, inquiries from tenants and landlords, general administrative and fiscal information, payment schedules and forms, termination notices, information shared with the temporary housing program staff from other agencies to prevent the duplication of benefits, leases, contracts, specifications for repair of disaster damaged residences, reasons for eviction or denial of aid, sales information after tenant purchase of housing units, and the status of disposition of applications for housing. </P>
                    <P>(d) Eligibility decisions for disaster aid from other Federal and State agencies (for example, the disaster loan program administered by the Small Business Administration, and disaster aid decisions of the State-administered Individual and Family Grants (IFG) and its successor program, Other Needs Assistance (ONA)) as they relate to determinations of individuals' eligibility for disaster assistance programs. </P>
                    <P>(e) State files, independently kept by the State, which contains records of persons who request disaster aid, specifically for IFG and its successor program, ONA, and administrative files and reports required by FEMA. As to individuals, the State keeps the same type of information as described above under registration, inspection, and temporary housing assistance records. As to administrative files and reporting requirements, the State uses forms 76-27, 76-28, 76-30, 76-32, 76-34, 76-35, and 76-38. This collection of information is essential to the effective monitoring and management of the IFG and the ONA Program by FEMA's Regional Office staff who have the oversight responsibility of ensuring that the State perform and adhere to FEMA regulations and policy guidance. </P>
                    <HD SOURCE="HD2">Authority for Maintenance of the System: </HD>
                    <P>Robert T. Stafford Disaster Relief and Emergency Assistance Act, 42 U.S.C. 5121-5206 and Reorganization Plan No. 3 of 1978. </P>
                    <HD SOURCE="HD2">Purpose(s): </HD>
                    <P>To register applicants needing disaster assistance, to inspect damaged homes, to verify information provided by each applicant, to make eligibility determinations regarding an applicant's request for assistance, and to identify and implement measures to reduce future disaster damage. </P>
                    <HD SOURCE="HD2">Routine uses of records maintained in the system, including categories of users and the purposes of such uses: </HD>
                    <P>
                        (a) FEMA may disclose applicant information to certain agencies as necessary and as described below to prevent a duplication of efforts or a duplication of benefits in determining eligibility for disaster assistance. FEMA shall only release as much information as is necessary to enable the recipient agency to determine eligibility for that agency's particular assistance program(s). The receiving agency is not permitted to alter or to further disclose our disclosed records to other disaster organizations. FEMA may make such disclosures under the following circumstances: 
                        <PRTPAGE P="65617"/>
                    </P>
                    <P>(1) To another Federal agency or State government agency charged with administering disaster relief programs to make available any additional Federal and State disaster assistance to individuals and households. </P>
                    <P>(2) When an applicant seeks assistance from a local government agency or a voluntary organization (as defined at 44 CFR 206.2(a)(27), as amended or superseded) charged under legislation or charter with administering disaster relief programs, and FEMA receives a written request from that local government or voluntary agency that includes the applicant's name, FEMA registration/application number and damaged dwelling address. The written request must explain the type of tangible assistance being offered and the type of verification required before the assistance can be provided. </P>
                    <P>(3) To voluntary organizations (as defined at 44 CFR 206.2(a)(27), as amended or superseded) that have an established disaster assistance program to address the disaster-related unmet needs of disaster victims, are actively involved in the recovery efforts of the disaster, and either have a national membership, in good standing, with the National Voluntary Organizations Active in Disaster (NVOAD), or are participating in the disaster's Long-Term Recovery Committee. When a voluntary agency satisfies all of the criteria listed in this sub-paragraph, FEMA may release lists of individuals' names, contact information, and their FEMA inspected loss amount to the volunteer agency for the sole purpose of providing additional disaster assistance. FEMA shall release this information only while the period for assistance for the current disaster is open. </P>
                    <P>(b) When an individual's eligibility, in whole or in part, for a DHS/FEMA disaster assistance program depends upon benefits already received or available from another source for the same purpose, FEMA may disclose information to relevant agencies, organizations, and institutions as necessary to determine what benefits are available from another source and to prevent the duplication of disaster assistance benefits (as described in section 312 of the Stafford Act). </P>
                    <P>(c) In response to a written request, FEMA may disclose information from this system of records to Federal, State, or local government agencies charged with the implementation of hazard mitigation measures and the enforcement of hazard-specific provisions of building codes, standards, and ordinances. FEMA may only disclose information for the following purposes: </P>
                    <P>(1) For hazard mitigation planning purposes to assist States and local communities in identifying high-risk areas and preparing mitigation plans that target those areas for hazard mitigation projects implemented under Federal, State or local hazard mitigation programs. </P>
                    <P>(2) For enforcement purposes, to enable State and local communities to ensure that owners repair or rebuild structures in conformance with applicable hazard-specific building codes, standards, and ordinances. </P>
                    <P>(d) Pursuant to the Debt Collection Improvement Act of 1996, 31 U.S.C. 3325(d) and 7701(c)(1), FEMA is required to collect and release to the United States Department of the Treasury the social security number of the person doing business with FEMA, including an applicant for a grant. Therefore, FEMA will release an applicant's social security number in connection with a request for payment to the U.S. Treasury in order to provide a disaster assistance payment to an applicant under the Individual Assistance program. </P>
                    <P>(e) FEMA may provide a list of applicants' names, amounts of assistance provided, and related information to a State in connection with billing that State for the applicable non-Federal cost share under the Individuals and Households Program. </P>
                    <P>(f) When an applicant is occupying a FEMA Temporary Housing unit, FEMA may release only the location of the FEMA Temporary Housing unit to local emergency managers for the sole purpose of preparing emergency evacuation plans. FEMA shall not release any information on an individual, such as their name, type or amount of disaster assistance received. </P>
                    <P>
                        (g) 
                        <E T="03">Routine Use—Investigations:</E>
                         Where a record, either on its face or in conjunction with other information, indicates a violation or potential violation of law—criminal, civil or regulatory—the relevant records may be referred to an appropriate Federal, State, territorial, tribal, local, international, or foreign agency law enforcement authority or other appropriate agency charged with investigating or prosecuting such a violation or enforcing or implementing such law. 
                    </P>
                    <P>
                        (h) 
                        <E T="03">Routine Use—Requesting Information:</E>
                         To a Federal, State, local, tribal, territorial, foreign, or international agency, if necessary to obtain information relevant to a DHS decision concerning the hiring or retention of an employee, the issuance of a security clearance, the reporting of an investigation of an employee, the letting of a contract, or the issuance of a license, grant or other benefit. 
                    </P>
                    <P>
                        (i) 
                        <E T="03">Routine Use—Requested Information:</E>
                         To a Federal, State, local, tribal, territorial, foreign, or international agency, in response to its request, in connection with the hiring or retention of an employee, the issuance of a security clearance, the reporting of an investigation of an employee, the letting of a contract, or the issuance of a license, grant, or other benefit by the requesting agency, to the extent that the information is relevant and necessary to the requesting agency's decision on the matter. 
                    </P>
                    <P>
                        <E T="03">(j) Routine Use—Congressional Inquiries:</E>
                         To a congressional office from the record of an individual in response to an inquiry from that congressional office made at the request of the individual to whom the record pertains. 
                    </P>
                    <P>
                        <E T="03">(k) Routine Use—Private Relief Legislation:</E>
                         To OMB at any stage of the legislative coordination and clearance process set out in OMB Circular No. A-19. 
                    </P>
                    <P>
                        <E T="03">(l) Routine Use—National Archives and Records Administration:</E>
                         To the National Archives and Records Administration or other Federal Government agencies pursuant to records management inspections being conducted under the authority of 44 U.S.C. sections 2904 and 2906. 
                    </P>
                    <P>
                        <E T="03">(m) Routine Use—Audits and Oversight:</E>
                         To an agency, organization, or individual for the purposes of performing authorized audit or oversight operations. 
                    </P>
                    <P>
                        <E T="03">(n) Routine Use—Contractors, et al.:</E>
                         To contractors, grantees, experts, consultants, students, and others performing or working on a contract, service, grant, cooperative agreement, or other assignment for the Federal Government, when necessary to accomplish an agency function related to this system of records. 
                    </P>
                    <P>
                        <E T="03">(o) Routine Use—Debt Collection:</E>
                         To the Department of the Treasury, Justice, the United States Attorney's Office, or a consumer reporting agency for further collection action on any delinquent debt when circumstances warrant. 
                    </P>
                    <P>
                        <E T="03">(p) Routine Use—Freedom of Information Act (FOIA) Discussions with Other Agencies Regarding DHS Documents and Vice Versa:</E>
                         To a Federal agency or entity that furnished the record or information for the purpose of permitting that agency or entity to make a decision regarding access to or correction of the record or information, or to a Federal agency or entity for purposes of providing guidance or advice regarding the handling of particular requests. 
                        <PRTPAGE P="65618"/>
                    </P>
                    <P>
                        <E T="03">(q) Routine Use—Litigation:</E>
                         To the Department of Justice (DOJ) or other Federal agency conducting litigation or in proceedings before any court, adjudicative or administrative body, when: (1) DHS, or (2) any employee of DHS in his/her official capacity, or (3) any employee of DHS in his/her individual capacity where DOJ or DHS has agreed to represent the employee, or (4) the United States or any agency thereof, is a party to the litigation or has an interest in such litigation. 
                    </P>
                    <P>
                        <E T="03">(r) Routine Use—Privacy Act Verification and Amendment:</E>
                         To a Federal, State, territorial, tribal, local, international, or foreign agency or entity for the purpose of consulting with that agency or entity (1) to assist in making a determination regarding access to or amendment of information, or (2) for the purpose of verifying the identity of an individual or the accuracy of information submitted by an individual who has requested access to or amendment of information. 
                    </P>
                    <P>
                        <E T="03">(s) Routine Use—Privacy Act/FOIA Access and Amendment:</E>
                         To the submitter or subject of a record or information to assist DHS in making a determination as to access or amendment. 
                    </P>
                    <HD SOURCE="HD2">Disclosure to consumer reporting agencies: </HD>
                    <P>Disclosure under 5 U.S.C. 552a(b)(12): FEMA may make disclosures from this system to consumer reporting agencies, as defined in the Fair Credit Reporting Act, 15 U.S.C. Section 1681a(f), or the Debt Collection Act of 1982, 31 U.S.C. Section 3711(e). </P>
                    <HD SOURCE="HD2">Policies and practices for storing, retrieving, accessing, retaining, and disposing of records in the system: </HD>
                    <HD SOURCE="HD2">STORAGE: </HD>
                    <P>Interactive database, computer discs, and paper records in file folders. </P>
                    <HD SOURCE="HD2">Retrievability: </HD>
                    <P>By an individual's name, address, social security number, and case file number. </P>
                    <HD SOURCE="HD2">Safeguards: </HD>
                    <P>
                        Only authorized individuals and FEMA employees have access to this information. Hardware and software computer security measures are used to control access to the data. Access to the data is based upon an individual's position in FEMA and/or their designated duties. Individuals are assigned specific “rights” or specific access (
                        <E T="03">e.g.</E>
                        , read only, modify, delete, etc.). The access granted is based upon an individual's position responsibilities for “official use” only. FEMA employees are allowed access to the data as a function of their specific job assignments within their respective organizations. Each FEMA employee's access to the data is restricted to that needed to carry out their duties. 
                    </P>
                    <P>
                        No individual applying for disaster assistance will have access to the entire database via the Internet. Applicants will have limited access to only their own information that they submitted via the Internet, and to the status of their own information regarding the processing of their own application (
                        <E T="03">e.g.</E>
                         the status of required documentation, inspection status, or SBA status). Applicants are provided a Logon id, password, and Personal Identification Number (PIN) that connect only to the applicant's data. The password and PIN ensures that the login id belongs to the applicant. Computer security software ensures that the login id is mapped only to the applicant's data. Applicants will have access to only their own application information after FEMA assigns them a properly authenticated user id, password, and PIN. Applicants will be registered and authenticated in accordance with National Institute of Standards and Technology Level 2 Assurance guidelines. 
                    </P>
                    <HD SOURCE="HD2">Retention and Disposal: </HD>
                    <P>Records covered by paragraphs (a) through (d) are covered by Records Schedule N1-311-86-1 4C10a and are destroyed after 6 years and 3 months. Records covered by paragraph (e) are covered by Records Schedules N1-311-86-1 4C7 and/or N1-311-86-1 4C10b and are destroyed 3 years after closeout. </P>
                    <HD SOURCE="HD2">System Manager(s) and Address: </HD>
                    <P>Division Director, Recovery Division, FEMA, 500 C Street SW., Washington, DC 20472 and applicable Regional Directors, as listed in Appendix A(1). </P>
                    <HD SOURCE="HD2">Notification Procedure: </HD>
                    <P>Requests for Privacy Act protected information generally are governed by DHS regulations found at 6 CFR Part 5 and FEMA's regulations at 44 CFR Part 6. They must be made in writing, and clearly marked as a “Privacy Act Request” on the envelope and letter. Inquiries should be addressed to FEMA—Records Management, National Processing Service Center, P.O. Box 10055 Hyattsville, MD 20782-7055. Include the full name of the individual, the appropriate personal identification, and the current address. The name of the requester, the nature of the record sought, and the verification of identity must be clearly indicated, as required by DHS regulation 6 CFR 5.21 and FEMA regulation at 44 CFR 6.30. Requests may also be sent to: Privacy Act Officer, DHS/FEMA Office of General Counsel (GL), room 840, 500 C Street, SW., Washington, DC 20472. </P>
                    <HD SOURCE="HD2">Record Access Procedures: </HD>
                    <P>Same as the Notification Procedure above. </P>
                    <HD SOURCE="HD2">Contesting record procedure: </HD>
                    <P>Same as the Notification Procedure above. The letter should state clearly and concisely what information you are contesting, the reasons for contesting it, and the proposed amendment to the information that you seek pursuant to DHS Privacy Act regulations at 6 CFR Part 5 and FEMA regulations at 44 CFR Part 6. </P>
                    <HD SOURCE="HD2">Record Source Categories: </HD>
                    <P>Applicants for disaster recovery assistance, credit rating bureaus, financial institutions, insurance companies, and state, local and voluntary agencies providing disaster relief. </P>
                    <HD SOURCE="HD2">Exemptions Claimed For the System: </HD>
                    <P>None. </P>
                </PRIACT>
                <SIG>
                    <DATED>Dated: November 9, 2004. </DATED>
                    <NAME>David A. Trissell, </NAME>
                    <TITLE>General Counsel, Emergency Preparedness and Response, Department of Homeland Security. </TITLE>
                </SIG>
                <APPENDIX>
                    <HD SOURCE="HED">Appendix A (1)</HD>
                    <HD SOURCE="HD2">Addresses for FEMA Regional Offices </HD>
                    <FP SOURCE="FP-1">Region I—Regional Director, FEMA, 99 High Street, 6th Floor, Boston, MA 02110; </FP>
                    <FP SOURCE="FP-1">Region II—Regional Director, FEMA, 26 Federal Plaza, New York, NY 10278-0002; </FP>
                    <FP SOURCE="FP-1">Region III—Regional Director, FEMA, One Independence Mall, 615 Chestnut Street, Philadelphia, PA 19106-4404; </FP>
                    <FP SOURCE="FP-1">Region IV—Regional Director, FEMA, 3003 Chamblee-Tucker Road, Atlanta, GA 30341; </FP>
                    <FP SOURCE="FP-1">Region V—Regional Director, FEMA, 536 S. Clark Street, Chicago, IL 60605; </FP>
                    <FP SOURCE="FP-1">Region VI—Regional Director, FEMA, Federal Center, 800 North Loop 288 Denton, TX 76209; </FP>
                    <FP SOURCE="FP-1">Region VII—Regional Director, FEMA, 2323 Grand Boulevard, Kansas City, MO 64108-2670; </FP>
                    <FP SOURCE="FP-1">Region VIII—Regional Director, FEMA, Denver Federal Center, Building 710, Box 25267, Denver, CO 80225-0267; </FP>
                    <FP SOURCE="FP-1">Region IX—Regional Director, FEMA, 1112 Broadway St. Oakland, CA 94607; </FP>
                    <FP SOURCE="FP-1">Region X—Regional Director, FEMA, Federal Regional Center, 130 228th Street, SW., Bothell, WA 98021-9796; </FP>
                </APPENDIX>
            </SUPLINF>
            <FRDOC>[FR Doc. 04-25284 Filed 11-12-04; 8:45 am] </FRDOC>
            <BILCOD>BILLING CODE 9110-10-P </BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <PRTPAGE P="65619"/>
                <AGENCY TYPE="S">DEPARTMENT OF HOMELAND SECURITY </AGENCY>
                <SUBAGY>Transportation Security Administration </SUBAGY>
                <DEPDOC>[Docket No. TSA-2004-19160] </DEPDOC>
                <SUBJECT>Notice of Final Order for Secure Flight Test Phase; Response to Public Comments on Proposed Order and Secure Flight Test Records </SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Transportation Security Administration (TSA), Department of Homeland Security (DHS). </P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice. </P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>
                        This notice responds to public comments received in response to three documents that the Transportation Security Administration (TSA) published in the 
                        <E T="04">Federal Register</E>
                         on September 24, 2004, related to testing of a new domestic passenger prescreening program known as Secure Flight. Secure Flight is an aviation passenger prescreening program that, once operational, would identify passengers known or reasonably suspected to be engaged in terrorist activity in order to allow action to be taken to prevent them from boarding a domestic flight or to ensure that appropriate additional security screening procedures are applied. Under the program, TSA would compare passenger reservation information for domestic flights, primarily in the form of passenger name records (PNRs), to information maintained by the Federal Government about individuals known or reasonably suspected to be engaged in terrorist activity. 
                    </P>
                    <P>
                        In preparation for testing the feasibility of the Secure Flight program, on September 24, 2004, TSA issued a 
                        <E T="04">Federal Register</E>
                         notice establishing a system of records under the Privacy Act for purposes of the Secure Flight program during the test phase. TSA also published a notice in the 
                        <E T="04">Federal Register</E>
                         that the agency had submitted to the Office of Management and Budget (OMB) a request for approval to collect PNRs from aircraft operators to test the Secure Flight program. That notice included the text of a proposed order to certain aircraft operators directing them to provide a limited set of historical PNRs to TSA. OMB subsequently has approved the information collection through March 31, 2005, and assigned OMB control number 1652-0025. In addition, TSA published a Privacy Impact Assessment for the testing phase of the Secure Flight program. 
                    </P>
                    <P>
                        This 
                        <E T="04">Federal Register</E>
                         notice that TSA publishes today addresses public comments received in response to the 
                        <E T="04">Federal Register</E>
                         notices published on September 24, 2004, and describes changes made to TSA's proposed order, which TSA now is issuing in final form. 
                    </P>
                </SUM>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Lisa Dean, Privacy Officer, Transportation Security Administration, 601 South 12th Street, Arlington, VA 22202-4220; telephone (571) 227-3947; facsimile (571) 227-2594; e-mail 
                        <E T="03">lisa.dean@dhs.gov.</E>
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <HD SOURCE="HD1">Background </HD>
                <P>
                    On September 24, 2004, TSA published in the 
                    <E T="04">Federal Register</E>
                     three notices related to TSA's plan to issue a final order to aircraft operators in order to obtain PNRs for testing of a new domestic passenger prescreening program known as Secure Flight (69 FR 57342, 57345, and 57352). This 
                    <E T="04">Federal Register</E>
                     notice that TSA is publishing today responds to public comments received in response to the notices published on September 24, 2004, and provides public notice of the final order that TSA is issuing for purposes of testing the Secure Flight program. 
                </P>
                <HD SOURCE="HD2">Secure Flight Program </HD>
                <P>The Secure Flight program is an effort to move the existing passenger prescreening process into the Federal Government in order to make the process more effective, consistent, and efficient for the traveling public. By administering this screening process within the Federal Government, the Secure Flight program will allow for better protection of government watchlist information that currently is provided to aircraft operators. </P>
                <P>Secure Flight will involve the comparison of information in PNRs from domestic flights to names in the Terrorist Screening Database (TSDB) maintained by the Terrorist Screening Center (TSC), including the expanded TSA No-Fly and Selectee Lists, in order to identify individuals known or reasonably suspected to be engaged in terrorist activity. TSA anticipates that it will also apply, within the Secure Flight system, a streamlined version of the existing passenger prescreening process, known as the Computer Assisted Passenger Prescreening System (CAPPS), which evaluates information in PNRs that passengers otherwise provide to aircraft operators in the normal course of business. </P>
                <P>Simple comparisons of PNR information against records maintained in the TSDB will not permit TSA to identify information provided by passengers that is incorrect or inaccurate, potentially rendering the comparisons less effective. Therefore, on a very limited basis, in addition to testing TSA's ability to compare passenger information with data maintained by TSC, TSA will separately test the use of commercial data to determine if use of such data is effective in identifying passenger information that is incorrect or inaccurate and reducing the number of false positive matches of passenger information against TSDB records. This test will involve commercial data aggregators whose procedures will be governed by strict privacy and data security protections. TSA will not receive the commercially available data that would be used by commercial data aggregators. TSA will use this test of commercial data to determine whether such use: (1) Could identify when passengers' information is inaccurate or incorrect and/or assist with the resolution of false positive matches; (2) would result in inappropriate differences in treatment of any protected category of persons; and (3) could be governed by data security safeguards and privacy protections that are sufficiently robust to ensure that commercial entities or other unauthorized entities do not gain access to passengers' personal information and to ensure that the government does not gain inappropriate access to commercial information about individuals. TSA will defer any decision of whether commercial data will be used in its prescreening programs, such as Secure Flight, until a thorough assessment of test results is completed. If TSA decides to use commercial data for Secure Flight, it will not do so until the agency publishes a new System of Records Notice announcing how commercial data will be used and individuals' privacy will be protected. </P>
                <P>TSA's efforts to develop and test the Secure Flight program are fully consistent with the recommendation in the final report of the National Commission on Terrorist Attacks Upon the United States (9/11 Commission), which states at page 392: </P>
                <EXTRACT>
                    <P>“[I]mproved use of “no-fly” and “automatic selectee” lists should not be delayed while the argument about a successor to CAPPS continues. This screening function should be performed by TSA and it should utilize the larger set of watch lists maintained by the Federal Government. Air carriers should be required to supply the information needed to test and implement this new system.” </P>
                </EXTRACT>
                <P>
                    The expansion of these watchlists to include information not previously included for security reasons will be possible as integration and consolidation of the information related to individuals known or suspected to be engaged in terrorist activity maintained 
                    <PRTPAGE P="65620"/>
                    by TSC is completed and the U.S. Government assumes the responsibility for administering the watchlist comparisons. Secure Flight will automate the vast majority of watchlist comparisons, will allow TSA to apply more consistent procedures where automated resolution of potential matches is not possible, and will allow for more consistent response procedures at airports for those passengers identified as potential matches. 
                </P>
                <P>Secure Flight represents a significant step in securing domestic air travel and safeguarding terrorism-related national security information, namely, the watchlists. It will dramatically improve consistency and effectiveness of comparisons of passenger information with data now maintained by TSC and will reduce the long-term costs to air carriers and passengers associated with maintaining the present system, which is operated individually by each aircraft operator that flies in the United States. </P>
                <HD SOURCE="HD2">Prior Federal Register Notices </HD>
                <P>
                    In order to test the feasibility of the Secure Flight program, TSA must obtain a sample of passenger information for domestic flights. In preparation for obtaining this information for testing purposes, on September 24, 2004, TSA published three public notices in the 
                    <E T="04">Federal Register</E>
                    . First, TSA published a system of records notice in accordance with the Privacy Act of 1974 (5 U.S.C. 552a), including a list of the proposed routine uses of information in the system of records. (69 FR 57345). The system of records notice establishes a new system entitled “Secure Flight Test Records” (hereafter referred to as DHS/TSA 017), which will govern the collection, maintenance, use, and disclosure of PNRs and other information obtained by TSA for purposes of testing the Secure Flight program. TSA requested public comment on the routine uses for DHS/TSA 017 during a 30-day comment period ending on October 25, 2004. 
                </P>
                <P>
                    Second, TSA published in the 
                    <E T="04">Federal Register</E>
                     a notice that TSA had submitted to the Office of Management and Budget in accordance with the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501, 
                    <E T="03">et seq.</E>
                    ) a request for emergency processing of OMB's review and approval for TSA to collect PNRs from aircraft operators to test the Secure Flight program (PRA notice). (69 FR 57342). That notice included the text of a proposed order to certain aircraft operators directing them to provide a limited set of historical PNRs to TSA that cover commercial scheduled domestic flights. Specifically, the proposed order covered PNRs with domestic flight segments flown during the month of June 2004 and excluded those PNRs with flight segments that occurred after June 30, 2004. The purpose of this limitation was to ensure that during the test phase, TSA does not obtain any information about future travel plans of passengers on domestic flights. The order also proposed to exclude PNR flight segments to or from the U.S. Although not required to do so, TSA requested public comment on the proposed order during a 30-day comment period ending on October 25, 2004. OMB subsequently has approved the information collection through March 31, 2005, and assigned OMB control number 1652-0025. 
                </P>
                <P>
                    Third, TSA published in the 
                    <E T="04">Federal Register</E>
                     a Privacy Impact Assessment for the test phase of the Secure Flight program, which TSA prepared in accordance with the E-Government Act of 2002. (69 FR 57352). 
                </P>
                <P>TSA received approximately 500 public comments on the Privacy Act system of records notice for DHS/TSA 017. Identical versions of most of those comments also were sent to OMB in response to TSA's PRA notice. TSA has reviewed and considered the issues raised by the public comments submitted to TSA and OMB. This notice addresses those issues and describes changes made to TSA's proposed order to aircraft operators, which, after carefully considering the comments, TSA now is issuing in final form. </P>
                <HD SOURCE="HD1">Public Comments </HD>
                <P>Public comments on the Secure Flight system of records notice and PRA notice generally focused on one or more of the following categories of issues: (1) The program's effect on individual privacy and civil liberties; (2) the routine uses established for the Secure Flight Test Records System (DHS/TSA 017); (3) passenger consent to the use of historical PNRs; (4) the absence of a redress process; (5) concerns with the use of commercial data; (6) the efficacy of the Secure Flight program; (7) TSA's compliance with the Privacy Act, the PRA, and other laws; and (8) possible conflicts of laws involving European Union (EU) data privacy requirements. </P>
                <HD SOURCE="HD2">Effect on Individual Privacy and Civil Liberties </HD>
                <P>A large majority of the commenters viewed the use of PNRs to prescreen passengers against government watchlists as an invasion of privacy and an infringement on their civil liberties, including individuals' right to travel and exercise other Constitutional rights that might be related to travel, such as the freedom of assembly. The National Business Travel Association (NBTA), stated that TSA should balance the need to establish better security measures with policies and procedures that protect civil liberties and privacy. The NBTA also stated that TSA should not impose unnecessary costs on business travelers. </P>
                <P>TSA is aware of, and sensitive to, the need to preserve Americans' freedoms while pursing better security. In implementing a new security measure that affects these interests, it is necessary to move deliberately and cautiously. It is for this very reason that TSA is testing the Secure Flight program before moving forward with an operational system. </P>
                <P>The prescreening of passengers against Government watchlists is a security measure that has been in place for several years, performed by aircraft operators, using watchlists provided by the Federal Government. Because the airlines have varying systems by which they implement passenger prescreening, the effectiveness, efficiency, and consistency in response for airline passengers of the current system is limited. The Secure Flight program is an effort to move this prescreening process into the Federal Government in order to make the process more effective, consistent, and efficient for the traveling public. This effort is consistent with a specific aviation security recommendation of the 9/11 Commission. </P>
                <P>The Secure Flight program will not impose an unconstitutional burden on an individual's right to travel or exercise other Constitutional rights. The Secure Flight program is a limited, reasonable security screening measure designed to further the Federal Government's compelling interest in protecting aviation security. Except in cases where a passenger may authorize TSA to retain information about him or her for purposes of redress, TSA has no long-term need to retain the information and is seeking approval from the National Archives and Records Administration (NARA) to destroy passenger information shortly after completion of the passenger's itinerary. Similarly, for purposes of the test phase of the program, TSA is seeking NARA approval to destroy PNRs used for the test after the test has been completed and the results have been evaluated. TSA's purpose in obtaining PNRs is to test the program, not to maintain information on individuals' travel.</P>
                <P>
                    TSA agrees with NBTA's comments regarding the need to have policies and procedures that protect passengers' civil liberties and privacy interests and to ensure the Secure Flight program is 
                    <PRTPAGE P="65621"/>
                    effective. TSA is in the process of developing redress procedures that will accomplish these goals, as discussed further below. 
                </P>
                <P>The Electronic Privacy Information Center (EPIC) objected to TSA's statement in the System of Records notice that the records created and maintained in the course of the Secure Flight test phase should be exempt from a number of the provisions of the Privacy Act, such as the provision allowing individuals to obtain access to certain records containing information about them. </P>
                <P>The Privacy Act specifically permits agencies to exempt from certain of its provisions investigatory materials compiled for law enforcement purposes, because allowing individuals access to law enforcement files could impair investigations, particularly those involving complex or continuing patterns of behavior. The intent of the exemption is to prevent access to law enforcement records if that access would alert subjects that their activities are being scrutinized and allow them to take countermeasures to escape detection and prosecution. </P>
                <P>In the Secure Flight system of records notice section entitled “Exemptions Claimed for the System”, TSA stated that for portions of the system it would invoke exemptions to the Privacy Act's requirements such as those that: (1) Permit individuals to obtain access to, and amend, information pertaining to them; and (2) require that information collected by the agency be relevant and necessary to the agency's statutory purpose. (69 FR 57348). TSA is in the process of preparing a notice of proposed rulemaking to implement these exemptions, which will include a detailed explanation of the basis for invoking the exemptions and will offer the public an opportunity to comment further. </P>
                <P>At this point, it is unclear whether TSA will need to invoke these exemptions for the Secure Flight program in its operational stage. In order, however, to preserve its ability to protect classified and law enforcement investigatory information from public disclosure, TSA identified these exemptions in the system of records notice as exemptions it may invoke, if necessary. EPIC noted in its comment that certain information in the system of records, such as PNRs, may not be subject to the exemptions and therefore should be releasable to the affected individual under the Privacy Act. TSA agrees with this view. As stated in the system of records notice, TSA will give individuals access to records in the system pertaining to them to the greatest extent feasible, consistent with law enforcement and national security concerns. It should become clearer during the test phase whether the records in the system may be structured in such a way as to exclude any information that must be withheld from the public for the reasons discussed above. </P>
                <P>With regard to the requirement that information collected by the agency be “relevant and necessary,” one of the objectives of the test phase is to confirm what information in a PNR is relevant and necessary to conduct an effective comparison of PNRs to information in the TSDB. The results of the test phase should enable TSA to determine more precisely what passenger information is relevant and necessary to the operation of the Secure Flight program and to limit its collection accordingly during the operational stage. </P>
                <P>A number of commenters expressed concern that the Secure Flight program could easily be expanded in the future beyond the scope outlined for the test phase. A number of other commenters anticipated that TSA would use passenger data to monitor where individuals travel and with whom they travel or whether they engage in other activities that could come within the First Amendment protection of freedom of assembly. These commenters have misconstrued the purpose of Secure Flight and the requirements that TSA has proposed for this test. </P>
                <P>TSA will neither use passenger information to monitor individuals' movements within the country nor share such information with other agencies or third parties. In fact, for the operational phase of Secure Flight, TSA intends to seek approval from NARA to destroy passenger information shortly after completion of the passenger's itinerary. This will preclude TSA from keeping any record of passenger movements around the country. TSA will not monitor the individuals with whom a particular passenger travels. </P>
                <P>If testing of the program indicates that it is a feasible and effective security measure, TSA will initiate a public rulemaking process in which it will provide an appropriate proposal for the workings of the system, as well as the redress process. This process, in conjunction with future publication of a Privacy Act system of records notice for the operational stage of the program will limit TSA's activities under Secure Flight to those outlined in the notice and serve as the basis for the operation of the program. To the extent that there are any substantial changes to collection of use of information under the program, these will be subject to additional notice and opportunity for public comment. This transparency will serve to prevent so-called “mission creep.” </P>
                <P>One commenter asked whether Secure Flight would use race, color, gender, age, religion, national origin, political views, origin of a passenger's name, disability, or other personal characteristics as the basis for screening decisions. One commenter suggested that TSA would use gun ownership as a basis for screening decisions. Several commenters stated that TSA should use ethnicity or national origin as a screening factor. </P>
                <P>With regard to the use of race, gender, national origin, or other factors listed above, Secure Flight will comply with the Constitution and other applicable law. TSA has adopted and complies with the “Guidance Regarding Use of Race by Federal Law Enforcement Agencies” issued by the United States Department of Justice in June 2003. </P>
                <HD SOURCE="HD2">Routine Uses </HD>
                <P>TSA received several comments on TSA's possible disclosure of personal data obtained for testing the Secure Flight program. Under the Privacy Act, TSA is required to list routine uses of the information it will maintain in the system of records created for testing the Secure Flight program. A routine use is a disclosure of a record outside the Department of Homeland Security for a purpose that is compatible with the purpose for which the information was collected. In its system of records notice for DHS/TSA 017, TSA listed the following routine uses for Secure Flight Test Records: </P>
                <P>(1) To the Federal Bureau of Investigation where TSA becomes aware of information that may be related to an individual identified in the Terrorist Screening Database as known or reasonably suspected to be or having been engaged in conduct constituting, in preparation for, in aid of, or related to terrorism; </P>
                <P>(2) To contractors, grantees, experts, consultants, or other like persons when necessary to perform a function or service related to the Secure Flight program or the system of records for which they have been engaged. Such recipients are required to comply with the Privacy Act, 5 U.S.C. 552a, as amended; </P>
                <P>
                    (3) To the Department of Justice (DOJ) or other Federal agency in the review, settlement, defense, and prosecution of claims, complaints, and lawsuits involving matters over which TSA exercises jurisdiction or when conducting litigation or in proceedings before any court, adjudicative or 
                    <PRTPAGE P="65622"/>
                    administrative body, when: (a) TSA; or (b) any employee of TSA in his/her official capacity; or (c) any employee of TSA in his/her individual capacity, where DOJ or TSA has agreed to represent the employee; or (d) the United States or any agency thereof, is a party to the litigation or has an interest in such litigation, and TSA determines that the records are both relevant and necessary to the litigation and the use of such records is compatible with the purpose for which TSA collected the records; 
                </P>
                <P>(4) To the National Archives and Records Administration (NARA) or other Federal agencies pursuant to records management inspections being conducted under the authority of 44 U.S.C. 2904 and 2906; </P>
                <P>(5) To a Congressional office from the record of an individual in response to an inquiry from that congressional office made at the request of the individual; and </P>
                <P>(6) To an agency, organization, or individual for the purposes of performing authorized audit or oversight operations. </P>
                <P>Some commenters objected to the disclosure of information to other agencies whose missions are unrelated to counterterrorism or security and to foreign governments. TSA has established a very limited set of routine uses for the Secure Flight Test Records. Consistent with the commenters' view, TSA will disclose information to the FBI in connection with its counterterrorism function where TSA becomes aware of information that may be related to an individual identified in the TSDB as known or reasonably suspected to be or having been engaged in conduct constituting, in preparation for, in aid of, or related to terrorism. The other routine uses applicable to DHS/TSA 017 are necessary for the operation of the agency or the operation and oversight of the Secure Flight program. TSA will not provide any of the information related to the Secure Flight program to foreign governments. </P>
                <P>One commenter expressed concern with TSA's plan to allow government contractors access to personal data and suggested that TSA ensure that strong contractual requirements are in place to deter weak data handling practices. TSA will put such contractual requirements in place. </P>
                <P>One commenter stated that TSA should ensure that if Secure Flight is used to screen actual passengers, any underlying information about the passenger used to make screening decisions should not be provided to the airlines or screeners. TSA agrees with this comment. One of the main purposes of Secure Flight is to bring within the Federal Government the watchlist comparison results that currently are in the hands of airlines. </P>
                <HD SOURCE="HD2">Passenger Consent </HD>
                <P>Many commenters objected to the government's collection of PNRs for testing purposes because they had not given consent to the collection. As discussed previously, aircraft operators currently use the information in PNRs to conduct passenger prescreening, including watchlists checks and the application of CAPPS. The existence of these prescreening measures has been public knowledge for many years. Therefore, when passengers provide information to aircraft operators in order to purchase air transportation, they have notice that their information will be used for prescreening purposes. In fact, the PNRs TSA will receive for testing Secure Flight already were already used for airline-implemented prescreening in June 2004. Therefore, TSA's collection of the PNRs is consistent with the purposes for which the information in those PNRs originally was collected, and passengers who traveled by air in June 2004 had notice of those purposes. </P>
                <HD SOURCE="HD2">Redress Process </HD>
                <P>Commenters noted that TSA has not yet established detailed redress procedures to handle cases where passengers believe they have been unfairly or inaccurately singled out for additional scrutiny as a result of the comparison of their PNRs to information in the TSDB. NBTA stated that TSA should develop a redress process to address inaccuracies in the databases TSA uses to prescreen passengers, including special procedures for corporate travelers to allow them to continue to fly while any security issue is resolved. </P>
                <P>TSA is in the process of developing a robust redress program and has begun hiring and is well into the process of developing redress procedures that will be refined during the Secure Flight test in November. For present purposes, however, TSA is only testing the Secure Flight concept. Because the data to be used concerns domestic flights that have already been completed during the month of June 2004 “ meaning that passengers were already screened “ and because the test results will not be used in an operational setting to conduct passenger screening, no passengers will need to avail themselves of the redress process during testing. With respect to special procedures for business travelers, TSA does not, at this point, believe that the Secure Flight program will cause delays that would warrant special treatment for any class of passengers. Information obtained through program testing, however, may be relevant to this issue, and TSA will consider it in developing the operational aspects of the Secure Flight program. </P>
                <HD SOURCE="HD2">Use of Commercial Data </HD>
                <P>A number of commenters had questions and concerns regarding TSA's plan to test the use of commercial data to identify passenger information that is incorrect or inaccurate. Commenters expressed concern that TSA's access to commercial information would open the door to abuse of individuals' privacy rights and possible theft of their personal information.</P>
                <P>As discussed in detail in the Privacy Impact Assessment for the Secure Flight Test Phase (69 FR 57352), TSA's testing of commercial data will be governed by stringent data security and privacy protections, including: contractual prohibitions on commercial entities' maintenance or use of PNR information for any purposes other than testing under TSA parameters; strict firewalls between the government and commercial data providers; real-time auditing procedures to determine when data has been accessed and by whom; and strict rules prohibiting the access or use of commercially held personal data by TSA. TSA will not have access to or store the commercially available data that would be used by commercial data aggregators. </P>
                <P>One commenter questioned TSA's need for passengers' credit card information as part of Secure Flight and whether TSA would be using commercial data to check credit histories and other personal information unrelated to Secure Flight. Commenters also had questions about the types of commercial information that could lead TSA to apply enhanced screening or deny an individual access to an aircraft. One commenter suggested that TSA use only those sources of commercial data that are easily corrected by consumers so that if there are errors in commercially available data that lead to incorrect screening decisions by TSA, those errors can be resolved in a timely manner. </P>
                <P>
                    These are all are key issues that TSA will be attempting to resolve during the testing phase. Once TSA has information about the feasibility and efficacy of using commercial data, such as credit card numbers, to gauge the accuracy of passenger information and reduce false positive matches to information in the TSDB, the agency will be in a position to provide specific answers to the types of questions raised 
                    <PRTPAGE P="65623"/>
                    by the commenters. TSA will not have access to individuals' credit histories, medical records, or other personal records. 
                </P>
                <P>A number of commenters expressed concern over access by data aggregators to passenger information during the testing. TSA will require the data aggregators with whom it works to abide by the requirements of the Privacy Act as well as to execute legally enforceable nondisclosure agreements prohibiting their use of information for any purpose other than for the testing of the effectiveness of the use of commercial data for Secure Flight. As a security mechanism, TSA has installed an auditing system as part of the platform on which the Secure Flight program will operate. The auditing mechanism will immediately detect any unauthorized access to the passenger data. Within TSA, individuals who are not conducting the test of the Secure Flight program will not have access to any passenger information. The real-time auditing mechanisms in place should prevent unauthorized access by individuals who are not part of the team conducting the test. TSA personnel with access to information for the testing phase will undergo specialized privacy training and will be required to hold appropriate security clearances and, therefore, will understand the sensitivity of the information to which they have access. </P>
                <P>Under section 552(d) of the Department of Homeland Security Appropriations Act, 2005 (Pub. L. 108-334), TSA may not test the use of commercial data until the agency has developed measures to determine the impact of the use of commercial data on aviation security and the Government Accountability Office (GAO) has reported on TSA's evaluation measures. TSA currently is working with GAO to provide the information GAO needs to evaluate TSA's measures. </P>
                <HD SOURCE="HD2">Efficacy of the Program </HD>
                <P>Commenters questioned the potential effectiveness of the Secure Flight program because, they claim, the information in the TSDB regarding individuals known or suspected of being engaged in terrorist activity is inaccurate. A number of commenters stated that TSA should instead focus its resources and effort on improved physical security measures such as improved checkpoint screening, increased numbers of Federal Air Marshals and Federal Flight Deck Officers, and improved screening of baggage and cargo. NBTA stated that TSA should stress test the Secure Flight system and develop operational safeguards and oversight policies for the program. </P>
                <P>TSA agrees with those commenters who have stated that TSA should ensure that the Secure Flight program is effective before going forward with implementation and should have a quick and effective redress process to address situations in which passengers are mistakenly subjected to enhanced scrutiny or believe that they have wrongly been included on a watchlist. </P>
                <P>With respect to the suggested choice between developing Secure Flight or directing TSA's resources towards other security measures, TSA approaches security as a layered process. TSA is committed to taking actions that will improve each layer of security and believes that such actions are not mutually exclusive. </P>
                <P>The American Civil Liberties Union (ACLU) commented that the continued expansion of government watchlists creates a risk of false positive matches of passengers on watchlists. Therefore, the ACLU stated, effective management of the watchlists will become even more important. Again, TSA agrees that the Secure Flight program must be shown to be effective in achieving its stated goals before it is implemented. In order to determine whether the program can be effective, however, TSA must test the system and is doing so while respecting the privacy and civil liberties of individuals. </P>
                <P>A number of commenters stated that Secure Flight would not be effective in identifying terrorists who may travel by air but are not currently known to the Federal Government and therefore are not included in the TSDB. Commenters also stated that even if an individual is included in the TSDB, Secure Flight will not detect that individual if he or she assumes the identity of a person not included in the TSDB, such as through identity theft. </P>
                <P>TSA agrees that checking passenger names against information in the TSDB will not identify unknown terrorists or those using a stolen identity. Commercial data may be useful in identifying instances where a passenger may have presented inaccurate or incorrect information. </P>
                <P>As discussed previously, however, Secure Flight will involve the use of a streamlined version of the existing CAPPS system that aircraft operators currently are using to prescreen passengers. That system evaluates information in PNRs that passengers otherwise provide to aircraft operators in the normal course of business. This element of Secure Flight will address the threat posed by an individual who may pose a threat but is not included in the TSDB or has assumed the identity of a person not included in the TSDB. </P>
                <P>A number of commenters stated that TSA should make public the results of the Secure Flight test phase. TSA will make the results available to the extent consistent with national security and homeland security. </P>
                <HD SOURCE="HD2">Compliance With the Privacy Act, PRA, and Other Laws</HD>
                <P>The EPIC stated that OMB should not approve the information collection until TSA provides more detailed information to the public about the Secure Flight program. </P>
                <P>The Secure Flight program is at a very early stage of development. The purpose of the test phase is to determine the technical feasibility of a consolidated system by which TSA may compare information in PNRs to information in the TSDB. At this point, therefore, TSA has provided as much detail as it can about the planned workings of the Secure Flight program. Once the test is completed and the results are analyzed, if the test phase indicates that the program is technically feasible, TSA will then be able to engage in a public rulemaking process that will involve a more detailed proposal for the Secure Flight program. This subsequent rulemaking will provide members of the public further opportunity to comment on operational and policy issues raised by the program. </P>
                <P>One commenter questioned whether TSA had a basis for receiving emergency processing from OMB of the information collection contained in the proposed order. TSA's request for emergency processing was based on the need to move forward with a new passenger prescreening system as quickly as possible, consistent with the 9/11 Commission's recently issued recommendation that TSA take over from aircraft operators the function of passenger prescreening using government watchlists. </P>
                <P>The commenter also articulated a number of aspects of the Secure Flight program that he argued are contrary to the requirements of the Privacy Act or other laws. First, he argued that PNRs constitute information regarding an individual's exercise of the First Amendment right of assembly because travel is a form of assembly. </P>
                <P>
                    The Privacy Act imposes certain limits on an agency's authority to collect records describing an individual's exercise of First Amendment Rights. See 5 U.S.C. 552a(e)(7). TSA does not agree that PNRs contain information related to the exercise of First Amendment rights, including the right of assembly. 
                    <PRTPAGE P="65624"/>
                </P>
                <P>
                    Second, the commenter argued that TSA's proposed order to aircraft operators to submit PNRs is inconsistent with the requirement that an agency collect information to the maximum extent practical directly from an individual when the information may result in an adverse determination about an individual's rights, benefits, or privileges. 
                    <E T="03">See</E>
                     5 U.S.C. 552a(e)(2). The commenter stated that TSA has failed to show that it would be impractical for TSA staff to collect information about passengers from them directly at the airport prior to boarding. 
                </P>
                <P>Collecting information from passengers at the airport for purposes of the Secure Flight test would impose a tremendous burden on the flying public in the form of additional time required for security screening. It also would not allow TSA to obtain and test the information in a PNR format, which is the form in which TSA would receive the information during the operational phase of the program. </P>
                <P>Third, the commenter, as well as others, stated that the proposed order is inconsistent with the Privacy Act because passengers whose information will be submitted to TSA under the order did not receive notice in accordance with section 552a(e)(3) of the Privacy Act, which requires a Federal agency to “inform each individual whom it asks to supply information” of: (1) The authority under which the request is made; (2) whether the disclosure of the information is mandatory or voluntary; (3) the principal purpose for which the information is intended to be used and the routine uses which may be made of the information; and (4) the effects on the individual if any, of not providing all or part of the information. </P>
                <P>The notice requirement under 5 U.S.C. 552a(e)(3) does not apply to the collection of the PNRs described in the proposed order. OMB has interpreted the notice requirement in section 552a(e)(3) to be inapplicable to situations in which an agency collects information about an individual from a third party. </P>
                <P>Fourth, the commenter argues that the system of records notice for Secure Flight fails to meet the requirement in 5 U.S.C. 552a(e)(4)(B) that it describe the categories of individuals on whom records are maintained in the system. The commenter notes that PNRs may contain the names of travel agents or other individuals who make, pay for, or process a passenger's travel but who are not passengers. The commenter also noted that the proposed order covered PNRs with itineraries that were entirely cancelled, thereby capturing individuals who had not flown. </P>
                <P>It is our understanding that the inclusion in PNRs of names other than those of passengers is rare. In any case, for purposes of testing the Secure Flight concept, TSA will not retrieve information from PNRs using the names of travel agents or other non-passengers who may be included in a PNR, because the purpose of Secure Flight is to screen passengers. The purpose of listing “Categories of individuals covered” in the system of records notice is to provide notice to those individuals whose records are subject to the Privacy Act because the records are retrieved by their name or personal identifier. The purpose is not to provide notice to every individual whose name may be incidentally mentioned in a record retrieved by the name of another individual. In addition, TSA has revised the final order to exclude from its scope any PNRs with itineraries that have been cancelled in whole, thereby avoiding collection of PNRs for individuals who have not actually completed any part of the itinerary in the PNR. For these reasons, the provision in the system of records notice meets the requirements of the Privacy Act. </P>
                <P>Fifth, the commenter argues that TSA has failed to meet certain requirements applicable to the promulgation of regulations under the Airline Deregulation Act, the Aviation and Transportation Security Act, and the Unfunded Mandates Reform Act of 1995, and the Regulatory Flexibility Act. Other commenters noted that TSA has not published a cost-benefit analysis for the Secure Flight program. </P>
                <P>As discussed previously, TSA is obtaining historical PNRs for the test phase of Secure Flight through the issuance of an order, not through rulemaking. Therefore, the foregoing statutes, as well as other statutes and Executive Orders that apply to agency rulemaking, do not apply in this instance. If testing of the program indicates that it is a feasible and effective security measure, TSA will initiate a public rulemaking process in which it will again fully comply with all applicable statutory requirements. </P>
                <P>Sixth, the commenter argued that TSA has no authority to establish a system of records for Secure Flight or order aircraft operators to provide PNRs to TSA. </P>
                <P>TSA has ample authority to conduct the Secure Flight test. Under the Aviation and Transportation Security Act and authority delegated to the Assistant Secretary of Homeland Security (Transportation Security Administration) by the Secretary of Homeland Security, TSA is responsible for, among other things, the screening of passengers and property transported in air transportation and intrastate air transportation. Also under its delegated authority, TSA has broad authority under 49 U.S.C. 40113(a) to issue orders necessary to carry out its statutory duties, which expressly include providing for security screening, under 49 U.S.C. 44901(a). TSA also is authorized to undertake research and development activities necessary to enhance transportation security under 49 U.S.C. 114(f)(8) and create a successor system to the existing CAPPS under 49 U.S.C. 44903(j)(2). Under these authorities, TSA may order aircraft operators to provide PNRs to TSA to test the Secure Flight program. Implementation of the Secure Flight test also is in furtherance of Homeland Security Presidential Directive-6/HSPD-6 of September 23, 2003 (“Integration and Use of Screening Information to Protect Against Terrorism”), which, among other things, directs Federal agencies to conduct screening at all appropriate opportunities using consolidated terrorist information and intelligence about individuals known or appropriately suspected to be or have been engaged in conduct constituting, in preparation for, in aid of, or related to terrorism. </P>
                <HD SOURCE="HD2">Potential Conflict With EU Laws </HD>
                <P>United Airlines and other commenters expressed concern that complying with the proposed order would expose U.S. airlines to liability for violating privacy laws of the Member States of the EU. United suggested that the U.S. government work closely with foreign governments to address any conflicts of laws that may arise. While TSA has clear statutory authority to require the submission of reservation information for use in prescreening passengers on domestic flight segments, TSA understands the sensitivity of aircraft operators to the possibility of conflicting legal obligations under U.S. law and the laws of EU Member States. Therefore, in the interest of implementing this test expeditiously, TSA has determined that for purposes of this test phase, aircraft operators may opt to exclude from PNRs submitted to TSA any PNR that includes a flight segment between the United States and the EU. </P>
                <P>
                    TSA and Department officials briefed European Commission (EC) representatives on October 25 to provide further details on Secure Flight testing, including the parameters of data to be 
                    <PRTPAGE P="65625"/>
                    submitted for the test. TSA informed the EC that carriers may elect not to submit to TSA for use in testing any PNRs with a flight segment between the EU and the United States. The Department and EC representatives will continue regular discussions to keep the EU fully apprised of TSA's progress regarding Secure Flight, and to receive EU feedback on Secure Flight issues. TSA, in conjunction with DHS, will continue to consult with the EU prior to and during Secure Flight implementation. 
                </P>
                <HD SOURCE="HD2">Other Issues </HD>
                <P>United Airlines stated in its comment the concern that the Secure Flight program might result in unnecessary costs to airlines if they are required to establish new systems to transmit passenger information to TSA, rather than relying on existing systems, such as those that U.S. Customs and Border Protection has in place for receiving advance passenger information for international flights. In planning and developing the operational stage of the Secure Flight program, TSA will work to use existing communications links between the airlines and the Federal Government in order to avoid imposing duplicative requirements on the airlines to the greatest extent possible. </P>
                <HD SOURCE="HD1">Final Order </HD>
                <P>The final order is largely unchanged from the proposed order, with the exception of the following provisions. </P>
                <P>First, in order to simplify and clarify compliance with the order, TSA changed the scope of PNRs that aircraft operators are required to provide and the description of the category of aircraft operators covered by the order. The proposed order would have required the submission of any PNRs with a flight segment completed during June 2004, so long as all the flight segments in the PNR had been completed by the end of June 2004. Thus, the proposed order covered PNRs with flight segments completed many months before June 2004. The final order applies only to those PNRs with all flight segments (flights between two locations) completed in June 2004. </P>
                <P>The proposed order applied to PNRs for any passenger on “a scheduled flight within the United States, in operations subject to a full security program under 49 CFR 1544.101(a).” This language was intended to cover any scheduled passenger or public charter operation conducted under a full security program. Because the proposed order did not specifically mention public charter operations and used the term “scheduled flight,” there was some confusion as to whether TSA intended to cover any public charter operations. The final order clarifies this point by stating the following: “This order applies to aircraft operators that conduct scheduled passenger or public charter operations subject to a full security program under 49 CFR 1544.101(a).” </P>
                <P>The proposed order directed aircraft operators to exclude from the PNRs submitted to TSA any flight segment to or from the United States. TSA now understands, however, that deleting information related to flight segments from PNRs is difficult and could inhibit aircraft operators from complying with the order in a timely manner. After reviewing this issue and considering the issues discussed above related to possible conflicts of law with EU Member States, TSA revised the order to allow aircraft operators to exclude entirely from its submission PNRs that include flight segments between the United States and the EU. </P>
                <P>TSA has modified the proposed order in response to questions about how the order applied to aircraft operators that use passenger manifests rather than PNRs. The final order provides that if an aircraft operator does not use PNRs, the order applies to the reservation data in whatever form the aircraft operators receive or maintain for operation of a flight, such as a passenger manifest. The final order also clarifies that with respect to codesharing operations, if an aircraft operator does not maintain PNRs or other passenger reservation information for the flights that it operates, the aircraft operator may comply with the order by stipulating in writing to TSA that the entity maintaining such PNRs or other passenger reservation information has agreed to provide the information to TSA on behalf of the aircraft operator. For example, a regional aircraft operator that relies on other aircraft operators to maintain PNRs for the regional operator's flights must stipulate that the other aircraft operators will submit PNRs to TSA on the regional aircraft operator's behalf. </P>
                <P>TSA also received questions about how to address situations where PNR history, which was excluded from the scope of the proposed order, includes completed flight segments, which were included in the scope of the proposed order. The final order clarifies that if the PNR history includes information on flight segments already flown, they must be included in the PNR submitted to TSA. In such cases, the aircraft operator may move information on flights flown out of the PNR history or include the entire PNR history in the information submitted to TSA, and TSA will extract the flown flight segments. The final order also clarifies that PNRs must include all data that would have been available to the aircraft operator prior to the completion of the itinerary (active fields), including any “remarks” sections, the reservation creation date, and CAPPS scores and codes. </P>
                <P>Finally, the final order provides additional information about how the PNRs are to be submitted, including a requirement that they be password protected. </P>
                <P>Based on the foregoing, TSA will issue the following final order to aircraft operators. The text of the final order is set forth below. </P>
                <SIG>
                    <DATED>Issued in Arlington, Virginia, on November 10, 2004. </DATED>
                    <NAME>Lisa S. Dean, </NAME>
                    <TITLE>Privacy Officer.</TITLE>
                </SIG>
                <EXTRACT>
                    <FP SOURCE="FP-1">OMB Control Number 1652-0025 </FP>
                    <FP SOURCE="FP-1">Expiration Date: March 31, 2005 </FP>
                    <HD SOURCE="HD1">Transportation Security Administration Order </HD>
                    <P>Pursuant to the authority vested in me as Assistant Secretary of Homeland Security (Transportation Security Administration) (TSA) by delegation from the Secretary of Homeland Security, 49 U.S.C. 40113(a), and other authorities described below, I hereby direct each aircraft operator listed in Attachment A to this order to provide passenger name records (PNRs) to TSA in accordance with the terms of this order. </P>
                    <HD SOURCE="HD2">Background and Authority </HD>
                    <P>1. The Secretary of Homeland Security has delegated to the Assistant Secretary of Homeland Security (TSA), subject to the Secretary's guidance and control, the authority vested in the Secretary by section 403(2) of the Homeland Security Act respecting TSA, including that related to civil aviation security under the Aviation and Transportation Security Act. </P>
                    <P>2. Under 49 U.S.C. 114(e)(1) and 44901(a), TSA is responsible for, among other things, providing for the screening of passengers traveling in air transportation and intrastate air transportation. </P>
                    <P>3. One component of passenger screening is the Computer-Assisted Passenger Prescreening System (CAPPS), an automated screening system developed by the Federal Aviation Administration (FAA) in cooperation with U.S. aircraft operators. U.S. aircraft operators implemented CAPPS in 1997. </P>
                    <P>
                        4. CAPPS evaluates information in PNRs that passengers otherwise provide to aircraft operators in the normal course of business to determine whether a passenger will be selected for a higher level of security screening prior to boarding. A PNR is a record that contains detailed information about an individual's travel on a particular flight, including information provided by the individual when making the flight reservation. While the Federal Government established the CAPPS selection criteria, CAPPS is operated entirely by U.S. aircraft operators. 
                        <PRTPAGE P="65626"/>
                    </P>
                    <P>5. Passenger prescreening also involves the comparison of identifying information of airline passengers against lists of individuals known to pose or suspected of posing a threat to civil aviation or national security. Aircraft operators currently carry out this function, using lists provided by TSA. Because the lists are provided in an unclassified form, the amount of information they include is limited. For this reason, TSA will take over from aircraft operators the function of screening passengers against such lists and use a larger set of data maintained by the Federal Government for this purpose. This is consistent with the recommendation by the National Commission on Terrorist Attacks upon the United States (9/11 Commission) related to the use of expanded “No-Fly” and “Automatic Selectee” lists, and the 9/11 Commission recommendation that aircraft operators be required to supply the information needed to test and implement such a system. </P>
                    <P>6. In accordance with the authority in 49 U.S.C. 44903(j)(2), TSA is in the process of developing a successor system to CAPPS that will be operated entirely by TSA and will incorporate the screening of passengers against data maintained by the Terrorist Screening Center (TSC) about individuals known or reasonably suspected to be or have been engaged in conduct constituting, in preparation for, in aid of, or related to terrorism. </P>
                    <P>7. In order to test such a system, TSA must have access to information contained in the PNRs for domestic passenger flights. TSA also must have access to passenger information from aircraft operators that maintain the information in forms other than PNRs, such as passenger manifests. </P>
                    <P>8. TSA has broad authority under 49 U.S.C. 40113(a) to issue orders necessary to carry out its functions, including its responsibility to provide for the security screening of passengers under 49 U.S.C. 44901(a). TSA also has authority to identify and undertake research and development activities necessary to enhance transportation security under 49 U.S.C. 114(f)(8). </P>
                    <HD SOURCE="HD2">Findings </HD>
                    <P>9. The security prescreening of passengers, as mandated by Congress, is vital to aviation security and national security. </P>
                    <P>10. After a lengthy review of the initial plans for a successor system to CAPPS, and consistent with the recommendation of the 9/11 Commission, the Department of Homeland Security is moving forward with a next generation system of domestic passenger prescreening that meets the following goals: (1) Identifying, in advance of flight, passengers known or suspected to be engaged in terrorist activity; (2) moving of passengers through airport screening more quickly and reducing the number of individuals unnecessarily selected for secondary screening; and (3) fully protecting passengers' privacy and civil liberties. </P>
                    <P>11. In the revised program, known as Secure Flight, TSA will compare information in airline PNRs or other passenger manifest formats for domestic flights to information in the Terrorist Screening Database (TSDB) maintained by TSC, including expanded TSA No-Fly and Selectee lists, in order to identify individuals known or reasonably suspected to be or having been engaged in conduct constituting, in preparation for, in aid of, or related to terrorism. The Secure Flight program also will test operation of a streamlined version of the existing CAPPS evaluation criteria. TSA will use the PNRs obtained under this order to test these aspects of the program. </P>
                    <P>12. TSA also will test whether comparing passenger information to other commercially available data can enhance TSA's ability to identify passenger information that is inaccurate or incorrect. </P>
                    <P>13. In order to develop and test such a system, TSA must obtain passenger information in PNRs, or other passenger manifest formats where PNRs are not used, from aircraft operators. </P>
                    <P>
                        14. On September 24, 2004, TSA published in the 
                        <E T="04">Federal Register</E>
                         a proposed order requiring aircraft operators to provide PNRs for testing the Secure Flight program. After considering the public comments received and making modifications to the proposed order, where appropriate, TSA is issuing this final order to aircraft operators for purposes of obtaining PNRs to test the Secure Flight program. 
                    </P>
                    <HD SOURCE="HD2">Action Ordered </HD>
                    <P>
                        15. 
                        <E T="03">Scope:</E>
                    </P>
                    <P>
                        a. 
                        <E T="03">Aircraft Operators:</E>
                    </P>
                    <P>This order applies to aircraft operators that conduct scheduled passenger or public charter operations subject to a full security program under 49 CFR 1544.101(a). </P>
                    <P>
                        b. 
                        <E T="03">Information:</E>
                    </P>
                    <P>This order applies to PNRs containing itineraries for domestic flights operated under a full security program and for which all flight segments in the itinerary were flown between June 1, 2004 and June 30, 2004, (after 2400 hours 31 May 2004 and before 0001 hours 1 July 2004). This includes PNRs for non-revenue and space available passengers. </P>
                    <P>For purposes of this order, “PNR” means the electronic record maintained by the aircraft operator detailing information about an individual's travel on a particular flight and any other information contained in that record. </P>
                    <P>For purposes of this order, “domestic flight” means a flight between two locations in the United States (to include the U.S. Virgin Islands, Puerto Rico, Guam, Saipan, and American Samoa). </P>
                    <P>This order does not apply to PNRs reflecting itineraries that were cancelled in whole. </P>
                    <P>An aircraft operator may elect to exclude from the scope of the order any PNRs which include any flight segments between the EU and the United States. </P>
                    <P>If an aircraft operator does not use PNRs, the order applies to the reservation data in whatever form aircraft operators receive or maintain for operation of a flight, such as a passenger manifest. </P>
                    <P>
                        c. 
                        <E T="03">Information in PNRs:</E>
                    </P>
                    <P>PNRs must include all data that would have been available to the aircraft operator in a displayed PNR prior to the completion of the itinerary (active fields), including any “remarks” sections, the reservation creation date, and CAPPS scores and codes. </P>
                    <P>PNRs may not include information related to changes in a PNR prior to completion of the flight itinerary (PNR history). If, however, the PNR history includes information on flight segments already flown, they must be included in the PNR. In such cases, the aircraft operator may move information on flights flown out of the PNR history or include the entire PNR history in the information submitted to TSA, and TSA will extract the flown flights segments (itinerary). </P>
                    <P>PNRs may be submitted in archive format. </P>
                    <P>
                        16. 
                        <E T="03">Submission of PNRs:</E>
                    </P>
                    <P>The aircraft operator must submit to TSA all PNRs described in paragraph 15 so that the data is received by TSA no later than 5 p.m. EST on November 23, 2004. </P>
                    <P>Mail all information through overnight carrier to: Lisa Dean, Privacy Officer, Transportation Security Administration, 601 S. 12th Street, TSA-9, Room E7-305N, Arlington, VA 22202, Phone: (571) 227-3947. </P>
                    <P>
                        17. 
                        <E T="03">Codesharing Operations:</E>
                    </P>
                    <P>If an aircraft operator does not maintain PNRs or other passenger reservation information for the flights that it operates, the aircraft operator may comply with this order by stipulating in writing to TSA that the entity maintaining such PNRs or other passenger reservation information has agreed to provide the information to TSA on behalf of the aircraft operator. For example, a regional aircraft operator that relies on other aircraft operators to maintain PNRs for the regional operator's flights must stipulate the other aircraft operators will submit PNRs to TSA on the regional aircraft operator's behalf. </P>
                    <P>Letters of stipulation, described above, must be signed and on company letterhead. They may be delivered in one of the following three ways: </P>
                    <P>
                        <E T="03">U.S. Mail:</E>
                         TSA/ONRA, Attention: Airline Team, P.O. Box 597, Annapolis Junction, MD 20701. 
                    </P>
                    <P>
                        <E T="03">FAX:</E>
                         (240) 568-3528. 
                    </P>
                    <P>
                        <E T="03">E-mail (scanned copies): SecureFlight@DHS.gov.</E>
                    </P>
                    <P>18. The aircraft operator must provide to TSA information about the aircraft operator's PNR data schema and layout, such as a PNR format book and a data dictionary that includes all acronyms and codes not standard to the International Air Transport Association. </P>
                    <P>
                        19. For purposes of the test, the aircraft operator must provide the PNRs to TSA on optical media in an unpacked or uncompressed form, in a structured data format or XML, if available. Information must be password-protected. The aircraft operator must supply TSA with the password via e-mail at 
                        <E T="03">SecureFlight@DHS.gov.</E>
                    </P>
                    <HD SOURCE="HD1">Attachment A—Aircraft Operators </HD>
                    <FP SOURCE="FP-1">1. Air Midwest Inc.</FP>
                    <FP SOURCE="FP-1">2. Air Wisconsin Airline Corp </FP>
                    <FP SOURCE="FP-1">3. AirTran Airways Inc. </FP>
                    <FP SOURCE="FP-1">4. Alaska Airlines Inc. </FP>
                    <FP SOURCE="FP-1">5. Allegiant Air </FP>
                    <FP SOURCE="FP-1">6. Aloha Airlines Inc. </FP>
                    <FP SOURCE="FP-1">7. America West Airlines Inc. </FP>
                    <FP SOURCE="FP-1">8. American Airlines Inc. </FP>
                    <FP SOURCE="FP-1">9. American Eagle </FP>
                    <FP SOURCE="FP-1">
                        10. American Trans Air Inc. 
                        <PRTPAGE P="65627"/>
                    </FP>
                    <FP SOURCE="FP-1">11. Atlantic Southeast Airlines (ASA) </FP>
                    <FP SOURCE="FP-1">12. Big Sky Airlines </FP>
                    <FP SOURCE="FP-1">13. Boston and Maine Airways </FP>
                    <FP SOURCE="FP-1">14. Cape Air (Hyannis Air Service) </FP>
                    <FP SOURCE="FP-1">15. Caribbean Air </FP>
                    <FP SOURCE="FP-1">16. Casino Airlines </FP>
                    <FP SOURCE="FP-1">17. Casino Express TEM Enterprises </FP>
                    <FP SOURCE="FP-1">18. Champion Air (Grand Holdings) </FP>
                    <FP SOURCE="FP-1">19. Chautauqua Airlines </FP>
                    <FP SOURCE="FP-1">20. Chicago Express Airlines </FP>
                    <FP SOURCE="FP-1">21. Colgan Air </FP>
                    <FP SOURCE="FP-1">22. Comair, Inc. </FP>
                    <FP SOURCE="FP-1">23. Commutair (Champlain Ent.) </FP>
                    <FP SOURCE="FP-1">24. Continental Airlines Inc. </FP>
                    <FP SOURCE="FP-1">25. Continental Micronesia Inc. </FP>
                    <FP SOURCE="FP-1">26. Corporate Airlines </FP>
                    <FP SOURCE="FP-1">27. Delta Air Lines Inc. </FP>
                    <FP SOURCE="FP-1">28. Executive Airlines/American Eagle </FP>
                    <FP SOURCE="FP-1">29. Expressjet Airlines (Cont. Express) </FP>
                    <FP SOURCE="FP-1">30. Falcon Air Express </FP>
                    <FP SOURCE="FP-1">31. Freedom Air </FP>
                    <FP SOURCE="FP-1">32. Freedom Airlines </FP>
                    <FP SOURCE="FP-1">33. Frontier Airlines </FP>
                    <FP SOURCE="FP-1">34. Great Lakes Aviation Ltd. </FP>
                    <FP SOURCE="FP-1">35. Gulfstream International Airlines</FP>
                    <FP SOURCE="FP-1">36. Hawaii Island Air (Island Air) </FP>
                    <FP SOURCE="FP-1">37. Hawaiian Airlines </FP>
                    <FP SOURCE="FP-1">38. Horizon Air </FP>
                    <FP SOURCE="FP-1">39. Independence  Air (Atlantic Coast Airline) </FP>
                    <FP SOURCE="FP-1">40. Jetblue Airways Corp. </FP>
                    <FP SOURCE="FP-1">41. Kenmore (start-up) </FP>
                    <FP SOURCE="FP-1">42. Mesa Airlines </FP>
                    <FP SOURCE="FP-1">43. Mesaba Aviation Inc. </FP>
                    <FP SOURCE="FP-1">44. Miami Air International </FP>
                    <FP SOURCE="FP-1">45. Midwest Airlines Inc. </FP>
                    <FP SOURCE="FP-1">46. North American Airlines </FP>
                    <FP SOURCE="FP-1">47. Northwest Airlines Inc. </FP>
                    <FP SOURCE="FP-1">48. Omni </FP>
                    <FP SOURCE="FP-1">49. Pace/Hooters </FP>
                    <FP SOURCE="FP-1">50. Pacific Island Aviation Inc. </FP>
                    <FP SOURCE="FP-1">51. Pacific Wings </FP>
                    <FP SOURCE="FP-1">52. Pan American Airways Corp. </FP>
                    <FP SOURCE="FP-1">53. Piedmont Airlines </FP>
                    <FP SOURCE="FP-1">54. Pinnacle Airlines (d/b/a Northwest Airlink) </FP>
                    <FP SOURCE="FP-1">55. Planet Air </FP>
                    <FP SOURCE="FP-1">56. Primaris Airlines, Inc. (Primaris) </FP>
                    <FP SOURCE="FP-1">57. PSA Airlines </FP>
                    <FP SOURCE="FP-1">58. Ryan International Airlines </FP>
                    <FP SOURCE="FP-1">59. Shuttle America </FP>
                    <FP SOURCE="FP-1">60. Sky King </FP>
                    <FP SOURCE="FP-1">61. Sky West Airlines </FP>
                    <FP SOURCE="FP-1">62. Skyway Airlines/Midwest Connect </FP>
                    <FP SOURCE="FP-1">63. Southeast Airlines </FP>
                    <FP SOURCE="FP-1">64. Southwest Airlines (U.S.A.) </FP>
                    <FP SOURCE="FP-1">65. Spirit Airlines </FP>
                    <FP SOURCE="FP-1">66. Sun Country Airlines Inc. </FP>
                    <FP SOURCE="FP-1">67. Trans States Airlines </FP>
                    <FP SOURCE="FP-1">68. Transmeridian Airlines </FP>
                    <FP SOURCE="FP-1">69. United Airlines Inc. </FP>
                    <FP SOURCE="FP-1">70. US Airways Inc. </FP>
                    <FP SOURCE="FP-1">71. USA3000 </FP>
                    <FP SOURCE="FP-1">72. World Airways</FP>
                </EXTRACT>
            </SUPLINF>
            <FRDOC>[FR Doc. 04-25396 Filed 11-12-04; 8:45 am] </FRDOC>
            <BILCOD>BILLING CODE 4910-62-P </BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="N">DEPARTMENT OF HOUSING AND URBAN DEVELOPMENT </AGENCY>
                <DEPDOC>[Docket No. FR-4665-N-20] </DEPDOC>
                <SUBJECT>Meeting of the Manufactured Housing Consensus Committee </SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Office of the Assistant Secretary for Housing—Federal Housing Commissioner, HUD. </P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice of upcoming meeting. </P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>This advises the public of an upcoming meeting of the Manufactured Housing Consensus Committee (the Committee) and publishes the schedule and proposed agenda for the meeting. The meeting is open to the public and the site is accessible to individuals with disabilities. </P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>The Committee will meet on November 30, 2004 and December 1, 2004, from 8 a.m. to 5 p.m., and on December 2, 2004, from 8 a.m. to 12 p.m. </P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>The Committee will meet at the Marriott San Diego Hotel &amp; Marina, 333 West Harbor Drive, San Diego, California 92101, telephone (619) 234-1500. </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>William W. Matchneer III, Administrator, Manufactured Housing Program, Office of Consumer and Regulatory Affairs, Department of Housing and Urban Development, 451 7th Street SW., Washington, DC 20410-8000, telephone (202) 708-6409 (this is not a toll-free number). Persons with hearing- or speech-impairments may access this number through TTY by calling the toll-free Federal Information Relay Service at (800) 877-8339. </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>Notice of this meeting is provided in accordance with section 10(a)(2) of the Federal Advisory Committee Act (5 U.S.C. App.2) and 41 CFR 102-3.150. The Manufactured Housing Consensus Committee was established under section 604(a)(3) of the National Manufactured Housing Construction and Safety Standards Act of 1974, as amended by the Manufacturer Housing Improvement Act of 2000, 42 U.S.C. 4503(a)(3). The Consensus Committee is charged with providing recommendations to the Secretary to adopt, revise, and interpret manufactured housing construction and safety standards and procedural and enforcement regulations, and with developing proposed model installation standards. </P>
                <HD SOURCE="HD2">Tentative Agenda </HD>
                <FP SOURCE="FP-1">A. Welcome and Introductions </FP>
                <FP SOURCE="FP-1">B. Departmental Status Report </FP>
                <FP SOURCE="FP-1">C. Subpart I </FP>
                <FP SOURCE="FP-1">D. Construction and Safety Standards </FP>
                <FP SOURCE="FP-1">E. Installation Standards </FP>
                <FP SOURCE="FP-1">F. Accessibility—Universal Design—Visitability </FP>
                <FP SOURCE="FP-1">G. Public Testimony </FP>
                <FP SOURCE="FP-1">H. Reports and Actions on Committee Work </FP>
                <FP SOURCE="FP-1">I. Adjourn </FP>
                <SIG>
                    <DATED>Dated: November 9, 2004. </DATED>
                    <NAME>John C. Weicher, </NAME>
                    <TITLE>Assistant Secretary for Housing—Federal Housing Commissioner. </TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 04-25389 Filed 11-10-04; 11:36 am] </FRDOC>
            <BILCOD>BILLING CODE 4210-27-P </BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="N">INTER-AMERICAN FOUNDATION</AGENCY>
                <SUBJECT>Sunshine Act Meeting</SUBJECT>
                <HD SOURCE="HD1">Agenda for Board of Directors' Meeting, November 30, 2004; 9:30 a.m.-1:30 p.m.</HD>
                <P>The meeting will be open except for the portion specified as a closed session as provided in 22 CFR 1004.4(f).</P>
                <FP SOURCE="FP-2">9:30 a.m.</FP>
                <FP SOURCE="FP1-2">Call to Order—Approval of the Minutes of the October 1, 2004 meeting</FP>
                <FP SOURCE="FP1-2">Executive Session (Closed session to discuss personnel issues, as provided in 22 CFR Part 1004.4(f)).</FP>
                <FP SOURCE="FP-2">10:30 a.m.</FP>
                <FP SOURCE="FP1-2">President's Report</FP>
                <FP SOURCE="FP1-2">The IAF Strategic Plan</FP>
                <FP SOURCE="FP1-2">The IAF Corporate Outreach program</FP>
                <FP SOURCE="FP-2">12 p.m.</FP>
                <FP SOURCE="FP1-2">Lunch</FP>
                <FP SOURCE="FP-2">12:30 p.m.</FP>
                <FP SOURCE="FP1-2">Discussion on the Role of the Advisory Council</FP>
                <FP SOURCE="FP1-2">Relations with OMB and Congress</FP>
                <FP SOURCE="FP1-2">Other Business</FP>
                <FP SOURCE="FP-2">1:30 p.m.</FP>
                <FP SOURCE="FP1-2">Adjournment</FP>
                <SIG>
                    <NAME>Carolyn Karr,</NAME>
                    <TITLE>Senior Vice President and General Counsel.</TITLE>
                </SIG>
            </PREAMB>
            <FRDOC>[FR Doc. 04-25372 Filed 11-10-04; 10:47 am]</FRDOC>
            <BILCOD>BILLING CODE 7025-01-M</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="N">DEPARTMENT OF THE INTERIOR </AGENCY>
                <SUBAGY>Fish and Wildlife Service </SUBAGY>
                <SUBJECT>Information Collection Renewal to be Submitted to the Office of Management and Budget (OMB) for Approval Under the Paperwork Reduction Act; OMB Control Number 1018-0103, Conservation Order for Control of Mid-Continent Light Geese, 50 CFR 21.60 </SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Fish and Wildlife Service, Interior. </P>
                </AGY>
                <ACT>
                    <PRTPAGE P="65628"/>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice; request for comments. </P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The Fish and Wildlife Service (We) will submit the collection of information described below to OMB for approval under the provisions of the Paperwork Reduction Act of 1995. </P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>You must submit comments on or before January 14, 2005. </P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        Send your comments on this information collection requirement to Hope Grey, Service Information Collection Clearance Officer, Fish and Wildlife Service, MS 222-ARLSQ, 4401 North Fairfax Drive, Arlington, VA 22203 (mail); 
                        <E T="03">Hope_Grey@fws.gov</E>
                         (e-mail); or (703) 358-2269 (fax). 
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>To request a copy of the information collection requirements or explanatory material, contact Hope Grey at the addresses above or by telephone at (703) 358-2482. </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>
                    The Office of Management and Budget regulations at 5 CFR 1320, which implement provisions of the Paperwork Reduction Act of 1995 (Public Law 104-13), require that interested members of the public and affected agencies have an opportunity to comment on information collection and recordkeeping activities (
                    <E T="03">see</E>
                     5 CFR 1320.8(d)). We plan to submit a request to OMB to renew approval of the collection of information for the Conservation Order for Control of Mid-Continent Light Geese. The current OMB Control Number for this information collection is 1018-0103, which expires March 31, 2005. We are requesting a 3-year term of approval for this information collection activity. Federal agencies may not conduct or sponsor and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number. 
                </P>
                <P>The number of light geese (lesser snow and Ross' geese) in the mid-continent region has nearly quadrupled during the past several decades due to a decline in adult mortality and an increase in winter survival. Lesser snow and Ross' geese are referred to as light geese because of their light coloration as opposed to dark geese such as white-fronted or Canada Geese. Because of their feeding activity, light geese have become seriously injurious to their habitat as well as to habitat important to other migratory birds. This poses a serious threat to the short- and long-term health and status of some migratory bird populations. We believe that the number of light geese in the mid-continent region has exceeded long-term sustainable levels for their arctic and subarctic breeding habitats and that the populations must be reduced. 50 CFR 21 provides authority for the management of overabundant mid-continent light geese. </P>
                <P>Light geese in the mid-continent region are separated into two different populations for management purposes. Lesser snow and Ross' geese that primarily migrate through North Dakota, South Dakota, Nebraska, Kansas, Iowa, and Missouri, and winter in Arkansas, Louisiana, Mississippi, and eastern, central, and southern Texas and other Gulf States are referred to as the mid-continent population of light geese. Lesser snow and Ross' geese that primarily migrate through Montana, Wyoming, and Colorado and winter in New Mexico, northwestern Texas, and Chihuahua, Mexico, are referred to as Western Central Flyway population of light geese. </P>
                <P>States that participate in the light geese conservation order must inform and brief all participants on the requirements in 50 CFR 21.60 and conservation order conditions that apply to the implementation of light geese control measures. Participating States must collect information on the number of birds taken during control efforts, the methods by which they were taken, and the date on which they were taken. We use this information to administer the conservation order and, particularly, to monitor the effectiveness of control strategies and to protect migratory birds. Each participating State must submit an annual report by August 30 of each year summarizing the activities it conducted. We contacted some participating States to estimate the burden hours for this information collection. </P>
                <P>
                    <E T="03">Title of Collection:</E>
                     Conservation Order for Control of Mid-Continent Light Geese, 50 CFR 21.60. 
                </P>
                <P>
                    <E T="03">OMB Control Number:</E>
                     1018-0103. 
                </P>
                <P>
                    <E T="03">Form Number:</E>
                     None. 
                </P>
                <P>
                    <E T="03">Frequency of Collection:</E>
                     Annually. 
                </P>
                <P>
                    <E T="03">Description of Respondents:</E>
                     States participating in the conservation order. 
                </P>
                <P>
                    <E T="03">Total Annual Burden Hours:</E>
                     1,776. 
                </P>
                <P>
                    <E T="03">Total Annual Responses:</E>
                     24. 
                </P>
                <P>We invite comments concerning this submission on (1) whether or not the collection of information is necessary for the proper performance of our migratory bird management functions, including whether or not the information will have practical utility; (2) the accuracy of our estimate of the burden of the collection of information; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents. The information collections in this program are part of a system of record covered by the Privacy Act (5 U.S.C. 552(a)). </P>
                <P>Our practice is to make comments, including names and home addresses of respondents, available for public review during regular business hours. Individual respondents may request that we withhold their home addresses from the record, which we will honor to the extent allowable by law. There may also be limited circumstances in which we would withhold a respondent's identity from the administrative record, as allowable by law. If you wish us to withhold your name and/or address, you must state this clearly at the beginning of your comment. We will not consider anonymous comments. We generally make all submissions from organizations or businesses and from individuals identifying themselves as representatives or officials of organizations or businesses available for public inspection in their entirety. </P>
                <SIG>
                    <DATED>Dated: November 1, 2004. </DATED>
                    <NAME>Hope Grey, </NAME>
                    <TITLE>Information Collection Clearance Officer, Fish and Wildlife Service. </TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 04-25267 Filed 11-12-04; 8:45 am] </FRDOC>
            <BILCOD>BILLING CODE 4310-55-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF THE INTERIOR </AGENCY>
                <SUBAGY>Bureau of Indian Affairs </SUBAGY>
                <SUBJECT>Proposed Agency Information Collection Activities; Comment Request </SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Bureau of Indian Affairs, Interior. </P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice. </P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>This notice announces that the Information Collection Request for Adult Education Annual Report Form OMB #1076-0120 requires renewal. The current Adult Education Annual Report Form OMB #1076-0120, with no appreciable changes, will be submitted after the comment period to the Office of Management and Budget (OMB) for review, as required by the Paperwork Reduction Act of 1995. The Bureau is soliciting public comments on the subject proposal. </P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Written comments must be submitted on or before January 14, 2005. </P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>Comments are to be mailed to Edward Parisian, Director, Office of Indian Education Programs, Department of the Interior, Bureau of Indian Affairs, 1849 C St., NW., Mail Stop 3609-MIB, Washington, DC 20240, or hand delivered to room 3623 at the above address. </P>
                </ADD>
                <FURINF>
                    <PRTPAGE P="65629"/>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>Garry Martin, Bureau of Indian Affairs, 202-208-3478. </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <HD SOURCE="HD1">I. Abstract </HD>
                <P>The information collection is necessary to assess the need for adult education programs in accordance with 25 CFR part 46, subpart A, sections 46.20 Program Requirements and 46.30 Records and Reporting Requirements of the Adult Education Program. </P>
                <HD SOURCE="HD1">II. Method of Collection </HD>
                <P>The Adult Education Program regulations under 25 CFR part 46, subpart 46, contain the program requirements which govern the program. Information collected from the contractors will be used for administrative planning, setting long- and short-term goals, and analyzing and monitoring the use of funds. </P>
                <HD SOURCE="HD1">III. Data </HD>
                <P>
                    <E T="03">Title of the Collection of Information:</E>
                     Bureau of Indian Affairs Adult Education Program Annual Report Form. 
                </P>
                <P>
                    <E T="03">OMB Control Number:</E>
                     1076-0120; Expiration Date: January 31, 2005. 
                </P>
                <P>
                    <E T="03">Type of Review:</E>
                     Renewal of a currently-approved information collection. 
                </P>
                <P>
                    <E T="03">Summary of the Collection of Information:</E>
                     The collection of information provides pertinent data concerning the adult education programs. 
                </P>
                <P>
                    <E T="03">Description of the need for the information and proposed use of the information:</E>
                     Submission of this information is necessary to assess the need for adult education programs. The information is needed for the utilization and management of program resources to provide education opportunities for adult American Indians and Alaska Natives to complete high school requirements, and to gain new skills and knowledge for individual student self enhancement. The information collected with the annual report will be used by the Bureau or tribally controlled programs for fiscal accountability and appropriate direct services documentation. The results of the data are used for administrative planning. 
                </P>
                <P>
                    <E T="03">Affected Entities:</E>
                     Tribal adult education contractors. 
                </P>
                <P>
                    <E T="03">Estimated number of respondents:</E>
                     70. Respondents are tribal adult education program administrators. 
                </P>
                <P>
                    <E T="03">Proposed frequency of responses:</E>
                     Annually. 
                </P>
                <P>
                    <E T="03">Burden:</E>
                     The estimate of total annual reporting and recordkeeping burden that will result from the collection of information: Reporting 4 hours per response x 70 respondents = 280 hours. 
                </P>
                <P>
                    <E T="03">Estimated Annual Costs:</E>
                     $5,040.00 (4 hours × 70 × $18.00 = salary dollars). Cost for recordkeeping and auditing is part of their costs for administering this program under Tribal Priority Allocation activity of the tribal budget. 
                </P>
                <HD SOURCE="HD1">IV. Request for Comments </HD>
                <P>The Department of the Interior invites comments on: </P>
                <P>(a) Whether the collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; </P>
                <P>(b) The accuracy of the agency's estimate of the burden (including the hours and cost) of the proposed collection of information, including the validity of the methodology and assumption used; </P>
                <P>(c) Ways to enhance the quality, utility, and clarity of the information to be collected; and </P>
                <P>(d) Ways to minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other collection techniques or other forms of information technology. </P>
                <P>
                    <E T="03">Burden</E>
                     means the total time, effort, or financial resources expended by persons to generate, maintain, retain, or disclose or provide information to or for a Federal agency. This includes the time needed to review instructions; to develop, acquire, install and utilize technology and systems for the purpose of collecting, validating, and verifying information, processing and maintaining information, and disclosing and providing information, to search data sources, to complete and review the collection of information; and to transmit or otherwise disclose the information. 
                </P>
                <P>
                    It is our policy to make all comments available to the public for review at the location listed in the 
                    <E T="02">ADDRESSES</E>
                     section, Room 3623, during the hours of 8 a.m. to 4:30 p.m., e.s.t., Monday through Friday, except for legal holidays. If you wish to have your name and/or address withheld, you must state this prominently at the beginning of your comments. We will honor your request according to the requirements of the law. All comments from organizations or representatives will be available for review. We may withhold comments from review for other reasons. 
                </P>
                <P>Comments submitted in response to this notice will be summarized and/or included in the request for OMB approval of this information collection; they also will become a matter of public record. </P>
                <P>An agency may not conduct or sponsor, and a person is not required to respond to a collection of information, unless it displays a currently valid Office of Management and Budget control number. </P>
                <SIG>
                    <DATED>Dated: November 5, 2004. </DATED>
                    <NAME>David W. Anderson, </NAME>
                    <TITLE>Assistant Secretary—Indian Affairs. </TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 04-25265 Filed 11-12-04; 8:45 am] </FRDOC>
            <BILCOD>BILLING CODE 4310-6W-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF THE INTERIOR </AGENCY>
                <SUBAGY>Bureau of Indian Affairs </SUBAGY>
                <SUBJECT>Proposed Agency Information Collection Activities; Comment Request </SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Bureau of Indian Affairs, Interior. </P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice. </P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The Bureau of Indian Affairs (BIA) is seeking comments in preparation for renewal of the Indian Child Welfare Annual Report form. The information collected will aid the BIA in fulfilling requirements of law. This renewal meets the requirements of the Paperwork Reduction Act of 1995. </P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Submit comments on or before January 14, 2005. </P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>Written comments should be sent directly to Larry Blair, Bureau of Indian Affairs, Office of Tribal Services, Division of Human Services, 1951 Constitution Avenue, NW., Mail Stop 320-SIB, Washington, DC 20240. </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>Interested persons may obtain copies of the information collection requests without charge by contacting Mr. Larry Blair, (202) 513-7621, Facsimile number (202) 208-2648. </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P/>
                <HD SOURCE="HD1">I. Abstract </HD>
                <P>
                    The information collection required by the use of this form is necessary to comply with Public Law 95-608, The Indian Child Welfare Act, and as codified in 25 CFR Part 23, Indian Child Welfare Act (ICWA). This information is collected through the use of a consolidated caseload form by tribal Indian Child Welfare Act program directors who are the providers of the ICWA services. The information is used to determine the extent of service needs in local Indian communities, assessment of the Indian Child Welfare Act program effectiveness, and to provide data for the annual program budget justification. 
                    <PRTPAGE P="65630"/>
                    The responses to this request for information collection are voluntary and the aggregated report is not considered confidential. The public is not required to respond unless a currently valid OMB control number is displayed. 
                </P>
                <HD SOURCE="HD1">II. Request for Comments </HD>
                <P>The Bureau of Indian Affairs requests your comments on this collection concerning: </P>
                <P>(a) The necessity of this information collection for the proper performance of the functions of the agency, including whether the information will have practical utility; </P>
                <P>(b) the accuracy of the agency's estimate of the burden (hours and cost) of the collection of information, including the validity of the methodology and assumptions used; </P>
                <P>(c) ways we could enhance the quality, utility and clarity of the information to be collected; and </P>
                <P>(d) ways we could minimize the burden of the collection of the information on the respondents, such as through the use of automated collection techniques or other forms of information technology. </P>
                <P>Please note that an agency may not sponsor or request, and an individual need not respond to, a collection of information unless it has a valid OMB Control Number. </P>
                <P>
                    All comments received will be available for public review 2 weeks after publication in the 
                    <E T="04">Federal Register</E>
                    . If you wish to have your name and address withheld from review, please make that known at the start of your comments. 
                </P>
                <P>
                    It is our policy to make all comments available to the public for review at the location listed in the 
                    <E T="02">ADDRESSES</E>
                     section, room 355-E, during the hours of 7 a.m. to 4 p.m., e.s.t., Monday through Friday except for legal holidays. All comments from organizations or representatives will be available for review. We may withhold comments from review for other reasons. 
                </P>
                <HD SOURCE="HD1">III. Data </HD>
                <P>
                    <E T="03">Title:</E>
                     Department of the Interior, Bureau of Indian Affairs, Indian Child Welfare Act Annual Report, 25 CFR Part 23.4. 
                </P>
                <P>
                    <E T="03">OMB Control Number:</E>
                     1076-0131. 
                </P>
                <P>
                    <E T="03">Type of review:</E>
                     Renewal. 
                </P>
                <P>
                    <E T="03">Brief Description of collection:</E>
                     Indian tribes are required to collect selected data on Indian child welfare cases and submit them to the Bureau for consolidation. This data is useful on a local level, to the tribes and tribal organizations that collect it, for case management purposes and on a nationwide basis for planning and budget purposes. 
                </P>
                <P>
                    <E T="03">Respondents:</E>
                     Indian tribes or tribal entities who are operating programs for Indian tribes. 
                </P>
                <P>
                    <E T="03">Number of Respondents:</E>
                     536. 
                </P>
                <P>
                    <E T="03">Estimated Time per Response:</E>
                     30 minutes. 
                </P>
                <P>
                    <E T="03">Frequency of Response:</E>
                     Quarterly. 
                </P>
                <P>
                    <E T="03">Estimated Annual Burden to Respondents:</E>
                     1072 hours. 
                </P>
                <SIG>
                    <DATED>Dated: November 5, 2004. </DATED>
                    <NAME>David W. Anderson, </NAME>
                    <TITLE>Assistant Secretary—Indian Affairs. </TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 04-25266 Filed 11-12-04; 8:45 am] </FRDOC>
            <BILCOD>BILLING CODE 4310-4J-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF THE INTERIOR </AGENCY>
                <SUBAGY>Minerals Management Service </SUBAGY>
                <SUBJECT>Environmental Documents Prepared for Proposed Oil and Gas Operations on the Gulf of Mexico Outer Continental Shelf (OCS) </SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Minerals Management Service, Interior. </P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice of the Availability of Environmental Documents.  Prepared for OCS Mineral Proposals on the Gulf of Mexico OCS. </P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>Minerals Management Service (MMS), in accordance with Federal Regulations that implement the National Environmental Policy Act (NEPA), announces the availability of NEPA-related Site-Specific Environmental Assessments (SEA) and Findings of No Significant Impact (FONSI), prepared by MMS for the following oil and gas activities proposed on the Gulf of Mexico OCS. </P>
                </SUM>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>Public Information Unit, Information Services Section at the number below. Minerals Management Service, Gulf of Mexico OCS Region, Attention: Public Information Office (MS 5034), 1201 Elmwood Park Boulevard, Room 114, New Orleans, Louisiana 70123-2394, or by calling 1-800-200-GULF. </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>MMS prepares SEAs and FONSIs for proposals that relate to exploration for and the development/production of oil and gas resources on the Gulf of Mexico OCS. These SEAs examine the potential environmental effects of activities described in the proposals and present MMS conclusions regarding the significance of those effects. Environmental Assessments are used as a basis for determining whether or not approval of the proposals constitutes major Federal actions that significantly affect the quality of the human environment in the sense of NEPA Section 102(2)(C). A FONSI is prepared in those instances where MMS finds that approval will not result in significant effects on the quality of the human environment. The FONSI briefly presents the basis for that finding and includes a summary or copy of the SEA. </P>
                <P>This notice constitutes the public notice of availability of environmental documents required under the NEPA Regulations. </P>
                <P>This listing includes all proposals for which the Gulf of Mexico OCS Region prepared a FONSI in the period subsequent to publication of the preceding notice.</P>
                <GPOTABLE COLS="3" OPTS="L2,tp0,i1" CDEF="s100,r200,10">
                    <TTITLE>  </TTITLE>
                    <BOXHD>
                        <CHED H="1">Activity/Operator </CHED>
                        <CHED H="1">Location </CHED>
                        <CHED H="1">Date </CHED>
                    </BOXHD>
                    <ROW>
                        <ENT I="01">Maritech Resources, Inc., Structure Removal SEA ES/SR 04-088 </ENT>
                        <ENT>West Delta, Block 17, Lease OCS-G 05668, located 10 miles from the nearest Louisiana shoreline </ENT>
                        <ENT>7/1/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Newfield Exploration Company, Structure Removal SEA ES/SR 04-094 </ENT>
                        <ENT>East Cameron, Block 38, Lease OCS-G 02562, located 8 miles from the nearest Louisiana shoreline </ENT>
                        <ENT>7/2/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Newfield Exploration Company, Structure Removal SEA ES/SR 04-090, 04-091, 04-092, 04-093 </ENT>
                        <ENT>West Cameron, Block 146, Lease OCS-G 01996, located 25 miles from the nearest Louisiana shoreline</ENT>
                        <ENT>7/2/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Seneca Resources Corporation, Structure Removal SEA ES/SR 04-098 </ENT>
                        <ENT>Eugene Island, Block 98, Lease OCS-G 17965, located 20 miles from the nearest Louisiana shoreline </ENT>
                        <ENT>7/7/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Newfield Exploration Company, Structure Removal SEA ES/SR 04-095 </ENT>
                        <ENT>Vermilion (South Addition), Block 308, Lease OCS-G 11892, located 78 miles from the nearest Louisiana shoreline </ENT>
                        <ENT>7/7/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">SPN Resources, LLC, Structure Removal SEA ES/SR 04-097 </ENT>
                        <ENT>South Marsh Island, Block 97, Lease OCS-G 21619, located 64 miles from the nearest Louisiana shoreline </ENT>
                        <ENT>7/9/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Newfield Exploration Company, Structure Removal SEA ES/SR 04-096 </ENT>
                        <ENT>South Timbalier, Block 194, Lease OCS-G 05610, located 37 miles from the nearest Louisiana shoreline </ENT>
                        <ENT>7/9/2004 </ENT>
                    </ROW>
                    <ROW>
                        <PRTPAGE P="65631"/>
                        <ENT I="01">El Paso Production, Structure Removal SEA ES/SR 04-099 </ENT>
                        <ENT>West Cameron (South), Block 526, Lease OCS-G 15100, located 90 miles from the nearest Louisiana shoreline </ENT>
                        <ENT>7/13/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">El Paso Production Oil &amp; Gas Company, Structure Removal SEA ES/SR 04-100</ENT>
                        <ENT>West Cameron (South Addition), Block 523, Lease OCS-G 19725, located 92 miles from the nearest Texas shoreline </ENT>
                        <ENT>7/14/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Chevron USA, Inc., Structure Removal SEA ES/SR 04-101</ENT>
                        <ENT>South Timbalier, Block 130, Lease OCS 00456, located 29 miles south of the Louisiana shoreline </ENT>
                        <ENT>7/20/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">El Paso Production GOM, Inc., Structure Removal SEA ES/SR 04-102, 04-103</ENT>
                        <ENT>Grand Isle, Blocks 30 &amp; 31, Leases OCS-G 23599 (RUE) &amp; 18065, located 11 to 12 miles from the nearest Louisiana shoreline </ENT>
                        <ENT>7/21/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">El Paso Production Company, Structure Removal SEA ES/SR 04-104, 04-105</ENT>
                        <ENT>Eugene Island, Block 52, Lease OCS-G 03148, located 10 miles from the nearest Louisiana shoreline </ENT>
                        <ENT>7/23/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">ATP Oil &amp; Gas Corporation, Structure Removal SEA ES/SR 04-115 </ENT>
                        <ENT>Vermilion, Block 63, Lease OCS-G 15167, located 18 miles from the nearest Louisiana shoreline </ENT>
                        <ENT>7/27/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Murphy Exploration &amp; Production Company, Structure Removal SEA ES/SR 04-106, 04-107, 04-108, 04-109, 04-110, 04-011, 04-112 </ENT>
                        <ENT>South Pelto, Block 12, Lease OCS 00072, located 6 miles from the nearest Louisiana shoreline </ENT>
                        <ENT>7/28/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Murphy Exploration &amp; Production Company, Structure Removal SEA ES/SR 04-113</ENT>
                        <ENT>South Pelto, Block 19, Lease OCS 00073, located 10 miles from the nearest Louisiana shoreline </ENT>
                        <ENT>7/28/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Murphy Exploration &amp; Production Company, Initial Exploration Plan SEA N-8098</ENT>
                        <ENT>LLoyd Ridge, Blocks 1 &amp; 2, Leases OCS-G 10486 &amp; 10487, located 105 miles from the nearest Louisiana shoreline </ENT>
                        <ENT>8/4/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Fugro GeoServices, Inc., Geological &amp; Geophysical Exploration Plan for Apache Corporation, SEA L04-49 </ENT>
                        <ENT>Located in the central Gulf of Mexico</ENT>
                        <ENT>8/4/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Energy Partners, Ltd., Structure Removal SEA ES/SR 04-114</ENT>
                        <ENT>West Cameron, Block 149, Lease OCS 00253, located 22 miles from the nearest Louisiana shoreline </ENT>
                        <ENT>8/6/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">SPN Resources, LLC, Structure Removal SEA ES/SR 04-119 </ENT>
                        <ENT>Eugene Island, Block 100, Lease OCS 00796, located 17 miles from the nearest Louisiana shoreline </ENT>
                        <ENT>8/10/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Dunhill Resources, Inc., Structure Removal SEA ES/SR 04-120 </ENT>
                        <ENT>High Island, Block 139, Lease OCS-G 03235, located 20 miles from the nearest Louisiana shoreline </ENT>
                        <ENT>8/10/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Fugro GeoServices, Inc., Geological &amp; Geophysical Exploration Plan for GulfTerra Energy Partners, LP, SEA L04-51 </ENT>
                        <ENT>Located in the central Gulf of Mexico</ENT>
                        <ENT>8/11/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">C &amp; C Technologies, Inc., Geological &amp; Geophysical Exploration Plan for BP America, Inc. SEA L04-54 </ENT>
                        <ENT>Located in the central Gulf of Mexico</ENT>
                        <ENT>8/12/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">SPN Resources, LLC, Structure Removal SEA ES/SR 04-118 </ENT>
                        <ENT>Eugene Island, Block 100, Lease OCS 00796, located 18 miles from the nearest Louisiana shoreline </ENT>
                        <ENT>8/17/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">SPN Resources, LLC, Structure Removal SEA ES/SR 89-059A </ENT>
                        <ENT>Eugene Island, Block 100, Lease OCS 00796, located 18 miles from the nearest Louisiana shoreline </ENT>
                        <ENT>8/17/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Multiwave Geophysical Company, Geological &amp; Geophysical Exploration Plan SEA L04-50</ENT>
                        <ENT>Located in the Mississippi Canyon area of the central Gulf of Mexico </ENT>
                        <ENT>8/17/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">BP America, Inc., Geological &amp; Geophysical Exploration Plan SEA L04-55 </ENT>
                        <ENT>Located in the central Gulf of Mexico</ENT>
                        <ENT>8/17/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Energy Partners, LTD, Structure Removal SEA ES/SR 04-121 </ENT>
                        <ENT>West Delta, Block 94, OCS 00839, located 25 miles from the nearest Louisiana shoreline </ENT>
                        <ENT>8/18/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Multiwave Geophysical Company, Geological &amp; Geophysical Exploration Plan for Shell E &amp; P, SEA L04-53 </ENT>
                        <ENT>Located in Mississippi Canyon of the central Gulf of Mexico south of the nearest Alabama shoreline </ENT>
                        <ENT>8/20/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Noble Energy, Inc., Structure Removal SEA ES/SR 04-124 </ENT>
                        <ENT>High Island (East South), Block A281, Lease OCS-G 03377, located 85 miles from the nearest Louisiana shoreline </ENT>
                        <ENT>8/26/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Forest Oil Corporation, Structure Removal SEA ES/SR 04-122, 04-123 </ENT>
                        <ENT>West Cameron &amp; High Island, Blocks 228 &amp; 132, ROW G 8607 &amp; OCS-G 18937, located 42 miles south of the nearest Cameron Parish, Louisiana shoreline; 51 miles southeast of the Sabine Pass, Texas shoreline; and 28 miles south of the Jefferson County, Texas shoreline </ENT>
                        <ENT>8/30/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Veritas DGC Corporation, Geological &amp; Geophysical Exploration Plan SEA L04-58</ENT>
                        <ENT>Located in the central Gulf of Mexico east of Galveston, Texas </ENT>
                        <ENT>9/1/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">The Louisiana Land &amp; Exploration Company, Structure Removal SEA ES/SR 04-089</ENT>
                        <ENT>Eugene Island (South Addition), Block 384, Lease OCS-G 03159, located 78 miles from the nearest Louisiana shoreline </ENT>
                        <ENT>9/8/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Chevron U.S.A., Inc., Structure Removal SEA ES/SR 04-126, 04-127, 04-128, 95-48A, 04-129, 04-130, 04-131 </ENT>
                        <ENT>Ship Shoal &amp; West Cameron, Blocks 108 &amp; 48, Leases OCS 00814 &amp; OCS-G 01351, located 19 miles southwest from the nearest Terrebonne Parish, Louisiana shoreline, and 4 miles south from the nearest Cameron Parish, Louisiana shoreline, respectively </ENT>
                        <ENT>9/13/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Calpine Natural Gas, LP, Structure Removal SEA ES/SR 04-125 </ENT>
                        <ENT>East Cameron, Block 89, Lease OCS-G 00935, located 22 miles from the nearest Louisiana shoreline </ENT>
                        <ENT>9/21/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">SPN Resources, LLC, Structure Removal SEA ES/SR 04-132 </ENT>
                        <ENT>Mobile, Block 830, Lease OCS-G 06845, located 4 miles from the nearest Alabama shoreline </ENT>
                        <ENT>9/21/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Hunt Petroleum (AEC), Inc., Structure Removal SEA ES/SR 04-133 </ENT>
                        <ENT>Vermilion, Block 248, Lease OCS-G 15195, located 65 miles from the nearest Louisiana shoreline </ENT>
                        <ENT>9/21/2004 </ENT>
                    </ROW>
                    <ROW>
                        <PRTPAGE P="65632"/>
                        <ENT I="01">Vintage Petroleum, Inc., Structure Removal SEA ES/SR 04-137 </ENT>
                        <ENT>Main Pass, Block 125, Lease OCS-G 04913, located 20 miles from the nearest Louisiana shoreline </ENT>
                        <ENT>9/23/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Maritech Resources, Inc., Structure Removal SEA ES/SR 04-136 </ENT>
                        <ENT>East Cameron, Block 38, Lease OCS-G 02562, located 8 miles from the nearest Louisiana shoreline </ENT>
                        <ENT>9/28/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Maritech Resources, Inc., Structure Removal SEA ES/SR 04-135 </ENT>
                        <ENT>Eugene Island, Block 28, Lease OCS-G 05478, located 12 miles from the nearest Louisiana shoreline </ENT>
                        <ENT>9/28/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">ATP Oil &amp; Gas Corporation, Structure Removal SEA ES/SR 04-134 </ENT>
                        <ENT>High Island (East South), Block A354, Lease OCS-G 17212, located 110 miles from the nearest Texas shoreline </ENT>
                        <ENT>9/28/2004 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Veritas DGC, Inc., Geological &amp; Geophysical Exploration Plan SEA L04-62 </ENT>
                        <ENT>Located in the central Gulf of Mexico south of Fourchon, Louisiana </ENT>
                        <ENT>9/30/2004 </ENT>
                    </ROW>
                </GPOTABLE>
                <P>
                    Persons interested in reviewing environmental documents for the proposals listed above or obtaining information about SEAs and FONSIs prepared for activities on the Gulf of Mexico OCS are encouraged to contact MMS at the address or telephone listed in the 
                    <E T="02">FOR FURTHER INFORMATION CONTACT</E>
                     section. 
                </P>
                <SIG>
                    <DATED>Dated: October 7, 2004. </DATED>
                    <NAME>Chris C. Oynes, </NAME>
                    <TITLE>Regional Director, Gulf of Mexico OCS Region. </TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 04-25242 Filed 11-12-04; 8:45 am] </FRDOC>
            <BILCOD>BILLING CODE 4310-MR-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF INTERIOR</AGENCY>
                <SUBAGY>Office of Surface Mining Reclamation and Enforcement</SUBAGY>
                <SUBJECT>Notice of Proposed Information Collection</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Office of Surface Mining Reclamation and Enforcement.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice and request for comments.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>In compliance with the Paperwork Reduction Act of 1995, the Office of Surface Mining Reclamation and Enforcement (OSM) is announcing that the information collection request for its Technical Evaluation customer surveys has been forwarded to the Office of Management and Budget (OMB) for review and comment. The information collection request describes the nature of the information collection and the expected burden and cost. The OMB control number for this collection of information is 1029-0114 and is on the forms along with the expiration date.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>OMB has up to 60 days to approve or disapprove the information collections but may respond after 30 days. Therefore, public comments should be submitted to OMB by December 15, 2004, in order to be assured of consideration.</P>
                </DATES>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        To request a copy of the information collection request, explanatory information and related form, contact John A. Trelease at (202) 208-2783, or electronically to 
                        <E T="03">jtreleas@osmre.gov.</E>
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>
                    The Office of Management and Budget (OMB) regulations at 5 CFR part 1320, which implement provisions of the Paperwork Reduction Act of 1995 (Pub. L. 104-13), require that interested members of the public and affected agencies have an opportunity to comment on information collection and recordkeeping activities (
                    <E T="03">see</E>
                     5 CFR 1320.8(d)). OSM has submitted a request to OMB to renew its approval of the collection of information contained in a series of technical evaluation customer surveys. OSM is requesting a 3-year term of approval for the information collection activity.
                </P>
                <P>An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. The OMB control number for this collection of information is 1029-0114.</P>
                <P>
                    As required under 5 CFR 1320.8(d), a 
                    <E T="04">Federal Register</E>
                     notice soliciting comments on this collection of information was published on June 24, 2204 (69 FR 35391). No comments were received. This notice provides the public with an additional 30 days in which to comment on the following information collection activity:
                </P>
                <P>
                    <E T="03">Title:</E>
                     Technical Evaluations Series.
                </P>
                <P>
                    <E T="03">OMB Control Number:</E>
                     1029-0114.
                </P>
                <P>
                    <E T="03">Summary:</E>
                     The series of surveys are needed to ensure that technical assistance activities, technology transfer activities and technical forums are useful for those who participate or receive the assistance. Specifically, representatives from State and tribal regulatory and reclamation authorities, representatives of industry, environmental or citizen groups, or the public, are the recipients of the assistance or participants in these forums. These surveys will be the primary means through which OSM evaluates its performance in meeting the performance goals outlined in its annual plans developed pursuant to the Government Performance and Results Act.
                </P>
                <P>
                    <E T="03">Bureau Form Number:</E>
                     None.
                </P>
                <P>
                    <E T="03">Frequency of Collection:</E>
                     Once.
                </P>
                <P>
                    <E T="03">Description of Respondents:</E>
                     26 State and tribal governments, industry organizations and individuals who request information or assistance.
                </P>
                <P>
                    <E T="03">Total Annual Responses:</E>
                     300.
                </P>
                <P>
                    <E T="03">Total Annual Burden Hours:</E>
                     25.
                </P>
                <P>Send comments on the need for the collection of information for the performance of the functions of the agency; the accuracy of the agency's burden estimates; ways to enhance the quality, utility and clarity of the information collection; and ways to minimize the information collection burden on respondents, such as use of automated means of collection of the information, to the following address. Please refer to the appropriate OMB control number in all correspondence.</P>
                <SUPLHD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        Please send comments to the Office of Information and Regulatory Affairs, Office of Management and Budget, Attention: Department of Interior Desk Officer, electronically to 
                        <E T="03">OIRA_DOCKET@omb.eop.gov,</E>
                         or via facsmile at (202) 395-6566. Also, please send a copy of your comments to John A. Trelease, Office of Surface Mining Reclamation and Enforcement, 1951 Constitution Ave, NW., Room 210-SIB, Washington, DC 20240, or electronically to 
                        <E T="03">jtreleas@osmre.gov.</E>
                    </P>
                </SUPLHD>
                <SIG>
                    <DATED>Dated: September 7, 2004.</DATED>
                    <NAME>Sarah E. Donnelly, </NAME>
                    <TITLE>Acting Chief, Division of Regulatory Support.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 04-25319  Filed 11-12-04; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4310-05-M</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="N">INTERNATIONAL TRADE COMMISSION </AGENCY>
                <DEPDOC>[Investigation No. 731-TA-1070 (Final)] </DEPDOC>
                <SUBJECT>Certain Tissue Paper Products and Crepe Paper Products From China </SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>United States International Trade Commission. </P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Revised schedule for the subject investigation. </P>
                </ACT>
                <EFFDATE>
                    <PRTPAGE P="65633"/>
                    <HD SOURCE="HED">EFFECTIVE DATE:</HD>
                    <P>November 5, 2004. </P>
                </EFFDATE>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Fred Forstall ((202) 205-3443), Office of Industries, U.S. International Trade Commission, 500 E Street SW., Washington, DC 20436. Hearing-impaired persons can obtain information on this matter by contacting the Commission's TDD terminal on (202) 205-1810. Persons with mobility impairments who will need special assistance in gaining access to the Commission should contact the Office of the Secretary at (202) 205-2000. General information concerning the Commission may also be obtained by accessing its internet server (
                        <E T="03">http://www.usitc.gov</E>
                        ). The public record for this investigation may be viewed on the Commission's electronic docket (EDIS) at 
                        <E T="03">http://edis.usitc.gov.</E>
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>
                    On October 4, 2004, the Commission issued a schedule for the conduct of the final phase of the subject investigation (69 FR 60423, October 8, 2004). Subsequently, counsel on behalf of petitioners in this investigation 
                    <SU>1</SU>
                    <FTREF/>
                     requested that the Commission extend the deadline for filing posthearing briefs on issues related to tissue paper (also applicable to the deadline for the submission of a written statement of information on issues related to tissue paper by any person who has not entered an appearance as a party to the investigation) by one week or more (letter from Collier Shannon Scott, PLLC to Marilyn R. Abbott, Secretary, October 21, 2004). Upon consideration of the reasons stated for the request, including an overlapping deadline with a related filing on crepe paper from China, the Commission is revising its schedule to extend the deadline for filing posthearing briefs and written statements by non-parties on issues related to tissue paper from January 5, 2005, to January 12, 2005. 
                </P>
                <FTNT>
                    <P>
                        <SU>1</SU>
                         Petitioners are Seaman Paper Company of Massachusetts, Inc.; American Crepe Corp.; Eagle Tissue LLC; Flower City Tissue Mills Co.; Garlock Printing &amp; Converting, Inc.; Paper Service Ltd.; Putney Paper Co., Ltd.; and the Paper, Allied-Industrial, Chemical and Energy Workers International Union AFL-CIO, CLC.
                    </P>
                </FTNT>
                <P>For further information concerning this investigation see the Commission's notice cited above and the Commission's Rules of Practice and Procedure, part 201, subparts A through E (19 CFR part 201), and part 207, subparts A and C (19 CFR part 207). </P>
                <AUTH>
                    <HD SOURCE="HED">Authority:</HD>
                    <P>This investigation is being conducted under authority of title VII of the Tariff Act of 1930; this notice is published pursuant to section 207.21 of the Commission's rules. </P>
                </AUTH>
                <SIG>
                    <P>By order of the Commission. </P>
                    <DATED>Issued: November 8, 2004. </DATED>
                    <NAME>Marilyn R. Abbott, </NAME>
                    <TITLE>Secretary to the Commission. </TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 04-25255 Filed 11-12-04; 8:45 am] </FRDOC>
            <BILCOD>BILLING CODE 7020-02-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="N">DEPARTMENT OF JUSTICE</AGENCY>
                <SUBAGY>Antitrust Division</SUBAGY>
                <SUBJECT>United States v. Cingular Wireless Corporation, SBC Communications Inc., BellSouth Corporation, and AT&amp;T Wireless Services, Inc.; Competitive Impact Statement, Proposed Final Judgment, Complaint, Preservation of Assets Stipulation and Order</SUBJECT>
                <P>
                    Notice is hereby given pursuant to the Antitrust Procedures and Penalties Act, 15 U.S.C. 16(b)-(h), that a Complaint, proposed Final Judgment, Preservation  of Assets Stipulation and Order, and Competitive Impact Statement have been filed with the U.S. District Court for the District of Columbia in 
                    <E T="03">United States</E>
                     v. 
                    <E T="03">Cingular Wireless Corps.</E>
                    , Civil Case No. 1:04CV01850 (RBW). On October 25, 2004, the United States, along with the Attorneys General from the states of Connecticut and Texas, filed a complaint alleging that the proposed acquisition of AT&amp;T Wireless Services, Inc. (“AT&amp;T Wireless”) by Cingular Wireless Corp. (“Cingular”), which is jointly owned by BellSouth Corporation (“BellSouth”) and SBC Communications, Inc. (“SBC”), would violate Section 7 of the Clayton Act, 15 U.S.C. 18, by substantially lessening competition in the provision of mobile wireless telecommunications services and mobile wireless broadband services. The proposed Final Judgment, filed at the same time as the Complaint and Preservation of Assets Stipulation and Order, requires Cingular to divest assets in eleven states—Connecticut, Georgia, Kansas, Kentucky, Louisiana, Massachusetts, Missouri, Michigan, Oklahoma, Tennessee, and Texas—in order to proceed with Cingular Wireless's $41 billion cash acquisition of AT&amp;T Wireless. A Competitive Impact Statement filed by the United States on October 29, 2004 describes the Complaint, the proposed Final Judgment, the industry, and the remedies available to private litigants who may have been injured by the alleged violation.
                </P>
                <P>Copies of the Complaint, proposed Final Judgment, Preservation of Assets Stipulation and Order, the Competitive Impact Statement, and all further papers filed with the Court in connection with the Complaint will be available for inspection at the Antitrust Documents Group, Antitrust Division, Liberty Place Building, Room 215, 325 7th Street, NW., Washington, DC 20530 (202-514-2481), and at the Office of the Clerk of the U.S. District Court for the District of Columbia. Copies of these materials may be obtained from the Antitrust Division upon request and payment of the copying fee set by Department of Justice regulations.</P>
                <P>Interested persons may submit comments in writing regarding the proposed consent decree to the United States. Such comments must be received by the Antitrust Division within sixty (60) days and will be filed with the Court by the United States. Comments should be addressed to Nancy Goodman, Chief, Telecommunications &amp; Media Enforcement Section, Antitrust Division, U.S. Department of Justice, 1401 H Street, NW., Suite 8000, Washington, DC 20530 (202-514-5621). At the conclusion of the sixty (60) day comment period. The U.S. District Court for the District of Columbia may enter the proposed consent decree upon finding that it serves the public interest.</P>
                <SIG>
                    <NAME>J. Robert Kramer II,</NAME>
                    <TITLE>Director of Operations, Antitrust Division.</TITLE>
                </SIG>
                <HD SOURCE="HD1">In the United States District Court for the District of Columbia</HD>
                <HD SOURCE="HD2">United State of America, State of Connecticut and State of Texas, Plaintiffs, v. Cingular Wireless Corporation, SBC Communications Inc., Bellsouth Corporation and AT&amp;T Wireless Services, Inc., Defendants; Competitive Impact Statement</HD>
                <FP>Civil No. 1:04CV01850 (RBW).</FP>
                <FP>Filed: October 29, 2004.</FP>
                <P>Plaintiff United States of America (“United States”), pursuant to Section 2(b) of the Antitrust Procedures and Penalties Act (“APPA” or “Tunney Act”), 15 U.S.C. § 16(b)-(h), files this Competitive Impact Statement relating to the proposed Final Judgment submitted for entry in this civil antitrust proceeding.</P>
                <HD SOURCE="HD1">I. Nature and Purpose of the Proceeding</HD>
                <P>
                    Defendants Cingular Wireless Corporation (“Cingular”), SBC Communications Inc. (“SBC”), BellSouth Corporation (“BellSouth”), and AT&amp;T Wireless Services, Inc. (“AT&amp;T Wireless Services”) entered into an Agreement and Plan of Merger dated February 17, 2004, pursuant to which Cingular will acquire AT&amp;T Wireless. Plaintiff United States and the states of Connecticut and Texas (“plaintiff states”) filed a civil antitrust Complaint on October 25, 2004, seeking to enjoin the proposed acquisition. The 
                    <PRTPAGE P="65634"/>
                    Compliant alleges that the likely effect of this acquisition would be to lessen competition substantially for mobile wireless telecommunications services and mobile wireless broadband services (collectively, “Mobile wireless services”) in violation of Section 7 of the Clayton Act, 15 U.S.C. 18. This loss of competition would result in consumers facing higher prices, lower quality or quantity of mobile wireless services, or delayed launch of new mobile wireless services.
                </P>
                <P>At the same time the Complaint was filed, plaintiff United States also filed a Preservation of Assets Stipulation and Order and proposed Final Judgment, which are designed to eliminate the anticompetitive effects of the acquisition. Under the proposed Final Judgment, which is explained more fully below, defendants are required to divest (1) AT&amp;T Wireless's mobile wireless services business and related assets in five markets (“Wireless Business Divesture Assets”); (2) Cingular's or AT&amp;T Wireless's minority interests in other mobile wireless services providers in five markets (“Minority Interests”); and (3) 10 MHz of contiguous PCS wireless spectrum in three markets (“Spectrum Divesture Assets”). Under the terms of the Preservation of Assets Stipulation and Order, defendants will take certain steps to ensure (a) that these assets are preserved and that the Wireless Business Divestiture Assets are operated as competitively independent, economically viable and ongoing businesses; (b) that they will remain independent and uninfluenced by defendants or the consummation of the transaction; and (c) that competition is maintained during the pendency of the ordered divestiture.</P>
                <P>Plaintiffs and defendants have stipulated that the proposed Final Judgment may be entered after compliance with the APPA. Entry of the proposed Final Judgment would terminate this action, except that the Court would retain jurisdiction to construe, modify, or enforce the provisions of the proposed Final Judgment and to punish violations thereof. Plaintiffs and defendants have also stipulation that defendants will comply with the terms of the Preservation of Assets Stipulation and Order and the proposed Final Judgment from the date of signing of the Preservation of Assets Stipulation and Order, pending entry of the proposed Final Judgment by the Court and the required divestitures. Should the Court decline to enter the proposed Final Judgment, defendants have also committed to continue to abide by its requirements and those of the Preservation of Assets Stipulation and Order until the expiration of time for appeal.</P>
                <HD SOURCE="HD1">II. Description of the Events Giving Rise to the Alleged Violation </HD>
                <HD SOURCE="HD2">A. The Defendants and the Proposed Transaction</HD>
                <P>Cingular, with headquarters in Atlanta, Georgia, is a company organized and existing under the laws of the State of Delaware. Cingular was formed in 2000 by SBC and BellSouth, who own equity interests in it of 60 and 40 percent, respectively. SBC and BellSouth evenly share management control of Cingular. Cingular is the second-largest provider of mobile wireless voice and data services in the United States by number of subscribers; it serves more than 24 million customers. Cingular provides mobile wireless services in areas throughout the United States and is one of only six providers with a national presence. In 2003, Cingular earned revenues of approximately $15.5 billion. </P>
                <P>SBC, with headquarters in San Antonio, Texas, is a corporation organized and existing under the laws of the state of Delaware. SBC is one of several regional Bell operating companies (“RBOCs”) formed in 1984 as a result of the breakup of AT&amp;T Corporation's local telephone business. SBC's wireline telecommunications businesses serve 54.7 million access lines in 13 states: Arkansas, California, Connecticut, Illinois, Indiana, Kansas, Michigan, Missouri, Nevada, Ohio, Oklahoma, Texas, and Wisconsin. In 2003, SBC earned approximately $40.8 billion in revenues. </P>
                <P>BellSouth, an RBOC with headquarters in Atlanta, Georgia, is a corporation organized and existing under the laws of the state of Georgia. BellSouth's wireline telecommunications businesses serve 23.7 million access lines in nine states: Alabama, Florida, Georgia, Kentucky, Louisiana, Mississippi, North Carolina, South Carolina, and Tennessee. Its total operating revenues for 2003 were approximately $22.6 billion. </P>
                <P>AT&amp;T Wireless, with headquarters in Redmond, Washington, is a corporation organized and existing under the laws of the state of Delaware. Spun off from AT&amp;T Corporation in 2001, it had more than 22 million subscribers as of August 2004 and earned revenues of approximately $16.6 billion in 2003. AT&amp;T Wireless is the third-largest U.S. mobile wireless services provider by number of subscribers, and, like Cingular, it provides mobile wireless services in areas throughout the United States and has a national presence. </P>
                <P>Pursuant to an Agreement and Plan of Merger dated February 17, 2004, Cingular will pay AT&amp;T Wireless shareholders $15 in cash per common share and thereby plans to acquire AT&amp;T Wireless for approximately $41 billion. If this transaction is consummated, Cingular and AT&amp;T Wireless combined would have more than 46 million subscribers, with over $32 billion in revenues, making it the largest mobile wireless services provider in the United States, with operations in 49 states covering 97 of the top 100 marketing areas. </P>
                <P>The proposed transaction, as initially agreed to by defendants, would lessen competition substantially for mobile wireless telecommunications service in 10 markets and for mobile wireless broadband services in three markets. This acquisition is the subject of the Complaint and proposed Final Judgment filed by plaintiffs. </P>
                <HD SOURCE="HD2">B. Mobile Wireless Services Industry</HD>
                <P>Mobile wireless services allow customers to make and receive telephone calls and use data services using radio transmissions without being confined to a small area during the call or data session, and without the need for unobstructed line-of-sight to the radio tower. This mobility is highly prized by customers, as demonstrated by the more than 160 million people in the United States who own mobile wireless telephones. In 2003, revenues for the sale of mobile wireless services in the United States were nearly $90 billion. To provide these services, mobile wireless services providers must acquire adequate and appropriate spectrum, deploy an extensive network of switches, radio transmitters, and receivers, and interconnect this network with those of local and long-distance wireline telecommunications providers and other mobile wireless services providers. </P>
                <P>
                    The first wireless voice systems were based on analog technology, now referred to as first-generation or “1G” technology. These analog systems were launched after the FCC issued the first licenses for mobile wireless telephone service: two cellular licenses (A-block and B-block) in each geographic area in the early to mid-1980s. The licenses are in the 800 MHz range of the radio spectrum, each license consists of 25 MHz of spectrum, and they are issued for each Metropolitan Statistical Area (“MSA”) and Rural Service Area (“RSA”) (collectively, “Cellular Marketing Areas” or “CMAs”), with a total of 734 CMAs covering the entire 
                    <PRTPAGE P="65635"/>
                    United States. In 1982, one of the licenses was issued to the incumbent local exchange carrier in the market, and the other was issued by lottery to someone other than the incumbent. Cellular licensees must support analog service until February 2008. 
                </P>
                <P>In 1995, the FCC allocated and subsequently issued licenses for additional spectrum for the provision of Personal Communications Services (“PCS”), a category of services that includes mobile wireless telephone services comparable to those offered by cellular licensees. These licenses are in the 1.8 GHz range of the radio spectrum and are divided into six blocks. A, B, and C, which consist of 30 MHz each; and D, E, and F, which consist of 10 MHz each. Geographically, the A and B-block 30 MHz licenses are issued by Major Trading Areas (“MTAs”), and C, D, E, and F-block licenses are issued by Basic Trading Areas (“BTAs”), several of which comprise each MTA. MTAs and BTAs do not generally correspond to MSAs and RSAs. With the introduction of the PCS license, both cellular and PCS licensees began offering digital services, thereby increasing capacity, shrinking handsets, and extending battery life. Unlike the cellular licensees, PCS licensees are not required to provide support for analog or any other technology standard. In 1996, one provider, a specialized mobile radio (“SMR” or “dispatch”) spectrum licensee, began to use its SMR spectrum of offer mobile wireless telephone services comparable to those offered by other mobile wireless services providers, in conjunction with its dispatch, or “push-to-talk,” service. </P>
                <P>Today, more than 90 percent of all mobile wireless services customers have digital service, and nearly all mobile wireless voice service has migrated to second-generation or “2G” digital technologies: TDMA (time division multiple access), GSM (Global Standard for Mobile, a type of TDMA standard used by all carriers in Europe), and CDMA (code division multiple access). Mobile wireless services providers have chosen to build their networks on these incompatible technologies and most have chosen CDMA or GSM, with TDMA having been orphaned by equipment vendors. (The SMR providers use a fourth incompatible technological standard better suited to the spectrum they own, and, as SMR licensees, they have no obligation to support a specific technology standard.) Even more advanced technologies (“2.5G”) have begun to be deployed for voice and data (e.g., IxRIT (a/k/a CDMA  2000), GPRS (General Packet Radio Service), and EDGE (Enhanced Data for GSM Evolution)). The data transmission speeds of these technologies vary. For example, 1xRTT provides average user speeds of 70 kilobits per second (“kbps”), and GPRS and EDGE provide average user speeds of 20 to 40 kbps and 80 to 110 kbps, respectively.</P>
                <P>Currently, the U.S. mobile wireless services industry is taking the next evolutionary step in wireless technology to third-generation or “3G” technologies (e.g., for GSM, UMTS (Universal Mobile Telecommunications System) and for CDMA, Ev-DO/DV (Evolution Data Only/Date Voice)) that provide for more capacity and higher data throughout. All of the national mobile wireless services providers and some of the regional providers are considering how and where they will deploy 3G services across their networks. Some providers have already deployed this service in some areas of the country.</P>
                <HD SOURCE="HD2">C. The Competitive Effects of the Transaction on Mobile Wireless Telecommunications Services and Mobile Wireless Broadband Services</HD>
                <P>Cingular's proposed acquisition of AT&amp;T Wireless will substantially lessen competition in mobile wireless telecommunications services and mobile wireless broadband services in the relevant geographic areas. Mobile wireless telecommunications services include both voice and data services provided over a radio network and allow customers to maintain their telephone calls or data sessions without wires, such as when traveling. Mobile wireless broadband services offer data speeds four to six times faster than the 2G and 2.5G data offerings currently provided by the mobile wireless services providers. Mobile wireless broadband services, which are now being launched using various 3G technologies, offer average data speeds of 200 to 300 kbps, peaking at 2 megabits per second or higher. These speeds rival wireline broadband services at peak speeds. At average speeds, they are comparable to low-end wireline high-speed data offerings and can support bandwidth-intensive services including video conferencing, video streaming, downloading of music and video files, and voice over Internet protocol (“VoIP”) calling, none of which can be used reliably at slower speeds. Fixed wireless services and other wireless services that have a limited range (e.g., Wi-Fi) do not offer a viable alternative to either mobile wireless telecommunications services or mobile wireless broadband services primarily because customers  using these services cannot maintain a call or data session while moving from one location to another.</P>
                <P>Most customers use mobile wireless services in close proximity to their workplaces and homes. Thus, customers purchasing mobile wireless telecommunications services and mobile wireless broadband  services choose among mobile wireless services providers that offer services where they are located and travel on a regular basis: home, work, other areas they commonly visit, and areas in between. The number and identity of mobile wireless services providers varies from geographic area to geographic area, along with the quality of their services and the breadth  of their geographic coverage, all of which  are significant factors in customers' purchasing  decisions. Mobile wireless services providers can and do offer different promotions, discounts, calling plans, and equipment subsidies in different geographic areas, effectively varying the actual price for customers by geographic area.</P>
                <P>
                    The relevant geographic markets for mobile wireless services are, therefore, local in nature and are generally centered around a metropolitan area or a population center and its environs. The FCC has licensed a limited number of mobile wireless services providers in these and other geographical areas based upon the availability of radio spectrum. These FCC spectrum licensing areas often represent the core of the business and social sphere where customers face the same competitive choices for mobile wireless services. Although not all FCC spectrum licensing areas are relevant geographic areas for the purpose of analyzing the antitrust impact  of this transaction, the FCC spectrum licensing areas that encompass the 13 geographic areas of  concern in this transaction are where consumers in these communities principally use their mobile wireless services. As described in the Complaint, the relevant geographic markets where the transactions will substantially  lessen competition for mobile wireless telecommunications services are represented by the following FCC spectrum licensing areas: Oklahoma City, Oklahoma (CMA 045), Topeka, Kansas (CMA 179), Pittsfield, Massachusetts (CMA 213), Athens, Georgia (CMA 234), St. Joseph, Missouri (CMA 275), Connecticut RSA-1 (CMA 357), Kentucky RSA-1 (CMA 443), Oklahoma RSA-3 (CMA 598), Texas RSA-11 (CMA 662), and Shreveport, Louisiana  (BTA 419). The relevant geographic markets where the transaction will substantially lessen competition for mobile wireless broadband services are represented by the following FCC spectrum licensing 
                    <PRTPAGE P="65636"/>
                    areas: Dallas-Fort Worth, Texas (CMA 009), Detroit, Michigan (BTA 112), and Knoxville, Tennessee (BTA 232).
                </P>
                <P>The 10 geographic markets of concern for mobile wireless telecommunications services were identified by a fact-specific, market-by-market analysis that included consideration of, but was not limited to, the following factors: the number of mobile wireless services providers and their competitive strengths and weaknesses, Cingular's and AT&amp;T Wireless's market shares along with those of the other providers, whether additional spectrum is or is likely soon to be available, whether any providers are limited by insufficient spectrum or other factors in their ability to add new customers or launch additional services, the population of a market as it affects the need for spectrum to serve the population, the concentration of the market, and the breadth and depth of coverage by different providers in each market.</P>
                <P>Cingular and AT&amp;T Wireless both own all or part of businesses that offer mobile wireless telecommunications services in the 10 relevant geographic areas. In five of these areas (Athens, Georgia; Topeka, Kansas; Pittsfield, Massachusetts; St. Joseph, Missouri; and Shreveport, Louisiana), Cingular or AT&amp;T Wireless also owns minority equity interests in another mobile wireless telecommunications services provider that would be a significant competitor to the merged firm for these services. The minority equity interests range from approximately 9 to 24 percent. Based upon these significant minority equity interests and the specific facts of the relationships, it was appropriate to attribute the shares and assets of the mobile wireless services businesses partially owned by Cingular or AT&amp;T Wireless in these markets to either Cingular or AT&amp;T Wireless, thus increasing the percentage of customers served by the merged firm.</P>
                <P>The individual market shares of Cingular's and AT&amp;T Wireless's mobile wireless telecommunications services businesses in the 10 relevant geographic markets as measures in terms of subscribers range from 9 to more than 71 percent, and their combined market shares range from 61 to nearly 90 percent. In each relevant geographic market, Cingular or AT&amp;T Wireless has the largest market share, and, in all but one, the other is the second-largest mobile wireless telecommunications services provider. In all but one of the relevant geographic markets, Cingular and AT&amp;T Wireless are the original cellular licensees and, as a result, have the network infrastructures with the greatest depth and breadth of coverage. Cingular and AT&amp;T Wireless are likely closer substitutes for each other than the other mobile wireless telecommunications services providers in the relevant geographic markets. Additionally in these markets, there will be insufficient remaining competitors post-merger with the ability to compete effectively to defeat a small, but significant price increase by the merged firm.</P>
                <P>The relevant geographic markets for mobile wireless telecommunications services are highly concentrated. As measured by the Herfindahl-Hirschman index (“HHI”), which is commonly employed in merger analysis and is defined and explained in Appendix A to the Compliant, concentration in these markets ranges from approximately 2600 to more than 5300, which is well above the 1800 threshold at which the Department considers a market to be highly concentrated. After Cingular's proposed acquisition of AT&amp;T Wireless is consummated, the HHIs in the relevant geographic markets will range from approximately 4400 to more than 8000, with increases in the HHI as a result of the merger ranging from approximately 1100 to more than 3500.</P>
                <P>Competition between Cingular and AT&amp;T Wireless in the relevant geographic markets has resulted in lower prices and higher quality in mobile wireless telecommunications services than would otherwise have existed in these geographic markets. If Cingular's proposed acquisition of AT&amp;T Wireless is consummated, the relevant geographic markets for mobile wireless telecommunications services will become substantially more concentrated, and the competition between Cingular and AT&amp;T Wireless in mobile wireless telecommunications services will be eliminated in these markets. As a result, the loss of competition between Cingular and AT&amp;T Wireless increases the likelihood of unilateral actions by the merged firm in the relevant geographic markets to increase prices, diminish the quality or quantity of services provided, refrain from or delay making investments in network improvements, and refrain from or delay launching new services.</P>
                <P>In the relevant geographic markets for mobile wireless broadband services, Cingular and AT&amp;T Wireless have either launched or are likely soon to launch mobile wireless broadband services. Each has the spectrum necessary to offer mobile wireless broadband services and has business plans to offer these services in these markets. Not all mobile wireless services providers have sufficient spectrum to launch mobile wireless broadband services in these markets, nor do they all have business plans to do so in the near future. In the relevant geographic markets, the current number of mobile wireless services providers that are likely to launch mobile wireless broadband services in the foreseeable future is limited. Because mobile wireless broadband services are nascent, however, HHIs are uninformative.</P>
                <P>The competition between Cingular and AT&amp;T Wireless has motivated their efforts to develop and launch mobile wireless broadband services in the relevant geographic markets. If Cingular's proposed acquisition of AT&amp;T Wireless is consummated, the relevant geographic markets will lose one of only a few existing and likely mobile wireless broadband services providers. As a result, the loss of competition between Cingular and AT&amp;T Wireless increases the likelihood of unilateral actions by the merged firm in these relevant geographic markets to increase prices, diminish the quality or quantity of services provided, and refrain from or delay the launch of mobile wireless broadband services.</P>
                <P>Entry by a new mobile wireless services provider in the relevant geographic markets would be difficult, time-consuming, and expensive, requiring the acquisition of spectrum licenses and the build-out of a network. Therefore, new entry in response to a small but significant price increase for mobile wireless telecommunications services or mobile wireless broadband services by the merged firm in the relevant geographic markets would not be timely, likely, or sufficient to thwart the competitive harm that would result from Cingular's proposed acquisition of AT&amp;T Wireless.</P>
                <P>For these reasons, plaintiffs concluded that Cingular's proposed acquisition of AT&amp;T Wireless will likely substantially lessen competition, in violation of Section 7 of the Clayton Act, in the provision of mobile wireless telecommunications services and mobile wireless broadband services in the relevant geographic markets.</P>
                <HD SOURCE="HD1">III. Explanation of the Proposed Final Judgment</HD>
                <P>
                    The divestiture requirements of the proposed Final Judgment will eliminate the anticompetitive effects of the acquisition in mobile wireless telecommunications services and mobile wireless broadband services in the 13 geographic markets of concern. The proposed Final Judgment requires defendants, within 120 days after the filing of the Complaint, or five days after notice of the entry of the Final Judgment by the Court, whichever is later, to 
                    <PRTPAGE P="65637"/>
                    divest the Wireless Business Divestiture Assets, the Minority Interests, and Spectrum Divestiture Assets (collectively, “Divestiture Assets”). The Wireless Business Divestiture Assets are essentially AT&amp;T Wireless's entire mobile wireless business in the five markets where Cingular and AT&amp;T Wireless both currently own and control providers of mobile wireless telecommunications services. These assets must be divested in such a way as to satisfy plaintiff United States in its sole discretion upon consultation with any relevant plaintiff state that they will be operated by the purchaser as a viable, ongoing business that can compete effectively in the relevant market. Defendants must take all reasonable steps necessary to accomplish the divestitures quickly and shall cooperate with prospective purchasers.
                </P>
                <P>With respect to the Wireless Business Divestiture Assets, in some markets the merged firm may retain some of AT&amp;T Wireless's wireless spectrum (Connecticut RSA-1, Kentucky RSA-1, and Texas RSA-11). The spectrum that must be divested is adequate to support the operation and expansion of the mobile wireless services business being divested, and allowing the merged firm to retain some of AT&amp;T Wireless's spectrum may benefit consumers by allowing the merged firm to provide improved or new services.</P>
                <P>In the five markets where either Cingular or AT&amp;T Wireless owns a minority interest in another mobile wireless services provider, the proposed Final Judgment requires defendants to divest these Minority Interests. The proposed Final Judgment allows defendants to retain the Minority Interests in the Missouri, Kansas, and Louisiana areas with the approval of plaintiff United States in its sole discretion if they demonstrate that the retained minority interest will become irrevocably and entirely passive so long as the merged firm owns the interest and will not significantly diminish competition. The size of the minority interests and market concentrations in the Georgia and Massachusetts markets created concerns that allowing the merged firm to continue to hold even a passive interest would diminish competition, and defendants are required to divest fully their interests in those markets.</P>
                <P>The Spectrum Divestiture Assets consist of 10 MHz of contiguous PCS spectrum in three markets and must be divested in such a way as to remedy the competitive harm from the transaction in the relevant mobile wireless broadband services markets. The availability of this spectrum will make it more likely that another mobile wireless services provider could offer high-speed data services in these areas. In Knoxville, Tennessee, the merged firm can alternatively restructure its relationship with another spectrum licensee in the market so that the merged firm no longer has an effective controlling interest in the licensee and that the licensee's spectrum will be used by it in a manner that resolves the competitive concerns identified in the Complaint, which is effectively the same as if the merged firm were to divest the required amount of spectrum.</P>
                <HD SOURCE="HD2">A. Timing of Divestitures</HD>
                <P>In antitrust cases involving mergers or joint ventures in which plaintiff United States seeks a divestiture remedy, it requires completion of the divestitures within the shortest time period reasonable under the circumstances. The proposed Final Judgment in this case requires, in Section IV.A, divestiture of the Divestiture Assets, within 120 days after the filing of the Complaint, or five days after notice of the entry of the Final Judgment by the Court, whichever is later. Plaintiff United States in its sole discretion upon consultation with any relevant plaintiff state may extend the date for divestiture of the Divestiture Assets by up to 60 days. Because the FCC's approval is required for the transfer of the wireless licenses to a purchaser, Section IV.A provides that if applications for transfer of a wireless license have been filed with the FCC, but the FCC has not acted dispositively before the end of the required divestiture period, the period for divestiture of those assets shall be extended until five days after the FCC has acted. This extension is to be applied only to the individual Divestiture Assets affected by the delay in approval of the license transfer and does not entitle defendants to delay the divestiture of any other Divestiture Assets for which license transfer approval has been granted.</P>
                <P>The divestiture timing provisions of the proposed Final Judgment will ensure that the divestitures are carried out in a timely manner, and at the same time will permit defendants an adequate opportunity to accomplish the divestitures through a fair and orderly process. Even if all Divestiture Assets have not been divested upon consummation of the transaction, there should be no adverse impact on competition given the limited duration of the period of common ownership and the detailed requirements of the Preservation of Assets Stipulation and Order.</P>
                <HD SOURCE="HD2">B. Use of a Management Trustee</HD>
                <P>The Preservation of Assets Stipulation and Order, entered by the Court on October 26, 2004, ensures, prior to divestiture, that the Divestiture Assets are maintained and the Wireless Business Divestiture Assets remain an ongoing business concern and that the other Divestiture Assets remain economically viable. The Divestiture Assets will remain preserved, independent and uninfluenced by defendants, so that competition is maintained during the pendency of the ordered divestiture.</P>
                <P>The Preservation of Assets Stipulation and Order appoints a management trustee selected by plaintiff United States upon consultation with plaintiff states to oversee the Divestiture Assets in the relevant geographic markets. The appointment of a management trustee in this unique situation is required because the Divestiture Assets are not independent facilities that can be held separate and operated as standalone units by the merged firm. Rather, the Wireless Business Divestiture Assets are an integral part of a nationwide network, and to maintain their competitive viability and economic value, they should remain part of that network during the divestiture period. To ensure that these assets are preserved and supported by defendants during this period, yet run independently, a management trustee is necessary to oversee the continuing relationship between defendants and these assets. The management trustee will have the power to operate the Wireless Business Divestiture Assets in the ordinary course of business, so that they will remain preserved, independent, and uninfluenced by defendants, and an ongoing and economically viable competitor to defendants and to other mobile wireless services providers. The management trustee will preserve the confidentiality of competitively sensitive marketing, pricing, and sales information; insure defendants' compliance with the Preservation of Assets Stipulation and Order and the proposed Final Judgment; and maximize the value of the Divestiture Assets so as to permit expeditious divestiture in a manner consistent with the proposed Final Judgment.</P>
                <P>
                    The Preservation of Assets Stipulation and Order provides that defendants will pay all costs and expenses of the management trustee, including the cost of consultants, accountants, attorneys, and other representatives and assistants hired by the management trustee as are reasonably necessary to carry out his or her duties and responsibilities. After his 
                    <PRTPAGE P="65638"/>
                    or her appointment becomes effective, the management trustee will file monthly reports with plaintiffs setting forth the efforts to accomplish the goals of the Preservation of Assets Stipulation and Order and the proposed Final Judgment and the extent to which defendants are fulfilling their responsibilities. Finally, the management trustee may become the divestiture trustee, pursuant to the provisions of Section V of the proposed Final Judgment.
                </P>
                <HD SOURCE="HD2">C. Use of a Divestiture Trustee</HD>
                <P>In the event that defendants do not accomplish the divestiture within the periods prescribed in the proposed Final Judgment, the Final Judgment provides that the Court will appoint a trustee selected by plaintiff United States upon consultation with any relevant plaintiff state to effect the divestitures. As part of this divestiture, defendants must relinquish any direct or indirect financial ownership interests and any direct or indirect role in management or participation in control. Pursuant to Section V of the proposed Final Judgment, the divestiture trustee will own and control the systems until they are sold to a final purchaser, subject to safeguards to prevent defendants from influencing their operation.</P>
                <P>Section V details the requirements for the establishment of the divestiture trust, the selection and compensation of the divestiture trustee, the responsibilities of the divestiture trustee in connection with the divestiture and operation of the Divestiture Assets, and the termination of the divestiture trust. The divestiture trustee will have the obligation and the sole responsibility, under Section V.D, for the divestiture of any transferred Divestiture Assets. The divestiture trustee has the authority to accomplish divestitures at the earliest possible time and “at the best price then obtainable upon a reasonable effort by the trustee.” In addition, to insure that the divestiture trustee can promptly locate and divest to an acceptable purchaser, plaintiff United States, in its sole discretion upon consultation with any relevant plaintiff state, may require defendants to include additional assets, or allow defendants to substitute substantially similar assets, which substantially relate to the Wireless Business Divestiture Assets to be divested by the divestiture trustee.</P>
                <P>The divestiture trustee will not only have responsibility for sale of the Divestiture Assets, but will also be the authorized holder of the wireless licenses, with full responsibility for the operations, marketing, and sales of the wireless businesses to be divested, and will not be subject to any control or direction by defendants. Defendants will no longer have any role in the ownership, operation, or management of the Divestiture Assets following consummation of the transaction, as provided by Section V, other than the right to receive the proceeds of the sale, and certain obligations to provide support to the Divestiture Assets, and cooperate with the divestiture trustee in order to complete the divestiture, as indicated in Section VI.L and in the Preservation of Assets Stipulation and Order.</P>
                <P>The proposed Final Judgment provides that defendants will pay all costs and expenses of the divestiture trustee. The divestiture trustee's commission will be structured, under Section V.G of the proposed Final Judgment, so as to provide an incentive for the divestiture trustee based on the price obtained and the speed with which the divestitures are accomplished. After his or her appointment becomes effective, the divestiture trustee will file monthly reports with the Court and plaintiffs setting forth his or her efforts to accomplish the divestitures. Section V.J requires the divestiture trustee to divest the Divestiture Assets to an acceptable purchaser or purchasers no later than six months after the assets are transferred to the divestiture trustee. At the end of six months, if all divestitures have not been accomplished, the trustee, plaintiff United States, and any relevant plaintiff state will make recommendations to the Court, which shall enter such orders as appropriate in order to carry out the purpose of the trust, including extending the trust or term of the trustee's appointment.</P>
                <P>The divestiture provisions of the proposed Final Judgment will eliminate the anticompetitive effects of the transaction in the provision of mobile wireless telecommunications services and mobile wireless broadband services. The divestitures of the Wireless Business Divestiture Assets and the Minority Interests will preserve competition in mobile wireless telecommunications services by maintaining an independent and economically viable competitor in the relevant geographic markets. The divestiture of the Spectrum Divestiture Assets will preserve competition in mobile wireless broadband services by making assets available to establish a new, independent, and economically viable competitor.</P>
                <HD SOURCE="HD1">IV. Remedies Available to Potential Private Litigants</HD>
                <P>Section 4 of the Clayton Act, 15 U.S.C. 15, provides that any person who has been injured as a result of conduct prohibited by the antitrust laws may bring suit in federal court to recover three times the damages the person has suffered, as well as costs and reasonable attorneys' fees. Entry of the proposed Final Judgment will neither impair nor assist the bringing of any private antitrust damage action. Under the provisions of Section 5(a) of the Clayton Act, 15 U.S.C. 16(a), the proposed Final Judgment has no prima facie effect in any subsequent private lawsuit that may be brought against defendants.</P>
                <HD SOURCE="HD1">V. Procedures Available for Modification of the Proposed Final Judgment</HD>
                <P>Plaintiffs and defendants have stipulated that the proposed Final Judgment may be entered by a Court after compliance with the provisions of the APPA, provided that plaintiffs have not withdrawn their consent. The APPA conditions entry upon the Court's determination that the proposed Final Judgment is in the public interest.</P>
                <P>
                    The APPA provides a period of at least sixty (60) days preceding the effective date of the proposed Final Judgment within which any person may submit to plaintiff United States written comments regarding the proposed Final Judgment. Any person who wishes to comment should do so within sixty (60) days of the date of publication of this Competitive Impact Statement in the 
                    <E T="04">Federal Register</E>
                    . All comments received during this period will be considered by the Department of Justice, which remains free to withdraw its consent to the proposed Final Judgment at any time prior to the Court's entry of judgment. The comments and the response of plaintiff United States will be filed with the Court and published in the 
                    <E T="04">Federal Register</E>
                    .
                </P>
                <P>Written comments should be submitted to: Nancy M. Goodman, Chief, Telecommunications and Media Enforcement Section, Antitrust Division, U.S. Department of Justice, 1401 H Street, NW., Suite 8000, Washington, DC 20530. The proposed Final Judgment provides that the Court retains jurisdiction over this action, and the parties may apply to the Court for any order necessary or appropriate for the modification, interpretation, or enforcement of the Final Judgment.</P>
                <HD SOURCE="HD1">VI. Alternatives to the Proposed Final Judgment</HD>
                <P>
                    Plaintiff United States considered, as an alternative to the proposed Final 
                    <PRTPAGE P="65639"/>
                    Judgment, a full trail on the merits against defendants. Plaintiff United States could have continued the litigation and sought preliminary and permanent injunctions against Cingular's acquisition of AT&amp;T Wireless. Plaintiff United States is satisfied, however, that the divestiture of assets and other relief described in the proposed Final Judgment will preserve competition for the provision of mobile wireless telecommunications services and mobile wireless  broadband services in the relevant markets identified in the Complaint.
                </P>
                <HD SOURCE="HD1">VII. Standard of Review Under the APPA for the Proposed Final Judgment</HD>
                <P>The APPA requires that proposed consent judgments in antitrust cases brought by the United States be subject to a sixty-day comment period, after which the Court shall determine whether entry of the proposed Final Judgment “is in the public interest.” 15 U.S.C. 16(e)(1). In making that determination, the Court shall consider:</P>
                <EXTRACT>
                    <P>(A) The competitive impact of such judgment, including termination of alleged violations, provisions for enforcement and modification, duration or relief sought, anticipated effects of alternative remedies actually considered, whether its terms are ambiguous, any other competitive considerations bearing upon the adequacy of such judgment that the court deems necessary to a determination of whether the consent judgment is in the public interest; and</P>
                    <P>(B) The impact of entry of such judgment upon competition in the relevant market or markets, upon the public generally and individuals alleging specific injury from the violations set forth in the complaint including consideration of the public benefit, if any, to be derived from a determination of the issues at trial. </P>
                </EXTRACT>
                <FP>
                    15 U.S.C. 16(e)(1)(A)  &amp; (B). As the United States Court of Appeals for the District of Columbia Circuit has held, the APPA permits a court to consider, among other things, the relationship between the remedy secured and the specific  allegations set  forth in the government's compliant, whether the consent judgment is sufficiently clear, whether enforcement mechanisms are sufficient, and whether the consent judgment may positively harm third parties. 
                    <E T="03">See United States</E>
                     v. 
                    <E T="03">Microsoft Corp.,</E>
                     56 F.3d 1448, 1458-62 (D.C. Cir. 1995).
                </FP>
                <P>
                    “Nothing in this section shall be construed to require the court to conduct an evidentiary hearing or to require the court to permit anyone to intervene.” 15 U.S.C. 16(e)(2). Thus, in conducting this inquiry, “[t]he court is nowhere compelled to go to trial or to engage in extended proceedings which might have the effect of vitiating the benefits of prompt and less costly settlement through the consent decree process.” 119 Cong. Rec. 24,598 (1973) (statement of Senator Tunney).
                    <SU>1</SU>
                    <FTREF/>
                     Rather:
                </P>
                <FTNT>
                    <P>
                        <SU>1</SU>
                         
                        <E T="03">See United States</E>
                         v. 
                        <E T="03">Gillette Co.,</E>
                         406 F. Supp. 713, 716 (D. Mass. 1975) (recognizing it was not the court's duty to settle; rather, the court must only answer “whether the settlement achieved [was] within the reaches of the public interest”). A “public interest” determination can be made properly on the basis of the Competitive Impact Statement and Response to Comments field by the Department of Justice pursuant to the APPA. Although the APPA authorizes the use of additional procedures, 15 U.S.C. 16(f), those procedures are discretionary. A court need not invoke any of them unless it believes that the comments have raised significant issues and  that further proceedings would aid the court in resolving those issues. 
                        <E T="03">See</E>
                         H.R. Rep. No. 93-1463, 93d Cong., 2d Sess. 8-9 (1974), 
                        <E T="03">reprinted</E>
                         in 1974 U.S.C.C.A.N. 6535, 6538-39.
                    </P>
                </FTNT>
                <EXTRACT>
                    <FP>[a]bsent a showing of corrupt failure of the government to discharge its duty, the Court, in making its public interest finding, should * * * carefully consider the explanations of the government in the competitive impact statement and its responses to comments in order to determine whether those explanations are reasonable under the circumstances.</FP>
                </EXTRACT>
                <FP>
                    <E T="03">United States</E>
                     v. 
                    <E T="03">Mid-America Dairymen, Inc.</E>
                    , 1977-1 Trade Cas. (CCH) ¶61,508, at 71,980 (W.D. Mo. 1977).
                </FP>
                <P>
                    Accordingly, with respect to the adequacy of the relief secured by the proposed Final Judgment, a court may not “engage in an unrestricted evaluation of what relief would best serve the public.” 
                    <E T="03">United States</E>
                     v. 
                    <E T="03">BNS Inc.</E>
                    , 858 F.2d 456, 462 (9th Cir. 1988) (citing 
                    <E T="03">United States</E>
                     v. 
                    <E T="03">Bechtel Corp.</E>
                    , 648 F.2d 660, 666 (9th Cir. 1981)); 
                    <E T="03">see also Microsoft</E>
                    , 56 F.3d at 1460-62. Courts have held that:
                </P>
                <EXTRACT>
                    <FP>
                        [t]he balancing of competing social and political interest affected by a proposed antitrust consent decree must be left, in the first instance, to the discretion of the Attorney General. The court's role in protecting the public interest is one of insuring that the government has not breached its duty to the public in consenting to the decree. The court is required to determine not whether a particular decree is the one that will best serve society, but whether the settlement is “
                        <E T="03">within the reaches of the public interest</E>
                        .” More elaborate requirements might undermine the effectiveness of antitrust enforcement by consent decree.
                    </FP>
                </EXTRACT>
                <FP>
                    <E T="03">Bechtel</E>
                    , 648 F.2d at 666 (emphasis added) (citations omitted).
                    <SU>2</SU>
                    <FTREF/>
                </FP>
                <FTNT>
                    <P>
                        <SU>2</SU>
                         
                        <E T="03">Cf. BNS</E>
                        , 858 F.2d at 464 (holding that the court's “ultimate authority under the [APPA] is limited to approving or disapproving the consent decree”); 
                        <E T="03">Gillette</E>
                        , 406 F. Supp. at 716 (noting that, in this way, the court is constrained to “look at the overall picture not hypercritically, nor with a microscope, but with an artist's reducing glass”); 
                        <E T="03">see generally Microsoft</E>
                        , 56 F.3d at 1461 (discussing whether “the remedies [obtained in the decree are] so inconsonant with the allegations charged as to fall outside of the ‘reaches of the public interest’ ”).
                    </P>
                </FTNT>
                <P>
                    The proposed Final Judgment, therefore, should not be reviewed under a standard of whether it is certain to eliminate every anticompetitive effect of a particular practice or whether it mandates certainty of free competition in the future. Court approval of a final judgment requires a standard more flexible and less strict than the standard required for a finding of liability. “[A] proposed decree must be approved even if it falls short of the remedy the court would impose on its own, as long as it falls within the range of acceptability or is ‘within the reaches of public interest.’ ” 
                    <E T="03">United States</E>
                     v. 
                    <E T="03">AT&amp;T Corp.</E>
                    , 552 F. Supp. 131, 151 (D.D.C. 1982) (citations omitted) (quoting 
                    <E T="03">Gillette</E>
                    , 406 F. Supp. at 716), 
                    <E T="03">aff'd sub nom. Maryland</E>
                     v. 
                    <E T="03">United States</E>
                    , 460 U.S. 1001 (1983); 
                    <E T="03">see also United States</E>
                     v. 
                    <E T="03">Alcan Aluminum Ltd.</E>
                    , 605 F. supp. 619, 622 (W.D. Ky. 1985) (approving the consent judgment even though the court would have imposed a greater remedy).
                </P>
                <P>
                    Moreover, the Court's role under the APPA is limited to reviewing the remedy in relationship to the violations that the United States has alleged in its Complaint, and does not authorize the Court to “construct [its] own hypothetical case and then evaluate the decree against that case.” 
                    <E T="03">Microsoft</E>
                    , 56 F.3d at 1459. Because the “court's authority to review the decree depends entirely on the government's exercising its prosecutorial discretion by bringing a case in the first place,” it follows that “the court is only authorized to review the decree itself,” and not to “effectively redraft the complaint” to inquire into other matters that the United States did not pursue. 
                    <E T="03">Id.</E>
                     at 1459-60.
                </P>
                <HD SOURCE="HD1">VIII. Determinative Documents</HD>
                <P>There are no determinative materials or documents within the meaning of the APPA that were considered by plaintiff United States in formulating the proposed Final Judgment.</P>
                <EXTRACT>
                    <FP>Dated: October 29, 2004.</FP>
                    <P>  Respectfully submitted,</P>
                    <FP SOURCE="FP-DASH">/s/</FP>
                    <FP>
                        Hillary B. Burchuk, 
                        <E T="03">(D.C. Bar # 366755)</E>
                    </FP>
                    <FP>Matthew C. Hammond</FP>
                    <FP>David T. Blonder</FP>
                    <FP>Benjamin Brown</FP>
                    <FP>Michael D. Chaleff</FP>
                    <FP>Benjamin Giliberti</FP>
                    <FP>Jeremiah M. Luongo</FP>
                    <FP>
                        Lorenzo McRae 
                        <E T="03">(D.C. Bar # 473660)</E>
                    </FP>
                    <FP>
                        <E T="03">Attorneys, Telecommunications &amp; Media, Enforcement Section, Antitrust Division, U.S. Department of Justice, City Center Building, 1401 H Street, NW., Suite 8000, Washington, DC 20530, (202) 514-5621, Facsimile: (202) 514-6381.</E>
                    </FP>
                </EXTRACT>
                <PRTPAGE P="65640"/>
                <HD SOURCE="HD1">Certificate of Service</HD>
                <P>
                    I hereby certify that copies of the Competitive Impact Statement have been mailed, by U.S. mail, postage preparid, to the attorneys listed below, the 
                    <E T="03">29th</E>
                     day of October 2004.
                </P>
                <EXTRACT>
                    <FP SOURCE="FP-1">Richard L. Rosen, Esq., Arnold &amp; Porter LLP, 555 Twelfth St., NW, Washington, DC 20004.</FP>
                    <HD SOURCE="HD2">Counsel For Defendants Cingular Wireless Corporation and SBC Communications, Inc.</HD>
                    <FP SOURCE="FP-1">Stephen M. Axinn, Esq., Axinn, Veltrop &amp; Harkrider LLP, 1801 K St., NW, Washington, DC 2006.</FP>
                    <HD SOURCE="HD2">Counsel For Defendants Cingular Wireless Corporation and BellSouth Corporation.</HD>
                    <FP SOURCE="FP-1">Ilene Knable Gotts, Esq., Wachtell, Lipton, Rosen &amp; Katz51 West 52nd Street, New York, NY 10019.</FP>
                    <HD SOURCE="HD2">Counsel for Defendant AT&amp;T Wireless Services, Inc.</HD>
                    <FP SOURCE="FP-1">John T. Prud'homme, Jr., Esq, Assistant Attorney General, Antitrust and Civil Medicare Fraud Department, Office of the Attorney General, 300 West 15th Street, 9th Floor, Austin, Texas 78701.</FP>
                    <HD SOURCE="HD2">Counsel for Plaintiff State of Texas.</HD>
                    <FP SOURCE="FP-1">Rachel O. Davis, Esq., Assistant Attorney General, Antitrust Department, 55 Elm Street, Hartford, Connecticut 06106.</FP>
                    <HD SOURCE="HD2">Counsel for Plaintiff State of Connecticut.</HD>
                    <FP SOURCE="FP-DASH">/s/</FP>
                    <FP>
                        Hillary B. Burchuk 
                        <E T="03">(D.C. Bar # 366755)</E>
                    </FP>
                    <FP>Matthew C. Hammond</FP>
                    <FP>
                        <E T="03">Attorneys, Telecommunications &amp; Media, Enforcement Section, Antitrust Division, U.S. Department of Justice, City Center Building, 1401 H Street, NW., Suite 8000, Washington, DC 20530, (202) 514-5621, Facsimile: (202) 514-6381.</E>
                    </FP>
                </EXTRACT>
                <HD SOURCE="HD1">In the United States District Court for the District of Columbia</HD>
                <HD SOURCE="HD2">United States of America, State of Connecticut and State of Texas, Plaintiffs, v. Cingular Wireless Corporation, SBC Communications Inc., BellSouth Corporation and AT&amp;T Wireless Services, Inc., Defendants; Final Judgment</HD>
                <FP>Civil No.: 1:04CV01850 (RBW)</FP>
                <FP>Filed: November 3, 2004</FP>
                <P>
                    <E T="03">Whereas,</E>
                     plaintiffs, United States of America, and the states of Connecticut and Texas (“plaintiff states”), filed their Complaint on October 25, 2004, plaintiffs and defendants, Cingular Wireless Corporation, SBC Communications Inc., BellSouth Corporation and AT&amp;T Wireless Services, Inc. (“AT&amp;T Wireless”), by their respective attorneys, have consented to the entry of this Final Judgment without trial or adjudication of any issue of fact or law, and without this Final Judgment constituting any evidence against or admission by any party regarding any issue of fact or law;
                </P>
                <P>
                    <E T="03">And Whereas,</E>
                     defendants agree to be bound by the provisions of this Final Judgment pending its approval by the Court;
                </P>
                <P>
                    <E T="03">And Whereas,</E>
                     the essence of this Final Judgment is the prompt and certain divestiture of certain rights or assets by the defendants to assure that competition is not substantially lessened;
                </P>
                <P>
                    <E T="03">And Whereas,</E>
                     plaintiffs require defendants to make certain divestitures for the purpose of remedying the loss of competition alleged in the Complaint;
                </P>
                <P>
                    <E T="03">And Whereas,</E>
                     defendants have represented to plaintiffs that the divestitures required below can and will be made and that defendants will later raise no claim of hardship or difficulty as grounds for asking the Court to modify any of the divestiture provisions contained below;
                </P>
                <P>
                    <E T="03">Now Therefore,</E>
                     before any testimony is taken, without trial or adjudication of any issue of fact or law, and upon consent of the parties, it is 
                    <E T="03">ordered, adjudged and decreed:</E>
                </P>
                <HD SOURCE="HD1">I. Jurisdiction</HD>
                <P>This Court has jurisdiction over the subject matter of and each of the parties to this action. The Complaint states a claim upon which relief may be granted against defendants under Section 7 of the Clayton Act, 15 U.S.C. 18.</P>
                <HD SOURCE="HD1">II. Definitions</HD>
                <P>As used in this Final Judgment:</P>
                <P>A. “Acquirer” or “Acquirers” means the entity or entities to whom defendants divest the Divestiture Assets.</P>
                <P>B. “AT&amp;T Wireless” means defendant AT&amp;T Wireless Services, Inc., a Delaware corporation with headquarters in Redmond, Washington, its successors and assigns, and its subsidiaries, divisions, groups, affiliates, partnerships and joint ventures, and their directors, officers, managers, agents, and employees.</P>
                <P>C. “BellSouth” means defendant BellSouth Corporation, a Georgia corporation with headquarters in Atlanta, Georgia, its successors and assigns, and its subsidiaries, divisions, groups, affiliates, partnerships and joint ventures, and their directors, officers, managers, agents, and employees.</P>
                <P>D. “Cingular” means defendant Cingular Wireless Corporation, a Delaware corporation with headquarters in Atlanta, Georgia, and Cingular Wireless LLC, a Delaware limited liability company formed as a joint venture between SBC and BellSouth, with headquarters in Atlanta, Georgia, their successors and assigns, and their subsidiaries, divisions, groups, affiliates, partnerships and joint ventures, and their directors, officers, managers, agents, and employees.</P>
                <P>E. “Divestiture Assets” means Wireless Business Divestiture Assets, Spectrum License Divestiture Assets, and Minority Interests, including any direct or indirect financial ownership or leasehold interests and any direct or indirect role in management or participation in control therein.</P>
                <P>F. “Minority Interests” means the equity interests owned by any defendant in the following entities that are the licensees or operators of mobile wireless services businesses in the specified Metropolitan Statistical Areas (“MSAs”) and Rural Statistical Areas (“RSAs”) (collectively, Cellular Marketing Areas (“CMAs”)) used to define cellular license areas by the Federal Communications Commission (“FCC”):</P>
                <P>(1) Alltel Communications of North Louisiana Cellular Limited Partnership, covering the Shreveport, Louisiana MSA (CMA 100), Monroe, Louisiana MSA (CMA 219), Louisiana RSA-1 (CMA 454), Louisiana RSA-2 (CMA 455) and Louisnana RSA-3 (CMA 456);</P>
                <P>(2) Athens Cellular Inc., covering the Athens, Georgia MSA (CMA 234);</P>
                <P>(3) CellTelCo, covering the St. Joseph, Missouri MSA (CMA 275);</P>
                <P>(4) Pittsfield Cellular Telephone Co., covering the Pittsfield, Massachusetts MSA (CMA 213); and</P>
                <P>(5) Topeka Cellular Telephone Co., Inc., covering the Topeka, Kansas MSA (CMA 179).</P>
                <P>As an alternative to the divestiture of the Alltel Communications of North Louisiana Cellular Limited Partnership, CellTelCo, and Topeka Cellular Telephone Co., Inc. Minority Interests as required by Section IV of this Final Judgment, defendants may request, at least 20 days prior to consummation of the Transaction, approval from plaintiff United States to retain such interests. Plaintiff United States in its sole discretion may approve this request if it is demonstrated that the retained minority interest will become irrevocably and entirely passive, so long as defendants own the minority interests, and will not significantly diminish competition.</P>
                <P>G. “Multi-line Business Customer” means a corporate or business customer that contracts with AT&amp;T Wireless for mobile wireless services to provide multiple telephones to its employees or members whose services are provided pursuant to a contract with a corporate or business customer.</P>
                <P>
                    H. “SBC” means defendant SBC Communications Inc., a Delaware corporation with headquarters in San 
                    <PRTPAGE P="65641"/>
                    Antonio, Texas, its successors and assigns, and its subsidiaries, divisions, groups, affiliates, partnerships and joint ventures, and their directors, officers, managers, agents, and employees.
                </P>
                <P>I. “Skagit” means Skagit Wireless LLC, an Oregon corporation with headquarters in Portland, Oregon, its successors and assigns, and its subsidiaries, divisions, groups, affiliates, partnerships and joint ventures, and their directors, officers, managers, agents, and employees.</P>
                <P>J. “Spectrum License Divestiture Assets” means a license for 10 MHz of contiguous PCS spectrum in the specified MSAs and Basic Trading Areas (“BTAs”) used to define cellular and PCS license areas by the FCC:</P>
                <P>(1) The Dallas-Fort Worth, Texas MSA (CMA 009);</P>
                <P>(2) The Detroit, Michigan BTA (BTA 112), provided that the license to be transferred does not have to include any PCS spectrum in Monroe and Sanilac counties; and</P>
                <P>(3) The Knoxville, Tennessee BTA (BTA 232), provided that as an alternative to the divestiture of a license for 10 MHz of contiguous PCS spectrum as required by Section IV of this Final Judgment, defendants, with the approval of plaintiff United States in its sole discretion, can restructure AT&amp;T Wireless's existing relationship with Skagit such that (i) defendants have no equity or leasehold interest in, hold no debt of, and have no managerial or operational interest in Skagit's PCS license in the Knoxville Tennessee BTA, and (ii) Skagit's PCS license in the Knoxville Tennessee BTA is contractually committed to be used in a manner that resolve the competitive concerns alleged by plaintiffs in the Complaint.</P>
                <P>K. “Transaction” means the Agreement and Plan of Merger By and Among AT&amp;T Wireless Services, Inc., Cingular Wireless Corporation, Cingular Wireless LLC, Links I Corporation, SBC Communications Inc., and BellSouth Corporation, dated February 17, 2004.</P>
                <P>L. “Wireless Business Divestiture Assets” means, for each mobile wireless business to be divested under this Final Judgment, all types of assets, tangible and intangible, used by defendants in the operation of the mobile wireless businesses to be divested (including the provision of long distance telecommunications services for wireless calls). “Wireless Business Divestiture Assets” shall be construed broadly to accomplish the complete divestitures of the entire business of AT&amp;T Wireless in each of the following MSA and RSA license areas as required by this Final Judgment and to ensure that the divested mobile wireless businesses remain viable, ongoing businesses:</P>
                <P>(a) Oklahoma City, Oklahoma MSA (CMA 045);</P>
                <P>(b) Connecticut RSA-1 (CMA 357), provided that defendants may retain 10 MHz of AT&amp;T Wireless's PCS spectrum, provided that 10 MHz of contiguous PCS spectrum throughout the RSA is divested to an Acquirer;</P>
                <P>(c) Kentucky RSA-1 (CMA 443), provided that defendants may retain 15 MHz of AT&amp;T Wireless's PCS spectrum in Fulton county and 10 MHz of AT&amp;T Wireless's PCS spectrum in the other counties contained within the RSA, provided that 30 MHz of contiguous PCS spectrum in Fulton county and 20 MHz of contiguous PCS spectrum in the other counties contained in the RSA is divested to an Acquirer;</P>
                <P>(d) Oklahoma RSA-3 (CMA 598); and</P>
                <P>(e) Texas RSA-11 (CMA 662), provided that defendants may retain 25 MHz of AT&amp;T Wireless's PCS spectrum in Sabine county, and 20 MHz of AT&amp;T Wireless's PCS spectrum in Angelina, Nacogdoches, and San Augustine counties, provided that 10 MHz of contiguous PCS spectrum throughout the RSA is divested to an Acquirer.</P>
                <P>Wireless Business Divestiture Assets shall include, without limitation, all types of real and personal property, monies and financial instruments, equipment, inventory, office furniture, fixed assets and furnishings, supplies and materials, contracts, agreements, leases, commitments, spectrum licenses issued by the FCC and all other licenses, permits and authorizations, operational support systems, cell sites, network infrastructure, switches, customer support and billing systems, interfaces with other service providers, business and customer records and information, customer contracts, customer lists, credit records, accounts, and historic and current business plans which relate primarily to the wireless business being divested, as well as any patents, licenses, sub-licenses, trade secrets, know-how, drawings, blueprints, designs, technical and quality specifications and protocols, quality assurance and control procedures, manuals and other technical information defendants supply to their own employees, customers, suppliers, agents, or licensees, and trademarks, trade names and service marks or other intellectual property, including all intellectual property rights under third-party licenses that are capable of being transferred to an Acquirer either in their entirety, for assets described in (1) below, or through a license obtained through or from the divesting defendant, for assets described in (2) below; provided that defendants shall only be required to divest Multi-line business Customer contracts, if 50 percent or more of the Multi-line Business Customer's subscribers reside or work within any of the five (5) license areas described herein, and further, any subscribers who obtain mobile wireless services through any such contract retained by defendants and who are located within the five (5) geographic areas identified above, shall be given the option to terminate their relationship with defendants, without financial cost, within one year of the closing of the Transaction. Defendants shall provide written notice to these subscribers within 45 days after the closing of the Transaction.</P>
                <P>These divestitures of the Wireless Business Divestiture Assets shall be accomplished by:</P>
                <P>(1) Transferring to the Acquirers the complete ownership and/or other rights to the assets (other than those assets used substantially in the operations of AT&amp;T Wireless's overall wireless business which must be retained to continue the existing operations of the wireless properties that defendants are not required to divest, and that either are not capable of being divided between the divested wireless businesses and those not divested, or are assets that the defendants and the Acquirer(s) agree, subject to approval of plaintiff United States upon consultation with any relevant plaintiff state, shall not be divided); and</P>
                <P>
                    (2) Granting to the Acquirer(s) an option to obtain a non-exclusive, transferable license from defendants for a reasonable period, subject to approval of plaintiff United States upon consultation with any relevant plaintiff state, at the election of an Acquirer to use any of AT&amp;T Wireless's retained assets under paragraph (1) above, used in the operation of the wireless business being divested, so as to enable the Acquirer to continue to operate the divested wireless business without impairment. Defendants shall identify in a schedule submitted to plaintiffs and filed with the Court, as expeditiously as possible following the filing of the Complaint and in any event prior to any divestitures and before the approval by the Court of this Final Judgment, any intellectual property rights under third-party licenses that are used by the wireless businesses being divested but that defendants could not transfer to an Acquirer entirely or by license without third-party consent, and the specific reasons why such consent is necessary and how such consent would be obtained for each asset.
                    <PRTPAGE P="65642"/>
                </P>
                <HD SOURCE="HD1">III. Applicability</HD>
                <P>A. This Final Judgment applies to defendants Cingular, SBC, BellSouth and AT&amp;T Wireless, as defined above, and all other persons in active concert or participation with any of them who receive actual notice of this Final Judgment by personal service or otherwise.</P>
                <P>B. Defendants shall require, as a condition of the sale or other disposition of all or substantially all of their assets or of lesser business units that include the Divestiture Assets, that the purchaser agrees to be bound by the provisions of this Final Judgment, provided that defendants need not obtain such an agreement from the Acquirer(s).</P>
                <HD SOURCE="HD1">IV. Divestitures</HD>
                <P>A. Defendants are ordered and directed, within 120 days after consummation of the Transaction, or five (5) days after notice of entry of this Final Judgment, whichever is later, to divest the Divestiture Assets to an Acquirer or Acquirers acceptable to plaintiff United States in its sole discretion upon consultation with any relevant plaintiff state, and, if applicable, to a Divestiture Trustee designated pursuant to Section V of this Final Judgment. Plaintiff United States, in its sole discretion upon consultation with any relevant plaintiff state, may agree to one or more extensions of this time period not to exceed 60 days in total, and shall notify the Court in such circumstances. With respect to divestiture of the Divestiture Assets by defendants or the Divestiture Trustee, if applications have been filed with the FCC within the period permitted for divestiture seeking approval to assign or transfer licenses to the Acquirer(s) of the Divestiture Assets, but an order or other dispositive action by the FCC on such applications has not been issued before the end of the period permitted for divestiture, the period shall be extended with respect to divestiture of those Divestiture Assets for which FCC approval has not been issued until five (5) days after such approval is received. Defendants agree to use their best efforts to accomplish the divestitures set forth in this Final Judgment and to seek all necessary regulatory approvals as expeditiously as possible. This Final Judgment does not limit the FCC's exercise of its regulatory powers and process with respect to the Divestiture Assets. Authorization by the FCC to conduct the divestiture of a Divestiture Asset in a particular manner will not modify any of the requirements of this decree.</P>
                <P>B. In accomplishing the divestitures ordered by this Final Judgment, defendants shall promptly make known, if they have not already done so, by usual and customary means, the availability of the Divestiture Assets. Defendants shall inform any person making inquiry regarding a possible purchase of the Divestiture Assets that they are being divested pursuant to this Final Judgment and provide that person with a copy of this Final Judgment. Defendants shall offer to furnish to all prospective Acquirers, subject to customary confidentiality assurances, all information and documents relating to the Divestiture Assets customarily provided in a due diligence process except such information or documents subject to the attorney-client or work productive privileges. Defendants shall make available such information to plaintiffs at the same time that such information is made available to any other person.</P>
                <P>C. Defendants shall provide to the Acquirer(s) and plaintiffs information relating to the personnel involved in the operation, development, and sale of the Wireless Business Divestiture Assets to enable the Acquirer(s) to make offers of employment. Defendants will not interfere with any negotiations by the Acquirer(s) to employ any defendant employee whose primary responsibility is the operation, development, and sale of the Wireless Business Divestiture Assets.</P>
                <P>D. Defendants shall permit prospective Acquirers of the Divestiture Assets to have reasonable access to personnel and to make inspections of the Divestiture Assets; access to any and all environmental, zoning, and other permit documents and information; and access to any and all financial, operational, and other documents and information customarily provided as part of a due diligence process.</P>
                <P>E. Defendants shall warrant to all Acquirer(s) that (1) each asset of the Wireless Business Divestiture Assets will be operational on the date of sale, and (2) every wireless spectrum license is in full force and effect on the date of sale.</P>
                <P>F. Defendants shall not take any action that will impede in any way the permitting, licensing, operation, or divestiture of the Divestiture Assets.</P>
                <P>G. Defendants shall warrant to the Acquirer(s) of the Divestiture Assets that there are no material defects in the environmental, zoning, licensing or other permits pertaining to the operation of each assets, and that following the sale of the Divestiture Assets, defendants will not undertake, directly or indirectly, any challenges to the environmental, zoning, licensing or other permits relating to the operation of the Divestiture Assets.</P>
                <P>H. Unless plaintiff United States otherwise consents in writing, upon consultation with any relevant plaintiff state, the divestitures pursuant to Section IV, or by a Divestiture Trustee appointed pursuant to Section V of this Final Judgment, shall include the entire Divestiture Assets and with respect to the Wireless Business Divestiture Assets and Spectrum License Divestiture Assets, shall be accomplished in such a way as to satisfy plaintiff United States, in its sole discretion upon consultation with any relevant plaintiff state, that these assets can and will be used by the Acquirer(s) as part of a viable, ongoing business engaged in the provision of mobile wireless services. Divestiture of the Divestiture Assets may be made to one or more Acquirers, provided that in each instance it is demonstrated to the sole satisfaction of plaintiff United States upon consultation with any relevant plaintiff state, that the Divestiture Assets will remain viable and the divestiture of such assets will remedy the competitive harm alleged in the Complaint. The divestitures of the Wireless Business Divestiture Assets and Spectrum License Divestiture Assets, whether pursuant to Section IV or Section V of this Final Judgment,</P>
                <P>(1) Shall be made to an Acquirer (or Acquirers) that, in plaintiff United State's sole judgment upon consultation with any relevant plaintiff state, has the intent and capability (including the necessary managerial, operational, technical, and financial capability) of competing effectively in the provision of mobile wireless services; and</P>
                <P>(2) Shall be accomplished so as to satisfy plaintiff United States in its sole discretion upon consultation with any relevant plaintiff state, that none of the terms of any agreement between the Acquirer (or Acquirers) and any defendant shall give defendants the ability unreasonably to raise the Acquirer's costs, to lower the Acquirer's efficiency, or otherwise to interfere with the ability of the Acquirer to compete effectively.</P>
                <P>
                    I. At the option of the Acquirer(s), defendants shall enter into a contract for transition services customarily provided in connection with the sale of a business providing mobile wireless services sufficient to meet all or part of the needs of the Acquirer'(s) needs for a period of up to one year. The terms and conditions of any contractual arrangement meant to satisfy this provision must be reasonably related to market conditions.
                    <PRTPAGE P="65643"/>
                </P>
                <P>J. To the extent that the mobile wireless businesses to be divested use intellectual property, as required to be identified by Section II.L, that cannot be transferred or assigned without the consent of the licensor or other third parties, defendants shall use their best efforts to obtain those consents.</P>
                <P>K. In the event plaintiff United States approves retention of any Minority Interests, defendants shall not obtain any additional equity interest in such entity.</P>
                <HD SOURCE="HD1">V. Appointment of Divestiture Trustee</HD>
                <P>A. If defendants have not divested the Divestiture Assets within the time period specified in Section IV.A, defendants shall notify plaintiff United States and any relevant plaintiff state of that fact in writing, specifically identifying the Divestiture Assets that have not been divested. Then, upon application of plaintiff United States, upon consultation with any plaintiff state, the Court shall appoint a Divestiture Trustee selected by plaintiff United States and approved by the Court to effect the divestiture of the Divestiture Assets. The Divestiture Trustee, will have all the rights and responsibilities of the Management Trustee appointed pursuant to the Preservation of Assets Stipulation and Order, and will be responsible for:</P>
                <P>(1) Accomplishing divestiture of  all Divestiture Assets transferred to the Divestiture Trustee from defendants, in accordance with the terms of this final Judgment, to an Acquirer or Acquirers approved by plaintiff United States, upon consultation with any relevant plaintiff state, under Sections IV.A and IV.C of this Final Judgment, and</P>
                <P>(2) Exercising the responsibilities of the licensee of any transferred Divestiture Assets and controlling and operating any transferred Wireless Business Divestiture Assets, to ensure that the businesses remain ongoing, economically viable competitors in the provision of mobile wireless services in the five (5) license areas specified in the Wireless Business Divestiture Assets, until they are divested to an Acquirer or Acquirers, and the Divestiture Trustee shall agree to be bound by this Final Judgment.</P>
                <P>B. Defendants shall submit a proposed trust agreement (“Trust Agreement”) to plaintiff United States and any relevant plaintiff state, which must be consistent with the terms of this Final Judgment and which must receive approval by plaintiff United States in its sole discretion, upon consultation with any relevant plaintiff state, who shall communicate to defendants within ten (10) business days its approval or disapproval of the proposed Trust Agreement, and which must be executed by the defendants and the Divestiture Trustee within five (5) business days after approval by plaintiff United States; and</P>
                <P>C. After obtaining any necessary approvals from the FCC for the assignment of the licenses of the remaining Divestiture Assets to the Divestiture Trustee, defendants shall irrevocably divest the remaining Divestiture Assets to the Divestiture Trustee, who will own such assets (or own the stock of the entity owning such assets, if divestiture is to be effected by the creation of such an entity for sale to Acquirer(s)) and control such assets, subject to the terms of the approved Trust Agreement.</P>
                <P>D. After the appointment of a Divestiture Trustee becomes effective, only the Divestiture Trustee shall have the right to sell the Divestiture Assets. The Divestiture Trustee shall have the power and authority to accomplish the divestiture to an Acquirer(s) acceptable to plaintiff United States, in its sole judgment upon consultation with any relevant plaintiff state, at such price and on such terms as are then obtainable upon reasonable effort by the Divestiture Trustee, subject to the provisions of Sections IV, V, and VI of this Final Judgment, and shall have such other powers as this Court deems appropriate. Subject to Section V.G of this Final Judgment, the Divestiture Trustee may hire at the cost and expense of defendants the Management Trustee appointed pursuant to the Preservation of Assets Stipulation and Order, and any investment bankers, attorneys or other agents, who shall he solely accountable to the Divestiture Trustee, reasonably necessary in the Divestiture Trustee's judgment to assist in the divestiture.</P>
                <P>E. In addition, notwithstanding any provision to the contrary, plaintiff United States, in its sole discretion upon consultation with any relevant plaintiff state, may require defendants to include additional assets, or allow, with the written approval of plaintiff United States, defendants to substitute substantially similar assets, which substantially relate to the Wireless Business Divestiture Assets to be divested by the Divestiture Trustee to facilitate prompt divestiture to an acceptable Acquirer.</P>
                <P>F. Defendants shall not object to a sale by the Divestiture Trustee on any ground other than the Divestiture Trustee's malfeasance. Any such objections by defendants must be conveyed in writing to plaintiff United States, any relevant plaintiff state, and the Divestiture Trustee within ten (10) calendar days after the Divestiture Trustee has provided the notice required under Section VI.</P>
                <P>G. The Divestiture Trustee shall serve at the cost and expense of defendants, on such terms and conditions as plaintiff United States approves, and shall account for all monies derived from the sale of the assets sold and all costs and expenses so incurred. After approval by the Court of the Divestiture Trustee's accounting, including fees for its services and those of any professionals and agents retained by the Divestiture Trustee, all remaining money shall be paid to defendants and the trust shall then be terminated. The compensation of the Divestiture Trustee and any professionals and agents retained by the Divestiture Trustee shall be reasonable in light of the value of the Divestiture Assets and based on a fee arrangement providing the Divestiture Trustee with an incentive based on the price and terms of the divestiture, and the speed with which it is accomplished, but timeliness is paramount.</P>
                <P>H. Defendants shall use their best efforts to assist the Divestiture Trustee in accomplishing the required divestitures including their best efforts to effect all necessary regulatory approvals and will provide any necessary representations or warranties as appropriate related to sale of the Divestiture Assets. The Divestiture Trustee and any consultants, accountants, attorneys, and other persons retained by the Divestiture Trustee shall have full and complete access to the personnel, books, records, and facilities of the business to be divested, and defendants shall develop financial and other information relevant to the assets to be divested as the Divestiture Trustee may reasonably request, subject to reasonable protection for trade secret or other confidential research, development, or commercial information. Defendants shall take no action to interfere with or to impede the Divestiture Trustee's accomplishment of the divestitures.</P>
                <P>
                    I. After its appointment, the Divestiture Trustee shall file monthly reports with plaintiff United states, any relevant plaintiff state, and the Court setting forth the Divestiture Trustee's efforts to accomplish the divestitures ordered under this Final Judgment. To the extent such reports contain information that the Divestiture Trustee deems confidential, such reports shall not be filed in the public docket of the Court. Such reports shall include the name, address, and telephone number of each person who, during the preceding 
                    <PRTPAGE P="65644"/>
                    month, made an offer to acquire, expressed an interest in acquiring, entered into negotiations to acquire, or was contacted or made an inquiry about acquiring, any interest in the Divestiture Assets, and shall describe in detail each contact with any such person. The Divestiture Trustee shall maintain full records of all efforts made to divest the Divestiture Assets.
                </P>
                <P>J. If the Divestiture Trustee has not accomplished such divestitures within six months after its appointment, the Divestiture Trustee shall promptly file with the Court a report setting forth (1) the Divestiture Trustee's efforts to accomplish the required divestitures, (2) the reasons, in the Divestiture Trustee's judgment, why the required divestitures have not been accomplished, and (3) the Divestiture Trustee's recommendations. To the extent such reports contain information that the Divestiture Trustee deems confidential, such reports shall not be filed in the public docket of the Court. The Divestiture Trustee shall at the same time furnish such report to the plaintiff United States and any relevant plaintiff state who shall have the right to make additional recommendations consistent with the purpose of the trust. The Court thereafter shall enter such orders as it shall deem appropriate to carry out the purpose of the Final Judgment, which may, if necessary, include extending the trust and the term of the Divestiture Trustee's appointment by a period requested by plaintiff United States upon consultation with any relevant plaintiff state.</P>
                <P>K. After defendants transfer the Divestiture Assets to the Divestiture Trustee, and until those Divestiture Assets have been divested to an Acquirer or Acquirers approved by plaintiff United States pursuant to Section IV.A and IV.H the Divestiture Trustee shall have sole and complete authority to manage and operate the Divestiture Assets and to exercise the responsibilities of the licensee, and shall not be subject to any control or direction by defendants. Defendants shall not retain any economic interest in the Divestiture Assets transferred to the Divestiture Trustee, apart from the right to receive the proceeds of the sale or other disposition of the Divestiture Assets.</P>
                <P>L. The Divestiture Trustee shall operate the Wireless Business Divestiture Assets consistent with the Preservation of Assets Stipulation and Order and this Final Judgment, with control over operations, marketing and sales. Defendants shall not attempt to influence the business decisions of the Divestiture trustee concerning the operation and management of the Wireless business Divestiture Assets, and shall not communicate with the Divestiture Trustee concerning divestiture of the Divestiture Assets or take any action to influence, interfere with, or impede the Divestiture trustee's accomplishment of the divestitures required by this Final Judgment, except that defendants may communicate with the Divestiture Trustee to the extent necessary for defendants to comply with this Final Judgment and to provide the Divestiture Trustee, if requested to do so, with whatever resources or cooperation may be required to complete divestiture of the Divestiture Assets and to carry out the requirements of the Preservation of Assets Stipulation and Order and this Final Judgment. Except as provided in this Final Judgment and the Preservation of Assets Stipulation and Order, in no event shall defendants provide to, or receive from, the Divestiture Trustee or the mobile wireless businesses under the Divestiture Trustee's control any non-public or competitively sensitive marketing, sales, or pricing information relating to their respective mobile wireless businesses.</P>
                <HD SOURCE="HD1">VI. Notice of Proposed Divestitures</HD>
                <P>A. Within two (2) business days following execution of a definitive divestiture agreement, defendants or the Divestiture Trustee, whichever is then responsible for effecting the divestitures required herein, shall notify plaintiff United States and any relevant plaintiff state in writing of any proposed divestiture required by Section IV or V of this Final Judgment. If the Divestiture Trustee is responsible, it shall similarly notify defendants. The notice shall set forth the details of the proposed divestiture and list the name, address, and telephone number of each person not previously identified who offered or expressed an interest in or desire to acquire any ownership interest in the Divestiture Assets, together with full details of the same.</P>
                <P>B. Within fifteen (15) calendar days of receipt by plaintiff United States and any relevant plaintiff state of such notice, plaintiff United States and any relevant plaintiff state may request from defendants, the proposed Acquirer or Acquirers, any other third party, or the Divestiture Trustee if applicable additional information concerning the proposed divestiture, the proposed Acquirer or Acquirers, and any other potential Acquirer. Defendants and the Divestiture Trustee shall furnish any additional information requested within fifteen (15) calendar days of the receipt of the request, unless the parties shall otherwise agree.</P>
                <P>C. Within thirty (30) calendar days after receipt of the notice or within twenty (20) calendar days after plaintiff United States and any relevant plaintiff state have been provided the additional information requested from defendants, the proposed Acquirer or Acquirers, any third party, and the Divestiture Trustee, whichever is later, plaintiff United States, upon consultation with any relevant plaintiff state, shall provide written notice to defendants and the Divestiture Trustee, if there is one, stating whether or not it objects to the proposed divestiture. If plaintiff United States provides written notice that it does not object, the divestiture may be consummated, subject only to defendants' limited right to object to the sale under Section V.F of this Final Judgment. Absent written notice that plaintiff United States does not object to the proposed Acquirer or upon objection by plaintiff United States, a divestiture proposed under Section IV or Section V shall not be consummated. Upon objection by defendants under Section V.F, a divestiture proposed under Section V shall not be consummated unless approved by the Court.</P>
                <HD SOURCE="HD1">VII. Financing</HD>
                <P>Defendants shall not finance all or any part of any divestiture made pursuant to Section IV or V of this Final Judgment.</P>
                <HD SOURCE="HD1">VIII. Preservation of Assets</HD>
                <P>Until the divestitures required by this Final Judgment have been accomplished, defendants shall take all steps necessary to comply with the Preservation of Assets Stipulation and Order entered by this Court. Defendants shall take no action that would jeopardize the divestitures ordered by this Court.</P>
                <HD SOURCE="HD1">IX. Affidavits</HD>
                <P>
                    A. Within twenty (20) calendar days of the filing of the Complaint in this matter, and every thirty (30) calendar days thereafter until the divestitures have been completed under Section IV or V of this Final Judgment, defendants shall deliver to plaintiff United States and any relevant plaintiff state and affidavit as to the fact and manner of its compliance with Section IV or V of this Final Judgment. Each such affidavit shall include the name, address, and telephone number of each person who during the preceding thirty (30) days, made an offer to acquire, expressed an interest in acquiring, entered into negotiations to acquire, or was contacted or made an inquiry about acquiring, any interest in the Divestiture 
                    <PRTPAGE P="65645"/>
                    Assets, and shall describe in detail each contact with any such person during that period. Each such affidavit shall also include a description of the efforts defendants have taken to solicit buyers for the Divestiture Assets, and to provide required information to prospective Acquirers, including the limitations, if any, on such information. Assuming the information set forth in the affidavit is true and complete, any objection by plaintiff United States, after consultation with any relevant state, to information provided by defendants, including limitation on information, shall be made within fourteen (14) calendar days of receipt of such affidavit.
                </P>
                <P>B. Within twenty (20) calendar days of the filing of the Complaint in this matter, defendants shall deliver to plaintiff United States and any relevant plaintiff state an affidavit that describes in reasonable detail all actions defendants have taken and all steps defendants have implemented on an ongoing basis to comply with Section VIII of this Final Judgment. Defendants shall deliver to plaintiff United States and any relevant plaintiff state an affidavit describing any changes to the efforts and actions outlined in defendants' earlier affidavits provided pursuant to this section within fifteen (15) calendar days after the change is implemented.</P>
                <P>C. Defendants shall keep all records of all efforts made to preserve and divest the Divestiture Assets until one year after such divestitures have been completed.</P>
                <HD SOURCE="HD1">X. Compliance Inspection</HD>
                <P>A. For the purposes of determining or securing compliance with this Final Judgment, or of determining whether the Final Judgment should be modified or vacated, and subject to any legally recognized privilege, from time to time duly authorized representatives of the United States Department of Justice, including consultants and other persons retained by the United States, shall, upon written request of a duly authorized representative of the Assistant Attorney General in charge of the Antitrust Division, and on reasonable notice to defendants, be permitted:</P>
                <P>(1) Access during defendants' office hours to inspect and copy, or at plaintiff United States' option, to require defendants provide copies of, all books, ledgers, accounts, records and documents in the possession, custody, or control of defendants, relating to any matters contained in this Final Judgment; and</P>
                <P>(2) To interview, either informally or on the record, defendants' officers, employees, or agents, who may have their individual counsel present, regarding such matters. The interviews shall be subject to the reasonable convenience of the interviewee and without restraint or interference by defendants.</P>
                <P>B. Upon the written request of a duly authorized representative of the Assistant Attorney General in charge of the Antitrust Division, defendants shall submit written reports, under oath if requested, relating to any of the matters contained in this Final Judgment as may be requested.</P>
                <P>C. No information or documents obtained by the means provided in this section shall be divulged by plaintiff United States to any person other than an authorized representative of the executive branch of the United States or, pursuant to a customary protective Order or waiver of confidentiality by defendants, the FCC, except in the course of legal proceedings to which the United States is a party (including grand jury proceedings), or for the purpose of securing compliance with this Final Judgment, or as otherwise required by law.</P>
                <P>D. If at the time information or documents are furnished by defendants to plaintiff United States, defendants represent and identify in writing the material in any such information or documents to which a claim of protection may be asserted under Rule 26(c)(7) of the Federal Rules of Civil Procedure, and defendants mark each pertinent page of such material, “Subject to claim of protection under Rule 26(c)(7) of the Federal Rules of Civil Procedure,” then plaintiff United States shall give defendants ten (10) calendar days notice prior to divulging such material in any legal proceeding (other than a grand jury proceeding).</P>
                <HD SOURCE="HD1">XI. No Reacquisition</HD>
                <P>Defendants may not reacquire or lease any part of the Divestiture Assets during the term of this Final Judgment.</P>
                <HD SOURCE="HD1">XII. Retention of Jurisdiction</HD>
                <P>This Court retains jurisdiction to enable any party to this Final Judgment to apply to this Court at any time for further orders and directions as may be necessary or appropriate to carry out or construe this Final Judgment, to modify any of its provisions, to enforce compliance, and to punish violations of its provisions.</P>
                <HD SOURCE="HD1">XIII. Expiration of Final Judgment</HD>
                <P>Unless this Court grants an extension, this Final Judgment shall expire ten years from the date of its entry.</P>
                <HD SOURCE="HD1">XIV. Public Interest Determination</HD>
                <P>Entry of this Final Judgment is in the public interest.</P>
                  
                <EXTRACT>
                    <FP SOURCE="FP-DASH">Date:</FP>
                    <FP SOURCE="FP-DASH"/>
                    <FP>
                        <E T="03">United States District Judge</E>
                    </FP>
                </EXTRACT>
                <HD SOURCE="HD1">In the United States District Court for the District of Columbia</HD>
                <HD SOURCE="HD2">United States of America, Department of Justice, Antitrust Division, 1401 H Street, NW., Suite 8000, Washington, DC 20530, State of Connecticut, Office of the Attorney General, 55 Elm Street, Hartford, CT 06106, and State of Texas, Office of the Attorney General, P.O. Box 12548, Austin, TX 78711, Plaintiffs, v. Cingular Wireless Corporation, 5565 Glenridge Connector, Atlanta, GA 30349, SBC Communications Inc., 174 East Houston, San Antonio, TX 78205, Bellsouth Corporation, 1155 Peachtree Street, NE., Atlanta, GA 30309, and AT&amp;T Wireless Services, Inc., 7277 164th Avenue, NE., Building 1, Redmond, WA 98052, Defendants; Complaint</HD>
                <FP>Civil No.: 1:04CV01850 (RBW)</FP>
                <FP>Filed: 10/25/04</FP>
                <P>The United States of America, acting under the direction of the Attorney General of the United States, and the states of Connecticut and Texas (“plaintiff states”), acting under the direction of their respective Attorneys General, or other authorized officials, bring this civil action to enjoin the merger of two of the largest mobile wireless telecommunications services providers in the United States, Cingular Wireless Corporation (“Cingular”) and AT&amp;T Wireless Services, Inc. (“AT&amp;T Wireless”), and to obtain other relief as appropriate. Plaintiffs allege as follows: </P>
                <P>1. On February 17, 2004, Cingular, a joint venture between SBC Communications  Inc. (“SBC”) and BellSouth Corporation (“BellSouth”), entered into an agreement to acquire AT&amp;T Wireless under which the two companies would combine their mobile wireless services businesses. Plaintiffs seek to enjoin this transaction because it will substantially lessen competition in several geographic markets for mobile wireless telecommunications services and mobile wireless broadband services (collectively, “mobile wireless services”). </P>
                <P>
                    2. Cingular and AT&amp;T Wireless are the second and third-largest mobile wireless services providers in the 
                    <PRTPAGE P="65646"/>
                    United States, with approximately 24 and 22 million subscribers, respectively. They both provide mobile wireless services in areas throughout the United States and are two of only six providers with a national presence. As a result, Cingular and AT&amp;T Wireless both provide mobile wireless services in hundreds of overlapping geographic areas, and in 13 of these areas the combination of Cingular's and AT&amp;T Wireless's assets and business will likely result in substantially less competition for mobile wireless services. In 10 of these overlapping geographic areas located in the states of Connecticut, Georgia, Kansas, Kentucky, Louisiana, Massachusetts, Missouri, Oklahoma, and Texas, the combination of Cingular and AT&amp;T Wireless will substantially lessen competition for mobile wireless telecommunications services, increasing the likelihood of unilateral actions by the merged firm to increase prices, diminish the quality or quantity of services provided, refrain from or delay making investments in network improvements, and refrain from or delay launching new services, substantially lessening competition for these services. In three of these overlapping geographic areas located in the states of Michigan, Tennessee, and Texas, both Cingular and AT&amp;T Wireless have launched or will likely soon launch mobile wireless broadband services, and the transaction will result in the loss of one of only a few existing and likely mobile wireless broadband services providers, substantially lessening competition for these services. 
                </P>
                <HD SOURCE="HD1">I. Jurisdiction and Venue</HD>
                <P>3. Complaint is filed by the United States under Section 15 of the Clayton Act, 15 U.S.C. 25, to prevent and restrain defendants from violating Section 7 of the Clayton Act, 15 U.S.C. 18. </P>
                <P>4. Plaintiff states bring this action under Section 16 of the Clayton Act, 15 U.S.C. 26, to prevent and restrain the violation by defendants of Section 7 of the Clayton Act, 15 U.S.C. 18. Plaintiff states, by and through their respective Attorneys General, or other authorized officials, bring this action in their sovereign capacities and as parens patriae on behalf of the citizens, general welfare, and economy of each of their states. </P>
                <P>5. Cingular, AT&amp;T Wireless, SBC, and BellSouth are engaged in interstate commerce and in activities substantially affecting interstate commerce. The Court has jurisdiction over this action pursuant to Sections 15 and 16 of the Clayton Act, 15 U.S.C. 25, 26, and 28 U.S.C. 1331, 1337. </P>
                <P>6. Cingular, AT&amp;T Wireless, SBC, and BellSouth transact business or are found in the District of Columbia. Venue is proper in this Court pursuant to Section 12 of the Clayton Act, 15 U.S.C. 22 and 28 U.S.C. 1391(b) and (c).</P>
                <HD SOURCE="HD1">II. The Defendants and the Transaction</HD>
                <P>7. Cingular, which headquarters in Atlanta, Georgia, is a company organized and existing under the laws of the state of Delaware. Cingular was formed in 2000 by SBC and BellSouth, who own equity interests in it of 60 and 40 percent, respectively, SBC and BellSouth evenly share management control of Cingular. Cingular is the second-largest provider of mobile wireless voice and data services in the United States by number of subscribers; it serves more than 24 million customers. In 2003, Cingular earned revenues of approximately $15.5 billion.</P>
                <P>8. SBC, with headquarters in San Antonio, Texas, is a corporation organized and existing under the laws of the state of Delaware. SBC is a regional bell operating company (“RBOC”), one of several regional holding companies formed in 1984 as a result of the breakup of AT&amp;T Corporation's local telephone business. SBC's wireless telecommunications businesses serve 54.7 million access lines in 13 states; Arkansas, California, Connecticut, Illinois, Indiana, Kansas, Michigan, Missouri, Nevada, Ohio, Oklahoma, Texas, and Wisconsin. In 2003, SBC earned approximately $40.8 billion in revenues.</P>
                <P>9. BellSouth, an RBOC with headquarters in Atlanta, Georgia, is a corporation organized and existing under the laws of the state of Georgia. BellSouth's wireline telecommunications businesses serves 23.7 million access lines in 9 states: Alabama, Florida, Georgia, Kentucky, Louisiana, Mississippi, North Caroline, South Carolina, and Tennessee. Its total operating revenues for 2003 were approximately $22.6 billion.</P>
                <P>10. AT&amp;T Wireless, with headquarters in Redmond, Washington, is a corporation organized and existing under the laws of the state of Delaware. spun off from AT&amp;T Corporation in 2001, it had more than 22 million subscribers as of August 2004 an earned revenues of approximately  $16.6 billion in 2003. AT&amp;T Wireless is  the third-largest U.S. mobile wireless services provider by number of subscribers.</P>
                <P>11.  Pursuant to an Agreement and Plan of Merger dated February 17, 2004, Cingular will pay AT&amp;T Wireless shareholders $15 per common share and thereby plans to acquire AT&amp;T Wireless for approximately $41 billion in cash. If this transaction is consummated, Cingular and AT&amp;T Wireless combined would have more than  46 million subscribers, with over $32 billion in revenues, making it the largest mobile wireless sevices provider in the United States, with operations in 49 states covering 97 of the top 100 marketing areas.</P>
                <HD SOURCE="HD1">III. Trade and Commerce</HD>
                <HD SOURCE="HD2">A. Nature of Trade and Commerce</HD>
                <P>12. Mobile wireless services allow customers to make and receive telephone calls and use data services using radio transmissions without being confined to a small area during the call or data session, and without the need for unobstructed line-of-sight to the radio tower. This mobility is highly prized by customers, as demonstrated by the more than 160 million people in the United States who own mobile wireless telephones. In 2003, revenues from the sale of mobile wireless services in the United States were nearly $90 billion.</P>
                <P>13. The first wireless voice systems were based on analog technology, now referred to as first-generation or “IG” technology. These analog systems were launched after the FCC issued the first licenses for mobile wireless telephone service: two cellular licenses (A-block and B-block) in each geographic area in the early to mid-1980s. The licenses are in the 800 MHz range of the radio spectrum, each license consists of 25 MHz of spectrum, and they are issued for each Metropolitan Statistical Area (“MSA”) and Rural Service Area (“RSA”) (collectively, “Cellular Marketing Areas” or “CMAs”), with a total of 734 CMAs covering the entire United States. In 1982, one of the licenses was issued to the incumbent local exchange carrier in the market, and the other was issued by lottery to someone other than the incumbent. Cellular licensees must support analog service until February 2008.</P>
                <P>
                    14. In 1995, the FCC allocated and subsequently issued licenses for additional spectrum for the provision of Personal Communications Services (“PCS”), a category of services that includes mobile wireless telephone services comparable to those offered by cellular licensees. These licenses are in the 1.8 GHz range of the radio spectrum and are divided into six blocks: A, B, and C, which consist of 30 MHz each; and D, E, and F, which consist of 10 MHz each. Geographically, the A- and B-block 30 MHz licenses are issued by Major Trading Areas (“MTAs”), and C-, D-, E-, and F-block licenses are issued by Basic Trading Areas 
                    <PRTPAGE P="65647"/>
                    (“BTAs”), several of which comprise each MTA. MTAs and BTAs do not generally correspond to MSAs and RSAs. With the introduction of the PCS licenses, both cellular and PCS licensees began offering digital services, thereby increasing capacity, shrinking handsets, and extending battery life. Unlike the cellular licenses, PCS licensees are not required to provide support for analog or any other technology standard. In 1996, one provider, a specialized mobile radio (“SMR” or “dispatch”) spectrum licensee, began to use its SMR spectrum to offer mobile wireless telephone services comparable to those offered by other mobile wireless services providers, in conjunction with its dispatch, or “push-to-talk,” service.
                </P>
                <P>15. Today, more than 90 percent of all mobile wireless services customers have digital service, and nearly all mobile wireless voice service has migrated to second-generation or “2G” digital technologies: TDMA (time division multiple access), GSM (Global Standard for Mobile, a type of TDMA standard used by all carriers in Europe), and CDMA (code division multiple access). Mobile wireless services providers have chosen to build their networks on these incompatible technologies and most have chosen CDMA or GSM, with TDMA having been orphaned by equipment vendors. (The SMR providers use a fourth incompatible technological standard better suited to the spectrum they own, and, as SMR licensees, they have no obligation to support a specific technology standard.) Even more advanced technologies (“2.5G”) have begun to be deployed for voice and data (e.g., 1xRTT (a/k/a CDMA 2000), GPRS (General Packet Radio Service), and EDGE (Enhanced Data for GSM Evolution)). The data transmission speeds of these technologies vary. For example, 1xRTT provides average user speeds of 70 kilobits per second (“kbps”), and GRPS and EDGE provide average user speeds of 20 to 40 kbps and 80 to 110 kbps, respectively.</P>
                <P>16. The U.S. mobile wireless services industry is taking the next evolutionary step in wireless technology to third-generation or “3G” technologies (e.g., for GSM, UMTS (Universal Mobile Telecommunications System) and for CDMA, Ev-DO/DV (Evolution Data Only/Data Voice)) that provide for more capacity and higher data throughout. All of the national mobile wireless services providers and some of the regional providers are considering how and where they will deploy 3G services across their networks. The data transmission speeds of these technologies vary. UMTS provides average user speeds of 200 to 300 kbps, whereas Ev-DO provides average user speeds of 300 to 500 kbps.</P>
                <HD SOURCE="HD2">B. Relevant Product Markets</HD>
                <P>17. Mobile wireless telecommunications services and mobile wireless broadband services are relevant product markets (collectively, “mobile wireless services”).</P>
                <HD SOURCE="HD3">1. Mobile Wireless Telecommunications Services</HD>
                <P>18. Mobile wireless telecommunications services include both voice and data services provided over a radio network and allow customers to maintain their telephone calls or data sessions without wires, such as when traveling. There are no cost-effective alternatives to mobile wireless telecommunications services. Fixed wireless services are not mobile, and other wireless services have a limited range (e.g., Wi-Fi); neither offers a viable alternative to mobile wireless telecommunications services. It is unlikely that a sufficient number of customers would switch away from mobile telecommunications services to make a small but significant price increase in those services unprofitable. Mobile wireless telecommunications services is a relevant product market under Section 7 of the Clayton Act, 15 U.S.C. 18.</P>
                <HD SOURCE="HD3">2. Mobile Wireless Broadband Services</HD>
                <P>19. Mobile wireless broadband services offer data speeds four to six times faster than the current data offerings fully deployed in any mobile wireless services provider's network. Mobile wireless broadband services, which are now being launched using various 3G technologies, offer average data speeds of 200 to 300 kbps, peaking at 2 megabits per second or higher. These speeds rival wireline broadband services at peak speeds. At average speeds, they are comparable to low-end wireline high-speed data offerings and can support bandwidth-intensive services including video conferencing, video streaming, downloading of music and video files, and voice over Internet protocol (“VoIP”) calling, none of which can be used reliably at slower speeds. There are no cost-effective alternatives to mobile wireless broadband services. As with mobile wireless telecommunications services, fixed wireless services and other wireless services that have a limited range (e.g., Wi-Fi) do not offer a viable alternative to mobile wireless broadband services. It is unlikely that a sufficient number of customers would switch away from mobile wireless broadband services to make a small but significant price increase in those services unprofitable. Mobile wireless broadband services is a relevant product market under Section 7 or the Clayton Act, 15 U.S.C. 18.</P>
                <HD SOURCE="HD2">C. Relevant Geographic Markets</HD>
                <P>20. The large majority of customers use mobile wireless services in close proximity to their workplaces and homes. Thus, customers purchasing mobile wireless telecommunications services and mobile wireless broadband services choose among mobile wireless services providers that offer services where they are located and travel on a regular basis: home, work, other areas they commonly visit, and areas in between. The number and identity of mobile wireless services providers varies from geographic area to geographic area, along with the quality of their services and the breadth of their geographic coverage, all of which are significant factors in customers' purchasing decisions. Mobile wireless services providers can and do offer different promotions, discounts, calling plans, and equipment subsidies in different geographic areas, effectively varying the actual price for customers by geographic area.</P>
                <P>21. The United States comprises numerous local geographic markets for mobile wireless services. These local geographic markets are generally centered around a metropolitan area or a population center and its environs. The FCC has licensed a limited number of mobile wireless services providers in these and other geographic areas based upon the availability of radio spectrum. These FCC spectrum licensing areas therefore often represent the core of the business and social sphere where customers face the same competitive choices for mobile wireless services. The relevant geographic markets in which this transaction will substantially lessen competition in mobile wireless telecommunications services and mobile wireless broadband services are effectively represented, but not defined, by FCC spectrum licensing areas.</P>
                <P>
                    22. The relevant geographic markets, under Section 7 of the Clayton Act, 15 U.S.C. 18, where the transaction will substantially lessen competition for mobile wireless telecommunications services are represented by the following FCC spectrum licensing areas: Oklahoma City, Oklahoma (CMA 045), Topeka, Kansas (CMA 179), Pittsfield, Massachusetts (CMA 213), Athens, Georgia (CMS 234), St. Joseph, Missouri (CMA 275), Connecticut RSA-1 (CMA 357), Kentucky RSA-1 (CMA 443), Oklahoma RSA-3 (CMA 598), Texas 
                    <PRTPAGE P="65648"/>
                    RSA-11 (CMA 662), and Shreveport, Louisiana (BTA 419).
                </P>
                <P>23. The relevant geographic markets, under Section 7 of the Clayton Act, 15 U.S.C. 18, where the transaction will substantially lessen competition for mobile wireless broadband services are represented by the following FCC spectrum licensing areas: Dallas-Fort Worth, Texas (CMA 009), Detroit, Michigan (BTA 112), and Knoxville, Tennessee (BTA 232).</P>
                <P>24. It is unlikely that a sufficient number of customers would switch to mobile wireless services providers in a different geographic market to make a small but significant price increase in the relevant geographic markets unprofitable for mobile wireless telecommunications services or mobile wireless broadband services.</P>
                <HD SOURCE="HD2">D. Anticompetitive Effects</HD>
                <HD SOURCE="HD3">1. Mobile Wireless Telecommunications Services</HD>
                <P>25. Currently, Cingular and AT&amp;T Wireless both own all or part of businesses that offer mobile wireless telecommunications services in the 10 relevant geographic areas. In Athens, Georgia; Topeka, Kansas; Pittsfield, Massachusetts; and St. Joseph, Missouri, AT&amp;T Wireless owns a minority equity interest in Verizon Wireless's business providing mobile wireless telecommunications services. In Shreveport, Louisiana, Cingular owns a minority equity interest in AllTel Corporations' business providing mobile wireless telecommunications services. The minority equity interest range from approximately 9 to 24 percent. Based upon these significant minority equity interests and the specific facts of the relationships, the shares and assets of the mobile wireless services business partially owned by Cingular or AT&amp;T Wireless in these markets should be attributed to either Cingular or AT&amp;T Wireless.</P>
                <P>26. The individual market shares of Cingular's and AT&amp;T Wireless's mobile wireless telecommunications services businesses in the relevant geographic markets as measured in terms of subscribers range from 9 to more than 71 percent, and their combined market shares range from 61 to nearly 90 percent. In each relevant geographic market, Cingular or AT&amp;T Wireless has the largest market share, and in all but one, the other is the second-largest mobile wireless telecommunications services provider. In all but one of the relevant geographic markets, Cingular and AT&amp;T Wireless are the original cellular licensees and, as a result, have the network infrastructures with the greatest depth and breadth of coverage. Therefore, Cingular and AT&amp;T Wireless are likely closer substitutes for each other than the other mobile wireless telecommunications services providers in the relevant geographic markets.</P>
                <P>27. The relevant geographic markets for mobile wireless telecommunications services are highly concentrated. As measured by the Herfindahl-Hirschman Index (“HHI”), which is commonly employed in merger analysis and is defined and explained in Appendix A to this Complaint, concentration in these markets ranges from approximately 2600 to more than 5300, which is well above the 1800 threshold at which the Department considers a market to be highly concentrated. After Cingular's proposed acquisition of AT&amp;T Wireless is consummated, the HHIs in the relevant geographic markets will range from approximately 4400 to more than 8000, with increases in the HHI as a result of the merger ranging from approximately 1100 to more than 3500, much higher than the thresholds below which the Department considers a transaction unlikely to cause competitive harm.</P>
                <P>28. Competition between Cingular and AT&amp;T Wireless in the relevant geographic markets has resulted in lower prices and higher quality in mobile wireless telecommunications services, than would otherwise  have existed in these geographic markets. If Cingular's proposed acquisition of AT&amp;T Wireless is consummated, the relevant geographic markets for mobile wireless telecommunications services will become substantially more concentrated, and the competition between Cingular and AT&amp;T Wireless in mobile wireless telecommunications services will be eliminated in these markets. As a result, the loss of competition between Cingular and AT&amp;T Wireless increases the likelihood of unilateral actions by the merged firm in the relevant geographic markets to increase prices, diminish the quality of services provided, refrain from or delay making investments in network improvements, and refrain from or delay launching new services. Therefore, Cingular's proposed acquisition of AT&amp;T Wireless will likely result in substantially less competition in mobile wireless telecommunications services in the relevant geographic markets.</P>
                <HD SOURCE="HD3">2. Mobile Wireless Broadband Services</HD>
                <P>29. In the relevant geographic markets for mobile wireless broadband services, Cingular and AT&amp;T Wireless have either launched or are likely soon to launch mobile wireless broadband services. Each has the available spectrum necessary to offer mobile wireless broadband services and has business plans to offer these services in these markets. Not all mobile wireless services providers have sufficient spectrum to launch mobile wireless broadband services in these markets, nor do they all have business plans to do so. In the relevant geographic markets, the current number of mobile wireless services providers that are likely to launch mobile wireless broadband services in the foreseeable future is limited. Because mobile wireless broadband services are nascent, however, HHIs are uninformative.</P>
                <P>30. The competition between Cingular and AT&amp;T Wireless has motivated their efforts to develop and launch mobile wireless broadband services in the relevant geographic markets. If Cingular's proposed acquisition of AT&amp;T Wireless is consummated, the relevant geographic markets will lose one of only a few existing and likely mobile wireless broadband services providers. As a result, the loss of competition between Cingular and AT&amp;T Wireless increases the likelihood of unilateral actions by the merged firm in these relevant geographic markets to increase prices, diminish the quality or quantity of services provided, refrain from or delay making investments in network improvements, and refrain from or delay launching mobile wireless broadband services. Therefore, Cingular's proposed acquisition of AT&amp;T Wireless will likely result in substantially less competition in mobile wireless broadband services in the relevant geographic markets.</P>
                <HD SOURCE="HD3">3. Entry</HD>
                <P>31. Entry by a new mobile wireless services provider in the relevant geographic markets would be difficult, time-consuming, and expensive, requiring the acquisition of spectrum licenses and the build-out of a network. Therefore, new entry in response to a small but significant price increase for mobile wireless telecommunications services or mobile wireless broadband services by the merged firm in the relevant geographic markets would not be timely, likely, or sufficient to thwart the competitive harm resulting from Cingular's proposed acquisition of AT&amp;T Wireless, if it were to be consummated.</P>
                <HD SOURCE="HD1">IV. Violation Alleged</HD>
                <P>
                    32. The effect of Cingular's proposed acquisition of AT&amp;T Wireless, if it were to be consummated, may be substantially to lessen competition in interstate trade and commerce in the relevant geographic markets for mobile 
                    <PRTPAGE P="65649"/>
                    wireless telecommunications services and mobile wireless broadband services, in violation of Section 7 of the Clayton Act, 15 U.S.C. 18.
                </P>
                <P>33. Unless restrained, the transaction will likely have the following effects in mobile wireless telecommunications services and mobile wireless broadband services in the relevant geographic markets, among others:</P>
                <P>a. Actual and potential competition between Cingular and AT&amp;T Wireless will be eliminated; </P>
                <P>b. Competition in general will be lessened substantially;</P>
                <P>c. Prices are likely to increase;</P>
                <P>d. The quality and quantity of services are likely to decrease;</P>
                <P>e. Incentives to improve wireless networks will be reduced; and</P>
                <P>f. Incentives to innovate or launch new services will be reduced.</P>
                <HD SOURCE="HD1">V. Requested Relief</HD>
                <P>34. That Cingular's proposed acquisition of AT&amp;T Wireless be adjudged to violate Section 7 of the Clayton Act, 15 U.S.C. 18;</P>
                <P>35. That defendants be permanently enjoined from and restrained from carrying out the Agreement and Plan of merger, dated February 17, 2004, or from entering into or carrying out any agreement, understanding, or plan, the effect of which would be to bring the wireless telecommunications services businesses of Cingular and AT&amp;T Wireless under common ownership or control;</P>
                <P>36. That plaintiffs be awarded their costs of this action; and</P>
                <P>37. That plaintiffs have such other relief as the Court may deem just and proper.</P>
                <EXTRACT>
                    <FP>Dated: October 25, 2004.</FP>
                    <P>  Respectfully Submitted,</P>
                    <HD SOURCE="HD3">For Plaintiff United States of America:</HD>
                    <FP SOURCE="FP-DASH">/s/</FP>
                    <FP>R. Hewitt Pate</FP>
                    <FP>
                        <E T="03">Assistant Attorney General, Antitrust Division.</E>
                    </FP>
                    <FP SOURCE="FP-DASH">/s/</FP>
                    <FP>J. Bruce McDonald</FP>
                    <FP>
                        <E T="03">Deputy Assistant Attorney General Antitrust Division.</E>
                    </FP>
                    <FP>J. Robert Kramer II,</FP>
                    <FP>
                        <E T="03">Director of Operations, Antitrust Division.</E>
                    </FP>
                    <FP SOURCE="FP-DASH">/s/</FP>
                    <FP>Nancy Goodman (D.C. Bar #251694),</FP>
                    <FP>
                        <E T="03">Chief, Telecommunications &amp; Media, Enforcement Section, Antitrust Division.</E>
                    </FP>
                    <FP SOURCE="FP-DASH">/s/</FP>
                    <FP>Laury Bobbish,</FP>
                    <FP>
                        <E T="03">Assistant Chief, Telecommunications &amp; Media Enforcement Section, Antitrust Division.</E>
                    </FP>
                    <FP SOURCE="FP-DASH">/s/</FP>
                    <FP>Hillary B. Burchuk (D.C. Bar #366755), </FP>
                    <FP>Matthew C. Hammond,</FP>
                    <FP>David T. Blonder,</FP>
                    <FP>Benjamin Brown,</FP>
                    <FP>Michael D. Chaleff,</FP>
                    <FP>Benjamin Giliberti,</FP>
                    <FP>Lorenzo McRae (D.C. Bar #473660),</FP>
                    <FP>Jeremiah M. Luongo,</FP>
                    <FP>
                        <E T="03">Attorneys, Telecommunications &amp; Media, Enforcement Section, Antitrust Division, U.S. Department of Justice, City Center Building, 1401 H Street, NW., Suite 8000, Washington, DC 20530, (202) 514-5621, Facsimile: (202) 514-6381.</E>
                    </FP>
                    <HD SOURCE="HD3">State of Connecticut</HD>
                    <FP>Richard Blumenthal,</FP>
                    <FP>
                        <E T="03">Attorney General.</E>
                    </FP>
                    <FP>Michael E. Cole,</FP>
                    <FP>
                        <E T="03">Assistant Attorney General, Department Head/Antitrust Department, Federal bar No. ct20115.</E>
                    </FP>
                    <FP SOURCE="FP-DASH">/s/</FP>
                    <FP>Rachel O. Davis,</FP>
                    <FP>
                        <E T="03">Assistant Attorney General, Antitrust Department, Federal bar No. ct07411, DC Bar No. 413157 (inactive), 55 Elm Street, Hartford, Connecticut 06106, Tel: (860) 808-5041, Fax: (860) 808-5033.</E>
                    </FP>
                    <HD SOURCE="HD3">For Plaintiff State of Texas</HD>
                    <FP>Greg Abbott,</FP>
                    <FP>
                        <E T="03">Attorney General of Texas.</E>
                    </FP>
                    <FP>Barry R. McBee,</FP>
                    <FP>
                        <E T="03">First Assistant Attorney General.</E>
                    </FP>
                    <FP>Edward D. Burbach,</FP>
                    <FP>
                        <E T="03">Deputy Attorney General for Litigation.</E>
                    </FP>
                    <FP>Mark Tobey,</FP>
                    <FP>
                        <E T="03">Assistant Attorney General, Chief, Antitrust &amp; Civil Medicaid Fraud Division.</E>
                    </FP>
                    <FP>Rebecca Fisher,</FP>
                    <FP>
                        <E T="03">Assistant Attorney General, Chief, Antitrust Section.</E>
                    </FP>
                    <FP SOURCE="FP-DASH">/s/</FP>
                    <FP>John T. Prud'homme, Jr.,</FP>
                    <FP>
                        <E T="03">Assistant Attorney General, TX Bar No. 24000322, Office of the Attorney General, P.O. Box 12548, Austin, Texas 78711-2548, 512/936-1697, 512/320-0975 (Facsimile).</E>
                    </FP>
                    <P>
                        Signature by the State of Texas on Complaint in 
                        <E T="03">United States of America, State of Connecticut and State of Texas</E>
                         v. 
                        <E T="03">Cingular Wireless Corporation, SBC Communications Inc., BellSouth Corporation and AT&amp;T Wireless Services, Inc.</E>
                    </P>
                </EXTRACT>
                <HD SOURCE="HD1">Appendix A—Herfindahl-Hirschman Index</HD>
                <EXTRACT>
                    <P>
                        “HHI” means the Herfindahl-Hirschman Index, a commonly accepted measure of market concentration. It is calculated by squaring the market share of each firm competing in the market and then summing the resulting numbers. For example, for a market consisting of four firms with shares of 30, 30, 20, and 20 percent, the HHI is 2600 (30
                        <SU>2</SU>
                         + 30
                        <SU>2</SU>
                         + 20
                        <SU>2</SU>
                         + 20
                        <SU>2</SU>
                         = 2600). (
                        <E T="04">Note:</E>
                         Throughout the Complaint, market share percentages have been rounded to the nearest whole number, but HHIs have been estimated using unrounded percentages in order to accurately reflect the concentration of the various markets.) The HHI takes into account the relative size distribution of the firms in a market and approaches zero when a market consists of a large number of small firms. The HHI increases both as the number of firms in the market decreases and as the disparity in size between those firms increases.
                    </P>
                    <P>
                        Markets in which the HHI is between 1000 and 1800 points are considered to be moderately concentrated, and those in which the HHI is in excess of 1800 points are considered to be highly concentrated. 
                        <E T="03">See Horizontal Merger Guidelines</E>
                         ¶1.51 (revised Apr. 8, 1997). Transactions that increase the HHI by more than 100 points in concentrated markets presumptively raise antitrust concerns under the guidelines issued by the U.S. Department of Justice and Federal Trade Commission. 
                        <E T="03">See id.</E>
                    </P>
                </EXTRACT>
                <HD SOURCE="HD1">In the United States District Court for the District of Columbia</HD>
                <HD SOURCE="HD2">United States of America, State of Connecticut and State of Texas, Plaintiffs, v. Cingular Wireless  Corporation, SBC Communications Inc., Bellsouth Corporation and AT&amp;T Wireless Services, Inc., Defendants; Preservation of Assets Stipulation and Order</HD>
                <P>Civil No.: 1:04CV01850 (RBW)</P>
                <P>Filed: 10/25/04</P>
                <P>It is hereby stipulated and agreed by and between the undersigned parties, subject to approval and entry by the Court, that:</P>
                <HD SOURCE="HD1">I. Definitions</HD>
                <P>As used in this Preservation of Assets Stipulation and Order:</P>
                <P>A. “Acquirer” or “Acquirers” means the entity or entities to whom defendants divest the  Divestiture Assets.</P>
                <P>B. “AT&amp;T Wireless” means defendant AT&amp;T Wireless Services, Inc., a Delaware corporation with headquarters in Redmond, Washington, its successors and assigns, and its subsidiaries, divisions, groups, affiliates, partnerships and joint ventures, and their directors, officers, managers, agents, and employees.</P>
                <P>C. “BellSouth” means defendant  BellSouth Corporation, a Georgia corporation with headquarters in Atlanta, Georgia, its successors and assigns, and its subsidiaries, divisions, groups, affiliates, partnerships and joint ventures, and their directors, officers, managers, agents, and employees.</P>
                <P>
                    D. “Cingular” means defendant Cingular Wireless Corporation, a Delaware corporation with headquarters in Atlanta, Georgia, and Cingular Wireless LLC, a Delaware limited liability company formed as a joint venture between SBC and BellSouth, with headquarters in Atlanta, Georgia, their successors and assigns, and their subsidiaries, divisions, groups, affiliates, partnerships and joint 
                    <PRTPAGE P="65650"/>
                    ventures, and their directors, officers, managers, agents, and employees.
                </P>
                <P>E. “Divestiture Assets” means Wireless Business  Divestiture Assets, Spectrum License Divestiture Assets, and Minority Interests, including any direct or indirect financial ownership or leasehold interests and any direct or indirect role in management or participation in control therein.</P>
                <P>F. “Minority Interests” means the equity interests owned by any defendant in the following entities that are the licensees or operators of wireless mobile telephone businesses in the specified Metropolitan Statistical Areas (“MSAs”) and Rural Statistical Areas (“RSAs”) (collectively, Cellular Marketing Areas (“CMAs”)) used to define cellular license areas by the Federal Communications Commission (“FCC”):</P>
                <P>(1) Alltel Communications of North Louisiana Cellular Limited Partnership, covering the Shreveport, Louisiana MSA (CMA 100), Monroe, Louisiana MSA (CMA 219), Louisiana RSA-1 (CMA 454), Louisiana RSA-2 (CMA 455) and Louisiana RSA-3 (CMA 456);</P>
                <P>Athens Cellular Inc., covering the Athens, Georgia MSA (CMA 234);</P>
                <P>(3) CellTelCo, covering the St. Joseph, Missouri MSA (CMA 275);</P>
                <P>(4) Pittsfield Cellular Telephone Co., covering the Pittsfield, Massachusetts MSA (CMA 213); and</P>
                <P>(5) Topeka Cellular Telephone Co., Inc., covering the  Topeka, Kansas MSA (CMA 179).</P>
                <FP>As an alternative to the divestiture of the Alltel Communications of North Louisiana Cellular Limited Partnership, CellTelCo, and Topeka Cellular Telephone Co., Inc. Minority Interests as required by Section IV of the proposed Final Judgment, defendants may request, at least 20 days prior to consummation of the Transaction, approval from plaintiff  United States to retain such interests. Plaintiff United States in its sole discretion may approve this request if it is demonstrated that the retained minority interest will become irrevocably and entirely passive, so long as defendants own the minority interests, and will not significantly diminish competition.</FP>
                <P>G. “Multi-line Business Customer” means a corporate or business customer that contracts with  AT&amp;T Wireless for mobile wireless services to provide multiple telephones to its employees or members whose services are provided pursuant to the contract with the corporate or business customer.</P>
                <P>H. “SBC” means defendant SBC Communications, Inc., a Delaware corporation with its headquarters in San Antonio, Texas, its successors and assigns, and its subsidiaries, divisions, groups, affiliates, partnerships and joint ventures, and their directors, officers, managers, agents, and employees.</P>
                <P>I. “Skagit” means Skagit Wireless LLC, an Oregon corporation with headquarters in Portland, Oregon, its successors and assigns, and its subsidiaries, divisions, groups, affiliates, partnerships and joint ventures, and their directors, officers, managers, agents, and employees.</P>
                <P>J. “Spectrum License Divestiture Assets” means a license for 10 MHz of contiguous PCS spectrum in the specified MSAs and Basic Trading Areas (“BTA”) used to define cellular and PCS license areas by the FCC:</P>
                <P>(1) The Dallas-Fort Worth, Texas MSA (CMA 009);</P>
                <P>(2) The Detroit, Michigan BTA (BTA 112), provided that the license to be transferred does not include any PCS spectrum in Monroe and Sanilac counties; and</P>
                <P>(3) The Knoxville, Tennessee BTA (BTA 232), provided that as an alternative to the divestiture of a license for 10 MHz of contiguous PCS spectrum as required by Section IV of the proposed Final Judgment, defendants, with the approval of plaintiff United States in its sole discretion, can restructure AT&amp;T Wireless's existing relationship with Skagit such that (i) defendants have no equity or leasehold interest in, hold no debt of, and have no managerial or operational interest in Skagit's PCS license in the Knoxville Tennessee BTA, and (ii) Skagit's PCS license in the Knoxville Tennessee BTA is contractually committed to be used in a manner that resolves the competitive concerns alleged by plaintiffs in the Complaint.</P>
                <P>K. “Transaction” means the Agreement and Plan of Merger By and Among AT&amp;T Wireless Services, Inc., Cingular Wireless Corporation, Cingular Wireless LLC, Links I Corporation, SBC Communications Inc., and Bell South Corporation, dated February 17, 2004.</P>
                <P>L. “Wireless Business Divestiture Assets” means, for each mobile wireless business to be divested under the proposed Final Judgment, all types of assets, tangible and intangible, used by defendants in the operation of the mobile wireless businesses to be divested (including the provision of long distance telecommunications services for wireless calls). “Wireless Business Divestiture Assets” shall be construed broadly to accomplish the complete divestitures of the entire business of AT&amp;T Wireless in each of the following MSA and RSA license areas as required by the proposed Final Judgment and to ensure that the divested mobile wireless businesses remain viable, ongoing businesses:</P>
                <P>(a) Oklahoma City, Oklahoma MSA (CMA 045);</P>
                <P>(b) Connecticut RSA-1 (CMA 357), provided that defendants may retain 10 MHz of AT&amp;T Wireless's PCS spectrum, provided that 10 MHz of contiguous PCS spectrum throughout the RSA is divested to the Acquirer;</P>
                <P>(c) Kentucky RSA-1 (CMA 443), provided that defendants may retain 15 MHz of AT&amp;T Wireless's PCS spectrum in Fulton country and 10 MHz of AT&amp;T Wireless's PCS spectrum in the other counties contained within the RSA, provided that 30 MHz of contiguous PCS spectrum in Fulton county and 20 MHz of contiguous PCS spectrum in the other counties contained in the RSA is divested to an Acquirer;</P>
                <P>(d) Oklahoma RSA-3 (CMA 598); and</P>
                <P>(e) Texas RSA-11 (CMA 662), provided that defendants may retain in Sabine County, 25 MHz of AT&amp;T Wireless's PCS spectrum, and in Angelina, Nacogdoches, and San Augustine counties, defendants may retain 20 MHz of AT&amp;T Wireless's PCS spectrum, provided that 10 MHz of contiguous PCS spectrum throughout the RSA is divested to an Acquirer.</P>
                <P>
                    Wireless Business Divestiture Assets shall include, without limitation, all types of real and personal property, monies and financial instruments, equipment, inventory, office furniture, fixed assets and furnishings, supplies and materials, contracts, agreements, leases, commitments, spectrum licenses issued by the FCC and all other licenses, permits and authorizations, operational support systems, cell sites, network infrastructure, switches, customer support and billing systems, interfaces with other service providers, business and customer records and information, customer contracts, customer lists, credit records, accounts, and historic and current business plans which relate primarily to the wireless business being divested, as well as any patents, licenses, sub-licenses, trade secrets, know-how, drawings, blueprints, designs, technical and quality specifications and protocols, quality assurance and control procedures, manuals and other technical information defendants supply to their own employees, customers, suppliers, agents, or licenses, and trademarks, trade names and service marks or other intellectual property, including all intellectual property rights under third-party licenses that are capable of being transferred to an Acquirer either in their entirety, for assets described in (1) below, or through a license obtained through or from the divesting defendant, 
                    <PRTPAGE P="65651"/>
                    for assets described in (2) below; provided that defendants shall only be required to divest Multi-line Business Customer contracts, if 50 percent or more of the Multi-line Business Customer's subscribers reside or work within any of the five (5) license areas described herein, and further, any subscribers who obtain mobile wireless services through any such contract retained by defendants and who are located within the five (5) geographic areas identified above, shall be given the option to terminate their relationship with defendants, without financial cost, within one year of the closing of the Transaction. Defendants shall provide written notice to these subscribers within 45 days after the closing of the Transaction. 
                </P>
                <P>These divestitures of the Wireless Business Divestiture Assets as defined in Section II.L shall be accomplished by:</P>
                <P>(1) Transferring to the Acquirer(s) the complete ownership and/or other rights to the assets (other than those assets used substantially in the operations of AT&amp;T Wireless's overall wireless business which must be retained to continue the existing operations of the wireless properties that defendants are not required to divest, and that either are not capable of being divided between the divested wireless businesses and those not divested, or are assets that the defendants and the Acquirer(s) agree, subject to approval of plaintiff United States upon consultation with any relevant plaintiff state, shall not be divided); and</P>
                <P>(2) Granting to the Acquirer(s) an option to obtain a non-exclusive, transferable license from defendants for a reasonable period, subject to approval of plaintiff United States upon consultation with any relevant plaintiff state, at the election of an Acquirer to use any of AT&amp;T Wireless's retained assets under paragraph (1) above, used in the operation of the wireless business being divested, so as to enable the Acquirer to continue to operate the divested wireless business without impairment. Defendants shall identify in a schedule submitted to plaintiffs and filed with the Court, as expeditiously as possible following the filing of the Complaint and in any event prior to any divestitures and before the approval by the Court of the proposed Final Judgment, any intellectual property rights under third-party licenses that are used by the wireless businesses being divested but that defendants could not transfer to an Acquirer entirely or by license without third-party consent, and the specific reasons why such consent is necessary and how such consent would be obtained for each asset.</P>
                <HD SOURCE="HD1">II. Objectives</HD>
                <P>The Final Judgment filed in this case is meant to ensure defendants' prompt divestiture of the Divestiture Assets for the purpose of preserving viable competitors in the provision of mobile wireless services in order to remedy the effects that plaintiffs allege would otherwise result from Cingular's acquisition of AT&amp;T Wireless. This Preservation of Assets Stipulation and Order ensures, prior to such divestitures, that competition is maintained during the pendency of the ordered divestitures, and that the Wireless Business Divestiture Assets remain an ongoing business concern and the Divestiture Assets remain economically viable. The Divestiture Assets will remain, as provided herein, preserved, independent and uninfluenced by defendants.</P>
                <HD SOURCE="HD1">III. Jurisdiction and Venue</HD>
                <P>This Court has jurisdiction over the subject matter of this action and each of the parties hereto, and venue of this action is proper in the United States District Court for the District of Columbia. The Complaint states a claim upon which relief may be granted against defendants under Section 7 of the Clayton Act, 15 U.S.C. 18.</P>
                <HD SOURCE="HD1">IV. Compliance With and Entry of Final Judgment</HD>
                <P>A. The parties stipulate that a proposed Final Judgment in the form attached hereto as Exhibit A may be filed with and entered by the Court, upon the motion of any party or upon the Court's own motion, at any time after compliance with the requirements of the Antitrust Procedures and Penalties Act, 15 U.S.C. 16, and without further notice to any party or other proceedings, provided that no plaintiff has withdrawn its consent, which it may do at any time before the entry of the proposed Final Judgment by serving notice thereof on defendants and other plaintiffs and by filing that notice with the Court.</P>
                <P>B. Defendants shall abide by and comply with the provisions of the proposed Final Judgment, pending the Judgment's entry by the Court, or until expiration of time for all appeals of any Court ruling declining entry of the proposed Final Judgment, and shall, from the date of the signing of this Stipulation by the parties, comply with all the terms and provisions of the proposed Final Judgment as though the same were in full force and effect as an order of the Court.</P>
                <P>C. Defendants shall not consummate the transaction sought to be enjoined by the Complaint herein before the Court has signed this Preservation of Assets Stipulation and Order.</P>
                <P>D. This Stipulation shall apply with equal force and effect to any amended proposed Final Judgment agreed upon in writing by the parties and submitted to the Court.</P>
                <P>E. In the event (1) any plaintiff has withdrawn its consent, as provided in Section IV.A above, or (2) the proposed Final Judgment is not entered pursuant to this Stipulation, the time has expired for all appeals of any Court declining entry of the proposed Final Judgment, and the Court has not otherwise ordered continued compliance with the terms and provisions of the proposed Final Judgment, then the parties are released from all further obligations under this Stipulation, and the making of this Stipulation shall be without prejudice to any party in this or any other proceeding.</P>
                <P>F. Defendants represent that the divestitures ordered in the proposed Final Judgment can and will be made, and that defendants will later raise no claim of mistake, hardship or difficulty of compliance as grounds for asking the Court to modify any of the provisions contained therein.</P>
                <HD SOURCE="HD1">V. Management Trustee</HD>
                <P>A. Plaintiff United States nominates Joseph J. Simons as Management Trustee in this case. The plaintiff states consent to, and defendants have no objection to, his immediate appointment by this Court. Accordingly, this Court appoints Joseph J. Simons as Management Trustee to serve as manager of the Divestiture Assets until the Divestiture Assets are sold or transferred to a Divestiture Trustee pursuant to Section V of the proposed Final Judgment. Nothing in this Stipulation shall be interpreted to prevent the Management Trustee from becoming the Divestiture Trustee pursuant to Section V of the proposed Final Judgment.</P>
                <P>
                    B. Within five (5) business days of the entry of this Stipulation by the Court, defendants shall enter into a trust agreement with Mr. Simons subject to the approval of plaintiff United States in its sole discretion upon consultation with plaintiff states, that will grant the rights, powers, and authorities necessary to permit him to perform the duties and responsibilities of the Management Trustee pursuant to this Stipulation. The trust agreement shall enable him to assume all rights, powers, and authorities necessary to perform his duties and responsibilities, pursuant to this Stipulation and the proposed Final Judgment and consistent with their 
                    <PRTPAGE P="65652"/>
                    purposes. Mr. Simons or any other subsequently appointed Management Trustee shall serve at the cost and expense of defendants, on such terms and conditions as plaintiff United States approves upon consultation with plaintiff states, with a fee arrangement that is reasonable in light of the person's experience and responsibilities.
                </P>
                <P>C. The Management Trustee will have the following powers and responsibilities with respect to the Divestiture Assets:</P>
                <P>(1) The Management Trustee will have the power to manage the Divestiture Assets in the ordinary course of business consistent with this Stipulation. Only with the prior written approval of plaintiff United States upon consultation with plaintiff states, may the Management Trustee make any decision, take any action, or enter any transaction that is outside the ordinary course of business;</P>
                <P>(2) The Management Trustee shall have a duty to, consistent with the terms of this Stipulation and the proposed Final Judgment, monitor the organization of the Divestiture Assets; manage the Divestiture Assets in order to maximize their value so as to permit expeditious divestitures in a manner consistent with the proposed Final Judgment; maintain the independence of the Divestiture Assets from defendants; control and operate the Wireless Business Divestiture Assets to ensure that the Wireless Business Divestiture Assets remain an independent, ongoing, economically viable competitor to the other mobile wireless services providers; and assure defendants' compliance with their obligations pursuant to this Stipulation and the proposed Final Judgment;</P>
                <P>(3) The Management Trustee shall have the authority to employ, at the cost and expense of defendants, such consultants, accountants, attorneys, and other representatives and assistants as are reasonably necessary to carry out the Management Trustee's duties and responsibilities;</P>
                <P>(4) The Management Trustee and any consultants, accountants, attorneys, and any other persons retained by the Management Trustee, shall have full and complete access to all personnel, books, records, documents, and facilities of the Divestiture Assets or to any other relevant information as the Management Trustee may reasonably request, including, but not limited to, all documents and records kept in the normal course of business that relate to the Divestiture Assets. Defendants shall develop such financial or other information as the Management Trustee may request and shall cooperate with the Management Trustee. Defendants shall take no action to interfere with or impede the Management Trustee's ability to monitor defendants' compliance with this Stipulation and the proposed Final Judgment or otherwise to perform his duties and responsibilities consistent with the terms of this Stipulation and the proposed Final Judgment;</P>
                <P>(5) The Management Trustee will ensure that the Divestiture Assets shall be staffed with sufficient employees to maintain their viability and competitiveness. To the extent that any employees whose principal responsibilities related to the Divestiture Assets leave or have left the Divestiture Assets prior to divestiture of the Divestiture Assets, the Management Trustee may replace departing or departed employees with persons who have similar experience and expertise or determine not to replace such departing or departed employees; and </P>
                <P>(6) Thirty (30) days after the Management Trustee has been appointed by the Court, and every thirty (30) days thereafter until the Divestiture Assets are either transferred to an Acquirer or to the Divestiture Trustee, the Management Trustee shall report in writing to the plaintiffs concerning the efforts to accomplish the purposes of this Stipulation and the proposed Final Judgment. Included within that report shall be the Management Trustee's assessment of the extent to which the Divestiture Assets are meeing (or exceeding) their projected goals as are reflected in existing or revised operating plans, budgets, projections or any other regularly prepared financial statements and the extent to which defendants are fulfilling their responsibilities under this Stipulation and the proposed Final Judgment.</P>
                <P>D. The following limitations shall apply to the Management Trustee:</P>
                <P>(1) The Management Trustee shall not be involved, in any way, in the operations of the other businesses of defendants;</P>
                <P>(2) The Management Trustee shall have no financial interests affected by defendants' revenues, profits or profit margins, except that the Management Trustee's compensation for managing the Divestiture Assets may include economic incentives dependent on the financial performance of the Divestiture Assets provided that those incentives are consistent with the objectives of this Stipulation and the proposed Final Judgment and are approved by plaintiff United States upon consultation with plaintiffs states; and</P>
                <P>(3) The Management Trustee shall be prohibited from performing any further work for defendants for two (2) years after the close of the divestiture transactions.</P>
                <P>E. Defendants and the Management Trustee will take all reasonable efforts to preserve the confidentiality of information that is material to the operation of either the Divestiture Assets or defendants' businesses. Defendants' personnel supplying services to the Divestiture Assets pursuant to this Stipulation must retain and maintain the confidentiality of any and all confidential information material to the Divestiture Assets. Except as permitted by this Stipulation and the proposed Final Judgment, such persons shall be prohibited from providing, discussing, exchanging, circulating or otherwise furnishing the confidential information of the Divestiture Assets to or with any person whose employment involves any of defendants' businesses, except as necessary to fulfill the purposes of this Stipulation and the proposed Final Judgment.</P>
                <P>F. If in the judgment of the Management Trustee, defendants fail to provide the services listed in Section VI of this Stipulation to the satisfaction of the Management Trustee, upon notification to defendants and approval by plaintiff United States upon consultation with plaintiff states, the Management Trustee may engage third parties unaffiliated with the defendants to provide those services for the Divestiture Assets, at the cost and expense of defendants, provided that defendants may have reasonable access to information to satisfy themselves that after the services have been provided, the Divestiture Assets are in compliance with all applicable laws, rules, and regulations.</P>
                <P>G. At the option of the Management Trustee, defendants may also provide other products and services, on an arms-length basis provided that the Management Trustee is not obligated to obtain any other product or service from defendants and may acquire any such products or services from third parties unaffiliated with defendants.</P>
                <P>
                    H. If the Management Trustee ceases to act or fails to act diligently and consistently with the purposes of this Stipulation and the proposed Final Judgment, if the Management Trustee proposed by plaintiff United States is not approved by this Court or resigns, or if for any other reason the Management Trustee ceases to serve in his or her capacity as Management Trustee, the United States may select upon consultation with any relevant plaintiff state, a substitute Management Trustee. In this event, plaintiff United States will 
                    <PRTPAGE P="65653"/>
                    identify to defendants the individual or entity it proposes to select as Management Trustee. Defendants must make any such objection to this selection within five (5) business days after plaintiff United States notifies defendants of the Management Trustee's selection. Upon application of the United States, the Court shall approve and appoint a substitute Management Trustee. Within five (5) business days of such appointment, defendants shall enter into a trust agreement with the Management Trustee subject to the approval of plaintiff United States in its sole discretion upon consultation with plaintiff states, as described in Section V.B of this Stipulation.
                </P>
                <HD SOURCE="HD1">VI. Preservation of Assets</HD>
                <P>Until the divestitures required by the proposed Final Judgment have been accomplished, except as otherwise approved in advance in writing by plaintiff United States upon consultation with plaintiff states:</P>
                <P>A. Defendants and the Management Trustee shall preserve, maintain, and continue to support the Divestiture Assets, take all steps necessary to manage the Divestiture Assets in order to maximize their revenue, profitability and viability so to permit expeditious divestitures in a manner consistent with this Stipulation and the proposed Final Judgment.</P>
                <P>B. The Wireless Business Divestiture Assets shall be operated by the Management Trustee as part of an independent, ongoing, economically viable competitive business to other mobile wireless services providers operating in the same license area. Defendants and the Management Trustee shall take all steps necessary to ensure that:</P>
                <P>(1) The management, sales, and operations of the Wireless Business Divestiture Assets are independent from defendants' other operations; provided at the request of the Management Trustee, defendants shall include the marketing, pricing and sales of the mobile wireless services generated by the Wireless Business Divestiture Assets in the license areas served by the Wireless Business Divestiture Assets within its marketing, promotional, and service offerings, in the ordinary course of business, in any national, regional, and local marketing programs. Nothing in this Section shall prohibit the Management Trustee from developing his own reasonable marketing, sales, pricing or promotional offers, which shall be funded and supported by defendants;</P>
                <P>(2) The Wireless Business Divestiture Assets are maintained by adhering to normal and planned repair, capital improvement, upgrade and maintenance schedules;</P>
                <P>(3) The management of the Wireless Business Divestiture Assets will not be influenced by defendants;</P>
                <P>(4) The books, records, competitively sensitive sales, marketing and pricing information, and decision-making concerning marketing, pricing or sales of mobile wireless services generated by the Wireless Business Divestiture Assets will be kept separate and apart from defendants' other operations; and</P>
                <P>(5) The management of the Wireless Business Divestiture Assets acts to maintain and increase the sales and revenues of the mobile wireless services generated by the Wireless Business Divestiture Assets, and maintain at previously approved levels for 2004 and 2005, whichever are higher, all promotional, advertising, sales, marketing, and technical support for the Wireless Business Divestiture Assets.</P>
                <P>C. The management of the Spectrum License Divestiture Assets and the Minority Interests shall be held entirely separate, distinct, and apart from those of defendants' other operations.</P>
                <P>D. Defendants shall provide sufficient working capital and lines and sources of credit as deemed necessary by the Management Trustee to continue to maintain the Divestiture Assets consistent with this Stipulation.</P>
                <P>E. Except (1) as recommended by the Management Trustee and approved by plaintiff United States upon consultation with plaintiff states, or (2) as part of a divestiture approved by plaintiff United States upon consultation with any relevant plaintiff state, in accordance with the terms of the proposed Final Judgment, defendants shall not remove, sell, lease, assign, transfer, pledge or otherwise dispose of any of the Divestiture Assets outside the ordinary course of business.</P>
                <P>F. The Management Trustee, with defendants' cooperation consistent with this Stipulation and the proposed Final Judgment, shall maintain, in accordance with sound accounting principles, separate, accurate, and complete financial ledgers, books and records that report on a periodic basis, such as the last business day of every month, consistent with past practices, the assets, liabilities, expenses, revenues, and income of the Divestiture Assets.</P>
                <P>G. Defendants shall take no action that would jeopardize, delay, or impede the sale of the Divestiture Assets nor shall defendants take any action that would interfere with the ability of any Divestiture Trustee appointed pursuant to the proposed Final Judgment to operate and manage the Divestiture Assets or to complete the divestitures pursuant to the proposed Final Judgment to an Acquirer(s) acceptable to plaintiff United States.</P>
                <P>H. Upon the filing of the Complaint in the action, defendants shall appoint sufficient employees for each of the Wireless Business Divestiture Assets, who are familiar with and have had responsibility for the management, operation, marketing, and sales of the Divestiture Assets, to assist the Management Trustee with his duties and responsibilities hereunder.</P>
                <P>I. Except for employees (1) whose primary employment responsibilities relate to the Divestiture Assets, or (2) who are involved in providing support services to the Divestiture Assets pursuant to Sections V and VI of this Stipulation and Section V of the proposed Final Judgment, defendants shall not permit any other of their employees, officers, or directors to be involved in the operations of the Divestiture Assets.</P>
                <P>J. Except as required by law in the course of (1) complying with this Stipulation and the proposed Final Judgment; (2) overseeing compliance with policies and standards concerning the safety, health, and environmental aspects of the operations of the Divestiture Assets and the integrity of their financial controls; (3) defending legal claims, investigations or enforcement actions threatened or brought against the Divestiture Assets; or (4) obtaining legal advice, defendants' employees (excluding employees (a) whose primary employment responsibilities relate to the Divestiture Assets, or (b) who are involved in providing support services to the Divestiture Assets pursuant to Sections V and VI of this Stipulation and Sections V of the proposed Final Judgment) shall not receive, or have access to, or use any material confidential information, not in the public domain, of the Divestiture Assets. Defendants may receive aggregate financial information relating to the Divestiture Assets to the extent necessary to allow defendants to prepare the defendants' consolidated financial reports, tax returns, reports required by securities laws, and personnel reports. Any such information that is obtained pursuant to this subparagraph shall be used only for the purposes set forth in this subparagraph.</P>
                <P>
                    K. Defendants may offer a bonus or severance to employees whose primary employment responsibilities relate to the Divestiture Assets, that continue their employment until divestiture (in addition to any other bonus or 
                    <PRTPAGE P="65654"/>
                    severance to which the employees would otherwise be entitled).
                </P>
                <P>L. Until the Divestiture Assets are divested to an Acquirer(s) acceptable to plaintiff United States upon consultation with any relevant plaintiff state, defendants shall provide to the Divestiture Assets, at no cost, support services needed to maintain the Divestiture Assets in the ordinary course of business, including but not limited to:</P>
                <P>(1) Federal and state regulatory policy development and compliance;</P>
                <P>(2) Human resources administrative services;</P>
                <P>(3) Environmental, health and safety services, and developing corporate policies and ensuring compliance with federal and state regulations and corporate policies;</P>
                <P>(4) Preparation of tax returns;</P>
                <P>(5) Financial accounting and reporting services;</P>
                <P>(6) Audit services;</P>
                <P>(7) Legal services;</P>
                <P>(8) Routine network maintenance, repair, improvements, and upgrades;</P>
                <P>(9) Switching, call completion, and other services necessary to allow subscribers to use mobile wireless services and complete calls; and </P>
                <P>(10) Billing, customer care and customer service related functions necessary to maintain the subscriber account and relationship.</P>
                <P>M. Within twenty (20) days after the filing of the Complaint, defendants will notify plaintiff United States and plaintiff states in writing of the steps defendants have taken to comply with this Section.</P>
                <P>N. This Preservation of Assets Stipulation and Order shall remain in effect until consummation of the divestitures required by the proposed Final Judgment or until further order of the Court.</P>
                <EXTRACT>
                    <FP>Dated: October 25, 2004</FP>
                    <P>  Respectfully submitted,</P>
                    <HD SOURCE="HD3">For Plaintiff United States</HD>
                    <FP SOURCE="FP-DASH">/s/</FP>
                    <FP>Hillary B. Burchuk (D.C. Bar # 366755),</FP>
                    <FP>Matthew C. Hammond,</FP>
                    <FP>
                        <E T="03">Attorneys, Telecommunications &amp; Media, Enforcement Section, Antitrust Division, U.S. Department of Justice, City Center Building, 1401 H Street, NW., Suite 8000, Washington, DC 20530, (202) 514-5621, Facsimile: (202) 514-6381.</E>
                    </FP>
                    <HD SOURCE="HD3">State of Connecticut</HD>
                    <FP>Richard Blumenthal,</FP>
                    <FP>
                        <E T="03">Attorney General.</E>
                    </FP>
                    <FP>Michael E. Cole, </FP>
                    <FP>
                        <E T="03">Assistant Attorney General, Department Head/Antitrust Department, Federal bar No. ct20115.</E>
                    </FP>
                    <FP SOURCE="FP-DASH">/s/</FP>
                    <FP>Rachel O. Davis,</FP>
                    <FP>
                        <E T="03">Assistant Attorney General, Antitrust Department, Federal bar No. ct07411, DC Bar No. 413157 (inactive), 55 Elm Street, Hartford, Connecticut 06106, Tel: (860) 808-5041, Fax: (860) 808-5033.</E>
                    </FP>
                    <HD SOURCE="HD3">For Plaintiff State of Texas</HD>
                    <FP>Greg Abbott,</FP>
                    <FP>
                        <E T="03">Attorney General of Texas.</E>
                    </FP>
                    <FP>Barry R. McBee,</FP>
                    <FP>
                        <E T="03">First Assistant Attorney General</E>
                    </FP>
                    <FP>Edward D. Burbach,</FP>
                    <FP>
                        <E T="03">Deputy Attorney General for Litigation.</E>
                    </FP>
                    <FP>Mark Tobey,</FP>
                    <FP SOURCE="FP-DASH">/s/ </FP>
                    <FP>
                        <E T="03">Assistant Attorney General, Chief, Antitrust &amp; Civil Medicaid Fraud Division.</E>
                    </FP>
                    <FP>Rebecca Fisher,</FP>
                    <FP SOURCE="FP-DASH">/s/ </FP>
                    <FP>
                        <E T="03">Assistant Attorney General, Chief, Antitrust Section.</E>
                    </FP>
                    <FP SOURCE="FP-DASH">/s/</FP>
                    <FP>John T. Prud'Homme, Jr., </FP>
                    <FP>
                        <E T="03">Assistant Attorney General, TX Bar No. 24000322, Office of the Attorney General, P.O. Box 12548, Austin, Texas 78711-2548, 512/936-1697 512/320-0975 (Facsimile).</E>
                    </FP>
                    <P>
                        Signature by the State of Texas on Preservation of Assets Stipulation and Order in 
                        <E T="03">United States of America, State of Connecticut and State of  Texas</E>
                         v. 
                        <E T="03">Cingular Wireless Corporation, SBC Communications Inc., BellSouth Corporation and AT&amp;T Wireless Services Inc.</E>
                    </P>
                    <HD SOURCE="HD3">For Defendants Cingular Wireless Corporation and SBC Communications Inc.</HD>
                    <FP SOURCE="FP-DASH">/s/</FP>
                    <FP>Richard L. Rosen (D.C. Bar # 307231),</FP>
                    <FP>
                        <E T="03">Arnold &amp; Porter LLP, 555 12th Street, NW., Washington, DC 20004, (202) 942-5000.</E>
                    </FP>
                    <HD SOURCE="HD3">For Defendants Cingular Wireless Corporation and BellSouth Corporation</HD>
                    <FP SOURCE="FP-DASH">/s/</FP>
                    <FP>Stephen M. Axinn, Esq. (D.C. Bar # 478335),</FP>
                    <FP>
                        <E T="03">Axinn, Veltrop &amp; Harkrider LLP, 1801 K Street, NW., Washington, DC 20006, (202) 912-4700.</E>
                    </FP>
                    <HD SOURCE="HD3">For Defendant AT&amp;T Wireless Services, Inc.</HD>
                    <FP SOURCE="FP-DASH">/s/</FP>
                    <FP>Ilene Knable Gotts (D.C. Bar # 384740),</FP>
                    <FP>
                        <E T="03">Wachtell, Lipton, Rosen &amp; Katz, 51 W. 52nd Street, New York, NY 10019, (212) 403-1247.</E>
                    </FP>
                </EXTRACT>
                <HD SOURCE="HD1">Order</HD>
                <EXTRACT>
                    <P>It is so ordered by the Court, this __ day of _____,  2004.</P>
                    <FP SOURCE="FP-DASH">/s/</FP>
                    <FP>
                        <E T="03">United States District Judge</E>
                    </FP>
                </EXTRACT>
            </PREAMB>
            <FRDOC>[FR Doc. 04-25323 Filed 11-12-04; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4410-11-M</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="N">DEPARTMENT OF LABOR </AGENCY>
                <SUBAGY>Employment and Training Administration </SUBAGY>
                <SUBJECT>Workforce Security Programs: Unemployment Insurance Program Letter Interpreting Federal Law </SUBJECT>
                <P>
                    The Employment and Training Administration interprets Federal law requirements pertaining to unemployment compensation. These interpretations are issued in Unemployment Insurance Program Letters (UIPLs) to the State Workforce Agencies. UIPL 30-04, Change 1 is published in the 
                    <E T="04">Federal Register</E>
                     in order to inform the public. 
                </P>
                <P>This UIPL provides additional guidance to the states regarding enacting legislation which conforms to the “SUTA Dumping Prevention Act of 2004,” which was signed by the President on August 9, 2004. </P>
                <SIG>
                    <DATED>Dated: November 8, 2004. </DATED>
                    <NAME>Emily Stover DeRocco, </NAME>
                    <TITLE>Assistant Secretary of Labor. </TITLE>
                </SIG>
                <EXTRACT>
                    <HD SOURCE="HD1">Employment and Training Administration, Advisory System, U.S. Department of Labor, Washington, DC 20210 </HD>
                    <FP SOURCE="FP-1">Advisory: Unemployment Insurance Program Letter No. 30-04 Change 1 </FP>
                    <FP SOURCE="FP-1">To: State Workforce Agencies. </FP>
                    <FP SOURCE="FP-1">From: Cheryl Atkinson, Administrator, Office of Workforce Security. </FP>
                    <FP SOURCE="FP-1">Subject: SUTA Dumping—Amendments to Federal Law Affecting the Federal-State Unemployment Compensation Program—Additional Guidance.</FP>
                    <P>
                        1. 
                        <E T="03">Purpose</E>
                        . To provide additional guidance to states concerning the amendments to Federal law designed to prohibit “SUTA Dumping.” 
                    </P>
                    <P>
                        2. 
                        <E T="03">References</E>
                        . Public Law (Pub. L.) 108-295, the “SUTA Dumping Prevention Act of 2004,” signed by the President on August 9, 2004; the Social Security Act (SSA); the Internal Revenue Code (IRC), including the Federal Unemployment Tax Act (FUTA); and Unemployment Insurance Program Letters (UIPLs) 30-04, 14-84, and 29-83, Change 3. 
                    </P>
                    <P>
                        3. 
                        <E T="03">Background</E>
                        . UIPL 30-04 informed states of the amendments to Federal unemployment compensation (UC) law made by Pub. L. 108-295, the “SUTA Dumping Prevention Act of 2004.” Pub. L. 108-295 amended the SSA by adding section 303(k) to establish a nationwide minimum standard for curbing SUTA dumping. States will need to amend their UC laws to conform with the new legislation. 
                    </P>
                    <P>
                        Since the issuance of UIPL 30-04, the Department of Labor has received requests for clarification and other questions on the Federal SUTA dumping requirements. This UIPL is issued to respond to these requests and questions. As was UIPL 30-04, it is a question and answer (Q&amp;A) format. States are especially directed to Q&amp;As 1, 2, 14, and 15, which include additions and modifications to the draft legislative language provided with UIPL 30-04. 
                        <PRTPAGE P="65655"/>
                    </P>
                    <P>
                        4. 
                        <E T="03">Action</E>
                        . State administrators should distribute this advisory to appropriate staff. States must adhere to the requirements of Federal law contained in this advisory. 
                    </P>
                    <P>
                        5. 
                        <E T="03">Inquiries</E>
                        . Questions should be addressed to your Regional Office. 
                    </P>
                    <P>
                        6. 
                        <E T="03">Attachment</E>
                        . 
                    </P>
                    <HD SOURCE="HD1">Questions and Answers (Q&amp;As) </HD>
                    <HD SOURCE="HD2">Mandatory Transfers—Section 303(k)(1)(A), SSA </HD>
                    <P>
                        <E T="03">1-1. Question:</E>
                         In anticipation of a major layoff, Employer A transfers the portion of its business and workforce which it will be laying off to a small company, Employer B. Since there is substantially common ownership, experience is also transferred. Employer B then lays off all of the transferred workforce and is charged for the resulting UC payments. Employer B then either ceases operating or operates with a greatly reduced workforce, thereby minimizing its UC costs. May the transfer of experience from Employer A to Employer B be voided in this case? If not, what can be done to avoid this type of SUTA dumping?
                    </P>
                    <P>
                        <E T="03">Answer:</E>
                         Since there is substantially common ownership, experience must be transferred from Employer A to Employer B under the mandatory transfer provisions.
                    </P>
                    <P>Although Federal law does not require states to prevent this type of SUTA dumping, states may take action. (States which charge benefits to the separating employer may be particularly vulnerable to this type of SUTA dumping.) If the state determines that a substantial purpose of the transfer of trade or business was to obtain a lower rate, then both Employer A and Employer B's accounts could be treated as a single account for experience rating purposes. This will prevent Employer A from escaping its poor experience. It is consistent with Federal law both because Section 303(k)(2)(B), SSA, permits states to define “employer” and because Section 3303(a)(1), FUTA, has long permitted the establishment of joint accounts. To this end, the draft legislative language contained in Attachment II to UIPL 30-04 is revised as follows: </P>
                    <P>• By inserting “(1)” after “(a)” in the provision addressing mandatory transfers, and </P>
                    <P>• By inserting the following new language: </P>
                    <P>(2) If, following a transfer of experience under paragraph (1), the Commissioner determines that a substantial purpose of the transfer of trade or business was to obtain a reduced liability for contributions, then the experience rating accounts of the employers involved shall be combined into a single account and a single rate assigned to such account. </P>
                    <P>The Department recommends that states consider addressing this matter. </P>
                    <P>Alternatively, nothing prohibits a state from revisiting its determination that Employer B was a separate legal entity for UC purposes. If, for example, the state determines that Employer B has no business existence separate and apart from Employer A, and, therefore, under its law should not have been established as a separate employer for UC purposes, then its establishment as a separate employer may be voided and its experience will revert to Employer A. (Note this approach would not cover transfers to a long-established business that has a separate business identity.) </P>
                    <P>
                        <E T="03">1-2. Question:</E>
                         Although the answer to Q&amp;A 5 of UIPL 30-04 provides that an “employer's workforce is necessarily a part of its business,” the draft legislative language attached to that UIPL does not specifically address transferring workforce. Instead, it simply refers to transfers of trade or business. May the draft legislative language be modified to specifically cite transfers of workforce or employees? 
                    </P>
                    <P>
                        <E T="03">Answer:</E>
                         Yes. The draft legislative language is just that—draft language. It may, therefore, be modified to explicitly provide that transfers of trade or business include situations where employees are transferred. The following language is added at the end of subsection (a) of the draft legislative language as optional language that the state may consider using: 
                    </P>
                    <P>The transfer of some or all of an employer's workforce to another employer shall be considered a transfer of trade or business when, as the result of such transfer, the transferring employer no longer performs trade or business with respect to the transferred workforce, and such trade or business is performed by the employer to whom the workforce is transferred. </P>
                    <P>Care should be taken to assure the state law does not require transfers of experience where an employee is “moved” from one employer to another, without any transfer of trade or business. See Q&amp;A 1-7. </P>
                    <P>
                        <E T="03">1-3. Question:</E>
                         The answer to Q&amp;A 6 in UIPL 30-04 indicates that the Department is not defining a “bright line” test of what constitutes “substantially common ownership, management, or control.” Does this mean state law may contain a test of “substantially common” that requires more than 90 percent commonality? Or more than 50 percent commonality? 
                    </P>
                    <P>
                        <E T="03">Answer:</E>
                         No, a 90 percent test would be a “substantial majority” test, while a 50 percent test would be a simple “majority” test. Congress could have specified either of these tests, but it instead chose a test of “substantial” commonality. Therefore, “substantially” could include less than 50% common ownership, management, or control. “Substantial” common management, for example, might even occur where Company A and Company B share only one manager, but that one manager exercises pervasive control as the chief executive officer of both companies. 
                    </P>
                    <P>
                        <E T="03">1-4. Question:</E>
                         The answer to Q&amp;A 8 in UIPL 30-04 “strongly recommends that states reassign rates immediately upon completion of the transfer” of experience to avoid a SUTA dump between the completion of a transfer and assignment of a new rate. If a state currently lacks the capability to assign two different rates to the same employer for the same year, may it retroactively change the employers' rates to the beginning of the rate year to reflect the transferred experience? 
                    </P>
                    <P>
                        <E T="03">Answer:</E>
                         No. Section 3303(a)(1), FUTA, requires that “reduced rates” be assigned to an employer based on “his” experience during “not less than the 3 consecutive years immediately preceding the computation date.” If a rate based on transferred experience is assigned to an employer for a period before it becomes “his” experience, the employer cannot be said to be receiving a rate based on “his” experience for that period. 
                    </P>
                    <P>States have other options to address this concern. States may establish a different employer account number for the employer(s) and assign the recalculated rate to that new account number. </P>
                    <P>
                        States may also retroactively impose the state's standard rate of contributions or the state's highest rate of contributions since these rates are not “reduced rates” subject to FUTA. (
                        <E T="03">See</E>
                         UIPL 14-84 for guidance in determining the state's standard rate. Caution should be taken in using standard rates since in some states the standard rate may be lower than the employer's experience rate, either prior to or after any transfer.) Although this approach is consistent with FUTA, states should consider whether retroactively imposing higher rates on employers is equitable since employers will not have budgeted for retroactive costs and because the rates are not based on experience. 
                    </P>
                    <P>
                        <E T="03">1-5. Question:</E>
                         Recalculating an employer's reduced rate in the middle of the rate year may be administratively cumbersome. May a state simply assign the employer the higher of the two rates for the remainder of the rate year? For example, assume Employer A has a rate of 5.0 percent and is purchased by Employer B which has a rate of 4.0 percent. May the state assign a rate of 5.0 percent to Employer B for the remainder of the rate year? (This method is authorized by UIPL 29-83, Change 3, which discusses transfers of experience, but only when Employer B is not an existing employer.) 
                    </P>
                    <P>
                        <E T="03">Answer:</E>
                         Yes, the state may assign the higher of the two rates. FUTA's experience rating requirements apply to “reduced rates.” This approach always serves to increase the employer's rate. As noted in UIPL 29-83, Change 3, “Since assigning the highest rate results in an increased rate (even though it may be less than the standard rate), there is no conflict with FUTA.” Although UIPL 29-83, Change 3, addressed only cases where the successor was not an existing employer, this principle also applies to cases where the successor is an employer. 
                    </P>
                    <P>States should note that this approach may raise fairness issues. For example, assuming substantial commonality of ownership, management, or control at the time of the transfer or trade or business, an employer with a workforce of 10 individuals and an experience rate of 5.4 percent could have its trade/business and experience transferred to an employer with a workforce of 1,000 individuals and an experience rate of 2.0 percent. The result of assigning a higher rate would be a significantly higher rate on a significantly larger workforce. </P>
                    <P>
                        <E T="03">1-6. Question:</E>
                         The answer to Q&amp;A 8 in UIPL 30-04 provides for the option of “immediately” recalculating an employer's rate “after the completion of the transfer of trade or business.” This could be problematic since this rate change could occur in the middle of a quarter. May the recalculated rate take effect with the start of the quarter following the transfer? 
                    </P>
                    <P>
                        <E T="03">Answer:</E>
                         Yes. Since nothing in the SUTA dumping amendments requires rates be 
                        <PRTPAGE P="65656"/>
                        recalculated prior to the next time the state calculates rates for all employers, states have latitude in this matter. 
                    </P>
                    <P>
                        <E T="03">1-7. Question:</E>
                         The answer to Q&amp;A 9 in UIPL 30-04, says that where “[a]n employee of one legal entity is moved to another legal entity,” no transfer of experience is required. (Emphasis added.) However, the answer to Q&amp;A 13 in that UIPL says the SUTA Dumping amendment applies to “all transfers, large and small.” What is the distinction between the two? 
                    </P>
                    <P>
                        <E T="03">Answer:</E>
                         Q&amp;A 13 applies to cases where there is a transfer of trade or business. (Q&amp;As 5 and 14 in UIPL 30-04 and 1-2 in this UIPL also apply to situations where trade or business is transferred.) 
                    </P>
                    <P>The answer to Q&amp;A 9 applies to cases where an employee is “moved” from one legal entity to another, but where there is no transfer of trade or business. For example, an owner of two separate legal entities “moves” an individual from head of widget making for Entity A to head of graphic design for Entity B, but does not transfer any of the widget-making trade/business to Entity B. In this case, no trade or business is transferred and the “move” of the individual is in the nature of a reassignment. </P>
                    <P>In cases where no trade or business has been transferred, experience may not be transferred. Therefore, when an employee's “move” is merely in the nature of a reassignment, the state may not transfer experience. </P>
                    <P>
                        <E T="03">1-8. Question:</E>
                         State law allows employers to voluntarily combine their experience rating histories into joint accounts under certain conditions. Does the SUTA dumping legislation affect this? 
                    </P>
                    <P>
                        <E T="03">Answer:</E>
                         No. Joint accounts may continue to be established in accordance with state law. 
                    </P>
                    <P>The SSA's mandatory transfer provisions affect joint accounts in the same way they affect individual employer accounts. That is, if an employer participating in a joint account transfers trade or business to another employer and a transfer of experience is required under provisions of state law implementing the SSA's mandatory transfer provisions, then any subsequent calculation of the experience rate of the joint account must take into account this transfer. </P>
                    <P>
                        <E T="03">1-9. Question:</E>
                         Do the amendments mandating a transfer of experience affect what constitute taxable wages? 
                    </P>
                    <P>
                        <E T="03">Answer:</E>
                         The amendments address the transfer of experience and of rates based on that experience. They do not affect determinations of what constitute taxable wages under the state's law. As a result, after trade and business is transferred, the state may either give effect to taxable wages paid by the predecessor in determining whether the taxable wage base is met, or “restart” the taxable wage base for the individual at zero. 
                    </P>
                    <P>
                        <E T="03">1-10. Question:</E>
                         Do the mandatory transfer provisions for SUTA Dumping apply when an employer is “reorganized?” 
                    </P>
                    <P>
                        <E T="03">Answer:</E>
                         The keys under section 303(k)(1)(A), SSA, are whether there is a transfer of trade or business and whether there is substantially common ownership, management, or control. Thus, the answer depends on whether the reorganization involves a transfer of trade or business between entities under substantially common ownership, management or control. 
                    </P>
                    <P>As used in bankruptcy law, a reorganization is a “financial restructuring of a corporation, esp. in the repayment of debts, under a plan created by a trustee and approved by a court.” (Black's Law Dictionary (8th edition, 2004).) Thus, if a single employer simply “financially restructures” itself, without transferring trade or business, then the mandatory transfer provisions do not apply. </P>
                    <P>In other cases, reorganizations are mergers of corporations which involve a transfer of trade or business. For example, a reorganization may be a “restructuring of a corporation, as by a merger or recapitalization, in order to improve its tax treatment under the Internal Revenue Code.” (Black's Law Dictionary (8th edition, 2004).) When there is a merger, the mandatory transfer provisions will apply if there is substantially common ownership, management, or control at the time of the transfer of trade or business. </P>
                    <P>Note the mandatory transfer provision of Section 303(k)(1)(A), SSA, does not speak in terms of “acquisitions.” In many reorganizations, there may be mergers involving stock swaps or stock-for-asset exchanges, and it may be argued that no “acquisition” has occurred, even though workforce has been moved to another legal entity within a corporate umbrella. For purposes of the mandatory SUTA dumping amendments, whether there has been an “acquisition” is immaterial. What is significant is whether trade or business was transferred when, at the time of the transfer, there is substantially common ownership, management, or control. If this occurs, then the experience must also be transferred. </P>
                    <HD SOURCE="HD2">Required Penalties—Section 303(k)(1)(D), SSA </HD>
                    <P>
                        <E T="03">1-11. Question:</E>
                         The draft legislative language attached to UIPL 30-04 provides that, in addition to any civil penalty, “any violation of this section 
                        <E T="03">may be</E>
                         prosecuted as a” criminal offense. (Emphasis added.) Does this mean that inclusion of criminal penalties is optional on the part of the state? 
                    </P>
                    <P>
                        <E T="03">Answer:</E>
                         No, section 303(k)(1)(D), SSA, clearly requires that state law must provide that “meaningful civil and criminal penalties” are imposed under certain circumstances. (
                        <E T="03">See</E>
                         Q&amp;A 19 in UIPL 30-04.) The draft legislative language quoted in the question merely indicates that the state has discretion to apply criminal penalties as appropriate. As noted in Q&amp;A 20 in UIPL 30-04, “States will take into account the amounts at issue and the likelihood of successful prosecution in determining which cases will result in criminal prosecutions.” 
                    </P>
                    <P>
                        <E T="03">1-12. Question:</E>
                         State law must provide for the imposition of penalties for persons who “knowingly” violate or attempt to violate those provisions of state law that implement section 303(k), SSA, and for those who “knowingly” advise another person to violate such provisions. Since it is often difficult to prove that an action is done “knowingly,” may state law provide that penalties may be imposed using a lower level of proof? 
                    </P>
                    <P>
                        <E T="03">Answer:</E>
                         Yes. The “knowingly” test is the minimum standard that state law must contain to meet the requirements of Section 303(k)(1)(D), SSA. States must assure that any such test is at least as encompassing as the “knowingly” standard. 
                    </P>
                    <HD SOURCE="HD2">Statute of Limitations </HD>
                    <P>
                        <E T="03">1-13. Question:</E>
                         Assume a “SUTA dump” occurred five years before the state identified it. The state's statute of limitations prevents the state from assessing contributions more than three years prior to the date of detection. Does this statute of limitations conflict with the SUTA dumping amendments? 
                    </P>
                    <P>
                        <E T="03">Answer:</E>
                         No. Nothing in the SUTA dumping legislation overrides a state's statute of limitations. As a result, in the above example, the state may limit its assessment of contributions to the three-year period provided in its statute of limitations. 
                    </P>
                    <HD SOURCE="HD2">Draft Legislative Language </HD>
                    <P>
                        <E T="03">1-14. Question:</E>
                         Subsection (c)(1) of the draft legislative language attached to UIPL 30-4 provides for civil penalties for persons knowingly violating or attempting to violate “subsections (a) 
                        <E T="03">and</E>
                         (b) or any other provision of this Chapter related to determining the assignment of a contribution rate? (Emphasis added.) Should the “and” be an “or”? 
                    </P>
                    <P>
                        <E T="03">Answer:</E>
                         Yes. The word “and” could be read to mean that the person must have violated, or attempted to violate, both the mandatory transfer provision and the prohibited transfer provision. Therefore the draft legislative language should be corrected by changing “and” to “or”. 
                    </P>
                    <P>
                        Also, note there is a typo in subsection (e)(2) of the draft legislative language. “Trade 
                        <E T="03">of</E>
                         business” should be corrected to “Trade 
                        <E T="03">or</E>
                         business.” (Emphasis added.) 
                    </P>
                    <P>
                        <E T="03">1-15. Question:</E>
                         Subsection (c)(4) of the draft legislative language attached to UIPL 30-4 provides that “In addition to the penalty imposed by paragraph (1), any violation of this section may be prosecuted.* * *” May “section” be changed to “Chapter”? 
                    </P>
                    <P>
                        <E T="03">Answer:</E>
                         Yes. Using the word “chapter” will have the effect of making the criminal penalties applicable to any other provision of the state's UC law related to determining the assignment of a contribution rate. Note that states are not required to apply the penalties they develop for SUTA dumping to other violations of state law. (
                        <E T="03">See</E>
                         Q&amp;A 24 in UIPL 30-04.) 
                    </P>
                </EXTRACT>
            </PREAMB>
            <FRDOC> [FR Doc. E4-3162 Filed 11-12-04; 8:45 am] </FRDOC>
            <BILCOD>BILLING CODE 4510-30-P </BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="N">MISSISSIPPI RIVER COMMISSION</AGENCY>
                <SUBJECT>Sunshine Act Meetings</SUBJECT>
                <PREAMHD>
                    <HD SOURCE="HED">Agency Holding the Meeting:</HD>
                    <P>Mississippi River Commission.</P>
                </PREAMHD>
                <PREAMHD>
                    <HD SOURCE="HED">Time and Date:</HD>
                    <P>1 p.m., December 15, 2004.</P>
                </PREAMHD>
                <PREAMHD>
                    <HD SOURCE="HED">Place:</HD>
                    <P>Mississippi River Commission Headquarters Building, 1400 Walnut Street, Vicksburg, MS.</P>
                </PREAMHD>
                <PREAMHD>
                    <PRTPAGE P="65657"/>
                    <HD SOURCE="HED">Status:</HD>
                    <P>Open to the public for observation, but not for participation.</P>
                </PREAMHD>
                <PREAMHD>
                    <HD SOURCE="HED">Matters To Be Considered:</HD>
                    <P>The Commission will consider the Louisiana Coastal Area Ecosystem Restoration Study, Final Report and Environmental Impact Statement.</P>
                </PREAMHD>
                <PREAMHD>
                    <HD SOURCE="HED">Contact Person for More Information:</HD>
                    <P>Mr. Stephen Gambrell, telephone (601) 634-5766.</P>
                </PREAMHD>
                <SIG>
                    <NAME>Brenda S. Bowen,</NAME>
                    <TITLE>Army Federal Register Liaison Officer.</TITLE>
                </SIG>
            </PREAMB>
            <FRDOC>[FR Doc. 04-25391 Filed 11-10-04; 11:22 am]</FRDOC>
            <BILCOD>BILLING CODE 3710-GX-M</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="N">NUCLEAR REGULATORY COMMISSION </AGENCY>
                <DEPDOC>[NUREG-1600] </DEPDOC>
                <SUBJECT>NRC Enforcement Policy </SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Nuclear Regulatory Commission. </P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Policy statement: revision. </P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The Nuclear Regulatory Commission (NRC) is revising its General Statement of Policy and Procedure for NRC Enforcement Actions (NUREG-1600) (Enforcement Policy or Policy) to include an administrative change that provides that the appropriate Regional Administrator will issue all Notices of Enforcement Discretion (NOEDs) for power reactors. </P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>This revision is effective November 15, 2004. Comments on this revision to the Enforcement Policy may be submitted on or before December 15, 2004. </P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        Submit written comments to: Michael T. Lesar, Chief, Rules and Directives Branch, Division of Administrative Services, Office of Administration, Mail Stop: T6D59, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001. Hand deliver comments to: 11555 Rockville Pike, Rockville, Maryland, between 7:30 a.m. and 4:15 p.m., Federal workdays. Copies of comments received may be examined at the NRC Public Document Room, Room O1F21, 11555 Rockville Pike, Rockville, MD. You may also e-mail comments to 
                        <E T="03">nrcrep@nrc.gov</E>
                        . 
                    </P>
                    <P>
                        The NRC maintains the current Enforcement Policy on its Web site at 
                        <E T="03">http://www.nrc.gov</E>
                        , select What We Do, Enforcement, then Enforcement Policy. 
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Herbert N. Berkow, Office of Nuclear Reactor Regulation, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, (301) 415-1395, e-mail (
                        <E T="03">HNB@nrc.gov</E>
                        ) or Renée Pedersen, Office of Enforcement, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, (301) 415-2742, e-mail (
                        <E T="03">RMP@nrc.gov</E>
                        ). 
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>Section VII.C of the Enforcement Policy describes the circumstances when the staff may exercise enforcement discretion in the form of a NOED for power reactors. </P>
                <P>On occasion, circumstances may arise where a licensee's compliance with a Technical Specification (TS) Limiting Condition for Operation (LCO) or other license condition would involve: (1) An unnecessary plant transient; (2) performance of testing, inspection, or system realignment that is inappropriate with the specific plant conditions; or, (3) unnecessary delays in plant startup without a corresponding health and safety benefit. The staff may also grant enforcement discretion in cases involving severe weather or other natural phenomena. This decision is based upon balancing the public health and safety or common defense and security of not operating against the potential radiological or other hazards associated with continued operation, resulting in a determination that safety will not be impacted unacceptably by exercising this discretion. The Commission is to be informed expeditiously following the granting of a NOED in such situations. </P>
                <P>
                    In these circumstances, the NRC staff may choose to not enforce the applicable TS or other license condition. This enforcement discretion, designated as a NOED, is only exercised if the NRC staff is clearly satisfied that the action is consistent with protecting the public health and safety. NRC guidance for implementing the NOED policy for power reactors is provided in the 
                    <E T="03">NRC Inspection Manual</E>
                     Part 9900 guidance. 
                </P>
                <P>The Enforcement Policy and implementing guidance have historically recognized the distinction between: (1) Those instances where a noncompliance is temporary and nonrecurring when an amendment is not practical, and (2) those instances where a noncompliance will occur during the brief period of time required for the NRC staff to process an emergency or exigent license amendment under the provisions of 10 CFR 50.91(a)(5) or (6). In the first situation, the Regional Administrator has issued the NOED and subsequently documented the decision for granting the NOED. In the second situation, the Director, Office of Nuclear Reactor Regulation (NRR) has issued the NOED and subsequently documented the decision for granting the NOED. In other words, the current distinction between region-issued and NRR-issued NOEDs for power reactors is based on the duration of the NOED and whether or not a follow-up license amendment is appropriate. </P>
                <P>This revision of the Enforcement Policy eliminates the distinction between region-issued and NRR-issued NOEDs for power reactors. Although historically most NOEDs have been issued and documented by the cognizant regions without follow-up license amendments, all NOED requests have been evaluated and decisions made jointly by the regional and NRR staffs. Thus, the distinction is unnecessary. </P>
                <P>The Enforcement Policy revision specifies that the associated regional and headquarters staff will together determine the appropriateness of granting a requested NOED. If the NOED is determined to be appropriate, regional staff will complete the documentation process associated with granting the NOED. </P>
                <P>The revision provides that, for all power reactor NOED determinations, the Regional Administrator, or his or her designee, may issue a NOED after consultation with headquarters and therefore eliminates the need to categorize NOEDs as regional- or headquarters-lead. This clarification will provide a more predictable, clear, and consistent process for licensees when requesting NRC to consider granting a NOED. </P>
                <P>This policy revision, as well as other NOED process improvements, was discussed with representatives of the Nuclear Energy Institute (NEI) and other stakeholders at a public meeting with the NRC staff on July 14, 2004. The NRC plans on completely revising and reissuing its Part 9900 guidance later in the year. In addition to the Enforcement Policy revision, other process improvements include emphasizing that the license amendment process should be used in preference to NOEDs whenever possible and developing improved guidance to address the NOED request requirement to demonstrate no net increase in radiological risk. In addition, other concurrent improvements to the NOED process will result in most NOEDs having follow-up license amendments regardless of the NOED duration. </P>
                <P>
                    The revision to the Enforcement Policy is strictly administrative in nature and will support simplification of the NOED process by providing a clear understanding of the roles and responsibilities of NRC regional and headquarters staff associated with issuance of NOEDs. 
                    <PRTPAGE P="65658"/>
                </P>
                <P>It is anticipated that the Enforcement Policy revision will have minimal, if any, impact on external stakeholders. </P>
                <HD SOURCE="HD1">Paperwork Reduction Act </HD>
                <P>
                    This policy statement does not contain new or amended information collection requirements subject to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 
                    <E T="03">et seq.</E>
                    ) Existing requirements were approved by the Office of Management and Budget (OMB), approval number 3150-0136. The approved information collection requirements contained in this policy statement appear in Section VII.C. 
                </P>
                <HD SOURCE="HD1">Public Protection Notification </HD>
                <P>The NRC may not conduct or sponsor, and a person in not required to respond to, collection of information unless it displays a currently valid OMB control number. </P>
                <HD SOURCE="HD1">Small Business Regulatory Enforcement Fairness Act </HD>
                <P>In accordance with the Small Business Regulatory Enforcement Fairness Act of 1996, the NRC had determined that this action is not a major rule and has verified this determination with the Office of Information and Regulatory Affairs of OMB. </P>
                <P>Accordingly, the proposed revision to the NRC Enforcement Policy reads as follows: </P>
                <HD SOURCE="HD1">General Statement of Policy and Procedure for NRC Enforcement Actions </HD>
                <STARS/>
                <HD SOURCE="HD1">VII. Exercise of Discretion </HD>
                <STARS/>
                <HD SOURCE="HD2">C. Notice of Enforcement Discretion for Power Reactors and Gaseous Diffusion Plants </HD>
                <P>On occasion, circumstances may arise where a power reactor's compliance with a Technical Specification (TS) Limiting Condition for Operation or with other license conditions would involve an unnecessary plant transient or performance of testing, inspection, or system realignment that is inappropriate with the specific plant conditions, or unnecessary delays in plant startup without a corresponding health and safety benefit. Similarly, for a gaseous diffusion plant (GDP), circumstances may arise where compliance with a Technical Safety Requirement (TSR) or technical specification or other certificate condition would unnecessarily call for a total plant shutdown or, notwithstanding that a safety, safeguards, or security feature was degraded or inoperable, compliance would unnecessarily place the plant in a transient or condition where those features could be required. </P>
                <P>In these circumstances, the NRC staff may choose not to enforce the applicable TS, TSR, or other license or certificate condition. This enforcement discretion, designated as a Notice of Enforcement Discretion (NOED), will only be exercised if the NRC staff is clearly satisfied that the action is consistent with protecting the public health and safety. The NRC staff may also grant enforcement discretion in cases involving severe weather or other natural phenomena, based upon balancing the public health and safety or common defense and security of not operating against the potential radiological or other hazards associated with continued operation, and a determination that safety will not be impacted unacceptably by exercising this discretion. The Commission is to be informed expeditiously following the granting of a NOED in these situations. A licensee or certificate holder seeking the issuance of a NOED must provide a written justification, or in circumstances where good cause is shown, oral justification followed as soon as possible by written justification, that documents the safety basis for the request and provides whatever other information necessary for the NRC staff to make a decision on whether to issue a NOED. </P>
                <P>For power reactors, the appropriate Regional Administrator, or his or her designee, may issue a NOED after consultation with the Director, Office of Nuclear Reactor Regulation, or his or her designee, to determine the appropriateness of granting a NOED where (1) the noncompliance is temporary and nonrecurring when an amendment is not practical or (2) if the expected noncompliance will occur during the brief period of time it requires the NRC staff to process an emergency or exigent license amendment under the provisions of 10 CFR 50.91 (a)(5() or (6). For gaseous diffusion plants, the appropriate Regional Administrator, or his or her designee, may issue and document a NOED where the noncompliance is temporary and nonrecurring and when an amendment is not practical. The Director, Office of Nuclear Materials Safety and Safeguards, or his or her designee, may issue a NOED if the expected noncompliance will occur during the brief period of time it requires the NRC staff to process a certificate amendment under 10 CFR 76.45. The person exercising enforcement discretion will document the decision. </P>
                <P>For an operating reactor, this exercise of enforcement discretion is intended to minimize the potential safety consequences of unnecessary plant transients with the accompanying operational risks and impacts or to eliminate testing, inspection, or system realignment which is inappropriate for the particular plant conditions. For plants in a shutdown condition, exercising enforcement discretion is intended to reduce shutdown risk by, again, avoiding testing, inspection or system realignment which is inappropriate for the particular plant conditions, in that, it does not provide a safety benefit or may, in fact, be detrimental to safety in the particular plant condition. Exercising enforcement discretion for plants attempting to startup is less likely than exercising it for an operating plant, as simply delaying startup does not usually leave the plant in a condition in which it could experience undesirable transients. In such cases, the Commission would expect that discretion would be exercised with respect to equipment or systems only when it has at least concluded that, notwithstanding the conditions of the license: (1) The equipment or system does not perform a safety function in the mode in which operation is to occur; (2) the safety function performed by the equipment or system is of only marginal safety benefit, provided remaining in the current mode increases the likelihood of an unnecessary plant transient; or (3) the TS or other license condition requires a test, inspection, or system realignment that is inappropriate for the particular plant conditions, in that it does not provide a safety benefit, or may, in fact, be detrimental to safety in the particular plant condition. </P>
                <P>
                    For GDPs, the exercise of enforcement discretion would be used where compliance with a certificate condition would involve an unnecessary plant shutdown or, notwithstanding that a safety, safeguards, or security feature was degraded or inoperable, compliance would unnecessarily place the plant in a transient or condition where those features could be required. Such regulatory flexibility is needed because a total plant shutdown is not necessarily the best response to a plant condition. GDPs are designed to operate continuously and have never been shut down. Although portions can be shut down for maintenance, the NRC staff has been informed by the certificate holder that restart from a total plant shutdown may not be practical and the staff agrees that the design of a GDP 
                    <PRTPAGE P="65659"/>
                    does not make restart practical. Hence, the decision to place either GDP in plant-wide shutdown condition would be made only after determining that there is inadequate safety, safeguards, or security and considering the total impact of the shutdown on safety, the environment, safeguards, and security. A NOED would not be used for noncompliances with other than certificate requirements, or for situations where the certificate holder cannot demonstrate adequate safety, safeguards, or security. 
                </P>
                <P>The decision to exercise enforcement discretion does not change the fact that a violation will occur nor does it imply that enforcement discretion is being exercised for any violation that may have led to the violation at issue. In each case where the NRC staff has chosen to issue a NOED, enforcement action will normally be taken for the root causes, to the extent violations were involved, that led to the noncompliance for which enforcement discretion was used. The enforcement action is intended to emphasize that licensees and certificate holders should not rely on the NRC's authority to exercise enforcement discretion as a routine substitute for compliance or for requesting a license or certificate amendment. </P>
                <P>Finally, it is expected that the NRC staff will exercise enforcement discretion in this area infrequently. Although a plant must shut down, refueling activities may be suspended, or plant startup may be delayed, absent the exercise of enforcement discretion, the NRC staff is under no obligation to take such a step merely because it has been requested. The decision to forego enforcement is discretionary. When enforcement discretion is to be exercised, it is to be exercised only if the NRC staff is clearly satisfied that the action is warranted from a health and safety perspective. </P>
                <STARS/>
                <SIG>
                    <DATED>Dated at Rockville, MD, this 8th day of November, 2004. </DATED>
                    <P>For the Nuclear Regulatory Commission. </P>
                    <NAME>Annette L. Vietti-Cook, </NAME>
                    <TITLE>Secretary of the Commission. </TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 04-25260 Filed 11-12-04; 8:45 am] </FRDOC>
            <BILCOD>BILLING CODE 7590-01-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">NUCLEAR REGULATORY COMMISSION </AGENCY>
                <DEPDOC>[Docket No. 030-34325] </DEPDOC>
                <SUBJECT>Notice of Availability of Environmental Assessment and Finding of No Significant Impact for License Amendment for Release of Facility for Unrestricted Use for the Department of Veterans Affairs Chicago Health Care System Lakeside Campus—Medical Sciences Building, Chicago, IL</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Nuclear Regulatory Commission. </P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice of availability. </P>
                </ACT>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        William Snell, Senior Health Physicist, Decommissioning Branch, Division of Nuclear Material Safety, Region III, U.S. Nuclear Regulatory Commission, 2443 Warrenville Road, Lisle, Illinois 60532; telephone: (630) 829-9871; fax number: (630) 515-1259; e-mail: 
                        <E T="03">wgs@nrc.gov.</E>
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <HD SOURCE="HD1">I. Introduction </HD>
                <P>The Nuclear Regulatory Commission (NRC) is issuing a license amendment to Material License No. 03-23853-01VA issued to the Department of Veterans Affairs (DVA) (the licensee), to authorize release of its Chicago Health Care System, Lakeside Campus—Medical Sciences Building in Chicago, Illinois for unrestricted use, and has prepared an Environmental Assessment (EA) in support of this amendment in accordance with the requirements of 10 CFR part 51. Based on the EA, the NRC has concluded that a Finding of No Significant Impact (FONSI) is appropriate. The amendment will be issued following the publication of this notice. </P>
                <HD SOURCE="HD1">II. EA Summary </HD>
                <P>The purpose of the proposed amendment is to allow for the release of the licensee's Chicago, Illinois facility for unrestricted use. The DVA has occupied the Chicago Health Care System, Lakeside Campus—Medical Sciences Building since 1978, and during that period was authorized to use byproduct, source, and special nuclear material for medical diagnosis, therapy, and research. The Chicago, Illinois facility is a permittee under the DVA NRC Master Material License (MML) Number 03-23853-01VA, and on October 1, 2004, requested the NRC release the facility for unrestricted use. The approval is consistent with a March 17, 2003, Letter of Understanding (LOU) between the NRC and DVA for DVA permittees. The LOU requires the DVA to submit for NRC review, permittee requests for the release of buildings for unrestricted use where radioactive materials with a half-life greater than 120 days were used. The DVA identified four isotopes with half-lives greater than 120 days that it used in the Medical Sciences Building: hydrogen-3, carbon-14, sodium-22, and chlorine-36. The DVA has conducted surveys of the facility and provided information to the NRC to demonstrate that the site meets the licensee termination criteria in subpart E of 10 CFR part 20 for unrestricted release. </P>
                <P>The staff has prepared an EA in support of the proposed license amendment. Based on its review, the staff determined there were no radiological or non-radiological environmental impacts associated with the action since no radiological remediation activities were required to complete the proposed action. The staff has determined that the proposed action is administrative and/or procedural in nature and will not affect listed species or critical habitat. Likewise, NRC staff has determined that the proposed action is not the type of activity that has the potential to cause effects on historic properties because it is an administrative and/or procedural action. </P>
                <HD SOURCE="HD1">III. Finding of No Significant Impact </HD>
                <P>The staff has prepared an EA in support of the proposed license amendment to release the site for unrestricted use. The staff has found that the radiological environmental impacts from the proposed amendment are bounded by the impacts evaluated by NUREG-1496, Volumes 1-3, “Generic Environmental Impact Statement in Support of Rulemaking on Radiological Criteria for License Termination of NRC-Licensed Facilities'' (ML042310492, ML042320379, and ML042330385). The staff has also found that the non-radiological impacts are not significant. On the basis of the EA, NRC has concluded that there are no significant environmental impacts from the proposed amendment and has determined not to prepare an environmental impact statement. </P>
                <HD SOURCE="HD1">IV. Further Information </HD>
                <P>
                    Documents related to this action, including the application for amendment and supporting documentation, are available electronically at the NRC's Electronic Reading Room at 
                    <E T="03">http://www.nrc.gov/reading-rm/adams.html</E>
                    . From this site, you can access the NRC's Agencywide Document Access and Management System (ADAMS), which provides text 
                    <PRTPAGE P="65660"/>
                    and image files of NRC's public documents. The ADAMS accession numbers for the documents related to this notice are: the DVA letter dated October 1, 2004 (Accession No. ML042920457); the Final Status Survey Report, VA Chicago—Lakeside Campus, Medical Sciences Building, September 9, 2004 (Accession No. ML042920463); and the EA summarized above (Accession No. ML043010491). Please note that on October 25, 2004, the NRC terminated public access to ADAMS and initiated an additional security review of publicly available documents to ensure that potentially sensitive information is removed from the ADAMS database accessible through the NRC's web site. Interested members of the public may obtain copies of the referenced documents for review and/or copying by contacting the Public Document Room pending resumption of public access to ADAMS. The NRC Public Documents Room is located at NRC Headquarters in Rockville, MD, and can be contacted at (800) 397-4209, (301) 415-4737 or by e-mail to 
                    <E T="03">pdr@nrc.gov</E>
                    . 
                </P>
                <P>These documents may also be viewed electronically on the public computers located at the NRC's PDR, O 1 F21, One White Flint North, 11555 Rockville Pike, Rockville, MD 20852. The PDR reproduction contractor will copy documents for a fee. </P>
                <SIG>
                    <DATED>Dated in Lisle, Illinois, this 4th day of November 2004. </DATED>
                    <P>For the Nuclear Regulatory Commission, </P>
                    <NAME>Kenneth G. O'Brien, </NAME>
                    <TITLE>Chief, Decommissioning Branch, Division of Nuclear Materials Safety, Region III. </TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 04-25258 Filed 11-12-04; 8:45 am] </FRDOC>
            <BILCOD>BILLING CODE 7590-01-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">NUCLEAR REGULATORY COMMISSION </AGENCY>
                <SUBJECT>Advisory Committee on Nuclear Waste; Notice of Meeting </SUBJECT>
                <P>The Advisory Committee on Nuclear Waste (ACNW) will hold its 155th meeting on November 16-18, 2004, Room T-2B3, 11545 Rockville Pike, Rockville, Maryland.</P>
                <P>The schedule for this meeting is as follows:</P>
                <HD SOURCE="HD1">Tuesday, November 16, 2004 </HD>
                <FP SOURCE="FP-1">
                    <E T="03">10:30 a.m.-10:40 a.m.: Opening Statement</E>
                     (Open)—The ACNW Chairman will open the meeting with brief opening remarks. 
                </FP>
                <FP SOURCE="FP-1">
                    <E T="03">10:40 a.m.-11:40 a.m.: NMSS Division Directors' Semi-Annual Briefing</E>
                     (Open)—The Committee will be briefed by the Director, Division of High Level Waste Repository Safety and the Director, Division of Waste Management and Environmental Protection on recent activities of interest. 
                </FP>
                <FP SOURCE="FP-1">
                    <E T="03">11:40 a.m.-12:40 p.m.: International Transportation Meetings</E>
                     (Open)—The Director, SFPO will report on recent international transportation-related meetings/activities of interest. 
                </FP>
                <FP SOURCE="FP-1">
                    <E T="03">2 p.m.-3 p.m.: Format and Content of the U.S. Department of Energy Yucca Mountain License Application</E>
                     (Open)—The Committee will be briefed by a DOE representative on the general DOE format and content of the forthcoming DOE license application. 
                </FP>
                <FP SOURCE="FP-1">
                    <E T="03">3:15 p.m.-5:15 p.m.: ACNW 2005 Action Plan</E>
                     (Open)—The ACNW Committee will continue its discussion of potential topics for inclusion in its draft 2005 Action Plan. 
                </FP>
                <HD SOURCE="HD1">Wednesday, November 17, 2004 </HD>
                <FP SOURCE="FP-1">
                    <E T="03">8:30 a.m.-8:35 a.m.: Opening Statement</E>
                     (Open)—The ACNW Chairman will make opening remarks regarding the conduct of today's sessions. 
                </FP>
                <FP SOURCE="FP-1">
                    <E T="03">8:35 a.m.-10 a.m.: Working Group Planning Session</E>
                     (Open)—The Committee Members will discuss potential future activities including proposed 2005 working group meetings. 
                </FP>
                <FP SOURCE="FP-1">
                    <E T="03">10 a.m.-12 Noon: Preparation of ACNW Reports</E>
                     (Open)—The Committee will discuss potential ACNW reports on matters discussed during this meeting. It may also discuss possible reports on matters discussed during prior meetings. 
                </FP>
                <HD SOURCE="HD1">Thursday, November 18, 2004 </HD>
                <FP SOURCE="FP-1">
                    <E T="03">8:30 a.m.-8:35 a.m.: Opening Remarks by the ACNW Chairman</E>
                     (Open)—The Chairman will make opening remarks regarding the conduct of today's sessions. 
                </FP>
                <FP SOURCE="FP-1">
                    <E T="03">8:35 a.m.-12 Noon: Miscellaneous</E>
                     (Open)—The Committee will discuss matters related to the conduct of Committee activities and matters and specific issues that were not completed during previous meetings, as time and availability of information permit. 
                </FP>
                <P>
                    Procedures for the conduct of and participation in ACNW meetings were published in the 
                    <E T="04">Federal Register</E>
                     on October 18, 2004 (69 FR 61416). In accordance with these procedures, oral or written statements may be presented by members of the public. Electronic recordings will be permitted only during those portions of the meeting that are open to the public. Persons desiring to make oral statements should notify Mr. Howard J. Larson, (Telephone (301) 415-6805), between 7:30 a.m. and 4:00 p.m. e.t., as far in advance as practicable so that appropriate arrangements can be made to schedule the necessary time during the meeting for such statements. Use of still, motion picture, and television cameras during this meeting will be limited to selected portions of the meeting as determined by the ACNW Chairman. Information regarding the time to be set aside for taking pictures may be obtained by contacting the ACNW office prior to the meeting. In view of the possibility that the schedule for ACNW meetings may be adjusted by the Chairman as necessary to facilitate the conduct of the meeting, persons planning to attend should notify Mr. Howard J. Larson as to their particular needs. 
                </P>
                <P>Further information regarding topics to be discussed, whether the meeting has been canceled or rescheduled, the Chairman's ruling on requests for the opportunity to present oral statements and the time allotted, therefore can be obtained by contacting Mr. Howard J. Larson. </P>
                <P>
                    ACNW meeting agenda, meeting transcripts, and letter reports are available through the NRC Public Document Room at 
                    <E T="03">pdr@nrc.gov,</E>
                     or by calling the PDR at 1-800-397-4209, or from the Publicly Available Records System (PARS) component of NRC's document system (ADAMS) which is accessible from the NRC Web site at 
                    <E T="03">http://www.nrc.gov/reading-rm/adams.html</E>
                     or 
                    <E T="03">http://www.nrc.gov/reading-rm/doc-collections/</E>
                     (ACRS &amp; ACNW Mtg schedules/agendas). 
                </P>
                <P>Video Teleconferencing service is available for observing open sessions of ACNW meetings. Those wishing to use this service for observing ACNW meetings should contact Mr. Theron Brown, ACNW Audiovisual Technician (301) 415-8066), between 7:30 a.m. and 3:45 p.m. e.t., at least 10 days before the meeting to ensure the availability of this service. Individuals or organizations requesting this service will be responsible for telephone line charges and for providing the equipment and facilities that they use to establish the video teleconferencing link. The availability of video teleconferencing services is not guaranteed. </P>
                <SIG>
                    <DATED>Dated: November 8, 2004. </DATED>
                    <NAME>Andrew L. Bates, </NAME>
                    <TITLE>Advisory Committee Management Officer. </TITLE>
                </SIG>
            </PREAMB>
            <FRDOC>[FR Doc. 04-25259 Filed 11-12-04; 8:45 am] </FRDOC>
            <BILCOD>BILLING CODE 7590-01-P </BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <PRTPAGE P="65661"/>
                <AGENCY TYPE="S">NUCLEAR REGULATORY COMMISSION </AGENCY>
                <DEPDOC>[Docket No. 40-8904] </DEPDOC>
                <SUBJECT>Establishment of the U.S. Department of Energy as the Long-Term Custodian of the L-Bar Uranium Mill Tailings Site Near Seboyeta, NM, and Termination of the Sohio Western Mining Company Source Materials License for the L-Bar Site </SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Nuclear Regulatory Commission. </P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice of establishment of the U.S. Department of Energy (DOE) as the long-term custodian of the L-Bar uranium mill tailings site near Seboyeta, New Mexico, under the general license provisions of 10 CFR 40.28, and termination of the Sohio Western Mining Company specific Source Materials License SUA-1472 for the L-Bar site.</P>
                </ACT>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Rick Weller, Project Manager, Fuel Cycle Facilities Branch, Division of Fuel Cycle Safety and Safeguards, Office of Nuclear Material Safety and Safeguards, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001. Telephone: (301) 415-7287; fax number: (301) 415-5955; e-mail: 
                        <E T="03">rmw2@nrc.gov.</E>
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <HD SOURCE="HD1">I. Introduction </HD>
                <P>On September 22, 2004, the Sohio Western Mining Company (SWMC) transferred ownership of the L-Bar uranium mill tailings site near Seboyeta, New Mexico, to the DOE, as required by 10 CFR 40, Appendix A, Criterion 11, prior to termination of SWMC's specific license. Subsequently, by letter dated October 13, 2004, the DOE submitted the final Long-Term Surveillance Plan (LTSP) for the L-Bar site for review by the U.S. Nuclear Regulatory Commission (NRC). Based on the review of the LTSP, the NRC has determined that the LTSP satisfies the requirements in 10 CFR part 40, Appendix A, Criterion 12, and § 40.28 for the long-term surveillance of a tailings disposal site. Accordingly, notice is hereby given that the NRC has accepted the LTSP for the L-Bar site. This acceptance establishes the DOE as the long-term custodian and caretaker of the L-Bar site under the general license specified in 10 CFR 40.28. In a concurrent action, the NRC has terminated the SWMC specific Source Materials License SUA-1472 for the L-Bar site. These actions complete all requirements for closure of the L-Bar site under the Uranium Mill Tailings Radiation Control Act of 1978, as amended. These actions do not require an environmental assessment as they are categorically excluded under 10 CFR 51.22(c)(11). </P>
                <HD SOURCE="HD1">II. Further Information </HD>
                <P>
                    The NRC has prepared correspondence which documents the actions that establish the DOE as the long-term custodian of the L-Bar site under the general license specified in 10 CFR 40.28 and terminate the SWMC specific Source Materials License SUA-1472 for the L-Bar site. In accordance with 10 CFR 2.390 of the NRC's “Rules of Practice,” copies of this correspondence, as well as the L-Bar LTSP submitted by DOE letter dated October 13, 2004, are available electronically at the NRC's Electronic Reading Room at 
                    <E T="03">http://www.nrc.gov/reading-rm/adams.html.</E>
                     From this site, you can access the NRC's Agencywide Document Access and Management System (ADAMS), which provides text and image files of NRC's public documents. The ADAMS accession numbers for the documents related to this notice are listed below. If you do not have access to ADAMS or if there are problems in accessing the documents located in ADAMS, contact the NRC Public Document Room (PDR) Reference staff at 1-800-397-4209, 301-415-4737, or by e-mail to 
                    <E T="03">pdr@nrc.gov.</E>
                </P>
                <HD SOURCE="HD2">Documents Related to This Notice </HD>
                <P>1. Letter dated October 13, 2004, from J. Sink, DOE, to G. Janosko, NRC, submitting the final LTSP for the L-Bar site. ML042920474. </P>
                <P>2. Letter dated October 21, 2004, from G. Janosko, NRC, to J. Sink, DOE, accepting the final LTSP for the L-Bar site. ML043020020. </P>
                <P>3. Letter dated October 21, 2004, from G. Janosko, NRC, to J. Trummel, Kennecott Energy Company, terminating the SWMC specific Source Materials License SUA-1472 for the L-Bar site. ML043020032. </P>
                <P>These documents may also be viewed electronically on the public computers located at the NRC's PDR, O 1 F21, One White Flint North, 11555 Rockville Pike, Rockville, MD 20852. The PDR reproduction contractor will copy documents for a fee. </P>
                <SIG>
                    <DATED>Dated in Rockville, Maryland, this 5th day of November, 2004.</DATED>
                    <P>For the Nuclear Regulatory Commission.</P>
                    <NAME>Gary S. Janosko, </NAME>
                    <TITLE>Chief, Fuel Cycle Facilities Branch, Division of Fuel Cycle Safety and Safeguards, Office of Nuclear Material Safety and Safeguards. </TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 04-25257 Filed 11-12-04; 8:45 am] </FRDOC>
            <BILCOD>BILLING CODE 7590-01-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="N">PENSION BENEFIT GUARANTY CORPORATION</AGENCY>
                <SUBJECT>Required Interest Rate Assumption for Determining Variable-Rate Premium; Interest Assumptions for Multiemployer Plan Valuations Following Mass Withdrawal</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Pension Benefit Guaranty Corporation.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice of interest rates and assumptions.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>
                        This notice informs the public of the interest rates and assumptions to be used under certain Pension Benefit Guaranty Corporation regulations. These rates and assumptions are published elsewhere (or can be derived from rates published elsewhere), but are collected and published in this notice for the convenience of the public. Interest rates are also published on the PBGC's Web site (
                        <E T="03">http://wow.pbgc.go</E>
                        ).
                    </P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>The required interest rate for determining the variable-rate premium under part 4006 applies to premium payment years beginning in November 2004. The interest assumptions for performing multiemployer plan valuations following mass withdrawal under part 4281 apply to valuation dates occurring in December 2004.</P>
                </DATES>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>Harold J. Ashier, Assistant General Counsel, Office of the General Counsel, Pension Benefit Guaranty Corporation, 1200 K Street, NW., Washington, DC 20005, 202-326-4024. (TTY/TDD users may call the Federal relay service toll-free at 1-800-877-8339 and ask to be connected to 202-326-4024.)</P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <HD SOURCE="HD1">Variable-Rate Premiums</HD>
                <P>
                    Section 4006(a)(3)(E)(iii)(II) of the Employee Retirement Income Security Act of 1974 (ERISA) and § 4006.4(b)(1) of the PBGC's regulation on Premium Rates (29 CFR part 4006) prescribe use of an assumed interest rate (the “required interest rate”) in determining a single-employer plan's variable-rate premium. Pursuant to the Pension Funding Equity Act of 2004, for premium payment years beginning in 2004 or 2005, the required interest rate is the “applicable percentage” (currently 85 percent) of the annual rate of interest determined by the Secretary of the Treasury on amounts invested conservatively in long-term investment grade corporate bonds for the month preceding the beginning of the plan year for which premiums are being paid. Thus, the required interest rate to be used in determining variable-rate premiums for premium payment years 
                    <PRTPAGE P="65662"/>
                    beginning in November 2004 is 4.73 percent (
                    <E T="03">i.e.</E>
                    , 85 percent of the 5.57 percent composite corporate bond rate for October 2004 as determined by the Treasury).
                </P>
                <P>The following table lists the required interest rates to be used in determining variable-rate premiums for premium payment years beginning between December 2003 and November 2004. Note that the required interest rate for premium payment years beginning in December 2003 was determined under the Job Creation and Worker Assistance Act of 2002, and that the required interest rates for premium payment years beginning in January through November 2004 were determined under the Pension Funding Equity Act of 2004.</P>
                <GPOTABLE COLS="2" OPTS="L2,tp0,i1" CDEF="s50,12">
                    <TTITLE>  </TTITLE>
                    <BOXHD>
                        <CHED H="1">For premium payment years beginning in: </CHED>
                        <CHED H="1">The required interest rate is: </CHED>
                    </BOXHD>
                    <ROW>
                        <ENT I="01">December 2003*</ENT>
                        <ENT>5.12 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">January 2004** </ENT>
                        <ENT>4.94 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">February 2004** </ENT>
                        <ENT>4.83 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">March 2004** </ENT>
                        <ENT>4.79 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">April 2004** </ENT>
                        <ENT>4.62 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">May 2004** </ENT>
                        <ENT>4.98 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">June 2004** </ENT>
                        <ENT>5.26 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">July 2004** </ENT>
                        <ENT>5.25 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">August 2004** </ENT>
                        <ENT>5.10 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">September 2004**</ENT>
                        <ENT>4.95 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">October 2004** </ENT>
                        <ENT>4.79 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">November 2004** </ENT>
                        <ENT>4.73 </ENT>
                    </ROW>
                    <TNOTE>* The required interest rate for premium payment years beginning in December 2003 was determined under the Job Creation and Worker Assistance Act of 2002. </TNOTE>
                    <TNOTE>** The required interest rates for premium payment years beginning in January through November 2004 were determined under the Pension Funding Equity Act of 2004. </TNOTE>
                </GPOTABLE>
                <HD SOURCE="HD1">Multiemployer Plan Valuations Following Mass Withdrawal</HD>
                <P>
                    The PBGC's regulation on Duties of Plan Sponsor Following Mass Withdrawal (29 CFR part 4281) prescribes the use of interest assumptions under the PBGC's regulation on Allocation of Assets in Single-Employer Plans (29 CFR part 4044). The interest assumptions applicable to valuation dates in December 2004 under part 4044 are contained in an amendment to part 4044 published elsewhere in today's 
                    <E T="04">Federal Register</E>
                    . Tables showing the assumptions applicable to prior periods are codified in appendix B to 29 CFR part 4044.
                </P>
                <SIG>
                    <DATED>Issued in Washington, DC, on this day of November 2004.</DATED>
                    <NAME>Joseph H. Grant,</NAME>
                    <TITLE>Deputy Executive Director and Chief Operating Officer, Pension Benefit Guaranty Corporation.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 04-25321 Filed 11-12-04; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 7708-01-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="N">RAILROAD RETIREMENT BOARD </AGENCY>
                <SUBJECT>Agency Forms Submitted for OMB Review </SUBJECT>
                <P>
                    <E T="03">Summary:</E>
                     In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35), the Railroad Retirement Board (RRB) has submitted the following proposal(s) for the collection of information to the Office of Management and Budget for review and approval. 
                </P>
                <HD SOURCE="HD2">Summary of Proposal(s)</HD>
                <P>
                    (1) 
                    <E T="03">Collection title:</E>
                     Report of Medicaid State Office on Beneficiary's Buy-In-Status. 
                </P>
                <P>
                    (2) 
                    <E T="03">Form(s) submitted:</E>
                     RL-380-F. 
                </P>
                <P>
                    (3) 
                    <E T="03">OMB Number:</E>
                     3220-0185. 
                </P>
                <P>
                    (4) 
                    <E T="03">Expiration date of current OMB clearance:</E>
                     02/28/2005. 
                </P>
                <P>
                    (5) 
                    <E T="03">Type of request:</E>
                     Extension of a currently approved collection. 
                </P>
                <P>
                    (6) 
                    <E T="03">Respondents:</E>
                     State, local or tribal government. 
                </P>
                <P>
                    (7) 
                    <E T="03">Estimated annual number of respondents:</E>
                     600. 
                </P>
                <P>
                    (8) 
                    <E T="03">Total annual responses:</E>
                     600. 
                </P>
                <P>
                    (9) 
                    <E T="03">Total annual reporting hours:</E>
                     100. 
                </P>
                <P>
                    (10) 
                    <E T="03">Collection description:</E>
                     Under the Railroad Retirement Act, the Railroad Retirement Board administers the Medicare program for persons covered by the railroad retirement system. The collection obtains the information needed to determine if certain railroad beneficiaries are entitled to receive Supplementary Medical Insurance program coverage under a state buy-in agreement in states in which they reside. 
                </P>
                <HD SOURCE="HD2">Additional Information or Comments</HD>
                <P>Copies of the forms and supporting documents can be obtained from Charles Mierzwa, the agency clearance officer (312-751-3363). </P>
                <P>Comments regarding the information collection should be addressed to Ronald J. Hodapp, Railroad Retirement Board, 844 North Rush Street, Chicago, Illinois, 60611-2092 and to the OMB Desk Officer for the RRB, at the Office of Management and Budget, Room 10230, New Executive Office Building, Washington, DC 20503. </P>
                <SIG>
                    <NAME>Charles Mierzwa, </NAME>
                    <TITLE>Clearance Officer. </TITLE>
                </SIG>
            </PREAMB>
            <FRDOC>[FR Doc. 04-25290 Filed 11-12-04; 8:45 am] </FRDOC>
            <BILCOD>BILLING CODE 7905-01-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="N">SECURITIES AND EXCHANGE COMMISSION</AGENCY>
                <SUBJECT>Sunshine Act Meeting</SUBJECT>
                <P>Notice is hereby given, pursuant to the provisions of the Government in the Sunshine Act, Pub. L. 94-409, that the Securities and Exchange Commission will hold the following meeting during the week of November 15, 2004:</P>
                <P>A closed meeting will be held on Tuesday, November 16, 2004, at 2 p.m. </P>
                <P>Commissioners, Counsel to the Commissioners, the Secretary to the Commission, and recording secretaries will attend the closed meeting. Certain staff members who have an interest in the matters may also be present.</P>
                <P>The General Counsel of the Commission, or his designee, has certified that, in his opinion, one or more of the exemptions set forth in 5 U.S.C. 552b(c)(3), (5), (6), (7), (9)(B), and (10) and 17 CFR 200.402(a)(3), (5), (7), 9(ii) and (10), permit consideration of the scheduled matters at the closed meeting.</P>
                <P>Commissioner Atkins, as duty officer, voted to consider the items listed for the closed meeting in closed session.</P>
                <P>The subject matter of the closed meeting scheduled for Tuesday, November 16, 2004, will be: </P>
                <P>Formal orders of investigations;</P>
                <P>Institution and settlement of injunctive actions; and</P>
                <P>Institution and settlement of administrative proceedings of an enforcement nature.</P>
                <P>At times, changes in Commission priorities require alterations in the scheduling of meeting items. For further information and to ascertain what, if any, matters have been added, deleted or postponed, please contact:</P>
                <P>The Office of the Secretary at (202) 942-7070.</P>
                <SIG>
                    <DATED>Dated: November 9, 2004.</DATED>
                    <NAME>Jonathan G. Katz,</NAME>
                    <TITLE>Secretary.</TITLE>
                </SIG>
            </PREAMB>
            <FRDOC>[FR Doc. 04-25381 Filed 11-10-04; 11:00 am]</FRDOC>
            <BILCOD>BILLING CODE 8010-01-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">SECURITIES AND EXCHANGE COMMISSION </AGENCY>
                <DEPDOC>[Release No. 34-50642; File No. SR-FICC-2004-06] </DEPDOC>
                <SUBJECT>Self-Regulatory Organizations; Fixed Income Clearing Corporation; Notice of Filing of Proposed Rule Change To Institute Fines for Late Payment of Cash Obligations and Margin and To Institute Informal Hearing Procedures for Fine Disputes </SUBJECT>
                <DATE>November 5, 2004. </DATE>
                <P>
                    Pursuant to section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”),
                    <SU>1</SU>
                    <FTREF/>
                     notice is hereby given that on March 18, 2004, the Fixed Income 
                    <PRTPAGE P="65663"/>
                    Clearing Corporation (“FICC”) filed with the Securities and Exchange Commission (“Commission”) and on April 16, 2004, amended the proposed rule change described in items I, II, and III below, which items have been prepared primarily by FICC. The Commission is publishing this notice to solicit comments on the proposed rule change from interested parties. 
                </P>
                <FTNT>
                    <P>
                        <SU>1</SU>
                         15 U.S.C. 78s(b)(1). 
                    </P>
                </FTNT>
                <HD SOURCE="HD1">I. Self-Regulatory Organization's Statement of the Terms of Substance of the Proposed Rule Change </HD>
                <P>
                    The purpose of the proposed rule change is to institute at the Mortgage Backed Securities Division (“MBSD”) (i) fines for the late payment of cash obligation items 
                    <SU>2</SU>
                    <FTREF/>
                     and margin deficits and (ii) informal hearing procedures for disputed MBSD fines. 
                </P>
                <FTNT>
                    <P>
                        <SU>2</SU>
                         Cash obligation items are cash receivables/payables that have been assigned a due date by the MBSD. 
                    </P>
                </FTNT>
                <HD SOURCE="HD1">II. Self-Regulatory Organization's Statement of the Purpose of, and Statutory Basis for, the Proposed Rule Change </HD>
                <P>
                    In its filing with the Commission, FICC included statements concerning the purpose of and basis for the proposed rule change and discussed any comments it received on the proposed rule change. The text of these statements may be examined at the places specified in item IV below. FICC has prepared summaries, set forth in sections (A), (B), and (C) below, of the most significant aspects of these statements.
                    <SU>3</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>3</SU>
                         The Commission has modified the text of the summaries prepared by FICC. 
                    </P>
                </FTNT>
                <HD SOURCE="HD2">(A) Self-Regulatory Organization's Statement of the Purpose of, and Statutory Basis for, the Proposed Rule Change </HD>
                <P>The purpose of the proposed rule change is to institute at the MBSD (i) fines for the late payment of cash obligation items and margin deficits and (ii) informal hearing procedures for disputed MBSD fines. </P>
                <HD SOURCE="HD3">1. Fines for Late Payments </HD>
                <P>
                    The MBSD has for some time imposed fees in order to promote greater compliance with its cash obligation and margin payment deadlines.
                    <SU>4</SU>
                    <FTREF/>
                     Fees differ from fines in that fines must be reported by FICC to the Commission. FICC management believes that, consistent with the practice of the Government Securities Division (“GSD”) of FICC, assessments for late payment of margin and cash obligation items should be categorized as fines. Management believes that this change will provide a greater incentive for participant compliance with appropriate payment timeframes which will reduce risk to all MBSD participants. 
                </P>
                <FTNT>
                    <P>
                        <SU>4</SU>
                         Currently, the MBSD rules state that failure to pay a cash settlement obligation will result in the assessment of a fine. However, the MBSD Schedule of Charges refers to such charges as “fees,” and they have been processed as fees by MBSD in the past. 
                    </P>
                </FTNT>
                <HD SOURCE="HD3">2. Procedures Relating to Disputed Fines </HD>
                <P>The rules of the MBSD currently contain procedures whereby a participant can dispute any fine assessment through a formal appeal process. FICC believes that, consistent with the practice of the GSD, the fine process would be more effective and equitable and would provide participants with additional due process if an initial less formal dispute process was also included in MBSD's rules. The initial dispute process would be utilized by participants prior to availing themselves of the formal appeal process. A participant that becomes subject to a fine would have the opportunity within seven calendar days to dispute the fine by explaining in writing any mitigating circumstances that contributed to the participant's infraction and to request a fine waiver. Based on such written documentation provided by the participant, management would have the discretion to waive a fine if it believed that sufficient mitigating circumstances had been shown by the participant. If management waives a fine, it would have to inform the Membership and Risk Management Committee (“Committee”) at the next regularly scheduled Committee meeting and would have to explain management's reasons for doing so. The Committee would then have the opportunity to overrule management's action with respect to the waiver. If management chooses to not waive a fine or if its waiver is overruled by the Committee, the participant would have the right to pursue the formal hearing process currently provided for in the FICC Rules. </P>
                <P>FICC is proposing to make parallel changes with respect to the fine dispute process to the MBSD's EPN rules. </P>
                <P>In addition, FICC is proposing certain technical changes to the MBSD's Schedules of Charges to (i) delete references to “MBSCC” and replace them with references to “MBSD” and (ii) eliminate obsolete fees which are no longer being charged by the MBSD.</P>
                <P>
                    FICC believes that the proposed rule change is consistent with the requirements of section 17A of the Act 
                    <SU>5</SU>
                    <FTREF/>
                     and the rules and regulations thereunder applicable to FICC because it is designed to perfect the mechanism of a national system for the prompt and accurate clearance and settlement of securities transactions by (i) encouraging participants to make timely payments of cash obligation items and margin to MBSD and (ii) clearly setting forth in FICC's rules procedures for management's review and possible waiver of fines which should provide members with a more efficient and less burdensome method for the possible resolution of disputed fines before a full hearing takes place. 
                </P>
                <FTNT>
                    <P>
                        <SU>5</SU>
                         15 U.S.C. 78q-1.
                    </P>
                </FTNT>
                <HD SOURCE="HD2">(B) Self-Regulatory Organization's Statement on Burden on Competition </HD>
                <P>FICC does not believe that the proposed rule change will have any impact or impose any burden on competition.</P>
                <HD SOURCE="HD2">(C) Self-Regulatory Organization's Statement on Comments on the Proposed Rule Change Received From Members, Participants or Others </HD>
                <P>Written comments relating to the proposed rule change have not yet been solicited or received. FICC will notify the Commission of any written comments received by FICC. </P>
                <HD SOURCE="HD1">III. Date of Effectiveness of the Proposed Rule Change and Timing for Commission Action </HD>
                <P>
                    Within 35 days of the date of publication of this notice in the 
                    <E T="04">Federal Register</E>
                     or within such longer period (i) as the Commission may designate up to ninety days of such date if it finds such longer period to be appropriate and publishes its reasons for so finding or (ii) as to which the self-regulatory organization consents, the Commission will:
                </P>
                <P>(A) By order approve such proposed rule change or </P>
                <P>(B) Institute proceedings to determine whether the proposed rule change should be disapproved. </P>
                <HD SOURCE="HD1">IV. Solicitation of Comments </HD>
                <P>Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods: </P>
                <HD SOURCE="HD2">Electronic Comments</HD>
                <P>
                    • Use the Commission's Internet comment form (
                    <E T="03">http://www.sec.gov/rules/sro.shtml</E>
                    ); or 
                </P>
                <P>
                    • Send an E-mail to 
                    <E T="03">rule-comments@sec.gov</E>
                    . Please include File Number SR-FICC-2004-06 on the subject line. 
                    <PRTPAGE P="65664"/>
                </P>
                <HD SOURCE="HD2">Paper Comments</HD>
                <P>• Send paper comments in triplicate to Jonathan G. Katz, Secretary, Securities and Exchange Commission, 450 Fifth Street, NW., Washington, DC 20549-0609. </P>
                <P>
                    All submissions should refer to File Number SR-FICC-2004-06. This file number should be included on the subject line if e-mail is used. To help the Commission process and review your comments more efficiently, please use only one method. The Commission will post all comments on the Commission's Internet Web site (
                    <E T="03">http://www.sec.gov/rules/sro.shtml</E>
                    ). Copies of the submission, all subsequent amendments, all written statements with respect to the proposed rule change that are filed with the Commission, and all written communications relating to the proposed rule change between the Commission and any person, other than those that may be withheld from the public in accordance with the provisions of 5 U.S.C. 552, will be available for inspection and copying in the Commission's Public Reference Section, 450 Fifth Street, NW., Washington, DC 20549. Copies of such filing also will be available for inspection and copying at the principal office of FICC and on FICC's Web site at 
                    <E T="03">http://www.ficc.com</E>
                    . All comments received will be posted without change; the Commission does not edit personal identifying information from submissions. You should submit only information that you wish to make available publicly. 
                </P>
                <P>All submissions should refer to File Number SR-FICC-2004-06 and should be submitted on or before December 6, 2004. </P>
                <SIG>
                    <P>
                        For the Commission by the Division of Market Regulation, pursuant to delegated authority.
                        <SU>6</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>6</SU>
                             17 CFR 200.30-3(a)(12). 
                        </P>
                    </FTNT>
                    <NAME>Margaret H. McFarland, </NAME>
                    <TITLE>Deputy Secretary.</TITLE>
                </SIG>
            </PREAMB>
            <FRDOC> [FR Doc. E4-3157 Filed 11-12-04; 8:45 am] </FRDOC>
            <BILCOD>BILLING CODE 8010-01-P </BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">SECURITIES AND EXCHANGE COMMISSION </AGENCY>
                <DEPDOC>[Release No. 34-50640; File No. SR-NASD-2004-172] </DEPDOC>
                <SUBJECT>Self-Regulatory Organizations; National Association of Securities Dealers, Inc.; Notice of Filing and Immediate Effectiveness of Proposed Rule Change Regarding Pilot Modifications and Minor Modifications to the Nasdaq Opening Process for Nasdaq-Listed Stocks </SUBJECT>
                <DATE>November 5, 2004. </DATE>
                <P>
                    Pursuant to section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”),
                    <SU>1</SU>
                    <FTREF/>
                     and Rule 19b-4 thereunder,
                    <SU>2</SU>
                    <FTREF/>
                     notice is hereby given that on November 3, 2004, the National Association of Securities Dealers, Inc. (“NASD”), through its subsidiary, The Nasdaq Stock Market, Inc. (“Nasdaq”), filed with the Securities and Exchange Commission (“Commission”) the proposed rule change as described in items I and II below, which items have been prepared by Nasdaq. Nasdaq has designated the proposed rule change as “non-controversial” under section 19(b)(3)(A) of the Act 
                    <SU>3</SU>
                    <FTREF/>
                     and Rule 19b-4(f)(6) thereunder,
                    <SU>4</SU>
                    <FTREF/>
                     which renders the proposed rule change effective upon filing with the Commission. The Commission is publishing this notice to solicit comments on the proposed rule change from interested persons. 
                </P>
                <FTNT>
                    <P>
                        <SU>1</SU>
                         15 U.S.C. 78s(b)(1).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>2</SU>
                         17 CFR 240.19b-4.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>3</SU>
                         15 U.S.C. 78s(b)(3)(A). 
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>4</SU>
                         17 CFR 240.19b-4(f)(6).
                    </P>
                </FTNT>
                <HD SOURCE="HD1">I. Self-Regulatory Organization's Statement of the Terms of Substance of the Proposed Rule Change </HD>
                <P>
                    Nasdaq is filing the proposed rule change to modify the opening process for Nasdaq securities as follows: (1) Establish a three-month pilot during which Nasdaq would reject the entry of Total Day Orders prior to 9:25 a.m.; (2) clarify the language of Rule 4704(a)(8) which governs the suspension between 9:28 and 9:30 a.m. of requests for cancellation or modification of Regular Hours Orders; and (3) clarify the language of Rule 4120(a)(7) which governs the opening of stocks that are subject to a trade halt. The text of the proposed rule change is set forth below.
                    <SU>5</SU>
                    <FTREF/>
                     Proposed new language is in italics; proposed deletions are in [brackets].
                    <SU>6</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>5</SU>
                         The proposed rule change is marked to show changes from the rule text appearing in the NASD Manual available at 
                        <E T="03">www.nasd.com</E>
                         and the rule text approved by the Commission in Securities Exchange Act Release No. 50405 (September 16, 2004), 69 FR 57118 (September 23, 2004) (SR-NASD-2004-071), and amended in Securities Exchange Act Release No. 50602 (October 28, 2004), 69 FR 64350 (November 4, 2004) (SR-NASD-2004-152). This sentence was corrected by the Commission to reflect the fact that the NASD Manual available at 
                        <E T="03">www.nasd.com</E>
                         has not been updated to include the rule text for NASD Rule 4704. Telephone conversation between Jeffrey S. Davis, Associate Vice President and Associate General Counsel, Nasdaq, and Ann E. Leddy, Special Counsel, Division of Market Regulation (“Division”), Commission (November 4, 2004). 
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>6</SU>
                         The Commission corrected proposed rule text on Nasdaq's behalf to mark changes in Rule 4704(a)(8) and new subparagraph (b)(3). Telephone conversation between Jeffrey S. Davis, Associate Vice President and Associate General Counsel, Nasdaq, and Ann E. Leddy, Special Counsel, Division, Commission (November 4, 2004).
                    </P>
                </FTNT>
                <STARS/>
                <HD SOURCE="HD3">4120. Trading Halts </HD>
                <P>(a) No Change. </P>
                <P>(b) Procedure for Initiating a Trading Halt. </P>
                <P>(1)-(6) No Change. </P>
                <P>(7) A trading halt initiated under Rule 4120(a)(7) shall be terminated when Nasdaq releases the security for trading. Prior to terminating the halt, there will be a 15-minute period during which market participants may enter quotes in that security in Nasdaq systems. [If the inside market is not locked or crossed at the conclusion of that 15-minute period, Nasdaq will release the security for trading and terminate the halt. If the inside market is locked or crossed at the conclusion of the initial 15-minute period, Nasdaq will extend the halt for an additional 15 minutes during which quotations may be entered in Nasdaq systems.] At the conclusion of the [second] 15-minute period, the halt shall be terminated and the security released for trading. </P>
                <STARS/>
                <HD SOURCE="HD3">4701. Definitions </HD>
                <P>(a)-(rr) No Change. </P>
                <P>(ss) The term “Total Day” or “X Order” shall mean, </P>
                <P>(a) No Change. </P>
                <P>
                    (b) For orders in Nasdaq-listed securities so designated, that if after entry into the Nasdaq Market Center, the order is not fully executed, the order (or unexecuted portion thereof) shall remain available for potential display [between 7:30 a.m. and 4:00 p.m. and for potential] 
                    <E T="03">and</E>
                     execution between 9:25 a.m. and 4:00 p.m., after which it shall be returned to the entering party. 
                    <E T="03">X Orders entered prior to 9:25 a.m. will be rejected back to the entering party.</E>
                </P>
                <P>(tt)-(uu) No Change. </P>
                <STARS/>
                <HD SOURCE="HD3">4704. Opening Process for Nasdaq-Listed Securities </HD>
                <P>
                    (a) Definitions. For the purposes of this rule the term: 
                    <PRTPAGE P="65665"/>
                </P>
                <P>(1)-(7) No Change. </P>
                <P>
                    (8) “Regular Hours Orders” shall mean any order that may be entered into the system and designated with a time-in-force of IOC, DAY, or GTC. Regular Hours Orders shall be available for execution only during the opening and then during normal trading hours. Regular Hours Orders shall be designated as “Early Regular Hours Orders” if entered into the system prior to 9:28 a.m. and designated as “Late Regular Hours Orders” if entered into the system at 9:28 a.m. or after. Beginning at 9:28 a.m., requests to cancel or modify Regular Hours Orders shall be suspended until after completion of the Opening Cross at which time such requests shall be processed
                    <E T="03">, to the extent that such orders remain available within the system.</E>
                </P>
                <P>(b) Trading Prior To Normal Market Hours. The system shall open all eligible Quotes[/Orders] in Nasdaq-listed securities at 9:25 a.m. in the following manner to prevent the creation of locked/crossed markets. </P>
                <P>(1) At 9:25 a.m., the system shall open all Quotes [and limit priced X Orders] in time priority. Quotes [and X Orders] whose limit price does not lock or cross the book shall be added to the book in strict time priority. Quotes [and X Orders] whose limit price would lock or cross the book shall be placed in an “In Queue” state. </P>
                <P>(2) Next, the system shall begin processing the In Queue Quotes[, IOX Orders, and X Orders] in strict time priority against the best bid (ask) if the In Queue order is a sell (buy) order. If an In Queue Quote [or X Order] is not executable when it is next in time for execution, the system shall automatically add that Quote [or X Order] to the book. </P>
                <P>[(3) All Quotes and X Orders that are entered while the system is completing subparagraphs (1) and (2) shall be added to the In Queue file in strict time priority.] </P>
                <P>
                    ([4]
                    <E T="03">3</E>
                    ) Once the process set forth in subparagraphs (1)-([3]
                    <E T="03">2</E>
                    ) is complete, the system shall begin processing Quotes and X and IOX Orders in accordance with their entry parameters 
                </P>
                <P>(5)-(6) Re-numbered as (4) and (5). </P>
                <P>(c)-(d) No Change. </P>
                <STARS/>
                <HD SOURCE="HD1">II. Self-Regulatory Organization's Statement of the Purpose of, and Statutory Basis for, the Proposed Rule Change </HD>
                <P>In its filing with the Commission, Nasdaq included statements concerning the purpose of and basis for the proposed rule change and discussed any comments it received on the proposed rule change. The text of these statements may be examined at the places specified in item IV below. Nasdaq has prepared summaries, set forth in sections A, B, and C below, of the most significant aspects of such statements. </P>
                <HD SOURCE="HD2">A. Self-Regulatory Organization's Statement of the Purpose of, and Statutory Basis for, the Proposed Rule Change </HD>
                <HD SOURCE="HD3">1. Purpose </HD>
                <P>
                    Nasdaq has previously proposed to create two new voluntary opening processes—the Modified Opening Process and the Nasdaq Opening Cross—that together constitute the beginning of the trading day for all Nasdaq-listed securities. The Commission approved that proposal on September 16, 2004.
                    <SU>7</SU>
                    <FTREF/>
                     Upon implementation of the Opening Cross, Nasdaq has identified several modifications to the operation and rules governing the pre-opening trading environment that it believes would improve the fair and orderly opening of the market in Nasdaq listed securities. 
                </P>
                <FTNT>
                    <P>
                        <SU>7</SU>
                         
                        <E T="03">See,</E>
                         Securities Exchange Act Release No. 50405 (September 16, 2004), 69 FR 57118 (September 23, 2004) (SR-NASD-2004-071). 
                    </P>
                </FTNT>
                <P>Specifically, upon implementing the improved pre-opening trading environment set forth in Rule 4704(b), Nasdaq identified a harmful unintended consequence of the Modified Opening Process (“MOP”) by which Nasdaq establishes its opening order book and unlocks and uncrosses the market. As described in SR-NASD-2004-071, firms have three options for determining the price at which their carryover quotes are opened at 9:25: (1) The last quotation price entered during the previous day; (2) the last quotation price the firm enters after 7:30 and before 9:25 a.m.; or (3) the quote limits for Nasdaq, currently $.01 (bid) and $2,000 (ask). Many Nasdaq participants have programmed their quotation management systems to select the first option, carrying over the final quotation entered during the previous trading day. At the same time, a small number of firms have entered X Orders into Nasdaq's system that cross the market by a significant amount, in some cases by as much as 20 dollars. When Nasdaq applies the MOP, which automatically executes orders that would cross the market, the system executes those X Orders that are significantly away from the market against the stale carryover quotations of other members resulting in inferior executions. </P>
                <P>To address this situation quickly, Nasdaq proposes to change the pre-opening trading environment for a three-month pilot period. Specifically, Nasdaq proposes to move the beginning entry time for X Orders from 7:30 a.m. to 9:25 a.m. As a result, X Orders would not participate in the market opening process described in Rule 4704(b), which begins at 9:25 a.m., and there would be no risk of X Orders automatically executing against a stale quote during that process. Nasdaq believes that this proposed change is necessary and sufficient to address quickly the harmful unintended consequence described above and preserve a fair and orderly opening of trading in Nadsaq. Nasdaq is aware that these changes impose a burden on some firms, but it has concluded that this approach would be the fastest way to effectively address the situation and improve the quality of executions in the MOP. It is important to note that participation in pre-opening trading is completely voluntary on firms' part, that the actual opening of the market and concomitant market maker obligations would continue to begin at 9:30 a.m. as is the case today. </P>
                <P>In addition, Nasdaq is already designing further system modifications that would address the problem on a permanent basis. Specifically, Nasdaq is considering three potential changes: (1) Applying the Market Opening Process at 9 a.m. rather than 9:25 as currently approved; (2) extending the availability of Total Day and Total Immediate or Cancel Orders to 9 a.m. from 9:25 as currently approved; and (3) establishing a system default that protects market participants from unexpected executions upon the opening of Nasdaq's execution functionality at 9 a.m. These modifications would provide a more efficient long-term solution, but they would take longer to implement than simply rejecting X Orders until 9:25. Nasdaq believes it is imperative to address the situation quickly and to simultaneously pursue a long-term solution. </P>
                <P>
                    Nasdaq has identified two additional technical modifications, unrelated to the substantive proposal at hand, that it believes would eliminate potential confusion about the effect of Nasdaq's approved rules. First, Nasdaq proposes to clarify that requests for suspension or modification of orders governed by Rule 4704(a)(8) would be processed only if such orders remain available for execution within Nasdaq's system. Such orders would not be available if, for example, the system executed the order during the Nasdaq Opening Cross or during the opening process for non-cross eligible Nasdaq securities. 
                    <PRTPAGE P="65666"/>
                </P>
                <P>Second, Nasdaq proposes to modify the language of Rule 4120(a)(7) to clarify the manner in which Nasdaq will open trading in stocks that are the subject of an initial public offering (“IPO”). Currently Rule 4120(a)(7) provides for up to two 15-minute Quote Only Periods prior to the release of trading in an IPO. The second quote only period is necessary only in the event that the market is locked or crossed at the end of the first quote only period. The MOP is designed to create an unlocked and uncrossed bid and offer for the opening of trading, and to execute quotes and orders that would lock or cross the market in a fair and orderly manner. Because Nasdaq would apply the MOP at the close of the first 15-minute Quote Only Period, and the MOP will automatically unlock/uncross the market, the second 15-minute period is unnecessary. </P>
                <HD SOURCE="HD3">2. Statutory Basis </HD>
                <P>
                    Nasdaq believes that the proposed rule change is consistent with the provisions of section 15A of the Act,
                    <SU>8</SU>
                    <FTREF/>
                     in general, and with section 15A(b)(6) of the Act,
                    <SU>9</SU>
                    <FTREF/>
                     in particular, in that section 15A(b)(6) requires, among other things, that the NASD's rules be designed to protect investors and the public interest. Nasdaq believes that its current proposal is consistent with the NASD's obligations under these provisions of the Act because it would result in a more orderly opening for all Nasdaq stocks. The proposed rule change would create a fair, orderly, and unified opening for Nasdaq stocks, prevent the occurrence of locked and crossed markets in halted securities, and preserve price discovery and transparency that is vital to an effective opening of trading. 
                </P>
                <FTNT>
                    <P>
                        <SU>8</SU>
                         15 U.S.C. 78
                        <E T="03">o</E>
                        -3.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>9</SU>
                         15 U.S.C. 78
                        <E T="03">o</E>
                        -3(b)(6).
                    </P>
                </FTNT>
                <HD SOURCE="HD2">B. Self-Regulatory Organization's Statement on Burden on Competition </HD>
                <P>Nasdaq does not believe that the proposed rule change would result in any burden on competition that is not necessary or appropriate in furtherance of the purposes of the Act.</P>
                <HD SOURCE="HD2">C. Self-Regulatory Organization's Statement on Comments on the Proposed Rule Change Received From Members, Participants or Others </HD>
                <P>Nasdaq neither solicited nor received written comments with respect to the proposed rule change. </P>
                <HD SOURCE="HD1">III. Date of Effectiveness of the Proposed Rule Change and Timing for Commission Action </HD>
                <P>Because the foregoing proposed rule change does not: </P>
                <P>(i) Significantly affect the protection of investors or the public interest; </P>
                <P>(ii) Impose any significant burden on competition; and </P>
                <P>
                    (iii) Become operative for 30 days from the date on which it was filed, or such shorter time as the Commission may designate, if consistent with the protection of investors and the public interest,
                    <SU>10</SU>
                    <FTREF/>
                     it has become effective pursuant to section 19(b)(3)(A) of the Act 
                    <SU>11</SU>
                    <FTREF/>
                     and Rule 19b-4(f)(6) thereunder.
                    <SU>12</SU>
                    <FTREF/>
                     At any time within 60 days of the filing of the proposed rule change, the Commission may summarily abrogate such rule change if it appears to the Commission that such action is necessary or appropriate in the public interest, for the protection of investors, or otherwise in furtherance of the purposes of the Act. 
                </P>
                <FTNT>
                    <P>
                        <SU>10</SU>
                         The Commission revised this section to add the representations on Nasdaq's behalf that the proposed rule change does not significantly affect the protection of investors or the public interest and does not impose any significant burden on competition. Nasdaq made these representations in the filing itself but failed to include them in the exhibit. Telephone conversation between Jeffrey S. Davis, Associate Vice President and Associate General Counsel, Nasdaq, and Ann E. Leddy, Special Counsel, Division, Commission (November 4, 2004). 
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>11</SU>
                         15 U.S.C. 78s(b)(3)(A).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>12</SU>
                         17 CFR 240.19b-4(f)(6). The Commission notes that Nasdaq provided written notice of its intent to file the proposed rule change, along with a brief description and text of the proposed rule change at least five business days prior to the date of filing of the proposed rule change. 
                    </P>
                </FTNT>
                <P>
                    Nasdaq has requested that the Commission waive the 30-day operative delay. The Commission believes that waiving the 30-day operative delay is consistent with the protection of investors and the public interest because it will allow Nasdaq to implement the proposed pilot without delay, which should provide a temporary remedy to the problem posed by X Orders automatically executing against stale quotes during the MOP. The Commission also believes that waiving the 30-day operative delay would permit Nasdaq to effect the clarifying changes to Rule 4120(b)(7) and Rule 4704(a)(8) without delay. For this reason, the Commission designates the proposal to be effective and operative upon filing with the Commission.
                    <SU>13</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>13</SU>
                         For purposes only of waiving the 30-day operative delay of the proposed rule change, the Commission considered the proposed rule's impact on efficiency, competition, and capital formation. 15 U.S.C. 78c(f). 
                    </P>
                </FTNT>
                <HD SOURCE="HD1">IV. Solicitation of Comments </HD>
                <P>Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods: </P>
                <HD SOURCE="HD2">Electronic Comments</HD>
                <P>
                    • Use the Commission's Internet comment form 
                    <E T="03">(http://www.sec.gov/rules/sro.shtml);</E>
                     or 
                </P>
                <P>
                    • Send an e-mail to 
                    <E T="03">rule-comments@sec.gov.</E>
                     Please include File Number SR-NASD-2004-172 on the subject line. 
                </P>
                <HD SOURCE="HD2">Paper Comments </HD>
                <P>• Send paper comments in triplicate to Jonathan G. Katz, Secretary, Securities and Exchange Commission, 450 Fifth Street, NW., Washington, DC 20549-0609. </P>
                <P>
                    All submissions should refer to File Number SR-NASD-2004-172. This file number should be included on the subject line if e-mail is used. To help the Commission process and review your comments more efficiently, please use only one method. The Commission will post all comments on the Commission's Internet Web site 
                    <E T="03">(http://www.sec.gov/rules/sro.shtml)</E>
                    . Copies of the submission, all subsequent amendments, all written statements with respect to the proposed rule change that are filed with the Commission, and all written communications relating to the proposed rule change between the Commission and any person, other than those that may be withheld from the public in accordance with the provisions of 5 U.S.C. 552, will be available for inspection and copying in the Commission's Public Reference Room. Copies of such filing also will be available for inspection and copying at the principal office of the NASD. All comments received will be posted without change; the Commission does not edit personal identifying information from submissions. You should submit only information that you wish to make available publicly. All submissions should refer to File Number SR-NASD-2004-172 and should be submitted on or before December 6, 2004. 
                </P>
                <SIG>
                    <PRTPAGE P="65667"/>
                    <P>
                        For the Commission, by the Division of Market Regulation, pursuant to delegated authority.
                        <SU>14</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>14</SU>
                             17 CFR 200.30-3(a)(12). 
                        </P>
                    </FTNT>
                    <NAME>Margaret H. McFarland, </NAME>
                    <TITLE>Deputy Secretary.</TITLE>
                </SIG>
            </PREAMB>
            <FRDOC> [FR Doc. E4-3160 Filed 11-12-04; 8:45 am] </FRDOC>
            <BILCOD>BILLING CODE 8010-01-P </BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">SECURITIES AND EXCHANGE COMMISSION </AGENCY>
                <DEPDOC>[Release No. 34-50647; File No. SR-NASD-2004-158] </DEPDOC>
                <SUBJECT>Self-Regulatory Organizations; Notice of Filing and Immediate Effectiveness of Proposed Rule Change by the National Association of Securities Dealers, Inc. To Establish Fee for Direct ECN Connections to the Nasdaq Market Center </SUBJECT>
                <DATE>November 8, 2004. </DATE>
                <P>
                    Pursuant to section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”),
                    <SU>1</SU>
                    <FTREF/>
                     and Rule 19b-4 thereunder,
                    <SU>2</SU>
                    <FTREF/>
                     notice is hereby given that on October 22, 2004, the National Association of Securities Dealers, Inc. (“NASD”), through its subsidiary, the Nasdaq Stock Market, Inc. (“Nasdaq”), filed with the Securities and Exchange Commission (“Commission”) the proposed rule change as described in items I, II, and III below, which Items have been prepared by Nasdaq. Nasdaq has designated this proposal as one establishing or changing a due, fee, or other charge imposed by the self-regulatory organization under section 19(b)(3)(A)(ii) of the Act 
                    <SU>3</SU>
                    <FTREF/>
                     and Rule 19b-4(f)(2) thereunder,
                    <SU>4</SU>
                    <FTREF/>
                     which renders the rule effective upon Commission receipt of this filing. The Commission is publishing this notice to solicit comments on the proposed rule change from interested persons. 
                </P>
                <FTNT>
                    <P>
                        <SU>1</SU>
                         15 U.S.C. 78s(b)(1).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>2</SU>
                         17 CFR 240.19b-4.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>3</SU>
                         15 U.S.C. 78s(b)(3)(A)(ii).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>4</SU>
                         17 CFR 240.19b-4(f)(2).
                    </P>
                </FTNT>
                <HD SOURCE="HD1">I. Self-Regulatory Organization's Statement of the Terms of the Substance of the Proposed Rule Change </HD>
                <P>Nasdaq proposes to establish a fee for direct connections by electronic communication networks (“ECNs”) to the Nasdaq Market Center. Nasdaq will implement the proposed rule change immediately. The text of the proposed rule change is below. Proposed new language is in italic. </P>
                <HD SOURCE="HD3">7000. Charges for Services and Equipment </HD>
                <HD SOURCE="HD3">7010. System Services </HD>
                <P>(a)-(e) No change. </P>
                <P>
                    (f) Nasdaq Workstation
                    <SU>TM</SU>
                     Service. 
                </P>
                <P>(1) (A) The following charges shall apply to the receipt of Level 2 or Level 3 Nasdaq Service via equipment and communications linkages prescribed for the Nasdaq Workstation II Service:</P>
                <GPOTABLE COLS="2" OPTS="L0,tp0,p0,8/9,g1,t1,i1" CDEF="s100,r200">
                    <TTITLE>  </TTITLE>
                    <BOXHD>
                        <CHED H="1">  </CHED>
                        <CHED H="1">  </CHED>
                    </BOXHD>
                    <ROW>
                        <ENT I="01">Service Charge </ENT>
                        <ENT>$2,035/month per service delivery platform (“SDP”) connected via T1 circuits; $1,000/month per SDP connected via Digital Subscriber Line (“DSL”), plus $1,000 per DSL early termination fee if service is terminated within 60 days of installation.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Display Charge </ENT>
                        <ENT>$525/month per logon for the first 150 logons; $200/month for each additional logon.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Additional Circuit/SDP Charge </ENT>
                        <ENT>$3,235/month.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="11">PD and SDP Maintenance:</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="03">Monthly maintenance agreement </ENT>
                        <ENT>$55/presentation device (“PD”) logon or SDP/month.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="03">Hourly fee for maintenance provided without monthly maintenance agreement</ENT>
                        <ENT>$195 per hour (two hour minimum), plus cost of parts.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">
                            <E T="03">ECN Direct Connection</E>
                              
                        </ENT>
                        <ENT>
                            <E T="03">$1,000 per port pair per month.</E>
                        </ENT>
                    </ROW>
                </GPOTABLE>
                (B)—(D) No change. 
                <P>(2) No change. </P>
                <P>(g)-(w) No change. </P>
                <STARS/>
                <HD SOURCE="HD1">II. Self-Regulatory Organization's Statement of the Purpose of, and Statutory Basis for, the Proposed Rule Change </HD>
                <P>In its filing with the Commission, Nasdaq included statements concerning the purpose of and basis for the proposed rule change and discussed any comments it received on the proposed rule change. The text of these statements may be examined at the places specified in item IV below. Nasdaq has prepared summaries, set forth in sections A, B, and C below, of the most significant aspects of such statements. </P>
                <HD SOURCE="HD2">A. Self-Regulatory Organization's Statement of the Purpose of, and Statutory Basis for, the Proposed Rule Change </HD>
                <HD SOURCE="HD3">1. Purpose </HD>
                <P>
                    Currently, ECNs connect to Nasdaq through an application programming interface (“API”) protocol that relies upon a Service Delivery Platform (“SDP”), a server machine containing Nasdaq-installed software that is located at the premises of the ECN. Nasdaq is now introducing an option for ECNs to connect to Nasdaq through a dedicated point-to-point linkage to Nasdaq Market Center host computers, rather than through an SDP. Nasdaq believes that allowing ECNs to establish a direct connection will enhance their ability to interact with the Nasdaq Market Center in an efficient manner, and that those ECNs that continue to quote in Nasdaq will respond favorably to being allowed to establish direct connections. In fact, one such ECN has already commenced testing such a connection and is prepared to avail itself of the service once it is made available. Accordingly, Nasdaq is proposing to offer such connections at a fee of $1,000 per port pair per month, as an alternative to an SPD/API connection. This fee compares favorably with the current fee of $2,035 per SPD per month.
                    <SU>5</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>5</SU>
                         NASD Rules provide that order-delivery ECNs must respond to messages sent to them by the system within 5 seconds on average, and in no event later than 30 seconds for any one message. Nasdaq recently filed a related proposed rule change to NASD Rule 4710 to provide that the response time of an order-delivery ECN may be measured either by the ECN's SDP (in the case of ECN's using SDPs) or by the Nasdaq Market Center (in the case of ECNs opting to establish direct connections. 
                        <E T="03">See</E>
                         SR-NASD-2004-156 (October 15, 2004).
                    </P>
                </FTNT>
                <HD SOURCE="HD3">2. Statutory Basis </HD>
                <P>
                    Nasdaq believes that the proposed rule change is consistent with the provisions of section 15A of the Act,
                    <SU>6</SU>
                    <FTREF/>
                     in general, and sections 15A(b)(5) of the Act,
                    <SU>7</SU>
                    <FTREF/>
                     in particular, in that it provides for the equitable allocation of reasonable dues, fees and other charges among members and issuers and other persons using any facility or system which the NASD operates or controls. The proposed rule change will provide ECNs 
                    <PRTPAGE P="65668"/>
                    with a cost-effective means to establish direct connections, which can be expected to improve the speed and certainty of execution in the market, to the benefit of all market participants.
                </P>
                <FTNT>
                    <P>
                        <SU>6</SU>
                         15 U.S.C. 78o-3.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>7</SU>
                         15 U.S.C. 78o-3(5).
                    </P>
                </FTNT>
                <HD SOURCE="HD2">B. Self-Regulatory Organization's Statement on Burden on Competition</HD>
                <P>Nasdaq does not believe that the proposed rule change will result in any burden on competition that is not necessary or appropriate in furtherance of the purposes of the Act.</P>
                <HD SOURCE="HD2">C. Self-Regulatory Organization's Statement on Comments on the Proposed Rule Change Received From Members, Participants, or Others</HD>
                <P>Written comments were neither solicited nor received.</P>
                <HD SOURCE="HD1">III. Date of Effectiveness of the Proposed Rule Change and Timing for Commission Action</HD>
                <P>
                    The foregoing rule change has become effective pursuant to section 19(b)(3)(A)(ii) of the Act 
                    <SU>8</SU>
                    <FTREF/>
                     and subparagraph (f)(2) of Rule 19b-4 thereunder,
                    <SU>9</SU>
                    <FTREF/>
                     because it establishes or changes a due, fee, or other charge. At any time within 60 days of the filing of the proposed rule change, the Commission may summarily abrogate such rule change if it appears to the Commission that such action is necessary or appropriate in the public interest, for the protection of investors, or otherwise in furtherance of the purposes of the Act.
                </P>
                <FTNT>
                    <P>
                        <SU>8</SU>
                         15 U.S.C. 78s(b)(3)(a)(ii).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>9</SU>
                         17 CFR 240.19b-4(f)(2).
                    </P>
                </FTNT>
                <HD SOURCE="HD1">IV. Solicitation of Comments</HD>
                <P>Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including whether the proposed rule change, as amended, is consistent with the Act. Comments may be submitted by any of the following methods:</P>
                <HD SOURCE="HD2">Electronic Comments</HD>
                <P>
                    • Use the Commission's Internet comment form (
                    <E T="03">http://www.sec.gov/rules/sro.shtml</E>
                    ); or
                </P>
                <P>
                    • Send an e-mail to 
                    <E T="03">rule-comments@sec.gov.</E>
                     Please include File Number SR-NASD-2004-158 on the subject line.
                </P>
                <HD SOURCE="HD2">Paper Comments</HD>
                <P>• Send paper comments in triplicate to Jonathan G. Katz, Secretary, Securities and Exchange Commission, 450 Fifth Street, NW., Washington, DC 20549-0609.</P>
                <P>
                    All submissions should refer to File Number SR-NASD-2004-158. This file number should be included on the subject line if e-mail is used. To help the Commission process and review your comments more efficiently, please use only one method. The Commission will post all comments on the Commission's Internet Web site (
                    <E T="03">http://www.sec.gov/rules/sro.shtml</E>
                    ). Copies of the submission, all subsequent amendments, all written statements with respect to the proposed rule change that are filed with the Commission, and all written communications relating to the proposed rule change between the Commission and any person, other than those that may be withheld from the public in accordance with the provisions of 5 U.S.C. 552, will be available for inspection and copying in the Commission's Public Reference Section, 450 Fifth Street, NW., Washington, DC 20549. Copies of such filing also will be available for inspection and copying at the principal office of the NASD. All comments received will be posted without change; the Commission does not edit personal identifying information from submissions. You should submit only information that you wish to make available publicly. All submissions should refer to File Number SR-NASD-2004-158 and should be submitted on or before December 6, 2004.
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>10</SU>
                         17 CFR 200.30-3(a)(12).
                    </P>
                </FTNT>
                <SIG>
                    <P>
                        For the Commission, by the Division of Market Regulation, pursuant to delegated authority.
                        <SU>10</SU>
                    </P>
                    <NAME>Jill M. Peterson,</NAME>
                    <TITLE>Assistant Secretary.</TITLE>
                </SIG>
            </PREAMB>
            <FRDOC>[FR Doc. E4-3163 Filed 11-12-04; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 8010-01-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">SECURITIES AND EXCHANGE COMMISSION </AGENCY>
                <DEPDOC>[Release No. 34-50643; File No. SR-PCX-2004-98] </DEPDOC>
                <SUBJECT>Self-Regulatory Organizations; Notice of Filing and Immediate Effectiveness of Proposed Rule Change by the Pacific Exchange, Inc. To Extend Until 1:15 (Pacific Time) the Core Trading Session and Change the Closing Auction Time for Certain ETFs </SUBJECT>
                <DATE>November 5, 2004. </DATE>
                <P>
                    Pursuant to section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”) 
                    <SU>1</SU>
                    <FTREF/>
                     and Rule 19b-4 thereunder,
                    <SU>2</SU>
                    <FTREF/>
                     notice is hereby given that on October 12, 2004, the Pacific Exchange, Inc. (“PCX” or “Exchange”) filed with the Securities and Exchange Commission (“Commission”) the proposed rule change as described in items I, II, and III below, which items have been prepared by the PCX. On November 3, 2004, the PCX filed Amendment No. 1 to the proposed rule change.
                    <SU>3</SU>
                    <FTREF/>
                     The Exchange proposed the rule change under section 19(b)(3)(A) of the Act 
                    <SU>4</SU>
                    <FTREF/>
                     and Rule 19b-4(f)(6) thereunder,
                    <SU>5</SU>
                    <FTREF/>
                     which renders it effective upon filing.
                    <SU>6</SU>
                    <FTREF/>
                     The Commission is publishing this notice to solicit comments on the proposed rule change, as amended, from interested persons. 
                </P>
                <FTNT>
                    <P>
                        <SU>1</SU>
                         15 U.S.C. 78s(b)(1).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>2</SU>
                         17 CFR 240.19b-4.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>3</SU>
                         
                        <E T="03">See</E>
                         Letter from Mai Shiver, Director, Regulatory Policy, PCX, to Nancy Sanow, Assistant Director, Division of Market Regulation, Commission, dated November 2, 2004 (“Amendment No. 1”). Amendment No. 1 replaced and superseded the original filing in its entirety.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>4</SU>
                         15 U.S.C. 78s(b)(3)(A).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>5</SU>
                         17 CFR 240.19b-4(f)(6).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>6</SU>
                         For purpose of calculating the 60-day period within which the Commission may summarily abrogate the proposed rule change under section 19(b)(3)(C) of the Act, the Commission considers that period to commence on November 3, 2004, the date that the PCX filed Amendment No. 1.
                    </P>
                </FTNT>
                <HD SOURCE="HD1">I. Self-Regulatory Organization's Statement of the Terms of Substance of the Proposed Rule Change </HD>
                <P>The PCX, through its wholly owned subsidiary PCX Equities, Inc. (“PCXE”), proposes to amend its Core Trading Session rule (PCXE Rule 7.34(a)(2)) and its Closing Auction rule (PCXE 7.35) as they apply to certain Exchange Traded Funds (“ETFs”). </P>
                <P>The text of the proposed rule change, as amended, is below. Proposed new language is in italics; proposed deletions are in brackets. </P>
                <STARS/>
                <P>Rule 7.34 Trading Sessions </P>
                <P>(a) (1) No change. </P>
                <P>(2) Core Trading Session. The Core Trading Session shall begin for each security at 6:30:00 am (Pacific Time) or at the conclusion of the Market Order Auction, whichever comes later, and conclude at 1:00:00 pm (Pacific Time). </P>
                <P>
                    <E T="03">(A) The Core Trading Session for the Exchange Traded Funds, defined in PCXE Rules 5.1(b)(13), 5.2(j)(3), and 8.100, shall conclude at 1:15:00 pm (Pacific Time) unless otherwise determined by the Corporation.</E>
                </P>
                <P>(3) No change. </P>
                <P>(b)-(f) No change. </P>
                <HD SOURCE="HD3">Rule 7.35 Auctions </HD>
                <P>(a)-(d) No change. </P>
                <P>(e) (1)-(3) No change. </P>
                <P>(A)-(C) No change. </P>
                <P>
                    <E T="03">(D) Notwithstanding other provisions of PCXE Rule 7.35(e):</E>
                </P>
                <P>
                    <E T="03">
                        i. The Closing Auction for the Exchange Traded Funds defined in PCXE Rules 5.1(b)(13), 5.2(j)(3), and 
                        <PRTPAGE P="65669"/>
                        8.100 and determination of the Closing Auction Price as defined in PCXE Rule 7.35(e)(3) will commence at 1:15 p.m. (Pacific Time) unless otherwise determined by the Corporation.
                    </E>
                </P>
                <P>
                    <E T="03">ii. Between 1:13 p.m. (Pacific Time) and the conclusion of the Closing Auction, Market-On-Close and Limit-On-Close Orders for the Exchange Traded Funds defined in PCXE Rules 5.1(b)(13), 5.2(j)(3), and 8.100 may not be cancelled.</E>
                </P>
                <P>
                    <E T="03">iii. Between 1:13 pm (Pacific Time) and the conclusion of the Closing Auction, Market-on-Close Orders and Limit-on-Close Orders for the Exchange Traded Funds defined in PCXE Rules 5.1(b)(13), 5.2(j)(3), and 8.100 may not be entered on the same side as the Imbalance. Market-on-Close Orders and Limit-on-Close Orders for these Exchange Traded Funds that create equilibrium and thereafter convert the Imbalance from a buy to a sell (or convert the Imbalance from a sell to a buy) Imbalance will be rejected.</E>
                </P>
                <STARS/>
                <HD SOURCE="HD1">II. Self-Regulatory Organization's Statement of the Purpose of, and Statutory Basis for, the Proposed Rule Change </HD>
                <P>In its filing with the Commission, the Exchange included statements concerning the purpose of, and basis for, the proposed rule change and discussed any comments it received on the proposed rule change. The text of these statements may be examined at the places specified in item IV below. The Exchange has prepared summaries, set forth in sections A, B, and C below, of the most significant aspects of such statements. </P>
                <HD SOURCE="HD2">A. Self-Regulatory Organization's Statement of the Purpose of, and Statutory Basis for, the Proposed Rule Change </HD>
                <HD SOURCE="HD3">1. Purpose </HD>
                <P>
                    As part of its continuing efforts to enhance participation on its Archipelago Exchange (“ArcaEx”) facility, the PCX is proposing to include certain ETFs 
                    <SU>7</SU>
                    <FTREF/>
                     in its Closing Auction process 
                    <SU>8</SU>
                    <FTREF/>
                     and to delay the commencement of the Closing Auction and the conclusion of the Core Trading Session 
                    <SU>9</SU>
                    <FTREF/>
                     for these ETFs. Currently the Closing Auction commences at the end of regular trading hours 
                    <SU>10</SU>
                    <FTREF/>
                     for all securities on ArcaEx other than ETFs. Unlike other securities in which regular trading hours cease at 1 p.m. (Pacific time), ETFs generally trade on other exchanges until 1:15 p.m. (Pacific time). Accordingly, the Exchange seeks to modify its Closing Auction start time for the ETFs defined in PCXE Rules 5.1(b)(13), 5.2(j)(3), and 8.100 to 1:15 p.m. (Pacific Time) unless otherwise determined. Consistently, the Exchange seeks to change the conclusion of the Core Trading Session for this same group of ETFs to 1:15:00 pm (Pacific Time) to coincide with the time of the closing session.
                </P>
                <FTNT>
                    <P>
                        <SU>7</SU>
                         The three ETFs that the Exchange seeks to include in this proposal are all subject to the delayed closing auction commencement time on the American Stock Exchange (“Amex”), and are as follows: Unit Investment Trusts as defined in PCXE Rule 5.1(b)(13) (Amex Rule 1, Commentary .03); Investment Company Units as defined in PCXE Rule 5.2(j)(3) (Amex Rule 1000A, Commentary .02(f)—known as Index Fund Shares); and Portfolio Depositary Receipts (“PDRs”) as defined in the PCXE Rule 8.100 (Amex Rule 1000, Commentary .02).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>8</SU>
                         
                        <E T="03">See</E>
                         PCXE Rule 7.35(e).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>9</SU>
                         
                        <E T="03">See</E>
                         PCXE Rule 7.34(a)(2).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>10</SU>
                         PCXE Rule 7.35(e) specifies that the Closing Auction occurs at 1 p.m. (Pacific time).
                    </P>
                </FTNT>
                <P>
                    In conjunction with modifying the Closing Auction start time, the PCX seeks to modify the timing of the determination of the Closing Auction Price as described in PCXE Rule 7.35(e)(3) to 1:15 p.m. (Pacific time) for these ETFs. In addition, the Exchange seeks to modify the freeze period for entering Market-on-Close and Limit-on-Close Orders for the Closing Auction as defined in PCXE Rule 7.35(e)(2)(iii) to 1:13 p.m. (Pacific time) for these ETFs in order to limit the freeze period to two minutes before the Closing Auction, as is the case for the Closing Auctions for other securities. All other Closing Auction times described in PCXE Rule 7.35(e) will remain unchanged. For example, the dissemination of the Indicative Match Price 
                    <SU>11</SU>
                    <FTREF/>
                     and Imbalances 
                    <SU>12</SU>
                    <FTREF/>
                     associated with the Closing Auction for these ETFs as described in PCXE Rule 7.35(e)(1) will commence at 12 p.m. (Pacific time) and end upon the conclusion of the Closing Auction. Similarly, the determination of re-opening after trading halts as described in PCXE Rule 7.35(f) for these ETFs will be consistent with other securities traded on ArcaEx. 
                </P>
                <FTNT>
                    <P>
                        <SU>11</SU>
                         
                        <E T="03">See</E>
                         PCXE Rule 1.1(r). 
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>12</SU>
                         
                        <E T="03">See</E>
                         PCXE Rule 1.1(q). 
                    </P>
                </FTNT>
                <P>
                    The PCX believes that implementing these rules to affect commencement times for the Closing Auctions and conclusion times for Core Trading Sessions for certain ETFs will provide investors and ETP Holders 
                    <SU>13</SU>
                    <FTREF/>
                     with greater opportunities for executing ETF orders at the close and will result in the Closing Auction being priced for such securities within the range of prices then found at the end of the day's regular trading session. 
                </P>
                <FTNT>
                    <P>
                        <SU>13</SU>
                         
                        <E T="03">See</E>
                         PCXE Rule 1.1(n). 
                    </P>
                </FTNT>
                <HD SOURCE="HD3">2. Statutory Basis </HD>
                <P>
                    The Exchange believes that the proposed rule change is consistent with section 6(b) of the Act,
                    <SU>14</SU>
                    <FTREF/>
                     in general, and furthers the objectives of section 6(b)(5) of the Act,
                    <SU>15</SU>
                    <FTREF/>
                     in particular, in that it is designed to prevent fraudulent and manipulative acts and practices, to promote just and equitable principles of trade, to foster cooperation and coordination with persons engaged in facilitating transactions in securities, and to remove impediments to and perfect the mechanism of a free and open market and a national market system. 
                </P>
                <FTNT>
                    <P>
                        <SU>14</SU>
                         15 U.S.C. 78f(b). 
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>15</SU>
                         15 U.S.C. 78f(b)(5). 
                    </P>
                </FTNT>
                <HD SOURCE="HD2">B. Self-Regulatory Organization's Statement on Burden on Competition </HD>
                <P>The Exchange does not believe that the proposed rule change will impose any burden on competition that is not necessary or appropriate in furtherance of the purposes of the Act. </P>
                <HD SOURCE="HD2">C. Self-Regulatory Organization's Statement on Comments on the Proposed Rule Change Received From Members, Participants, or Others </HD>
                <P>Written comments on the proposed rule change were neither solicited nor received. </P>
                <HD SOURCE="HD1">III. Date of Effectiveness of the Proposed Rule Change and Timing for Commission Action </HD>
                <P>
                    PCX has designated that the proposed rule change as a “non-controversial” rule change pursuant to section 19(b)(3)(A) of the Act 
                    <SU>16</SU>
                    <FTREF/>
                     and subparagraph (f)(6) of Rule 19b-4 thereunder.
                    <SU>17</SU>
                    <FTREF/>
                     The Exchange has stated that the foregoing rule change: (1) Does not significantly affect the protection of investors or the public interest; (2) does not impose any significant burden on competition; and (3) by its terms does not become operative for 30 days after the date of this filing, or such shorter time as the Commission may designate, if consistent with the protection of investors and the public interest.
                    <SU>18</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>16</SU>
                         15 U.S.C. 78s(b)(3)(A). 
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>17</SU>
                         17 CFR 240.19b-4(f)(6). 
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>18</SU>
                         Rule 19b-4(f)(6)(iii) under the Act also requires that a self-regulatory organization provide the Commission with written notice of its intent to file a proposed rule change, along with a brief description and text of the proposed rule change, at least five days prior to the date of filing the proposed rule change. The Exchange complied with this requirement. 
                    </P>
                </FTNT>
                <P>
                    The PCX has requested that the Commission waive the 30-day operative delay. The Commission believes that 
                    <PRTPAGE P="65670"/>
                    PCX's proposal does not raise any new regulatory issues because the Commission previously has approved trading of the same ETFs until 4:15 p.m. (eastern time) on the Amex.
                    <SU>19</SU>
                    <FTREF/>
                     Therefore, the Commission believes that waiving the 30-day operative delay is consistent with the protection of investors and the public interest. The Commission hereby waives the 30-day operative delay. 
                </P>
                <FTNT>
                    <P>
                        <SU>19</SU>
                         Securities Act Release No. 30394 (February 21, 1992), 57 FR 7409 (March 2, 1992) (SR-Amex-90-06) (approving the trading of Unit Investment Trusts); Securities Act Release No. 36947 (March 8, 1996), 61 FR 10606 (March 14, 1996) (SR-Amex-95-43) (approving the trading of Index Fund Shares); Securities Act Release No. 31591 (December 11, 1992), 57 FR 60253 (December 18, 1992) (SR-Amex-92-18) (approving the trading of PDRs). 
                    </P>
                </FTNT>
                <P>
                    At any time within 60 days of the filing of the proposed rule change, the Commission may summarily abrogate the rule change if it appears to the Commission that the action is necessary or appropriate in the public interest, for the protection of investors, or would otherwise further the purposes of the Act.
                    <SU>20</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>20</SU>
                         
                        <E T="03">See supra</E>
                         note 6. 
                    </P>
                </FTNT>
                <HD SOURCE="HD1">IV. Solicitation of Comments </HD>
                <P>Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods: </P>
                <HD SOURCE="HD2">Electronic Comments</HD>
                <P>
                    • Use the Commission's Internet comment form (
                    <E T="03">http://www.sec.gov/rules/sro.shtml</E>
                    ); or 
                </P>
                <P>
                    • Send an e-mail to 
                    <E T="03">rule-comments@sec.gov</E>
                    . Please include File No. SR-PCX-2004-98 on the subject line. 
                </P>
                <HD SOURCE="HD2">Paper Comments</HD>
                <P>• Send paper comments in triplicate to Jonathan G. Katz, Secretary, Securities and Exchange Commission, 450 Fifth Street, NW., Washington, DC 20549-0609. </P>
                <P>
                    All submissions should refer to File No. SR-PCX-2004-98. This file number should be included on the subject line if e-mail is used. To help the Commission process and review your comments more efficiently, please use only one method. The Commission will post all comments on the Commission's Internet Web site (
                    <E T="03">http://www.sec.gov/rules/sro.shtml</E>
                    ). Copies of the submission, all subsequent amendments, all written statements with respect to the proposed rule change that are filed with the Commission, and all written communications relating to the proposed rule change between the Commission and any person, other than those that may be withheld from the public in accordance with the provisions of 5 U.S.C. 552, will be available for inspection and copying in the Commission's Public Reference Room, 450 Fifth Street, NW., Washington, DC 20549. Copies of such filing will also be available for inspection and copying at the principal office of the PCX. All comments received will be posted without change; the Commission does not edit personal identifying information from submissions. You should submit only information that you wish to make available publicly. All submissions should refer to File No. SR-PCX-2004-98 and should be submitted on or before December 6, 2004. 
                </P>
                <SIG>
                    <P>
                        For the Commission, by the Division of Market Regulation, pursuant to delegated authority.
                        <SU>21</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>21</SU>
                             17 CFR 200.30-3(a)(12). 
                        </P>
                    </FTNT>
                    <NAME>Margaret H. McFarland, </NAME>
                    <TITLE>Deputy Secretary. </TITLE>
                </SIG>
            </PREAMB>
            <FRDOC>[FR Doc. E4-3158 Filed 11-12-04; 8:45 am] </FRDOC>
            <BILCOD>BILLING CODE 8010-01-P </BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">SECURITIES AND EXCHANGE COMMISSION </AGENCY>
                <DEPDOC>[Release No. 34-50645; File No. SR-PCX-2004-59] </DEPDOC>
                <SUBJECT>Self-Regulatory Organizations; Notice of Filing of Proposed Rule Change and Amendment Nos. 1 and 2 Thereto by the Pacific Exchange, Inc. Relating to a New Order Modifier Entitled “Proactive if Locked Reserve” </SUBJECT>
                <DATE>November 5, 2004. </DATE>
                <P>
                    Pursuant to section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”),
                    <SU>1</SU>
                    <FTREF/>
                     and Rule 19b-4 thereunder,
                    <SU>2</SU>
                    <FTREF/>
                     notice is hereby given that on July 1, 2004, the Pacific Exchange, Inc. (“PCX” or “Exchange”), through its wholly-owned subsidiary PCX Equities, Inc. (“PCXE”), filed with the Securities and Exchange Commission (“Commission”) the proposed rule change as described in items I, II, and III below, which items have been prepared by the PCX. On October 26, 2004, the PCX submitted Amendment No. 1 to the proposed rule change.
                    <SU>3</SU>
                    <FTREF/>
                     On October 28, 2004, the PCX submitted Amendment No. 2 to the proposed rule change.
                    <SU>4</SU>
                    <FTREF/>
                     The Commission is publishing this notice to solicit comments on the proposed rule change, as amended, from interested persons. 
                </P>
                <FTNT>
                    <P>
                        <SU>1</SU>
                         15 U.S.C. 78s(b)(1). 
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>2</SU>
                         17 CFR 240.19b-4. 
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>3</SU>
                         
                        <E T="03">See</E>
                         letter from Steven B. Matlin, Senior Counsel, Regulatory Policy, PCX, to Nancy J. Sanow, Assistant Director, Division of Market Regulation (“Division”), Commission, dated October 25, 2004 and accompanying Form 19b-4 (“Amendment No. 1”). Amendment No. 1 replaced and superceded the originally filed proposed rule change. 
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>4</SU>
                         
                        <E T="03">See</E>
                         letter from Steven B. Matlin, Senior Counsel, Regulatory Policy, PCX, to Nancy J. Sanow, Assistant Director, Division, Commission, dated October 25, 2004 (“Amendment No. 2”). Amendment No. 2 made technical corrections to the proposed rule text of the proposed rule change, as amended. 
                    </P>
                </FTNT>
                <HD SOURCE="HD1">I. Self-Regulatory Organization's Statement of the Terms of Substance of the Proposed Rule Change </HD>
                <P>
                    The PCX proposes to amend its rules governing the Archipelago Exchange (“ArcaEx”), the equities trading facility of PCXE, by adding new processing capability for ArcaEx Reserve Orders in situations where a Reserve Order in an exchange-listed security is locked by another market. Below is the text of the proposed rule change. Proposed new language is 
                    <E T="03">italicized</E>
                    ; proposed deletions are in [brackets]. 
                </P>
                <STARS/>
                <HD SOURCE="HD3">Rule 7 </HD>
                <HD SOURCE="HD3">Equities Trading </HD>
                <HD SOURCE="HD3">Orders and Modifiers </HD>
                <STARS/>
                <HD SOURCE="HD3">Rule 7.31 Orders and Modifiers </HD>
                <STARS/>
                <P>
                    <E T="03">(hh) Proactive if Locked Reserve. A Reserve Order that will route to another market center pursuant to PCXE Rule 7.37(d) for the away market's displayed size up to such reserve amount in the instance in which the other market center has locked the order and the locking market has not resolved the locked market situation in a timely manner based upon average response times from ITS Participants. In the event that the order routed from the Archipelago Exchange to the other market center is not executed in its entirety, the Archipelago Exchange shall post the order or portion thereof in the ArcaEx Book. Proactive if Locked Reserve will apply only to exchange-listed securities.</E>
                </P>
                <STARS/>
                <HD SOURCE="HD1">II. Self-Regulatory Organization's Statement of the Purpose of, and Statutory Basis for, the Proposed Rule Change </HD>
                <P>
                    In its filing with the Commission, the Exchange included statements concerning the purpose of, and basis for, the proposed rule change, as amended, and discussed any comments it received 
                    <PRTPAGE P="65671"/>
                    on the proposed rule change. The text of these statements may be examined at the places specified in item IV below. The Exchange has prepared summaries, set forth in sections A, B, and C below, of the most significant aspects of such statements. 
                </P>
                <HD SOURCE="HD2">A. Self-Regulatory Organization's Statement of the Purpose of, and Statutory Basis for, the Proposed Rule Change </HD>
                <HD SOURCE="HD3">1. Purpose </HD>
                <P>The PCX states that, as part of its continuing efforts to enhance participation on the ArcaEx facility, it is proposing to include additional processing capability for ArcaEx Reserve Orders in exchange-listed securities. The new order modifier would be entitled “Proactive if Locked Reserve” and would be utilized when a Reserve Order in an exchange-listed security is locked by another market and the offending market has not shipped a commitment or moved their quote to clear the lock. </P>
                <P>
                    Currently, PCXE Rule 7.56 describes interaction between markets in exchange-listed securities when an order in the ArcaEx Book is locked by an away market. Specifically, the ITS Plan and the provisions of this rule require that, in locked market situations, upon receiving a locked market complaint, the offending market shall either ship a commitment to trade to the market that was locked or move its quote so as to unlock the market.
                    <SU>5</SU>
                    <FTREF/>
                     The Exchange states that, in many cases, however, away markets that lock or cross ArcaEx do not adequately respond to complaints or do not move quotes to unlock or uncross the market. The proposed Proactive if Locked Reserve order modifier is designed to address this issue. 
                </P>
                <FTNT>
                    <P>
                        <SU>5</SU>
                         
                        <E T="03">See</E>
                         ITS Plan Exhibit B, Section (d).
                    </P>
                </FTNT>
                <P>
                    Under the proposed rule change, Equity Trading Permit Holders (“ETP Holders”) using the Proactive if Locked Reserve modifier would be able to request, for exchange-listed securities, that the away market's displayed size up to the reserve amount for a Reserve Order 
                    <SU>6</SU>
                    <FTREF/>
                     be shipped to an away market when the Reserve Order has been locked (or crossed) by the away market and there has been no resolution of the locked (or crossed) market by the offending away market. According to the Exchange, if the away market does not promptly respond to a locked market complaint as provided for under the ITS Plan, ArcaEx would proactively ship commitments to the offending market under the Proactive if Locked Reserve process.
                    <SU>7</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>6</SU>
                         Reserve Orders, defined in PCXE Rule 7.31, are limit orders with a portion of the size displayed and with a reserve portion of the size not displayed.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>7</SU>
                         
                        <E T="03">See</E>
                         ITS Plan Exhibit B, Section (d). 
                    </P>
                </FTNT>
                <P>
                    For example, assume ArcaEx posts a Reserve order with a Proactive if Locked Reserve Modifier for 50,000 Buy at 30.10, with 1,000 shares displayed and 49,000 shares in reserve. An away market subsequently locks this quote by offering 10,000 shares at 30.10. ArcaEx would first send an ITS complaint to the offending away market, indicating that the away market has locked a quote on ArcaEx. ArcaEx would simultaneously begin to monitor the time elapsing before receiving a response to its complaint. If the away market does not respond within a sufficient amount of time based upon average response times from ITS Participants, ArcaEx would ship 10,000 shares of the 49,000 shares in reserve to the away market (
                    <E T="03">i.e.</E>
                    , the away market's displayed quote) from the ArcaEx Reserve order at 30.10. In the above example, ArcaEx would ship as many shares as it had in reserve for the order with a Proactive if Locked Reserve Modifier to match the away market's displayed quote. Accordingly, if the away market was offering 50,000 shares at 30.10 instead of 10,000 shares, ArcaEx would ship all 49,000 shares in the Reserve order while keeping the 1,000 shares displayed.
                </P>
                <P>
                    The proposed Proactive if Locked Reserve modifier is utilized only if the offending market does not respond to the ArcaEx ITS complaint within an acceptable time period, based upon average response times from ITS Participants. If the away market declines the ArcaEx commitment, ArcaEx would post the declined total back to the Reserve order,
                    <SU>8</SU>
                    <FTREF/>
                     for example, showing 1,000 shares Buy at 30.10 with a reserve amount of 49,000 shares. If the order is executed by the away market, and ArcaEx remains locked (or crossed), ArcaEx would ship the away market's display amount from the reserve portion of the Reserve Order to the offending market again, until the order is depleted. The display portion of the Reserve Order, however, will continue to be displayed and will not ship to the away market. 
                </P>
                <FTNT>
                    <P>
                        <SU>8</SU>
                         The Exchange states that any portion of an order which is sent to an away market and declined would re-enter ArcaEx as part of the original Reserve Order with its original time priority in accordance with PCXE Rule 7.36. To the extent the Reserve Order is executed in its entirety in the interim, the portion of the order that was sent to an away market and declined would establish a new time priority upon re-posting in the Arca Book pursuant to PCXE Rule 7.36.
                    </P>
                </FTNT>
                <P>Furthermore, in the instance where a limit order in the Arca Book that is at the same price as, but superior in time to, the Proactive if Locked Reserve Order is locked by an away market, ArcaEx would follow the aforementioned procedures. Specifically, ArcaEx would first send an ITS complaint to the offending away market indicating that the away market locked the ArcaEx limit order. If the away market does not respond within a sufficient amount of time based upon average response times from ITS Participants, ArcaEx would ship from the Proactive if Locked Reserve Order the away market's displayed size up to the reserve amount. The limit order and display portion of the Proactive if Locked Reserve Order would continue to be displayed. Any portion of the Proactive if Locked Reserve Order that is sent to the away market and subsequently declined would be re-posted in the Arca Book pursuant to the description above. </P>
                <P>The PCX believes that the proactive shipping of commitments facilitated by the proposed Proactive if Locked Reserve modifier will mitigate locked or crossed markets, prevent unresponsive away markets from delaying executions, and provide increased opportunities for executing orders. The Exchange believes that the Proactive if Locked Reserve modifier will therefore aid enhanced order interaction and foster price competition. The PCX believes that the proposal also promotes a more efficient and effective market operation, and enhances the investment choices available to investors over a broad range of trading scenarios. </P>
                <HD SOURCE="HD3">2. Statutory Basis </HD>
                <P>
                    The Exchange believes that the proposed rule change is consistent with section 6(b) of the Act 
                    <SU>9</SU>
                    <FTREF/>
                     in general, and furthers the objectives of section 6(b)(5) of the Act 
                    <SU>10</SU>
                    <FTREF/>
                     in particular, because it is designed to promote just and equitable principles of trade, to foster cooperation and coordination with persons engaged in facilitating transactions in securities, and to remove impediments and perfect the mechanism of a free and open market, and, in general, to protect investors and the public interest. 
                </P>
                <FTNT>
                    <P>
                        <SU>9</SU>
                         15 U.S.C. 78f(b).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>10</SU>
                         15 U.S.C. 78f(b)(5).
                    </P>
                </FTNT>
                <HD SOURCE="HD2">B. Self-Regulatory Organization's Statement on Burden on Competition </HD>
                <P>
                    The Exchange does not believe that the proposed rule change will impose any burden on competition that is not necessary or appropriate in furtherance of the purposes of the Act. 
                    <PRTPAGE P="65672"/>
                </P>
                <HD SOURCE="HD2">C. Self-Regulatory Organization's Statement on Comments on the Proposed Rule Change Received From Members, Participants, or Others </HD>
                <P>Written comments on the proposed rule change were neither solicited nor received. </P>
                <HD SOURCE="HD1">III. Date of Effectiveness of the Proposed Rule Change and Timing for Commission Action </HD>
                <P>
                    Within 35 days of the date of publication of this notice in the 
                    <E T="04">Federal Register</E>
                     or within such longer period (i) as the Commission may designate up to 90 days of such date if it finds such longer period to be appropriate and publishes its reasons for so finding, or (ii) as to which the Exchange consents, the Commission will: 
                </P>
                <P>(A) By order approve such proposed rule change; or </P>
                <P>(B) Institute proceedings to determine whether the proposed rule change should be disapproved. </P>
                <HD SOURCE="HD1">IV. Solicitation of Comments </HD>
                <P>Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods: </P>
                <HD SOURCE="HD2">Electronic Comments </HD>
                <P>
                    • Use the Commission's Internet comment form (
                    <E T="03">http://www.sec.gov/rules/sro.shtml</E>
                    ); or 
                </P>
                <P>
                    • Send an e-mail to 
                    <E T="03">rule-comments@sec.gov</E>
                    . Please include File Number SR-PCX-2004-59 on the subject line. 
                </P>
                <HD SOURCE="HD2">Paper Comments</HD>
                <P>• Send paper comments in triplicate to Jonathan G. Katz, Secretary, Securities and Exchange Commission, 450 Fifth Street, NW., Washington, DC 20549-0609. </P>
                <P>
                    All submissions should refer to File Number SR-PCX-2004-59. This file number should be included on the subject line if e-mail is used. To help the Commission process and review your comments more efficiently, please use only one method. The Commission will post all comments on the Commission's Internet Web site (
                    <E T="03">http://www.sec.gov/rules/sro.shtml</E>
                    ). Copies of the submission, all subsequent amendments, all written statements with respect to the proposed rule change that are filed with the Commission, and all written communications relating to the proposed rule change between the Commission and any person, other than those that may be withheld from the public in accordance with the provisions of 5 U.S.C. 552, will be available for inspection and copying in the Commission's Public Reference Section, 450 Fifth Street, NW., Washington, DC 20549. Copies of such filing also will be available for inspection and copying at the principal office of the PCX. All comments received will be posted without change; the Commission does not edit personal identifying information from submissions. You should submit only information that you wish to make available publicly. All submissions should refer to File Number SR-PCX-2004-59 and should be submitted on or before December 6, 2004. 
                </P>
                <SIG>
                    <P>
                        For the Commission, by the Division of Market Regulation, pursuant to delegated authority.
                        <SU>11</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>11</SU>
                             17 CFR 200.30-3(a)(12).
                        </P>
                    </FTNT>
                    <NAME>Margaret H. McFarland, </NAME>
                    <TITLE>Deputy Secretary. </TITLE>
                </SIG>
            </PREAMB>
            <FRDOC> [FR Doc. E4-3159 Filed 11-12-04; 8:45 am] </FRDOC>
            <BILCOD>BILLING CODE 8010-01-P </BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="N">SMALL BUSINESS ADMINISTRATION</AGENCY>
                <DEPDOC>[License No. 02/72-0610]</DEPDOC>
                <SUBJECT>Gefus SBIC, L.P.; Notice Seeking Exemption Under Section 312 of the Small Business Investment Act, Conflicts of Interest</SUBJECT>
                <P>Notice is hereby given that Gefus SBIC, L.P., 375 Park Avenue, Suite 2401, New York, NY 10152, a Federal Licensee under the Small Business Investment Act of 1958, as amended (“the Act”), in connection with the financing of a small concern, has sought an exemption under section 312 of the Act and section 107.730, Financings which Constitute Conflicts of Interest of the Small Business Administration (“SBA”) Rules and Regulations (13 CFR 107.730). Gefus SBIC, L.P. proposes to provide equity/debt security financing to Idetic, Inc. The financing is contemplated for operating expenses and for general corporate purposes.</P>
                <P>The financing is brought within the purview of § 107.730(a)(1) of the Regulations because Gefus Capital Partners I, L.P. , Gefus Strategic Partners I, L.P., Inman Ventures I, L.P. and Admiral Bobby Inman, all Associates of Gefus SBIC, L.P., own more than ten percent of Idetic, Inc.</P>
                <P>Notice is hereby given that any interested person may submit written comments on the transaction to the Associate Administrator for Investment, U.S. Small Business Administration, 409 Third Street, SW., Washington, DC 20416.</P>
                <SIG>
                    <DATED>Dated: November 9, 2004.</DATED>
                    <NAME>Harry Haskins,</NAME>
                    <TITLE>Acting Associate Administrator for Investment.</TITLE>
                </SIG>
            </PREAMB>
            <FRDOC>[FR Doc. 04-25312 Filed 11-12-04; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 8025-01-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">SMALL BUSINESS ADMINISTRATION</AGENCY>
                <SUBJECT>Psilos Group Partners II SBIC, L.P; License No. 02/72-0617; Notice Seeking Exemption Under Section 312 of the Small Business Investment Act, Conflicts of Interest</SUBJECT>
                <P>Notice is hereby given that Psilos Group Partners II SBIC, L.P., 625 Avenue of the Americas, Fourth Floor, New York, NY 10011, a Federal Licensee under the Small Business Investment Act of 1958, as amended (“the Act”), in connection with the financing of a small concern, has sought an exemption under Section 312 of the Act and Section 107.730, Financings which Constitute Conflicts of Interest of the Small Business Administration (“SBA”) Rules and Regulations (13 CFR 107.730 (2000). Psilos Group Partners II SBIC, L.P. proposes to provide equity/debt security financing to Caregiver Services, Inc. The financing is contemplated for national sales force expansion and working capital.</P>
                <P>The financing is brought within the purview of Sec. 107.730(a)(1) of the Regulations because Psilos Group Partners, L.P., CCP/Psilos GerAssist, LLC, Psilos Group Partners II, L.P. and Psilos Group Partners IIA, L.P., all Associates of Psilos Group Partners II SBIC, L.P., collectively own more than ten percent of Caregiver Services, Inc.</P>
                <P>Notice is hereby given that any interested person may submit written comments on the transaction to the Associate Administrator for Investment, U.S. Small Business Administration, 409 Third Street, SW., Washington, DC 20416.</P>
                <SIG>
                    <DATED>Dated: November 2, 2004.</DATED>
                    <NAME>Jeffrey Pierson,</NAME>
                    <TITLE>Associate Administrator for Investment.</TITLE>
                </SIG>
            </PREAMB>
            <FRDOC>[FR Doc. 04-25227 Filed 11-12-04; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 8025-01-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <PRTPAGE P="65673"/>
                <AGENCY TYPE="S">SMALL BUSINESS ADMINISTRATION</AGENCY>
                <SUBJECT>Telesoft Partners II SBIC, L.P.; License No. 09/79-0432; Notice Seeking Exemption Under Section 312 of the Small Business Investment Act, Conflicts of Interest</SUBJECT>
                <P>Notice is hereby given that Telesoft Partners II SBIC, L.P., 1450 Fashion Island Blvd., Suite 610, San Mateo, CA 94404, a Federal Licensee under the Small Business Investment Act of 1958, as amended (“the Act”), in connection with the financing of a small concern, has sought an exemption under Section 312 of the Act and Section 107.730, Financings which Constitute Conflicts of Interest of the Small Business Administration (“SBA”) Rules and Regulations (13 CFR 107.730). Telesoft Partners II SBIC, L.P. proposes to provide equity/debt security financing to CreekPath Systems, Inc. The financing is contemplated for working capital and general corporate purposes.</P>
                <P>The financing is brought within the purview of § 107.730(a)(1) of the Regulations because Telesoft Partners II QP, L.P., Telesoft Partners II, L.P. and Telesoft NP Employee Fund, LLC, all Associates of Telesoft Partners II SBIC, L.P., own more than ten percent of CreekPath Systems, Inc.</P>
                <P>Notice is hereby given that any interested person may submit written comments on the transaction to the Associate Administrator for Investment, U.S. Small Business Administration, 409 Third Street, SW., Washington, DC 20416.</P>
                <SIG>
                    <DATED>Dated: November 2, 2004.</DATED>
                    <NAME>Jeffrey Pierson,</NAME>
                    <TITLE>Associate Administrator for Investment.</TITLE>
                </SIG>
            </PREAMB>
            <FRDOC>[FR Doc. 04-25228 Filed 11-12-04; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 8025-01-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">SMALL BUSINESS ADMINISTRATION</AGENCY>
                <SUBJECT>Telesoft Partners II SBIC, L.P.; License No. 09/79-0432; Notice Seeking Exemption Under Section 312 of the Small Business Investment Act, Conflicts of Interest</SUBJECT>
                <P>Notice is hereby given that Telesoft Partners II SBIC, L.P., 1450 Fashion Island Blvd., Suite 610, San Mateo, CA 94404, a Federal Licensee under the Small Business Investment Act of 1958, as amended (“the Act”), in connection with the financing of a small concern, has sought an exemption under Section 312 of the Act and Section 107.730, Financings which Constitute Conflicts of Interest of the Small Business Administration (“SBA”) Rules and Regulations (13 CFR 107.730). Telesoft Partners II SBIC, L.P. proposes to provide equity/debt security financing to LogLogic, Inc. The financing is contemplated for working capital and general corporate purposes.</P>
                <P>The financing is brought within the purview of § 107.730(a)(1) of the Regulations because Telesoft Partners II QP, L.P., Telesoft Partners II, L.P. and Telesoft NP Employee Fund, LLC, all Associates of Telesoft Partners II SBIC, L.P., own more than ten percent of LogLogic, Inc.</P>
                <P>Notice is hereby given that any interested person may submit written comments on the transaction to the Associate Administrator for Investment, U.S. Small Business Administration, 409 Third Street, SW., Washington, DC 20416.</P>
                <SIG>
                    <DATED>Dated: November 2, 2004.</DATED>
                    <NAME>Jeffrey Pierson,</NAME>
                    <TITLE>Associate Administrator for Investment.</TITLE>
                </SIG>
            </PREAMB>
            <FRDOC>[FR Doc. 04-25229 Filed 11-12-04; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 8025-01-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">SMALL BUSINESS ADMINISTRATION</AGENCY>
                <DEPDOC>[Declaration of Disaster #P056; Amendment #1]</DEPDOC>
                <SUBJECT>State of Georgia</SUBJECT>
                <P>In accordance with a notice received from the Department of Homeland Security—Federal Emergency Management Agency—effective October 30, 2004, the above numbered Public Assistance declaration is hereby amended to establish the incident period for this disaster as beginning September 3, 2004, and continuing through October 30, 2004.</P>
                <P>
                    All other information remains the same, 
                    <E T="03">i.e.</E>
                    , the deadline for filing applications for physical damage is November 23, 2004.
                </P>
                <EXTRACT>
                    <FP>(Catalog of Federal Domestic Assistance Program Nos. 59008.)</FP>
                </EXTRACT>
                <SIG>
                    <DATED>Dated: November 8, 2004.</DATED>
                    <NAME>Herbert L. Mitchell,</NAME>
                    <TITLE>Associate Administrator for Disaster Assistance.</TITLE>
                </SIG>
            </PREAMB>
            <FRDOC>[FR Doc. 04-25310 Filed 11-12-04; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 8025-01-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">SMALL BUSINESS ADMINISTRATION</AGENCY>
                <DEPDOC>[Declaration of Disaster #3629; Amendment #3]</DEPDOC>
                <SUBJECT>State of Georgia</SUBJECT>
                <P>In accordance with a notice received from the Department of Homeland Security—Federal Emergency Management Agency—effective October 30, 2004, the above numbered declaration is hereby amended to establish the incident period for this disaster as beginning September 14, 2004, and continuing through October 30, 2004.</P>
                <P>
                    All other information remains the same, 
                    <E T="03">i.e.</E>
                    , the deadline for filing applications for physical damage is November 17, 2004, and for economic injury the deadline is June 20, 2005.
                </P>
                <EXTRACT>
                    <FP>(Catalog of Federal Domestic Assistance Program Nos. 59002 and 59008.)</FP>
                </EXTRACT>
                <SIG>
                    <DATED>Dated: November 8, 2004.</DATED>
                    <NAME>Herbert L. Mitchell,</NAME>
                    <TITLE>Associate Administrator for Disaster Assistance.</TITLE>
                </SIG>
            </PREAMB>
            <FRDOC>[FR Doc. 04-25311 Filed 11-12-04; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 8025-01-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">SMALL BUSINESS ADMINISTRATION</AGENCY>
                <SUBJECT>Small Business Size Standards: Waiver of the Nonmanufacturer Rule</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>U.S. Small Business Administration.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice of waiver of the nonmanufacturer rule for sporting and athletic goods manufacturing.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The U.S. Small Business Administration (SBA) is granting a waiver of the Nonmanufacturer Rule for Sporting and Athletic Goods Manufacturing. The basis for waivers is that no small business manufacturers are supplying these classes of products to the Federal government. The effect of a waiver would be to allow otherwise qualified regular dealers to supply the products of any domestic manufacturer on a Federal contract set aside for small businesses, service disabled veteran-owned small businesses, SBA's Very Small Business Program or awarded through the SBA's 8(a) Business Development Program.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATE:</HD>
                    <P>This waiver is effective November 30, 2004.</P>
                </DATES>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATI0N CONTACT:</HD>
                    <P>
                        Edith Butler, Program Analyst, by telephone at (202) 619-0422; by FAX at (202) 205-7280; or by e-mail at 
                        <E T="03">edith.butler@sba.gov</E>
                        .
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>
                    Section 8(a)(17) of the Small Business Act, (Act) 15 U.S.C. 637(a)(17), requires that recipients of Federal contracts set aside for small businesses, service disabled veteran-owned small businesses, SBA's Very Small Business Program or awarded through the SBA's 8(a) Business Development Program provide the product of a small business manufacturer or processor, if the recipient is other than the actual 
                    <PRTPAGE P="65674"/>
                    manufacturer or processor of the product.
                </P>
                <P>This requirement is commonly referred to as the Nonmanufacturer Rule. The SBA regulations imposing this requirement are found at 13 CFR 121.406(b). Section 8(a)(17)(b)(iv) of the Act authorizes SBA to waive the Nonmanufacturer Rule for any “class of products” for which there are no small business manufacturers or processors available to participate in the Federal market.</P>
                <P>As implemented in SBA's regulations at 13 CFR 121.1204, in order to be considered available to participate in the Federal market for a class of products, a small business manufacturer must have submitted a proposal for a contract solicitation or received a contract from the Federal government within the last 24 months. The SBA defines “class of products” based on six digit coding systems. The first coding system is the Office of Management and Budget North American Industry Classification System (NAICS). The second is the Product and Service Code established by the Federal Procurement Data System.</P>
                <P>
                    The SBA received a request on July 15, 2004 to waive the Nonmanufacturer Rule for Sporting and Athletic Goods Manufacturing. In response, on July 30, 2004, SBA published in the 
                    <E T="04">Federal Register</E>
                     a notice of intent to waive the Nonmanufacturer Rule for Sporting and Athletic Goods Manufacturing.
                </P>
                <P>SBA explained in the notice that it was soliciting comments and sources of small business manufacturers of this class of products. In response to this notice, comments were received from interested parties. SBA has determined from these sources that there are no small business manufacturers of this class of products, and is therefore granting the waiver of the Nonmanufacturer Rule for Sporting and Athletic Goods Manufacturing, NAICS 339920.</P>
                <AUTH>
                    <HD SOURCE="HED">Authority:</HD>
                    <P>15 U.S.C. 637(a)(17).</P>
                </AUTH>
                <SIG>
                    <DATED>Dated: November 3, 2004.</DATED>
                    <NAME>Arthur Collins,</NAME>
                    <TITLE>Deputy Associate Administrator for Government Contracting.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 04-24973 Filed 11-12-04; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 8025-01-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="N">OFFICE OF THE UNITED STATES TRADE REPRESENTATIVE </AGENCY>
                <SUBJECT>Andean Trade Preference Act (ATPA), as Amended: Notice Regarding the 2003 and 2004 Annual Reviews </SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Office of the United States Trade Representative. </P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice. </P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The Office of the United States Trade Representative (USTR) received petitions in September 2004 to review certain practices in certain beneficiary developing countries to determine whether such countries are in compliance with the ATPA eligibility criteria. This notice publishes a list of the September 2004 petitions that were filed in response to the announcement of the annual review. In addition, this notice specifies the status of those petitions filed in 2003 that have remained under review. </P>
                </SUM>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>Bennett M. Harman, Deputy Assistant U.S. Trade Representative for Latin America, at (202) 395-9446. </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>
                    The ATPA (19 U.S.C. 3201 
                    <E T="03">et seq.</E>
                    ), as renewed and amended by the Andean Trade Promotion and Drug Eradication Act of 2002 (ATPDEA) in the Trade Act of 2002 (Pub. L. 107-210), provides trade benefits for eligible Andean countries. Pursuant to section 3103(d) of the ATPDEA, USTR promulgated regulations (15 CFR part 2016) (68 FR 43922) regarding the review of eligibility of countries for the benefits of the ATPA, as amended. 
                </P>
                <P>
                    In a 
                    <E T="04">Federal Register</E>
                     notice dated August 14, 2003, USTR initiated the 2003 ATPA Annual Review and announced a deadline of September 15, 2003, for the filing of petitions (68 FR 48657). Several of these petitions requested the review of certain practices in certain beneficiary developing countries regarding compliance with the eligibility criteria set forth in sections 203(c) and (d) and section 204(b)(6)(B) of the ATPA, as amended (19 U.S.C. 3203 (c) and (d); 19 U.S.C. 3203(b)(6)(B)). 
                </P>
                <P>
                    In a 
                    <E T="04">Federal Register</E>
                     notice dated November 13, 2003, USTR published a list of the responsive petitions filed pursuant to the announcement of the annual review. The Trade Policy Staff Committee (TPSC) has conducted a preliminary review of these petitions. 15 CFR 2016.2(b) provides for announcement of the results of the preliminary review on or about December 1. 15 CFR 2016.2(b) also provides for modification of the schedule if specified by 
                    <E T="04">Federal Register</E>
                     notice. In a 
                    <E T="04">Federal Register</E>
                     notice dated December 30, 2003, USTR modified the schedule for this review, specifying that the results would be announced on or about March 31, 2004. In a 
                    <E T="04">Federal Register</E>
                     notice dated April 5, 2004, USTR modified the schedule for this review. In a 
                    <E T="04">Federal Register</E>
                     notice dated July 21, 2004, USTR announced that the Trade Policy Staff Committee had determined that certain of the petitions do not require action and terminated their review. The TPSC also decided to modify the date of the announcement of the results of preliminary review for the remaining 2003 petitions to coincide with the 2004 review: Engelhard—Peru; Princeton Dover—Peru; LeTourneau—Peru; Duke Energy—Peru; AFL-CIO—Ecuador; Human Rights Watch—Ecuador; and US/LEAP—Ecuador. 
                </P>
                <P>
                    In a 
                    <E T="04">Federal Register</E>
                     notice dated August 17, 2004, USTR initiated the 2004 ATPA Annual Review and announced a deadline of September 15, 2004 for the filing of petitions (69 FR 51138). Following is the list of responsive petitions that were filed for the 2004 review: 
                </P>
                <FP SOURCE="FP-1">Ecuador—American Cast Iron Pipe Company </FP>
                <FP SOURCE="FP-1">Ecuador—Chevron Texaco </FP>
                <FP SOURCE="FP-1">Ecuador—Electrolux Home Products, Inc. </FP>
                <FP SOURCE="FP-1">Peru—Parsons Corporation </FP>
                <P>USTR also received updated information regarding certain matters under consideration from the 2003 ATPA review: </P>
                <FP SOURCE="FP-1">Ecuador—Human Rights Watch </FP>
                <FP SOURCE="FP-1">Ecuador—U.S./Labor Education in the Americas Project </FP>
                <FP SOURCE="FP-1">Peru—LeTourneau of Peru </FP>
                <P>USTR will announce the results of the preliminary review of the 2004 petitions and the remaining 2003 petitions on or about December 1, 2004. </P>
                <SIG>
                    <NAME>Carmen Suro-Bredie, </NAME>
                    <TITLE>Chairman, Trade Policy Staff Committee. </TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 04-25240 Filed 11-12-04; 8:45 am] </FRDOC>
            <BILCOD>BILLING CODE 3190-W4-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">OFFICE OF THE UNITED STATES TRADE REPRESENTATIVE </AGENCY>
                <SUBJECT>Generalized System of Preferences (GSP): Extension of Deadline for Submission of Petitions for the 2004 Annual GSP Product and Country Eligibility Practices Review </SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Office of the United States Trade Representative. </P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice. </P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>
                        This notice extends the deadline for the submission of petitions 
                        <PRTPAGE P="65675"/>
                        for the 2004 Annual GSP Product and Country Eligibility Practices Review to December 13, 2004. Notification of which petitions are accepted for the 2004 Annual GSP Review and of other relevant dates will be published in the 
                        <E T="04">Federal Register</E>
                        . 
                    </P>
                </SUM>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        Submit petitions by electronic mail (e-mail) to 
                        <E T="03">FR0441@ustr.gov.</E>
                         If unable to submit petitions by e-mail, contact the GSP Subcommittee of the Trade Policy Staff Committee (TPSC), Office of the United States Trade Representative (USTR), 1724 F Street, NW., Room F-220, Washington, DC 20508, at (202) 395-6971. 
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>The GSP Subcommittee of the Trade Policy Staff Committee (TPSC), Office of the United States Trade Representative (USTR), 1724 F Street, NW., Room F-220, Washington, DC 20508. The telephone number is (202) 395-6971.</P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>
                    The GSP provides for the duty-free importation of designated articles when imported from beneficiary developing countries. The GSP is authorized by Title V of the Trade Act of 1974 (19 U.S.C. 2461, 
                    <E T="03">et seq.</E>
                    ), as amended (the “Trade Act”), and is implemented in accordance with Executive Order 11888 of November 24, 1975, as modified by subsequent Executive Orders and Presidential Proclamations. 
                </P>
                <HD SOURCE="HD1">2004 Annual GSP Review </HD>
                <P>
                    The GSP regulations (15 CFR part 2007) provide the schedule of dates for conducting an annual review, unless otherwise specified by 
                    <E T="04">Federal Register</E>
                     notice. Notice is hereby given that, in order to be considered in the 2004 Annual GSP Product and Country Eligibility Practices Review, all petitions to modify the list of articles eligible for duty-free treatment under GSP or to review the GSP status of any beneficiary developing country must be received by the GSP Subcommittee of the Trade Policy Staff Committee no later than 5 p.m. on December 13, 2004. Petitions submitted after the extended deadline will not be considered for review. 
                </P>
                <P>Interested parties, including foreign governments, may submit petitions to: (1) Designate additional articles as eligible for GSP benefits, including to designate articles as eligible for GSP benefits only for countries designated as least-developed beneficiary developing countries, or only for countries designated as beneficiary sub-Saharan African countries under the African Growth and Opportunity Act (AGOA); (2) withdraw, suspend or limit the application of duty-free treatment accorded under the GSP with respect to any article, either for all beneficiary developing countries, least-developed beneficiary developing countries or beneficiary sub-Saharan African countries, or for any of these countries individually; (3) waive the “competitive need limitations” for individual beneficiary developing countries with respect to specific GSP-eligible articles (these limits do not apply to either least-developed beneficiary developing countries or beneficiary sub-Saharan African countries); and (4) otherwise modify GSP coverage. As specified in 15 CFR 2007.1, all product petitions must include a detailed description of the product and the subheading of the Harmonized Tariff Schedule of the United States (HTSUS) under which the product is classified. </P>
                <P>Any person may also submit petitions to review the designation of any beneficiary developing country, including any least-developed beneficiary developing country, with respect to any of the designation criteria listed in sections 502(b) or 502(c) of the Trade Act (19 U.S.C. 2462(b) and (c)) (petitions to review the designation of beneficiary Sub-Saharan African countries are considered in the Annual Review of the AGOA, a separate administrative process not governed by the GSP regulations). Such petitions must comply with the requirements of 15 CFR 2007.0(b). </P>
                <HD SOURCE="HD1">Requirements for Submissions </HD>
                <P>
                    All such submissions must conform to the GSP regulations set forth at 15 CFR part 2007, except as modified below. These regulations are reprinted in “A Guide to the U.S. Generalized System of Preferences (GSP)” (August 1991) (“GSP Guidebook”), available at 
                    <E T="03">http://www.ustr.gov.</E>
                </P>
                <P>Any person or party making a submission is strongly advised to review the GSP regulations. Submissions that do not provide the information required by sections 2007.0 and 2007.1 of the GSP regulations will not be accepted for review, except upon a detailed showing in the submission that the petitioner made a good faith effort to obtain the information required. Petitions with respect to waivers of the “competitive need limitations” must meet the information requirements for product addition requests in section 2007.1(c) of the GSP regulations. A model petition format is available from the GSP Subcommittee and is included in the GSP Guidebook. Petitioners are requested to use this model petition format so as to ensure that all information requirements are met. Furthermore, interested parties submitting petitions that request action with respect to specific products should list on the first page of the petition the following information after typing “2004 Annual GSP Review”: (1) The requested action; (2) the HTSUS subheading in which the product is classified; and (3) if applicable, the beneficiary developing country. Petitions and requests must be submitted, in English, to the Chairman of the GSP Subcommittee, Trade Policy Staff Committee, and must be received no later than December 13, 2004. Submissions in response to this notice will be available for public inspection by appointment with the staff of the USTR Public Reading Room, except for information granted “business confidential” status pursuant to 15 CFR 2003.6. If the submission contains business confidential information, a non-confidential version of the submission must also be submitted that indicates where confidential information was redacted by inserting asterisks where material was deleted. In addition, the confidential submission must be clearly marked “BUSINESS CONFIDENTIAL” in large, bold letters at the top and bottom of each and every page of the document. The public version that does not contain business confidential information must also be clearly marked in large, bold letters at the top and bottom of each and every page (either “PUBLIC VERSION” or “NON-CONFIDENTIAL”). Documents that are submitted without any marking might not be accepted or will be considered public documents. </P>
                <P>
                    In order to facilitate prompt consideration of submissions, USTR strongly urges and prefers electronic mail (e-mail) submissions in response to this notice. Hand-delivered submissions will not be accepted. E-mail submissions should be single copy transmissions in English with the total submission including attachments not to exceed 50 pages in 12-point type and 3 megabytes as a digital file attached to an e-mail transmission. E-mail submissions should use the following subject line: “2004 Annual GSP Review-Petition.” Documents must be submitted as either WordPerfect (“.WPD”), MSWord (“.DOC”), or text (“.TXT”) file. Documents cannot be submitted as electronic image files or contain imbedded images (for example, “.JPG”, “.TIF”, “.PDF”, “.BMP”, or “.GIF”) as these type files are generally excessively large. E-mail submissions containing such files will not be accepted. Supporting documentation submitted as spreadsheets are acceptable as Quattro Pro or Excel, pre-formatted for printing 
                    <PRTPAGE P="65676"/>
                    on 8
                    <FR>1/2</FR>
                     by 11 inch paper. To the extent possible, any data attachments to the submission should be included in the same file as the submission itself, and not as separate files. E-mail submissions should not include separate cover letters or messages in the message area of the e-mail; information that might appear in any cover letter should be included directly in the attached file containing the submission itself, including identifying information on the sender, including sender's e-mail address. 
                </P>
                <P>
                    For any document containing business confidential information submitted as an electronic attached file to an e-mail transmission, in addition to the proper marking at the top and bottom of each page as previously specified, the file name of the business confidential version should begin with the characters “BC-”, and the file name of the public version should begin with the characters “P-”. The “P-” or “BC-” should be followed by the name of the person or party (government, company, union, association, etc.) submitting the petition. Submissions by e-mail should not include separate cover letters or messages in the message area of the e-mail; information that might appear in any cover letter should be included directly in the attached file containing the submission itself. The electronic mail address for these submissions is 
                    <E T="03">FR0441@USTR.GOV.</E>
                </P>
                <P>Documents not submitted in accordance with the GSP regulations as modified by these instructions might not be considered in this review. </P>
                <P>Public versions of all documents relating to this review will be available for review approximately 30 days after the due date by appointment in the USTR Public Reading Room, 1724 F Street, NW., Washington, DC. Availability of documents may be ascertained, and appointments may be made from 9:30 a.m. to noon and 1 p.m. to 4 p.m., Monday through Friday, by calling (202) 395-6186. </P>
                <SIG>
                    <DATED>Dated: </DATED>
                    <NAME>H.J. Rosenbaum,</NAME>
                    <TITLE>Acting Executive Director GSP; Acting Chairman, GSP Subcommittee of the Trade Policy Staff Committee. </TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 04-25264 Filed 11-12-04; 8:45 am] </FRDOC>
            <BILCOD>BILLING CODE 3190-W5-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="N">DEPARTMENT OF TRANSPORTATION </AGENCY>
                <SUBAGY>Office of the Secretary </SUBAGY>
                <SUBJECT>Notice of Disclosure </SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Office of the Secretary (OST), Department of Transportation. </P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice on disclosure of higher prices for airfares purchased over the telephone via telephone reservations centers or at airline ticket offices, and surcharges that may be listed separately in fare advertisements. </P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The Department is publishing the following notice disclosure of higher prices for airfares purchased over the telephone via telephone reservations centers or at airline ticket offices, and surcharges that be listed separately in fare advertisements. </P>
                </SUM>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>Nicholas Lowry, Attorney, Office of Aviation Enforcement and Proceedings (C-70), 400 7th Street, SW., Washington, DC 20590 (202) 366-9349. </P>
                    <P>
                        This notice is intended to provide guidance on two matters related to compliance with 14 CFR 399.84, the Department's rule on full fare advertising, and the underlying statutory proscription in 49 U.S.C. 41712 against unfair and deceptive trade practices. First, we address the disclosure in fare advertisements of higher prices, recently introduced by several air carriers, for tickets purchased at ticket counters or by telephone.
                        <SU>1</SU>
                        <FTREF/>
                         Second, by this notice, we are advising carriers of the current policy of the Office of Aviation Enforcement and Proceedings (Aviation Enforcement Office) with regard to the disclosure of “government-approved” surcharges. 
                    </P>
                    <FTNT>
                        <P>
                            <SU>1</SU>
                             Some carriers have referred to this increase in the price for tickets bought from them over the telephone or at a ticket counter as a “service fee” or by a similar phrase. However, in the context of the full fare advertising rule, such carrier-imposed “fees” are a part of the fare and must be treated as such in airfare advertising.
                        </P>
                    </FTNT>
                    <P>A number of air carriers and foreign air carriers have recently started charging higher prices for tickets purchased by telephone or at ticket offices. Such airlines advertise base fares on the Internet or in print or other media, make the advertised fares available for purchase via the Internet only, and charge higher prices if customers purchase their tickets via an airline's telephone reservation system or at its airport or city ticket counter. Section 399.84 mandates that the advertised fare be the full fare to be paid by the customer. Any practice of excluding from advertised fares extra “fees” charged to customers that purchase tickets over the telephone through airline reservation centers, or at airport or city ticket counters, therefore, would violate 14 CFR 399.84, and constitute an unfair and deceptive trade practice and an unfair method of competition in violation of 49 U.S.C. 41712. </P>
                    <P>
                        In order to avoid enforcement action, carriers and their agents who charge more for tickets not purchased over the Internet (
                        <E T="03">e.g.</E>
                         by telephone or at ticket offices) must prominently disclose to customers that specific fares advertised are available only for tickets purchased via the Internet. In addition, we believe that 49 U.S.C. 41712 and 14 CFR 399.84 require carriers to state in such advertising that tickets cost more than the advertised price if purchased over the telephone or at an airport or city ticket office. Moreover, we believe it would be informative and beneficial for consumers if carriers also state the amount of the increased price in the advertisements, for example, by stating that tickets cost $5 more if purchased by telephone or at an airport or city ticket office. However, this increase in price may not be characterized as a carrier-imposed “fee” lest the advertisement run afoul of the full fare advertising rule.
                        <SU>2</SU>
                        <FTREF/>
                         Accordingly, the Aviation Enforcement Office will pursue enforcement action with regard to the advertisements in question if the increased fare is merely described in terms of a service, processing, administrative, ticketing center, call center, or similar carrier-imposed “fee.” 
                    </P>
                    <FTNT>
                        <P>
                            <SU>2</SU>
                             The full-fare advertising rule was adopted in large part to eliminate the prior practice where sellers of air transportation hid the true price of tickets by listing “service fees” in the fine print of advertisements. The Aviation Enforcement Office, therefore, does not believe the increased price of tickets purchased at ticket counters or by telephone should be referred to in terms of a “service fee” in fare advertisement because this could lead to significant confusion and a return to the prior unacceptable advertising practice.
                        </P>
                    </FTNT>
                    <P>Carriers, however, may use the aforementioned “fee” terms when describing the additional charge for telephone and/or ticket counter purchases in contexts that do not list specific fares and are thus not subject to 14 CFR 399.84. Carriers may disclose such charges and refer to them as “fees,” for example, in an audio introduction on an airline telephone reservation system, stating that tickets purchased over the telephone via the airline telephone reservation system, and/or at airline ticket counters, are subject to an additional carrier-imposed “fee,” so long as the total fares eventually quoted to consumers include the “fee.” </P>
                    <P>
                        A second topic we wish to address relates to “government-approved surcharges.” In the past, we have not pursued enforcement action against carriers that listed in fare advertisements “government-imposed and government-approved” surcharges separately from the base fare quotations, so long as the existence of these 
                        <PRTPAGE P="65677"/>
                        surcharges and their amounts were stated elsewhere in the advertisement. The “government-approved” surcharges were limited to security surcharges approved in the mid-1980's that affected foreign air transportation only and were approved by both the foreign government involved and the U.S. government. Recently, tariff regulation, owing to expanded open-skies agreements and other factors, has been revised to the extent that there is no longer a consistent practice of joint approvals of surcharges, in many instances resulting in the filing of tariffs that may include surcharges that are approved by only one government. In addition, the desire of carriers to pass on the higher costs of certain expenses discretely, such as insurance and fuel, has led to such expenses being filed separately from the “base” fare in tariffs, a situation that the Department cannot effectively monitor.
                        <SU>3</SU>
                        <FTREF/>
                         In view of these developments, the Enforcement Office will no longer allow the separate listing of “government-approved” surcharges in fare advertising. We will consider the separate listing of such charges in fare advertisements an unfair and deceptive trade practice and unfair method of competition in violation of 14 CFR 399.84 and 49 U.S.C. 41712 and will pursue enforcement action where such violations are found. With respect to “government-imposed” surcharges, for example PFCs and foreign airport charges, however, our policy remains that such charges may be omitted from the fare quotations provided that they are not 
                        <E T="03">ad valorem</E>
                         in nature, that they are collected on a per-passenger basis, and that their existence and amount are clearly indicated in the advertisement so that the consumer can determine the full fare to be paid. 
                    </P>
                    <FTNT>
                        <P>
                            <SU>3</SU>
                             In open-skies and other markets governed by bilateral agreements containing double-disapproval pricing articles, the Department has exempted carriers from fare filing. See 14 CFR part 293. See also, Letter from Paul L. Gretch, Director of International Aviation, to air carriers dated October 14, 2004, which was distributed electronically by ATPCO to its members.
                        </P>
                    </FTNT>
                    <P>Questions concerning this notice or the applicability of the Department's fare advertising rules may be addressed to the Office of Aviation Enforcement and Proceedings. </P>
                    <SIG>
                        <DATED>Dated: November 5, 2004. </DATED>
                        <NAME>Samuel Podberesky, </NAME>
                        <TITLE>Assistant General Counsel for Aviation Enforcement and Proceedings. </TITLE>
                    </SIG>
                    <P>
                        An electronic version of this document is available on the World Wide Web at 
                        <E T="03">http://dms.dot.gov/reports</E>
                         and 
                        <E T="03">http://airconsumer.ost.dot.gov/rules/index.htm.</E>
                    </P>
                </FURINF>
            </PREAMB>
            <FRDOC>[FR Doc. 04-25253 Filed 11-12-04; 8:45 am] </FRDOC>
            <BILCOD>BILLING CODE 4910-62-P </BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF TRANSPORTATION</AGENCY>
                <SUBAGY>Federal Aviation Administration</SUBAGY>
                <DEPDOC>[Summary Notice No. PE-2004-79]</DEPDOC>
                <SUBJECT>Petitions for Exemption; Summary of Petitions Received</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Federal Aviation Administration (FAA), DOT.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice of petition for exemption received.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>Pursuant to FAA's rulemaking provisions governing the application, processing, and disposition of petitions for exemption, part 11 of Title 14, Code of Federal Regulations (14 CFR), this notice contains a summary of certain petitions seeking relief from specified requirements of 14 CFR. The purpose of this notice is to improve the public's awareness of, and participation in, this aspect of FAA's regulatory activities. Neither publication of this notice nor the inclusion or omission of information in the summary is intended to affect the legal status of any petition or its final disposition.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Comments on petitions received must identify the petition docket number involved and must be received on or before December 6, 2004.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>You may submit comments identified by DOT DMS Docket Number FAA-2004-18751 by any of the following methods:</P>
                    <P>
                        • 
                        <E T="03">Web Site: http://dms.dot.gov.</E>
                    </P>
                    <P>Follow the instructions for submitting comments on the DOT electronic docket site.</P>
                    <P>
                        • 
                        <E T="03">Fax:</E>
                         1-202-493-2251.
                    </P>
                    <P>
                        • 
                        <E T="03">Mail:</E>
                         Docket Management Facility; U.S. Department of Transportation, 400 Seventh Street, SW., Nassif Building, Room PL-401, Washington, DC 20590-0001.
                    </P>
                    <P>
                        • 
                        <E T="03">Hand Delivery:</E>
                         Room PL-401 on the plaza level of the Nassif Building, 400 Seventh Street, SW., Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays.
                    </P>
                    <P>
                        <E T="03">Docket:</E>
                         For access to the docket to read background documents or comments received, go to 
                        <E T="03">http://dms.dot.gov</E>
                         at any time or to Room PL-401 on the plaza level of the Nassif Building, 400 Seventh Street, SW., Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays.
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>John Linsenmeyer (202) 267-5174 or Susan Lender (202) 267-8029, Office of Rulemaking (ARM-1), Federal Aviation Administration, 800 Independence Avenue, SW., Washington, DC 20591.</P>
                    <P>This notice is published pursuant to 14 CFR 11.85 and 11.91.</P>
                    <SIG>
                        <DATED>Issued in Washington, DC, on November 5, 2004.</DATED>
                        <NAME>Anthony F. Fazio,</NAME>
                        <TITLE>Director, Office of Rulemaking.</TITLE>
                    </SIG>
                    <HD SOURCE="HD1">Petitions for Exemption</HD>
                    <P>
                        <E T="03">Docket No.:</E>
                         FAA-2004-18751.
                    </P>
                    <P>
                        <E T="03">Petitioner:</E>
                         Vaughn College of Aeronautics &amp; Technology.
                    </P>
                    <P>
                        <E T="03">Sections of 14 CFR Affected:</E>
                         14 CFR 147, Appendix C
                    </P>
                    <P>
                        <E T="03">Description of Relief Sought:</E>
                         To allow the petitioner to teach certain welding, soldering, and brazing curriculum in the Airframe Structures section of Appendix C to Teaching level 1 instead of Teaching level 2.
                    </P>
                </FURINF>
            </PREAMB>
            <FRDOC>[FR Doc. 04-25322 Filed 11-12-04; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4910-13-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="N">DEPARTMENT OF THE TREASURY</AGENCY>
                <SUBAGY>Fiscal Service</SUBAGY>
                <SUBJECT>Surety Companies Acceptable on Federal Bonds; Roche Surety and Casualty Company, Inc.</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Financial Management Service, Fiscal Service, Department of the Treasury.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice. </P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>This is Supplement No. 3 to the Treasury Department Circular 570; 2004 Revision, published July 1, 2004, at 69 FR 40224.</P>
                </SUM>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>Surety Bond Branch at (202) 874-1033.</P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>A Certificate of Authority as an acceptable surety on Federal bonds is hereby issued to the following Company under 31 U.S.C. 9304 to 9308. Federal bond-approving officers should annotate their reference copies of the Treasury Circular 570, 2004 Revision, on page 40254 to reflect this addition.</P>
                <P>
                    <E T="03">Company Name:</E>
                     Roche Surety and Casualty Company, Inc.
                </P>
                <P>
                    <E T="03">Business Address:</E>
                     1910 Orient Road, Tampa, Florida 33619.
                </P>
                <P>
                    <E T="03">Phone:</E>
                     (813) 623-5042. UNDERWRITING LIMITATION b/: $450,000.
                </P>
                <P>
                    <E T="03">Surety Licenses c/:</E>
                     AR, FL, GA, IN, KS, LA, MD, MO, NE, NV, NJ, OK, SC, TN, TX. Incorporated in: Florida.
                </P>
                <P>
                    Certificates of Authority expire on June 30 each year, unless revoked prior 
                    <PRTPAGE P="65678"/>
                    to that date. The Certificates are subject to subsequent annual renewal as long as the companies remain qualified (31 CFR Part 223). A list of qualified companies is published annually as of July 1 in Treasury Department Circular 570, with details as to underwriting limitations, areas in which licensed to transact surety business and other information.
                </P>
                <P>
                    The Circular may be viewed and downloaded through the Internet at 
                    <E T="03">http://www.fms.treas.gov/c570.</E>
                     A hard copy may be purchased from the Government Printing Office (GPO) Subscription Service, Washington, DC, Telephone (202) 512-1800. When ordering the Circular from GPO, use the following stock number: 769-004-04926-1. 
                </P>
                <P>Questions concerning this Notice may be directed to the U.S. Department of the Treasury, Financial Management Service, Financial Accounting and Services Division, Surety Bond Branch, 3700 East-West Highway, Room 6F07, Hyattsville, MD 20782.</P>
                <SIG>
                    <DATED>Dated: November 4, 2004.</DATED>
                    <NAME>Vivian L. Cooper,</NAME>
                    <TITLE>Director, Financial Accounting and Services Division, Financial Management Service.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 04-25283  Filed 11-12-04; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4810-35-M</BILCOD>
        </NOTICE>
    </NOTICES>
    <VOL>69</VOL>
    <NO>219</NO>
    <DATE>Monday, November 15, 2004</DATE>
    <UNITNAME>Presidential Documents</UNITNAME>
    <PRESDOCS>
        <PRESDOCU>
            <PROCLA>
                <TITLE3>Title 3—</TITLE3>
                <PRES>
                    The President
                    <PRTPAGE P="65515"/>
                </PRES>
                <PROC>Proclamation 7845 of November 9, 2004</PROC>
                <HD SOURCE="HED">World Freedom Day, 2004</HD>
                <PRES>By the President of the United States of America</PRES>
                <PROC>A Proclamation</PROC>
                <FP>Fifteen years ago, the people of East and West Germany tore down the Berlin Wall, and freedom triumphed over Communism. The dismantling of the Berlin Wall reunited Germany and helped spread freedom across Central and Eastern Europe. With free elections and the spread of democratic values, these countries won their liberty, and their people became free. These democracies today contribute to a strong Europe, and the United States values their friendship and their partnership.</FP>
                <FP>On World Freedom Day, we recognize all of those who fought for liberty and helped end the oppression of Central and Eastern Europe. We stand by those who today are enjoying the blessings of liberty. And we reaffirm our commitment to extending peace and freedom in the world.</FP>
                <FP>NOW, THEREFORE, I, GEORGE W. BUSH, President of the United States of America, by virtue of the authority vested in me by the Constitution and laws of the United States, do hereby proclaim November 9, 2004, as World Freedom Day. I call upon the people of the United States to observe this day with appropriate ceremonies and activities and to reaffirm their dedication to freedom and democracy.</FP>
                <FP>IN WITNESS WHEREOF, I have hereunto set my hand this ninth day of November, in the year of our Lord two thousand four, and of the Independence of the United States of America the two hundred and twenty-ninth.</FP>
                <PSIG>B</PSIG>
                <FRDOC>[FR Doc. 04-25438</FRDOC>
                <FILED>Filed 11-12-04; 8:45 am]</FILED>
                <BILCOD>Billing code 3195-01-P</BILCOD>
            </PROCLA>
        </PRESDOCU>
    </PRESDOCS>
    <VOL>69</VOL>
    <NO>219</NO>
    <DATE>Monday, November 15, 2004</DATE>
    <UNITNAME>CORRECTIONS</UNITNAME>
    <CORRECT>
        <EDITOR>!!!Michele</EDITOR>
        <PREAMB>
            <PRTPAGE P="65679"/>
            <AGENCY TYPE="F">DEPARTMENT OF THE TREASURY</AGENCY>
            <SUBAGY>Office of the Comptroller of the Currency</SUBAGY>
            <DEPDOC>[Docket No. 04-22]</DEPDOC>
            <AGENCY TYPE="O">FEDERAL RESERVE SYSTEM</AGENCY>
            <DEPDOC>[Docket No. OP-1215]</DEPDOC>
            <AGENCY TYPE="O">FEDERAL DEPOSIT INSURANCE CORPORATION</AGENCY>
            <AGENCY TYPE="O">DEPARTMENT OF THE TREASURY</AGENCY>
            <SUBAGY>Office of Thrift Supervision</SUBAGY>
            <DEPDOC>[No. 2004-48]</DEPDOC>
            <SUBJECT>Internal Ratings-Based Systems for Retail Credit Risk for Regulatory Capital</SUBJECT>
        </PREAMB>
        <SUPLINF>
            <HD SOURCE="HD2">Correction</HD>
            <P>In notice document 04-23771 beginning on page 62748 in the issue of Wednesday, October 27, 2004 make the following correction:</P>
            <P>
                On page 62774, after the heading 
                <E T="03">Example 3b: Portfolio Growth and the Timing of Default Measurements</E>
                , the table is corrected to read as set forth below.
            </P>
            <GPOTABLE COLS="6" OPTS="L2,tp0,i1" CDEF="s25,12,12,12,12,12">
                <TTITLE>  </TTITLE>
                <BOXHD>
                    <CHED H="1">Annual portfolio growth rate </CHED>
                    <CHED H="1">Total portfolio accounts </CHED>
                    <CHED H="2">Start of year </CHED>
                    <CHED H="2">End of year </CHED>
                    <CHED H="1">
                        Accounts 
                        <LI>defaulted </LI>
                        <LI>by end </LI>
                        <LI>of year </LI>
                    </CHED>
                    <CHED H="1">
                        PD from 
                        <LI>start of year portfolio </LI>
                    </CHED>
                    <CHED H="1">
                        PD from end of year portfolio 
                        <LI/>
                    </CHED>
                </BOXHD>
                <ROW>
                    <ENT I="01">−5%</ENT>
                    <ENT>1,000,000</ENT>
                    <ENT>950,000</ENT>
                    <ENT>20,000</ENT>
                    <ENT>2.0%</ENT>
                    <ENT>2.1% </ENT>
                </ROW>
                <ROW>
                    <ENT I="01">−10%</ENT>
                    <ENT>1,000,000</ENT>
                    <ENT>900,000</ENT>
                    <ENT>20,000</ENT>
                    <ENT>2.0%</ENT>
                    <ENT>2.2% </ENT>
                </ROW>
                <ROW>
                    <ENT I="01">5%</ENT>
                    <ENT>1,000,000</ENT>
                    <ENT>1,050,000</ENT>
                    <ENT>20,000</ENT>
                    <ENT>2.0%</ENT>
                    <ENT>1.9% </ENT>
                </ROW>
                <ROW>
                    <ENT I="01">10%</ENT>
                    <ENT>1,000,000</ENT>
                    <ENT>1,100,000</ENT>
                    <ENT>20,000</ENT>
                    <ENT>2.0%</ENT>
                    <ENT>1.8%</ENT>
                </ROW>
                <TNOTE>
                    <E T="02">Note:</E>
                     It is assumed that all 20,000 defaults that occurred during the year were accounts that were part of the portfolio on January 1. The Other Retail risk weight curve was used for this example, and LGD is assumed to be 90% in all four cases. 
                </TNOTE>
            </GPOTABLE>
        </SUPLINF>
        <FRDOC>[FR Doc. C4-23771  Filed 11-12-04; 8:45 am]</FRDOC>
        <BILCOD>BILLING CODE 1505-01-D</BILCOD>
    </CORRECT>
    <VOL>69</VOL>
    <NO>219</NO>
    <DATE>Monday, November 15, 2004</DATE>
    <UNITNAME>Rules and Regulations</UNITNAME>
    <NEWPART>
        <PTITLE>
            <PRTPAGE P="65681"/>
            <PARTNO>Part II</PARTNO>
            <BOOK>Book 2 of 4 Books</BOOK>
            <PGS>Pages 65681-66234</PGS>
            <AGENCY TYPE="P">Department of Health and Human Services</AGENCY>
            <SUBAGY>Centers for Medicare &amp; Medicaid Services</SUBAGY>
            <HRULE/>
            <CFR>42 CFR Part 419</CFR>
            <TITLE>Medicare Program; Changes to the Hospital Outpatient Prospective Payment System and Calendar Year 2005 Rates; Final Rule </TITLE>
        </PTITLE>
        <RULES>
            <RULE>
                <PREAMB>
                    <PRTPAGE P="65682"/>
                    <AGENCY TYPE="S">DEPARTMENT OF HEALTH AND HUMAN SERVICES </AGENCY>
                    <SUBAGY>Centers for Medicare &amp; Medicaid Services </SUBAGY>
                    <CFR>42 CFR Part 419 </CFR>
                    <DEPDOC>[CMS-1427-FC] </DEPDOC>
                    <RIN>RIN 0938-AM75 </RIN>
                    <SUBJECT>Medicare Program; Changes to the Hospital Outpatient Prospective Payment System and Calendar Year 2005 Payment Rates </SUBJECT>
                    <AGY>
                        <HD SOURCE="HED">AGENCY:</HD>
                        <P>Centers for Medicare &amp; Medicaid Services (CMS), HHS. </P>
                    </AGY>
                    <ACT>
                        <HD SOURCE="HED">ACTION:</HD>
                        <P>Final rule with comment period.</P>
                    </ACT>
                    <SUM>
                        <HD SOURCE="HED">SUMMARY:</HD>
                        <P>This final rule with comment period revises the Medicare hospital outpatient prospective payment system to implement applicable statutory requirements and changes arising from our continuing experience with this system and to implement certain related provisions of the Medicare Prescription Drug, Improvement, and Modernization Act (MMA) of 2003. In addition, the final rule with comment period describes final changes to the amounts and factors used to determine the payment rates for Medicare hospital outpatient services paid under the prospective payment system. These changes are applicable to services furnished on or after January 1, 2005. </P>
                        <P>In this final rule with comment period, we are responding to public comments received on the January 6, 2004 interim final rule with comment period relating to MMA provisions that were effective January 1, 2004, and finalizing those policies. Further, we are responding to public comments received on the November 7, 2003 final rule with comment period pertaining to the ambulatory payment classification assignment of Healthcare Common Procedure Coding System (HCPCS) codes identified in Addendum B of that rule with the new interim (NI) comment indicators (formerly referred to as condition codes). </P>
                    </SUM>
                    <EFFDATE>
                        <HD SOURCE="HED">DATES:</HD>
                        <P>
                            <E T="03">Effective Date:</E>
                             This final rule with comment period is effective on January 1, 2005. 
                        </P>
                        <P>Comment Date: We will consider comments on the ambulatory payment classification assignments of HCPCS codes identified in Addendum B with new interim comment codes and other areas specified throughout this preamble, if we receive them at the appropriate address, as provided below no later than 5 p.m. on January 14, 2005. </P>
                    </EFFDATE>
                    <ADD>
                        <HD SOURCE="HED">ADDRESSES:</HD>
                        <P>In commenting, please refer to file code CMS-1427-FC. Because of staff and resource limitations, we cannot accept comments by facsimile (FAX) transmission. </P>
                        <P>You may submit comments in one of three ways (no duplicates, please): </P>
                    </ADD>
                    <HD SOURCE="HD2">1. Electronically </HD>
                    <P>
                        You may submit electronic comments to 
                        <E T="03">http://www.cms.hhs.gov/regulations/ecomments</E>
                         (Attachments should be in Microsoft Word, WordPerfect, or Excel; however, we prefer Microsoft Word). 
                    </P>
                    <HD SOURCE="HD2">2. By Mail </HD>
                    <P>You may mail written comments (one original and two copies) to the following address only: Centers for Medicare &amp; Medicaid Services, Department of Health and Human Services, Attention: CMS-1427-FC, P.O. Box 8010, Baltimore, MD 21244-8018. </P>
                    <P>Please allow sufficient time for mailed comments to be received before the close of the comment period. </P>
                    <HD SOURCE="HD2">3. By Hand or Courier </HD>
                    <P>If you prefer, you may deliver (by hand or courier) your written comments (one original and two copies) before the close of the comment period to one of the following addresses. If you intend to deliver your comments to the Baltimore address, please call telephone number (410) 786-7195 in advance to schedule your arrival with one of our staff members. Room 445-G, Hubert H. Humphrey Building, 200 Independence Avenue, SW., Washington, DC 20201, or 7500 Security Boulevard, Baltimore, MD 21244-1850. </P>
                    <EXTRACT>
                        <FP>(Because access to the interior of the Hubert H. Humphrey Building is not readily available to persons without Federal Government identification, commenters are encouraged to leave their comments in the CMS drop slots located in the main lobby of the building. A stamp-in clock is available for persons wishing to retain proof of filing by stamping in and retaining an extra copy of the comments being filed.) </FP>
                    </EXTRACT>
                    <P>Comments mailed to the addresses indicated as appropriate for hand or courier delivery may be delayed and received after the comment period. </P>
                    <P>
                        <E T="03">Inspection of Public Comments:</E>
                         All comments received before the close of the comment period are available for viewing by the public, including any personally identifiable or confidential business information that is included in a comment. After the close of the comment period, CMS posts all electronic comments received before the close of the comment period on its public website. Written comments received timely will be available for public inspection as they are received, generally beginning approximately 4 weeks after publication of a document, at the headquarters of the Centers for Medicare &amp; Medicaid Services, 7500 Security Boulevard, Baltimore, MD 21244, Monday through Friday of each week from 8:30 a.m. to 4 p.m. To schedule an appointment to view public comments, phone (410) 786-7195. 
                    </P>
                    <FURINF>
                        <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                        <P>Dana Burley, (410) 786-0378, Outpatient prospective payment issues and Suzanne Asplen, (410) 786-4558, Partial hospitalization and community mental health center issues. </P>
                    </FURINF>
                </PREAMB>
                <SUPLINF>
                    <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                    <HD SOURCE="HD2">Availability of Copies and Electronic Access </HD>
                    <P>
                        <E T="03">Copies:</E>
                         To order copies of the 
                        <E T="04">Federal Register</E>
                         containing this document, send your request to: New Orders, Superintendent of Documents, PO Box 371954, Pittsburgh, PA 15250-7954. Specify the date of the issue requested and enclose a check or money order payable to the Superintendent of Documents, or enclose your Visa or Master Card number and expiration date. Credit card orders can also be placed by calling the order desk at (202) 512-1800 (or toll-free at 1-888-293-6498) or by faxing to (202) 512-2250. The cost for each copy is $10. As an alternative, you can view and photocopy the 
                        <E T="04">Federal Register</E>
                         document at most libraries designated as Federal Depository Libraries and at many other public and academic libraries throughout the country that receive the 
                        <E T="04">Federal Register</E>
                        . 
                    </P>
                    <P>
                        This 
                        <E T="04">Federal Register</E>
                         document is also available from the 
                        <E T="04">Federal Register</E>
                         online database through 
                        <E T="03">GPO Access,</E>
                         a service of the U.S. Government Printing Office. The Web site address is: 
                        <E T="03">http://www.gpoaccess.gov/fr/index.html.</E>
                    </P>
                    <EXTRACT>
                        <HD SOURCE="HD1">Alphabetical List of Acronyms Appearing in the Final Rule With Comment Period </HD>
                        <FP SOURCE="FP-2">ACEP—American College of Emergency Physicians </FP>
                        <FP SOURCE="FP-2">AHA—American Hospital Association </FP>
                        <FP SOURCE="FP-2">AHIMA—American Health Information Management Association </FP>
                        <FP SOURCE="FP-2">AMA—American Medical Association </FP>
                        <FP SOURCE="FP-2">APC—Ambulatory payment classification </FP>
                        <FP SOURCE="FP-2">AMP—Average manufacturer price </FP>
                        <FP SOURCE="FP-2">ASP—Average sales price </FP>
                        <FP SOURCE="FP-2">ASC—Ambulatory surgical center </FP>
                        <FP SOURCE="FP-2">AWP—Average wholesale price </FP>
                        <FP SOURCE="FP-2">BBA—Balanced Budget Act of 1997, Public Law 105-33 </FP>
                        <FP SOURCE="FP-2">BIPA—Medicare, Medicaid, and SCHIP Benefits Improvement and Protection Act of 2000, Public Law 106-554 </FP>
                        <FP SOURCE="FP-2">BBRA—Medicare, Medicaid, and SCHIP Balanced Budget Refinement Act of 1999, Public Law 106-113 </FP>
                        <FP SOURCE="FP-2">CAH—Critical access hospital </FP>
                        <FP SOURCE="FP-2">CCR—(Cost center specific) cost-to-charge ratio </FP>
                        <FP SOURCE="FP-2">
                            CMHC—Community mental health center 
                            <PRTPAGE P="65683"/>
                        </FP>
                        <FP SOURCE="FP-2">CMS—Centers for Medicare &amp; Medicaid Services (formerly known as the Health Care Financing Administration) </FP>
                        <FP SOURCE="FP-2">CORF—Comprehensive outpatient rehabilitation facility </FP>
                        <FP SOURCE="FP-2">CPT—[Physicians'] Current Procedural Terminology, Fourth Edition, 2004, copyrighted by the American Medical Association </FP>
                        <FP SOURCE="FP-2">CRNA—Certified registered nurse anesthetist </FP>
                        <FP SOURCE="FP-2">CY—Calendar year </FP>
                        <FP SOURCE="FP-2">DMEPOS—Durable medical equipment, prosthetics, orthotics, and supplies </FP>
                        <FP SOURCE="FP-2">DMERC—Durable medical equipment regional carrier </FP>
                        <FP SOURCE="FP-2">DRG—Diagnosis-related group </FP>
                        <FP SOURCE="FP-2">DSH—Disproportionate share hospital </FP>
                        <FP SOURCE="FP-2">EACH—Essential Access Community Hospital </FP>
                        <FP SOURCE="FP-2">E/M—Evaluation and management </FP>
                        <FP SOURCE="FP-2">EPO—Erythropoietin </FP>
                        <FP SOURCE="FP-2">ESRD—End-stage renal disease </FP>
                        <FP SOURCE="FP-2">FACA—Federal Advisory Committee Act, Public Law 92-463 </FP>
                        <FP SOURCE="FP-2">FDA—Food and Drug Administration </FP>
                        <FP SOURCE="FP-2">FI—Fiscal intermediary </FP>
                        <FP SOURCE="FP-2">FSS—Federal Supply Schedule </FP>
                        <FP SOURCE="FP-2">FY—Federal fiscal year </FP>
                        <FP SOURCE="FP-2">HCPCS—Healthcare Common Procedure Coding System </FP>
                        <FP SOURCE="FP-2">HCRIS—Hospital Cost Report Information System </FP>
                        <FP SOURCE="FP-2">HHA—Home health agency </FP>
                        <FP SOURCE="FP-2">HIPAA—Health Insurance Portability and Accountability Act of 1996, Public Law 104-191 </FP>
                        <FP SOURCE="FP-2">ICD-9-CM—International Classification of Diseases, Ninth Edition, Clinical Modification </FP>
                        <FP SOURCE="FP-2">IME—Indirect medical education </FP>
                        <FP SOURCE="FP-2">IPPS—(Hospital) inpatient prospective payment system </FP>
                        <FP SOURCE="FP-2">IVIG—Intravenous immune globulin </FP>
                        <FP SOURCE="FP-2">LTC—Long-term care </FP>
                        <FP SOURCE="FP-2">MedPAC—Medicare Payment Advisory Commission </FP>
                        <FP SOURCE="FP-2">MDH—Medicare-dependent hospital </FP>
                        <FP SOURCE="FP-2">MMA—Medicare Prescription Drug, Improvement, and Modernization Act of 2003, Public Law 108-173 </FP>
                        <FP SOURCE="FP-2">MSA—Metropolitan Statistical Area </FP>
                        <FP SOURCE="FP-2">NCCI—National Correct Coding Initiative </FP>
                        <FP SOURCE="FP-2">NCD—National Coverage Determination </FP>
                        <FP SOURCE="FP-2">OCE—Outpatient code editor </FP>
                        <FP SOURCE="FP-2">OMB—Office of Management and Budget </FP>
                        <FP SOURCE="FP-2">OPD—(Hospital) outpatient department </FP>
                        <FP SOURCE="FP-2">OPPS—(Hospital) outpatient prospective payment system </FP>
                        <FP SOURCE="FP-2">PET—Positron Emission Tomography </FP>
                        <FP SOURCE="FP-2">PHP—Partial hospitalization program </FP>
                        <FP SOURCE="FP-2">PM—Program memorandum </FP>
                        <FP SOURCE="FP-2">PPI—Producer Price Index </FP>
                        <FP SOURCE="FP-2">PPS—Prospective payment system </FP>
                        <FP SOURCE="FP-2">PPV—Pneumococcal pneumonia (virus) </FP>
                        <FP SOURCE="FP-2">PRA—Paperwork Reduction Act </FP>
                        <FP SOURCE="FP-2">QIO—Quality Improvement Organization </FP>
                        <FP SOURCE="FP-2">RFA—Regulatory Flexibility Act </FP>
                        <FP SOURCE="FP-2">RRC—Rural referral center </FP>
                        <FP SOURCE="FP-2">SBA—Small Business Administration </FP>
                        <FP SOURCE="FP-2">SCH—Sole community hospital </FP>
                        <FP SOURCE="FP-2">SDP—Single drug pricer </FP>
                        <FP SOURCE="FP-2">SI—Status indicator </FP>
                        <FP SOURCE="FP-2">TEFRA—Tax Equity and Fiscal Responsibility Act of 1982, Public Law 97-248 </FP>
                        <FP SOURCE="FP-2">TOPS—Transitional outpatient payments </FP>
                        <FP SOURCE="FP-2">USPDI—United States Pharmacopoeia Drug Information </FP>
                    </EXTRACT>
                    <P>To assist readers in referencing sections contained in this document, we are providing the following outline of contents: </P>
                    <EXTRACT>
                        <HD SOURCE="HD1">Outline of Contents </HD>
                        <FP SOURCE="FP-2">I. Background </FP>
                        <FP SOURCE="FP1-2">A. Legislative and Regulatory Authority for the Outpatient Prospective Payment System </FP>
                        <FP SOURCE="FP1-2">B. Excluded OPPS Services and Hospitals </FP>
                        <FP SOURCE="FP1-2">C. Prior Rulemaking </FP>
                        <FP SOURCE="FP1-2">D. APC Advisory Panel </FP>
                        <FP SOURCE="FP1-2">1. Authority for the APC Panel </FP>
                        <FP SOURCE="FP1-2">2. Establishment of the APC Panel </FP>
                        <FP SOURCE="FP1-2">3. APC Panel Meetings and Organizational Structure </FP>
                        <FP SOURCE="FP1-2">E. Provisions of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 </FP>
                        <FP SOURCE="FP1-2">F. Summary of the Provisions of the August 16, 2004 Proposed Rule </FP>
                        <FP SOURCE="FP1-2">G. Public Comments Received on the August 16, 2004 Proposed Rule </FP>
                        <FP SOURCE="FP1-2">H. Public Comments Received on the January 6, 2004 Interim Final Rule with Comment Period </FP>
                        <FP SOURCE="FP1-2">I. Public Comments Received on the November 7, 2003 Final Rule with Comment Period </FP>
                        <FP SOURCE="FP-2">II. Changes Related to Ambulatory Payment Classifications (APCs) </FP>
                        <FP SOURCE="FP1-2">A. APC Changes: General </FP>
                        <FP SOURCE="FP1-2">B. APC Panel Review and Recommendations </FP>
                        <FP SOURCE="FP1-2">1. February 2004 Panel Meeting. </FP>
                        <FP SOURCE="FP1-2">2. September 2004 Panel Meeting </FP>
                        <FP SOURCE="FP1-2">3. Contents of This Section of the Preamble </FP>
                        <FP SOURCE="FP1-2">4. APC 0018: Biopsy of Skin/Puncture of Lesion </FP>
                        <FP SOURCE="FP1-2">5. Level I and II Arthroscopy </FP>
                        <FP SOURCE="FP1-2">6. Angiography and Venography Except Extremity </FP>
                        <FP SOURCE="FP1-2">a. February 2004 Panel Meeting </FP>
                        <FP SOURCE="FP1-2">b. Public Comments Received </FP>
                        <FP SOURCE="FP1-2">c. Final Policy for CY 2005 </FP>
                        <FP SOURCE="FP1-2">7. Packaged Codes in APCs </FP>
                        <FP SOURCE="FP1-2">C. Limits on Variations Within APCs: Application of the 2 Times Rule </FP>
                        <FP SOURCE="FP1-2">1. Cardiac and Ambulatory Blood Pressure Monitoring </FP>
                        <FP SOURCE="FP1-2">2. Electrocardiograms </FP>
                        <FP SOURCE="FP1-2">3. Excision/Biopsy </FP>
                        <FP SOURCE="FP1-2">4. Posterior Segment Eye Procedures </FP>
                        <FP SOURCE="FP1-2">5. Laparoscopy </FP>
                        <FP SOURCE="FP1-2">6. Anal/Rectal Procedures </FP>
                        <FP SOURCE="FP1-2">7. Nerve Injections </FP>
                        <FP SOURCE="FP1-2">8. Anterior Segment Eye Procedures </FP>
                        <FP SOURCE="FP1-2">9. Pathology </FP>
                        <FP SOURCE="FP1-2">10. Immunizations </FP>
                        <FP SOURCE="FP1-2">11. Pulmonary Tests </FP>
                        <FP SOURCE="FP1-2">12. Clinic Visits </FP>
                        <FP SOURCE="FP1-2">13. Other APC Assignment Issues </FP>
                        <FP SOURCE="FP1-2">a. Catheters for Brachytherapy Services </FP>
                        <FP SOURCE="FP1-2">b. Peripherally Inserted Central Catheters (PICC) </FP>
                        <FP SOURCE="FP1-2">c. External Fixation Devices </FP>
                        <FP SOURCE="FP1-2">d. Apheresis </FP>
                        <FP SOURCE="FP1-2">e. Imaging for Intravenous Cholangiogram (IVC) Filter Placement and Breast Biopsy </FP>
                        <FP SOURCE="FP1-2">f. Hysteroscopic Endometrial Ablation Procedures </FP>
                        <FP SOURCE="FP1-2">g. Hysteroscopic Female Sterilization </FP>
                        <FP SOURCE="FP1-2">h. Urinary Bladder Residual Study </FP>
                        <FP SOURCE="FP1-2">i. Intracranial Studies, Electrodiagnostic Testing, Autonomic Testing, and EEG </FP>
                        <FP SOURCE="FP1-2">j. Therapeutic Radiation Treatment </FP>
                        <FP SOURCE="FP1-2">k. Hyperthermia Procedures </FP>
                        <FP SOURCE="FP1-2">l. Physician Blood Bank Services </FP>
                        <FP SOURCE="FP1-2">m. Caloric Vestibular Test </FP>
                        <FP SOURCE="FP1-2">n. APC 0365—Level II Audiometry </FP>
                        <FP SOURCE="FP1-2">o. Noncoronary Intravascular Ultrasound (IVUS) </FP>
                        <FP SOURCE="FP1-2">p. Electronic Analysis of Neurostimulator Pulse Generators </FP>
                        <FP SOURCE="FP1-2">q. Endoscopic Ultrasound Services </FP>
                        <FP SOURCE="FP1-2">r. External Counterpulsation </FP>
                        <FP SOURCE="FP1-2">D. Exceptions to the 2 Times Rule </FP>
                        <FP SOURCE="FP1-2">E. Coding for Stereostatic Radiosurgery Services </FP>
                        <FP SOURCE="FP1-2">1. Background </FP>
                        <FP SOURCE="FP1-2">2. Proposal for CY 2005 </FP>
                        <FP SOURCE="FP1-2">3. Public Comments Received and Departmental Responses </FP>
                        <FP SOURCE="FP1-2">4. Final Policy for CY 2005 </FP>
                        <FP SOURCE="FP1-2">F. Movement of Procedures from New Technology APCs to Clinically Appropriate APCs </FP>
                        <FP SOURCE="FP1-2">1. Background </FP>
                        <FP SOURCE="FP1-2">2. APC Panel Review and Recommendation </FP>
                        <FP SOURCE="FP1-2">3. Proposed and Final Policy for CY 2005 </FP>
                        <FP SOURCE="FP1-2">a. Computerized Reconstruction CT of Aorta</FP>
                        <FP SOURCE="FP1-2">b. Left Ventricular Pacing, Lead and Connector </FP>
                        <FP SOURCE="FP1-2">c. Positron Emission Tomography (PET) Scans </FP>
                        <FP SOURCE="FP1-2">d. Bard Endoscopic Suturing System </FP>
                        <FP SOURCE="FP1-2">e. Stretta System </FP>
                        <FP SOURCE="FP1-2">f. Gastrointestinal Tract Capsule Endoscopy </FP>
                        <FP SOURCE="FP1-2">g. Proton Beam Therapy </FP>
                        <FP SOURCE="FP1-2">4. Public Comments Received Relating to Other New Technology APC Issues </FP>
                        <FP SOURCE="FP1-2">a. Computerized Reconstruction CT of Aorta </FP>
                        <FP SOURCE="FP1-2">b. Kyphoplasty </FP>
                        <FP SOURCE="FP1-2">c. Laser Treatment of Benign Prostatic Hyperplasia (BPH) </FP>
                        <FP SOURCE="FP1-2">d. Computerized Tomographic Angiography (CTA) </FP>
                        <FP SOURCE="FP1-2">e. Acoustic Heart Sound Services </FP>
                        <FP SOURCE="FP1-2">f. Laparoscopic Ablation Renal Mass </FP>
                        <FP SOURCE="FP1-2">g. Intrabeam Intra-Operative Therapy </FP>
                        <FP SOURCE="FP1-2">h. New Technology Process Issues </FP>
                        <FP SOURCE="FP1-2">G. Changes to the Inpatient List </FP>
                        <FP SOURCE="FP1-2">H. Assignment of “Unlisted” HCPCS Codes </FP>
                        <FP SOURCE="FP1-2">1. Background </FP>
                        <FP SOURCE="FP1-2">2. Proposed and Final Policies for CY 2005 </FP>
                        <FP SOURCE="FP1-2">I. Addition of New Procedure Codes </FP>
                        <FP SOURCE="FP1-2">J. OPPS Changes Relating to Coverage of Initial Preventive Physical Examinations and Mammography under Public Law 108-173 </FP>
                        <FP SOURCE="FP1-2">1. Payment for Initial Preventive Physical Examinations (Section 611 of Pub. L. 108-173) </FP>
                        <FP SOURCE="FP1-2">a. Background </FP>
                        <FP SOURCE="FP1-2">b. Amendments to Regulations </FP>
                        <FP SOURCE="FP1-2">c. Assignment of New HCPCS Codes for Payment of Initial Preventive Physical Examinations </FP>
                        <FP SOURCE="FP1-2">d. APC Assignment of Initial Preventive Physical Examinations </FP>
                        <FP SOURCE="FP1-2">2. Payment for Certain Mammography Services (Section 614 of Pub. L. 108-173) </FP>
                        <FP SOURCE="FP-2">III. Recalibration of APC Relative Weights for CY 2005 </FP>
                        <FP SOURCE="FP1-2">
                            A. Database Construction 
                            <PRTPAGE P="65684"/>
                        </FP>
                        <FP SOURCE="FP1-2">1. Treatment of Multiple Procedure Claims </FP>
                        <FP SOURCE="FP1-2">2. Use of Single Procedure Claims </FP>
                        <FP SOURCE="FP1-2">B. Calculation of Median Costs for CY 2005 </FP>
                        <FP SOURCE="FP1-2">C. Adjustment of Median Costs for CY 2005 </FP>
                        <FP SOURCE="FP1-2">1. Device-Dependent APCs </FP>
                        <FP SOURCE="FP1-2">a. APC 0226: Implantation of Drug Infusion Reservoir </FP>
                        <FP SOURCE="FP1-2">b. APC 0048: Arthroscopy with Prosthesis </FP>
                        <FP SOURCE="FP1-2">c. APC 0385: Level I Prosthetic Urological Procedures </FP>
                        <FP SOURCE="FP1-2">d. APC 0119: Implantation of Infusion Device and APC 0115: Cannula/Access Device Procedures </FP>
                        <FP SOURCE="FP1-2">2. Treatment of Specified APCs </FP>
                        <FP SOURCE="FP1-2">a. APC 0315: Level II Implantation of Neurostimulator </FP>
                        <FP SOURCE="FP1-2">b. APC 0651: Complex Interstitial Radiation Application </FP>
                        <FP SOURCE="FP1-2">c. APC 0659: Hyperbaric Oxygen Therapy </FP>
                        <FP SOURCE="FP1-2">3. Other APC Median Cost Issues </FP>
                        <FP SOURCE="FP1-2">a. APC 0312 Radioelement Applications </FP>
                        <FP SOURCE="FP1-2">b. Percutaneous Radiofrequency Ablation of Liver Tumors </FP>
                        <FP SOURCE="FP1-2">c. Heparin Coated Stents </FP>
                        <FP SOURCE="FP1-2">d. Aqueous Drainage Assist Device </FP>
                        <FP SOURCE="FP1-2">4. Required Use of C-Codes for Devices </FP>
                        <FP SOURCE="FP1-2">5. Submission of External Data </FP>
                        <FP SOURCE="FP1-2">D. Calculation of Scaled OPPS Payment Weights </FP>
                        <FP SOURCE="FP-2">IV. Payment Changes For Devices </FP>
                        <FP SOURCE="FP1-2">A. Pass-Through Payments For Devices </FP>
                        <FP SOURCE="FP1-2">1. Expiration of Transitional Pass-Through Payments for Certain Devices </FP>
                        <FP SOURCE="FP1-2">2. Proposed and Final Policies for CY 2005 </FP>
                        <FP SOURCE="FP1-2">B. Provisions for Reducing Transitional Pass-Through Payments to Offset Costs Packaged Into APC Groups </FP>
                        <FP SOURCE="FP1-2">1. Background </FP>
                        <FP SOURCE="FP1-2">2. Proposed and Final Policies for CY 2005 </FP>
                        <FP SOURCE="FP1-2">C. Criteria for Establishing New Pass-Through Device Categories </FP>
                        <FP SOURCE="FP-2">V. Payment Changes for Drugs, Biologicals, and Radiopharmaceutical Agents, and Blood and Blood Products </FP>
                        <FP SOURCE="FP1-2">A. Transitional Pass-Through Payment for Additional Costs of Drugs and Biologicals </FP>
                        <FP SOURCE="FP1-2">1. Background </FP>
                        <FP SOURCE="FP1-2">2. Expiration in CY 2004 of Pass-Through Status for Drugs and Biologicals </FP>
                        <FP SOURCE="FP1-2">3. Drugs and Biologicals With Pass-Through Status in CY 2005 </FP>
                        <FP SOURCE="FP1-2">B. Drugs, Biologicals, and Radiopharmaceuticals Without Pass-Through Status </FP>
                        <FP SOURCE="FP1-2">1. Background </FP>
                        <FP SOURCE="FP1-2">2. Criteria for Packaging Payment for Drugs, Biologicals, and Radiopharmaceuticals </FP>
                        <FP SOURCE="FP1-2">3. Payment for Drugs, Biologicals, and Radiopharmaceuticals Without Pass-Through Status That Are Not Packaged </FP>
                        <FP SOURCE="FP1-2">a. Payment for Specified Covered Outpatient Drugs </FP>
                        <FP SOURCE="FP1-2">b. Treatment of Three Sunsetting Pass-Through Drugs as Specified Covered Outpatient Drugs </FP>
                        <FP SOURCE="FP1-2">c. CY 2005 Payment for Nonpass-Through Drugs, Biologicals, and Radiopharmaceuticals with HCPCS Codes But Without OPPS Hospital Claims Data </FP>
                        <FP SOURCE="FP1-2">d. Payment for Separately Payable Nonpass-Through Drugs and Biologicals </FP>
                        <FP SOURCE="FP1-2">e. CY 2005 Change in Payment Status for HCPCS Code J7308 </FP>
                        <FP SOURCE="FP1-2">4. Public Comments Received on the January 6, 2004 Interim Final rule With Comment Period and Departmental Responses </FP>
                        <FP SOURCE="FP1-2">C. Coding and Billing for Specified Outpatient Drugs </FP>
                        <FP SOURCE="FP1-2">D. Payment for New Drugs, Biologicals, and Radiopharmaceuticals Before HCPCS Codes Are Assigned </FP>
                        <FP SOURCE="FP1-2">1. Background </FP>
                        <FP SOURCE="FP1-2">2. Provisions of Public Law 108-173 </FP>
                        <FP SOURCE="FP1-2">E. Payment for Vaccines </FP>
                        <FP SOURCE="FP1-2">F. Changes in Payment for Single Indication Orphan Drugs </FP>
                        <FP SOURCE="FP1-2">G. Changes in Payment Policy for Radiopharmaceuticals </FP>
                        <FP SOURCE="FP1-2">H. Coding and Payment for Drug Administration </FP>
                        <FP SOURCE="FP1-2">I. Payment for Blood and Blood Products </FP>
                        <FP SOURCE="FP-2">VI. Estimated Transitional Pass-Through Spending in CY 2005 for Drugs, Biologicals, and Devices </FP>
                        <FP SOURCE="FP1-2">A. Basis for Pro Rata Reduction </FP>
                        <FP SOURCE="FP1-2">B. Estimate of Pass-Through Spending for CY 2005 </FP>
                        <FP SOURCE="FP-2">VII. Other Policy Decisions and Policy Changes </FP>
                        <FP SOURCE="FP1-2">A. Statewide Average Default Cost-to-Charge Ratios </FP>
                        <FP SOURCE="FP1-2">B. Transitional Corridor Payments: Technical Change </FP>
                        <FP SOURCE="FP1-2">C. Status Indicators and Comment Indicators Assigned in Outpatient Code Editor (OCE) </FP>
                        <FP SOURCE="FP1-2">1. Payment Status Indicators </FP>
                        <FP SOURCE="FP1-2">2. Comment Indicators </FP>
                        <FP SOURCE="FP1-2">D. Observation Services </FP>
                        <FP SOURCE="FP1-2">E. Procedures That Will be Paid Only as Inpatient Procedures </FP>
                        <FP SOURCE="FP1-2">F. Hospital Coding for Evaluation and Management Services </FP>
                        <FP SOURCE="FP1-2">1. Background </FP>
                        <FP SOURCE="FP1-2">2. Proposal for Evaluation and Management Guidelines </FP>
                        <FP SOURCE="FP1-2">G. Brachytherapy Payment Issues Related to Public Law 108-173 </FP>
                        <FP SOURCE="FP1-2">1. Payment for Brachytherapy Sources (Section 621(b) of Pub. L. 108-173) </FP>
                        <FP SOURCE="FP1-2">2. HCPCS Codes and APC Assignments for Brachytherapy Sources </FP>
                        <FP SOURCE="FP1-2">H. Payment for APC 0375, Ancillary Outpatient Services When Patient Expires </FP>
                        <FP SOURCE="FP-2">VIII. Conversion Factor Update for CY 2005 </FP>
                        <FP SOURCE="FP-2">IX. Wage Index Changes for CY 2005 </FP>
                        <FP SOURCE="FP-2">X. Determination of Payment Rates and Outlier Payments for CY 2005 </FP>
                        <FP SOURCE="FP1-2">A. Calculation of the National Unadjusted Medicare Payment </FP>
                        <FP SOURCE="FP1-2">B. Hospital Outpatient Outlier Payments </FP>
                        <FP SOURCE="FP1-2">C. Payment for Partial Hospitalization </FP>
                        <FP SOURCE="FP1-2">1. Background </FP>
                        <FP SOURCE="FP1-2">2. PHP APC Update for CY 2005 </FP>
                        <FP SOURCE="FP1-2">3. Separate Threshold for Outlier Payments to CMHCs </FP>
                        <FP SOURCE="FP1-2">D. General Public Comments </FP>
                        <FP SOURCE="FP-2">XI. Beneficiary Copayments for CY 2005 </FP>
                        <FP SOURCE="FP1-2">A. Background </FP>
                        <FP SOURCE="FP1-2">B. Copayment for CY 2005 </FP>
                        <FP SOURCE="FP-2">XII. Addendum Files Available to the Public Via Internet </FP>
                        <FP SOURCE="FP-2">XIII. Collection of Information Requirements </FP>
                        <FP SOURCE="FP-2">XIV. Regulatory Impact Analysis </FP>
                        <FP SOURCE="FP1-2">A. OPPS: General </FP>
                        <FP SOURCE="FP1-2">B. Impact of Changes in this Final Rule with Comment Period </FP>
                        <FP SOURCE="FP1-2">C. Alternatives Considered </FP>
                        <FP SOURCE="FP1-2">D. Limitations of Our Analysis </FP>
                        <FP SOURCE="FP1-2">E. Estimated Impacts of this Final Rule with Comment Period on Hospitals </FP>
                        <FP SOURCE="FP1-2">F. Projected Distribution of Outlier Payment </FP>
                        <FP SOURCE="FP1-2">G. Estimated Impacts of This Final Rule with Comment Period on Beneficiaries </FP>
                        <FP SOURCE="FP-2">XV. Regulation Text </FP>
                        <HD SOURCE="HD1">Addenda </HD>
                        <FP SOURCE="FP-2">Addendum A—List of Ambulatory Payment Classification (APCs) with Status Indicators, Relative Weights, Payment Rates, and Copayment Amounts for CY 2005 </FP>
                        <FP SOURCE="FP-2">Addendum B—Payment Status by HCPCS Code and Related Information—CY 2005 </FP>
                        <FP SOURCE="FP-2">Addendum C—Healthcare Common Procedure Coding System (HCPCS) Codes by Ambulatory Payment Classification (APC) (Available only on CMS Web site via Internet. See section XIII. of the preamble of this final rule with comment period.) </FP>
                        <FP SOURCE="FP-2">Addendum D1—Payment Status Indicators for Hospital Outpatient Prospective Payment System </FP>
                        <FP SOURCE="FP-2">Addendum D2—Comment Indicators </FP>
                        <FP SOURCE="FP-2">Addendum E—CPT Codes That Are Paid Only as Inpatient Procedures </FP>
                    </EXTRACT>
                    <HD SOURCE="HD1">I. Background </HD>
                    <HD SOURCE="HD2">A. Legislative and Regulatory Authority for the Outpatient Prospective Payment System </HD>
                    <P>
                        When the Medicare statute was originally enacted, Medicare payment for hospital outpatient services was based on hospital-specific costs. In an effort to ensure that Medicare and its beneficiaries pay appropriately for services and to encourage more efficient delivery of care, the Congress mandated replacement of the cost-based payment methodology with a prospective payment system (PPS). The Balanced Budget Act of 1997 (BBA) (Pub. L. 105-33), enacted on August 5, 1997, added section 1833(t) to the Social Security Act (the Act) authorizing implementation of a PPS for hospital outpatient services. The Medicare, Medicaid, and SCHIP Balanced Budget Refinement Act of 1999 (BBRA) (Pub. L. 106-113), enacted on November 29, 1999, made major changes that affected the hospital outpatient PPS (OPPS). The Medicare, Medicaid, and SCHIP Benefits Improvement and Protection Act of 2000 (BIPA) (Pub. L. 106-554), enacted on December 21, 2000, made further changes in the OPPS. Section 1833(t) of the Act was also recently amended by the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA), Public Law 108-173, enacted on December 8, 2003 (these amendments are discussed later under section I.E. of this final rule with comment period). The OPPS was first 
                        <PRTPAGE P="65685"/>
                        implemented for services furnished on or after August 1, 2000. Implementing regulations for the OPPS are located at 42 CFR Part 419. 
                    </P>
                    <P>Under the OPPS, we pay for hospital outpatient services on a rate-per-service basis that varies according to the ambulatory payment classification (APC) group to which the service is assigned. We use Healthcare Common Procedure Coding System (HCPCS) codes (which include certain Current Procedural Terminology (CPT) codes) and descriptors to identify and group the services within each APC group. The OPPS includes payment for most hospital outpatient services, except those identified in section I.B. of this final rule with comment period. Section 1833(t)(1)(B)(ii) of the Act provides for Medicare payment under the OPPS for certain services designated by the Secretary that are furnished to inpatients who have exhausted their Part A benefits or who are otherwise not in a covered Part A stay. In addition, the OPPS includes payment for partial hospitalization services furnished by community mental health centers (CMHCs). </P>
                    <P>The OPPS rate is an unadjusted national payment amount that includes the Medicare payment and the beneficiary copayment. This rate is divided into a labor-related amount and a nonlabor-related amount. The labor-related amount is adjusted for area wage differences using the inpatient hospital wage index value for the locality in which the hospital or CMHC is located. </P>
                    <P>All services and items within an APC group are comparable clinically and with respect to resource use (section 1833(t)(2)(B) of the Act). In accordance with section 1833(t)(2) of the Act, subject to certain exceptions, services and items within an APC group cannot be considered comparable with respect to the use of resources if the highest median (or mean cost, if elected by the Secretary) for an item or service in the APC group is more than 2 times greater than the lowest median cost for an item or service within the same APC group (referred to as the “2 times rule”). In implementing this provision, we use the median cost of the item or service assigned to an APC group. </P>
                    <P>Special payments under the OPPS may be made for new technology items and services in one of two ways. Section 1833(t)(6) of the Act provides for temporary additional payments or “transitional pass-through payments” for certain drugs, biological agents, brachytherapy devices used for the treatment of cancer, and categories of medical devices for at least 2 but not more than 3 years. For new technology services that are not eligible for pass-through payments and for which we lack sufficient data to appropriately assign them to a clinical APC group, we have established special APC groups based on costs, which we refer to as APC cost bands. These cost bands allow us to price these new procedures more appropriately and consistently. Similar to pass-through payments, these special payments for new technology services are also temporary; that is, we retain a service within a new technology APC group until we acquire adequate data to assign it to a clinically appropriate APC group. </P>
                    <HD SOURCE="HD2">B. Excluded OPPS Services and Hospitals </HD>
                    <P>Section 1833(t)(1)(B)(i) of the Act authorizes the Secretary to designate the hospital outpatient services that are paid under the OPPS. While most hospital outpatient services are payable under the OPPS, section 1833(t)(1)(B)(iv) of the Act excluded payment for ambulance, physical and occupational therapy, and speech-language pathology services, for which payment is made under a fee schedule. The Secretary exercised the broad authority granted under the statute to exclude from the OPPS those services that are paid under fee schedules or other payment systems. Such excluded services include, for example, the professional services of physicians and nonphysician practitioners paid under the Medicare Physician Fee Schedule; laboratory services paid under the clinical diagnostic laboratory fee schedule; services for beneficiaries with end-stage renal disease (ESRD) that are paid under the ESRD composite rate; and services and procedures that require an inpatient stay that are paid under the hospital inpatient prospective payment system (IPPS). We set forth the services that are excluded from payment under the OPPS in § 419.22 of the regulations. </P>
                    <P>Under § 419.20 of the regulations, we specify the types of hospitals and entities that are excluded from payment under the OPPS. These excluded entities include Maryland hospitals, but only for services that are paid under a cost containment waiver in accordance with section 1814(b)(3) of the Act; critical access hospitals (CAHs); hospitals located outside of the 50 States, the District of Columbia, and Puerto Rico; and Indian Health Service hospitals. </P>
                    <HD SOURCE="HD2">C. Prior Rulemaking </HD>
                    <P>
                        On April 7, 2000, we published in the 
                        <E T="04">Federal Register</E>
                         a final rule with comment period (65 FR 18434) to implement a prospective payment system for hospital outpatient services. The hospital OPPS was first implemented for services furnished on or after August 1, 2000. Section 1833(t)(9) of the Act requires the Secretary to review certain components of the OPPS not less often than annually and to revise the groups, relative payment weights, and other adjustments to take into account changes in medical practice, changes in technology, and the addition of new services, new cost data, and other relevant information and factors. Since implementing the OPPS, we have published final rules in the 
                        <E T="04">Federal Register</E>
                         annually to implement statutory requirements and changes arising from our experience with this system. For a full discussion of the changes to the OPPS, we refer readers to these 
                        <E T="04">Federal Register</E>
                         final rules.
                        <SU>1</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>1</SU>
                             Interim final rule with comment period, August 3, 2000 (65 FR 47670); interim final rule with comment period, November 13, 2000 (65 FR 67798); final rule and interim final rule with comment period, November 2, 2001 (66 FR 55850 and 55857); final rule, November 30, 2001 (66 FR 59856); final rule, December 31, 2001 (66 FR 67494); final rule, March 1, 2002 (67 FR 9556); final rule, November 1, 2002 (67 FR 66718); final rule with comment period, November 7, 2003 (68 FR 63398); and interim final rule with comment period, January 6, 2004 (69 FR 820).
                        </P>
                    </FTNT>
                    <P>
                        On November 7, 2003, we published a final rule with comment period in the 
                        <E T="04">Federal Register</E>
                         (68 FR 63398) that revised the OPPS to update the payment weights and conversion factor for services payable under the calendar year (CY) 2004 OPPS on the basis of claims data from April 1, 2002 through December 31, 2002. In this final rule with comment period, we are finalizing the APC assignments and addressing public comments received pertaining to the new interim HCPCS codes listed in Addendum B of the November 7, 2003 final rule with comment period identified by new interim (NI) comment indicators (formerly referred to as condition codes). Subsequent to publishing the November 7, 2003 final rule with comment period, we published a correction of the final rule with comment period on December 31, 2003 (68 FR 75442). That December 31, 2003 document corrected technical errors in the November 7, 2003 final rule with comment period and included responses to a number of public comments that were inadvertently omitted from the November 2003 final rule with comment period. 
                    </P>
                    <P>
                        On January 6, 2004, we published in the 
                        <E T="04">Federal Register</E>
                         an interim final rule with comment period (69 FR 820) that implemented provisions of Public Law 108-173 that affected payments made under the OPPS, effective January 1, 2004. We are finalizing this interim 
                        <PRTPAGE P="65686"/>
                        final rule and addressing public comments associated with that rule in this final rule with comment period. 
                    </P>
                    <HD SOURCE="HD2">D. APC Advisory Panel </HD>
                    <HD SOURCE="HD3">1. Authority of the APC Panel </HD>
                    <P>Section 1833(t)(9)(A) of the Act, as amended by section 201(h) of the BBRA of 1999, requires that we consult with an outside panel of experts to review the clinical integrity of the payment groups and weights under the OPPS. The Advisory Panel on APC Groups (the APC Panel), discussed under section I.D.2. of this preamble, fulfills this requirement. The Act further specifies that the Panel will act in an advisory capacity. This expert panel, which is to be composed of 15 representatives of providers subject to the OPPS (currently employed full-time, not consultants, in their respective areas of expertise), reviews and advises us about the clinical integrity of the APC groups and their weights. The APC Panel is not restricted to using our data and may use data collected or developed by organizations outside the Department in conducting its review. </P>
                    <HD SOURCE="HD3">2. Establishment of the APC Panel </HD>
                    <P>On November 21, 2000, the Secretary signed the charter establishing the Advisory Panel on APC Groups. The APC Panel is technical in nature and is governed by the provisions of the Federal Advisory Committee Act (FACA), as amended (Public Law 92-463). On November 1, 2002, the Secretary renewed the charter. The renewed charter indicates that the APC Panel continues to be technical in nature, is governed by the provisions of the FACA, may convene up to three meetings per year, and is chaired by a Federal official. </P>
                    <P>
                        Originally, in establishing the APC Panel, we solicited members in a notice published in the 
                        <E T="04">Federal Register</E>
                         on December 5, 2000 (65 FR 75943). We received applications from more than 115 individuals who nominated either colleagues or themselves. After carefully reviewing the applications, we chose 15 highly qualified individuals to serve on the APC Panel. Because of the loss of four APC Panel members due to the expiration of terms of office on March 31, 2004, we published a 
                        <E T="04">Federal Register</E>
                         notice on January 23, 2004 (69 FR 3370) that solicited nominations for APC Panel membership. From the 24 nominations that we received, we chose four new members. The entire APC Panel membership is identified on the CMS Web site at 
                        <E T="03">http://www.cms.hhs.gov/faca/apc/apcmem.asp.</E>
                    </P>
                    <HD SOURCE="HD3">3. APC Panel Meetings and Organizational Structure </HD>
                    <P>
                        The APC Panel first met on February 27, February 28, and March 1, 2001. Since that initial meeting, the APC Panel has held five subsequent meetings, with the last meeting taking place on September 1, 2, and 3, 2004. Prior to each of these biennial meetings, we published a notice in the 
                        <E T="04">Federal Register</E>
                         to announce each meeting and, when necessary, to solicit nominations for APC Panel membership. For a more detailed discussion about these announcements, refer to the following 
                        <E T="04">Federal Register</E>
                         notices: December 5, 2000 (65 FR 75943), December 14, 2001 (66 FR 64838), December 27, 2002 (67 FR 79107), July 25, 2003 (68 FR 44089), and December 24, 2003 (68 FR 74621), and August 5, 2004 (69 FR 47446). 
                    </P>
                    <P>During these meetings, the APC Panel established its operational structure that, in part, includes the use of three subcommittees to facilitate its required APC review process. Currently, the three subcommittees are the Data Subcommittee, the Observation Subcommittee, and the Packaging Subcommittee. The Data Subcommittee is responsible for studying the data issues confronting the APC Panel and for recommending viable options for resolving them. This subcommittee was initially established on April 23, 2001, as the Research Subcommittee and reestablished as the Data Subcommittee on April 13, 2004. The Observation Subcommittee, which was established on June 24, 2003, and reestablished with new members on March 8, 2004, reviews and makes recommendations to the APC Panel on all issues pertaining to observation services paid under the OPPS, such as coding and operational issues. The Packaging Subcommittee, which was established on March 8, 2004, studies and makes recommendations on issues pertaining to services that are not separately payable under the OPPS but are bundled or packaged APC payments. Each of these subcommittees was established by a majority vote of the APC Panel during a scheduled APC Panel meeting. All subcommittee recommendations are discussed and voted upon by the full APC Panel. </P>
                    <P>For a detailed discussion of the APC Panel meetings, refer to the hospital OPPS final rules cited in section I.C. of this preamble. Full discussions of the APC Panel's February 2004 and September 2004 meetings and the resulting recommendations are included in sections II., III., IV., V., and VI. of this preamble under the appropriate subject headings. </P>
                    <HD SOURCE="HD2">E. Provisions of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 </HD>
                    <P>On December 8, 2003, the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA), Public Law 108-173, was enacted. Public Law 108-173 made changes to the Act relating to the Medicare OPPS. In a January 6, 2004 interim final rule with comment period, we implemented provisions of Public Law 108-173 relating to the OPPS that were effective for CY 2004. In this final rule with comment period, we are responding to public comments received on the January 6, 2004 interim final rule and finalizing that rule. In addition, in this final rule with comment period, we are implementing the following sections of Public Law 108-173 that are effective for CY 2005: </P>
                    <P>• Section 611, which provides for Medicare coverage of an initial preventive physical examination under Part B, subject to the applicable deductible and coinsurance, as an outpatient department (OPD) service payable under the OPPS. The provisions of section 611 apply to services furnished on or after January 1, 2005, but only for individuals whose coverage period under Medicare Part B begins on or after that date. </P>
                    <P>• Section 614, which provides that screening mammography and diagnostic mammography services are excluded from payment under the OPPS. This amendment applies to screening mammography services furnished on or after the date of enactment of Public Law 108-173 (that is, December 8, 2003), and in the case of diagnostic mammography, to services furnished on or after January 1, 2005. </P>
                    <P>• Section 621(a)(1), which requires special classification of certain separately paid radiopharmaceutical agents and drugs or biologicals, and specifies the pass-through payment percentages, effective for services furnished on or after January 1, 2005, for the three categories of “specified covered OPD drugs” defined in the statute: sole source drug; innovator multiple source drug; and noninnovator multiple source drug. In addition, payment for these drugs for CYs 2004 and 2005 does not have to be made in a budget neutral manner. </P>
                    <P>
                        • Section 621(a)(2), which specifies the reduced threshold for the establishment of separate APCs with respect to drugs or biologicals from $150 to $50 per administration for drugs and biologicals furnished in CYs 2005 and 2006. 
                        <PRTPAGE P="65687"/>
                    </P>
                    <P>• Section 621(a)(3), which excludes separate drug APCs from outlier payments. Specifically, no additional payment will be made in the case of APC groups established separately for drugs and biologicals. </P>
                    <P>• Section 621(b), which requires that all devices of brachytherapy consisting of a seed or seeds (or radioactive source) furnished on or after January 1, 2004, and before January 1, 2007, be paid based on the hospital's charges for each device, adjusted to cost. This provision also requires that these brachytherapy services be excluded from outlier payments. </P>
                    <HD SOURCE="HD2">F. Summary of the Provisions of the August 16, 2004 Proposed Rule </HD>
                    <P>
                        On August 16, 2004, we published a proposed rule in the 
                        <E T="04">Federal Register</E>
                         (69 FR 50447) that set forth proposed changes to the Medicare hospital OPPS and to implement provisions of Public Law 108-173 specified in section I.E. of this preamble that would be effective for services furnished on or after January 1, 2005. The following is a summary of the major changes that we proposed to make: 
                    </P>
                    <HD SOURCE="HD3">1. Changes to the APC Groups </HD>
                    <P>As required by section 1833(t)(9)(A) of the Act, we proposed the annual update of the APC groups and the relative payment weights. This section also requires that we consult with an outside panel of experts, the Advisory Panel on APC Groups, to review the clinical integrity of the groups and weights under the OPPS. Based on analyses of Medicare claims data and recommendations of the APC Panel, we proposed to establish a number of new APCs and to make changes to the assignment of HCPCS codes under a number of existing APCs. </P>
                    <P>We also discussed the application of the 2 times rule and proposed exceptions to it; coding for stereotactic radiosurgery services; the proposed movement of procedures from the new technology APCs; the proposed changes to the list of procedures that will be paid as inpatient services; and the proposed addition of new procedure codes to the APCs. </P>
                    <HD SOURCE="HD3">2. Recalibrations of APC Relative Payment Weights </HD>
                    <P>In the proposed rule, we discussed the methodology used to recalibrate the proposed APC relative payment weights and set forth the proposed recalibration of the relative weights for CY 2005. </P>
                    <HD SOURCE="HD3">3. Payment Changes for Devices </HD>
                    <P>In the proposed rule, we discussed proposed changes to the pass-through payment for devices and the methodology used to reduce, if applicable, transitional pass-through payments to offset costs packaged into APC groups. </P>
                    <HD SOURCE="HD3">4. Payment Changes for Drugs, Biologicals, Radiopharmaceutical Agents, and Blood and Blood Products </HD>
                    <P>In the proposed rule, we discussed our proposed payment changes for drugs, biologicals, radiopharmaceutical agents, and blood and blood products. </P>
                    <HD SOURCE="HD3">5. Estimated Transitional Pass-Through Spending in CY 2005 for Drugs, Biologicals, and Devices </HD>
                    <P>In the proposed rule, we discussed the proposed methodology for measuring whether there should be an estimated pro rata reduction for transitional pass-through drugs, biologicals, and devices for CY 2005. </P>
                    <HD SOURCE="HD3">6. Other Policy Decisions and Proposed Policy Changes </HD>
                    <P>In the proposed rule, we presented our proposals for CY 2005 regarding the following: </P>
                    <P>• Update of statewide default cost-to-charge ratios (CCRs). </P>
                    <P>• A conforming change to the regulation relating to the use of the first available cost reporting period ending after 1996 and before 2001 for determining a provider's payment-to-cost ratio to calculate transitional corridor payments for hospitals paid under the OPPS that did not have a 1996 cost report. </P>
                    <P>• Changes in the status indicators and comment indicators assigned to APCs for CY 2005. </P>
                    <P>• Elimination of the diagnostic tests criteria as a requirement for hospitals to qualify for separate payment of observation services under APC 0339 (Observation) and changes to the guidelines to hospitals for counting patients' time spent in observation care. </P>
                    <P>• Payment under the OPPS for certain procedures currently assigned to the inpatient list. </P>
                    <P>• Strategy for giving the public notice of new implementation guidelines for new evaluation and management codes. </P>
                    <P>• Addition of three new HCPCS codes and descriptors for brachytherapy sources that would be paid separately, pursuant to Public Law 108-173. </P>
                    <P>• Modification of the HCPCS code descriptors for brachytherapy source descriptors for which units of payment are not already delineated. </P>
                    <P>• Payment for services furnished emergently to an outpatient who dies before admission to a hospital as an inpatient. </P>
                    <HD SOURCE="HD3">7. Conversion Factor Update for CY 2005 </HD>
                    <P>As required by section 1833(5)(3)(C)(ii) of the Act, in the proposed rule, we proposed to update the conversion factor used to determine payment rates under the OPPS for CY 2005. </P>
                    <HD SOURCE="HD3">8. Wage Index Changes for CY 2005 </HD>
                    <P>In the proposed rule, we discussed the proposed retention of our current policy to apply the IPPS wage indices to wage adjust the APC median costs in determining the OPPS payment rate and the copayment standardized amount. These indices reflect major changes for CY 2005 relating to hospital labor market areas as a result of OMB revised definitions of geographical statistical areas; hospital reclassifications and redesignations, including the one-time reclassifications under section 508 of Public Law 108-173; and the wage index adjustment based on commuting patterns of hospital employees under section 505 of Public Law 108-173. </P>
                    <HD SOURCE="HD3">9. Determination of Payment Rates and Outlier Payments for CY 2005 </HD>
                    <P>In the proposed rule, we discussed how APC payment rates are calculated and how the payment rates are adjusted to reflect geographic differences in labor-related costs. We also discussed proposed changes in the way we would calculate outlier payments for CY 2005. </P>
                    <HD SOURCE="HD3">10. Regulatory Impact Analysis </HD>
                    <P>In the proposed rule, we set forth our analysis of the impact that the proposed changes would have on affected hospitals and CMHCs. </P>
                    <HD SOURCE="HD2">G. Public Comments Received on the August 16, 2004 Proposed Rule </HD>
                    <P>We received over 550 timely pieces of correspondence containing multiple comments on the August 16, 2004 proposed rule. Summaries of the public comments and our responses to those comments are set forth in the various sections of this preamble under the appropriate heading. </P>
                    <P>We received a number of general public comments on our proposed changes to the OPPS for CY 2005. </P>
                    <P>
                        <E T="03">Comment:</E>
                         Some commenters were concerned about the extent to which OPPS payment rates have fluctuated from year to year. Because Medicare payment is a very significant portion of income for most hospitals, they stated that the instability in the OPPS payment rates makes it difficult for hospitals to plan and budget. They indicated that there is a tremendous degree of variation across APCs in terms of payment to cost ratios and that they 
                        <PRTPAGE P="65688"/>
                        would expect that after three years of operating the OPPS, the payment to cost ratios would be much more stable. One commenter offered to share analysis of payment to cost ratios with CMS. Commenters stated that such variation in payments compared to costs puts full-service hospitals and their communities at risk because limited-service, or “niche” providers can easily identify and redirect patients with more lucrative APCs to their facilities, leaving full-service hospitals with a disproportionate share of patients who receive services that are assigned to the underpaid APCs. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We recognize hospitals' need for stability in payments for hospital outpatient services. We would appreciate receiving studies of the extent to which there is variation across APCS in terms of payment to cost ratios across the multiple years of the OPPS to aid us in assessing factors that might contribute to instability in the payment rates. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         One commenter indicated that the entire OPPS is underfunded, as it pays only 87 cents of every dollar of hospital outpatient care provided to Medicare beneficiaries. The commenter stated that it will continue to work with Congress to address inadequate payment rates and updates in order to ensure access to hospital-based outpatient services for Medicare beneficiaries. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         Our early analyses indicated that the OPPS was, in its inception, based on payment that was less than cost due to statutory reductions in payment for hospital outpatient costs prior to the enactment of the Balanced Budget Act of 1997, which authorized the current OPPS. We agree that the commenter will need to work with Congress to change certain fundamental features of the OPPS. For example, the base amounts upon which the OPPS was established, the rules concerning budget neutrality, and subsequent out-year adjustments such as annual reductions in coinsurance and adjustments to outlier and pass-through payment allocations are established in statute and, as such, would require legislation to amend. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         One commenter objected to the use of the display date to start the 60-day comment period for the proposed rule. The commenter stated that the display copy did not contain all of the information included in the proposed rule, such as the comment due date, and did not satisfy the statute's requirement that the notice of proposed rulemaking be published in the 
                        <E T="04">Federal Register</E>
                        , with provision for a 60-day comment period. The commenter indicated that the use of the display date to start the comment period gives reviewers too short a period of time to comment properly and also, in this case, gives CMS an inadequate period of time to review the comments and prepare the final rule. The commenter urged CMS to publish a proposed rule no later than late July to provide more time for CMS to consider public comments. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         While the law requires that we provide a 60-day public comment period and that the notice of proposed rulemaking be published in the 
                        <E T="04">Federal Register</E>
                        , it does not require that the date of 
                        <E T="04">Federal Register</E>
                         publication be the first day of the comment period. The two requirements are independent. We post the proposed rule on the CMS Web site on the date of display of the proposed rule at the 
                        <E T="04">Federal Register</E>
                        , thereby making the proposed rule far more easily available to the public than was the case when the only public dissemination was publication in the 
                        <E T="04">Federal Register</E>
                        , and satisfying the requirement for a 60-day comment period. By making the proposed rule available on the CMS Web site (as well as at the 
                        <E T="04">Federal Register</E>
                        ), we provided the public with access to not only the proposed rule but also to all of the supporting files and documents cited in the proposed rule in a manner that can be used for analysis. We note that the computer files posted on the Web site can be manipulated for independent analysis. Therefore, we believe that beginning the comment period for the proposed rule with the display date at the 
                        <E T="04">Federal Register</E>
                        , and posting the proposed rule and data files on the CMS Web site on the display date, fully complies with the statute and provides a far better opportunity for the public to have meaningful input than the past practice under which the comment period began with the publication date in the 
                        <E T="04">Federal Register</E>
                         a week or longer after the display date and no other data in any other form was furnished. 
                    </P>
                    <P>With respect to the publication date of the proposed rule, we publish the proposed rule as soon as it is practicable for us to do so. Our process for development of the proposed rule begins with a winter meeting of the APC Panel based on the earliest possible data analysis for the forthcoming year. We then pull claims for the period ending December of the data year and also pull cost report data for development of CCRs to apply to the claims data. This step cannot be started until approximately March 1 of the year and the development of the proposed rule data takes considerable time as there are many analyses to be performed and decisions to be made before each stage of data development can be undertaken. We have to balance the need to improve the process and to deal with each year's special issues with the need to issue a proposed rule in sufficient time to permit the public to comment and to permit us sufficient time to review the comments and develop the final rule. Each year we review the timeline and process to determine how we can best achieve that balance, while ensuring that we issue the best possible proposed rule for public comment. </P>
                    <HD SOURCE="HD2">H. Public Comments Received on the January 6, 2004 Interim Final Rule With Comment Period </HD>
                    <P>We received approximately 40 timely pieces of correspondence containing multiple comments on the MMA provisions relating to payment for drugs and brachytherapy under the OPPS that were included in the January 6, 2004 interim final rule with comment period. Summaries of the public comments and our responses to those comments are set forth in sections V. and VII.G. of this preamble under the appropriate heading. </P>
                    <HD SOURCE="HD2">I. Public Comments Received on the November 7, 2003 Final Rule With Comment Period</HD>
                    <P>We received 25 timely pieces of correspondence on the November 7, 2003 final rule with comment period, some of which contained multiple comments on the APC assignment of HCPCS codes identified with the new interim condition indicators (now referred to as condition codes) in Addendum B of that final rule with comment period. Summaries of the public comments and our responses to those comments are set forth in various sections of this preamble under the appropriate subject areas. </P>
                    <HD SOURCE="HD1">II. Changes Related to Ambulatory Payment Classifications (APCs) </HD>
                    <P>
                        Section 1833(t)(2)(A) of the Act requires the Secretary to develop a classification system for covered hospital outpatient services. Section 1833(t)(2)(B) provides that this classification system may be composed of groups of services, so that services within each group are comparable clinically and with respect to the use of resources. In accordance with these provisions, we developed a grouping classification system, referred to as the Ambulatory Payment Classification Groups (or APCs), as set forth in § 419.31 of the regulations. We use Level I and Level II Healthcare Common Procedure Coding System (HCPCS) codes and descriptors to identify and group the services within each APC. The APCs are organized such that each 
                        <PRTPAGE P="65689"/>
                        group is homogeneous both clinically and in terms of resource use. (However, new technology APCs that are temporary groups for certain approved services are structured based on cost rather than clinical homogeneity.) Using this classification system, we have established distinct groups of surgical, diagnostic, and partial hospitalization services, and medical visits. Because of the transitional pass-through provisions, we also have developed separate APC groups for certain medical devices, drugs, biologicals, radiopharmaceuticals, and devices of brachytherapy. 
                    </P>
                    <P>We have packaged into each procedure or service within an APC group the cost associated with those items or services that are directly related and integral to performing a procedure or furnishing a service. Therefore, we would not make separate payment for packaged items or services. For example, packaged items and services include: Use of an operating, treatment, or procedure room; use of a recovery room; use of an observation bed; anesthesia; medical/surgical supplies; pharmaceuticals (other than those for which separate payment may be allowed under the provisions discussed in section V. of this preamble); and incidental services such as venipuncture. Our packaging methodology is discussed in section IV.B.3. of this final rule with comment period. </P>
                    <HD SOURCE="HD2">A. APC Changes: General </HD>
                    <P>Under the OPPS, we pay for hospital outpatient services on a rate-per-service basis that varies according to the APC group to which the service is assigned. Each APC weight represents the median hospital cost of the services included in that APC relative to the median hospital cost of the services included in APC 0601, Mid-Level Clinic Visits. The APC weights are scaled to APC 0601 because a mid-level clinic visit is one of the most frequently performed services in the outpatient setting. </P>
                    <P>Section 1833(t)(9)(A) of the Act requires the Secretary to review the components of the OPPS not less than annually and to revise the groups and relative payment weights and make other adjustments to take into account changes in medical practice, changes in technology, and the addition of new services, new cost data, and other relevant information and factors. Section 1833(t)(9)(A) of the Act, as amended by section 201(h) of the BBRA of 1999, also requires the Secretary, beginning in CY 2001, to consult with an outside panel of experts to review the APC groups and the relative payment weights. </P>
                    <P>Finally, section 1833(t)(2) of the Act provides that, subject to certain exceptions, the items and services within an APC group cannot be considered comparable with respect to the use of resources if the highest median (or mean cost, if elected by the Secretary) for an item or service in the group is more than 2 times greater than the lowest median cost for an item or service within the same group (referred to as the “2 times rule”). We use the median cost of the item or service in implementing this provision. The statute authorizes the Secretary to make exceptions to the 2 times rule in unusual cases, such as low volume items and services. </P>
                    <P>Section 419.31 of the regulations sets forth the requirements for the APC system and the determination of the payment weights. In this section, we discuss the changes that we proposed to the APC groups; the APC Panel's review and recommendations from the February 2004 meeting and our proposals in response to those recommendations; the application of the 2 times rule and proposed exceptions to it; coding for stereotactic radiosurgery services; the proposed movement of procedures from the new technology APCs; the proposed changes to the inpatient list; and the proposed additions of new procedures codes to the APCs. In addition, in this section under the appropriate subject heading, we present the APC Panel's review and recommendations of items discussed at the September 1, 2, and 3, 2004 meeting held after publication of the proposed rule and our final decisions on these recommendations. We then present our final policies that are effective for CY 2005. </P>
                    <HD SOURCE="HD2">B. APC Panel Review and Recommendations </HD>
                    <HD SOURCE="HD3">1. February 2004 Panel Meeting </HD>
                    <P>
                        As stated above, the APC Panel held its first 2004 meeting on February 18, 19, and 20, 2004, to discuss the revised APCs for the CY 2005 OPPS. In preparation for that meeting, we published a notice in the 
                        <E T="04">Federal Register</E>
                         on December 24, 2003 (68 FR 74621), to announce the location, date, and time of the meeting; the agenda items; and the fact that the meeting was open to the public. In that notice, we solicited public comment specifically on the items included on the agenda for that meeting. We also provided information about the APC Panel meeting on the CMS Web site: 
                        <E T="03">http://www.cms.hhs.gov/faca/apc/panel.</E>
                    </P>
                    <P>
                        Oral presentations and written comments submitted for the February 2004 APC Panel meeting met, at a minimum, the adopted guidelines for presentations set forth in the 
                        <E T="04">Federal Register</E>
                         document (68 FR 74621). In conducting its APC review, the APC Panel heard testimony and received evidence in support of the testimonies from a number of interested parties. For the February 2004 deliberations, the APC Panel used hospital outpatient claims data for the period January 1, 2003, through September 30, 2003, that provided, at a minimum, median costs for the APC structure in place in CY 2004 and that was based on CCRs used for setting the CY 2004 payment rates. The data set presented to the APC Panel represented 9 months of the CY 2003 data that we proposed to use to recalibrate the APC relative weights and to calculate the proposed APC payment rates for CY 2005. In sections II.B.4. through 7. and sections II.C. through I. of this preamble, we summarize the APC issues discussed during the APC Panel's February 2004 meeting, the Panel's recommendations, the proposals that we included in the August 16, 2004 proposed rule, our proposals with respect to those recommendations, and the policies that we are finalizing for CY 2005 in this final rule with comment period. 
                    </P>
                    <HD SOURCE="HD3">2. September 2004 Panel Meeting </HD>
                    <P>
                        As stated earlier, the APC Panel held its second 2004 meeting on September 1-3, 2004. In preparation for that meeting, we published a notice in the 
                        <E T="04">Federal Register</E>
                         on August 5, 2004 (69 FR 47446) to announce the location, date, and time of the meeting, the agenda items, and the fact that the meeting was open to the public. In that notice, we solicited public comments specifically on the items included on the agenda for that meeting. During the September 2004 APC Panel meeting, the APC Panel heard testimony on a number of the proposed changes in APCs included in the August 16, 2004 proposed rule. We are summarizing the topics that were discussed at the September 2004 Panel meeting and the APC Panel's recommendations on each topic in the chart below. We have included references to the appropriate section of this preamble for the more detailed discussion of each recommendation. 
                    </P>
                    <P>
                        For the September 2004 deliberations, the APC Panel used the hospital outpatient claims data that we used in developing the proposed rule; that is, data for the period of January 1, 2003, 
                        <PRTPAGE P="65690"/>
                        through December 31, 2003, including updated CCRs. 
                    </P>
                    <BILCOD>BILLING CODE 4120-01-P</BILCOD>
                    <GPH SPAN="3" DEEP="622">
                        <GID>ER15NO04.000</GID>
                    </GPH>
                    <PRTPAGE P="65691"/>
                    <HD SOURCE="HD3">3. Contents of This Section of the Preamble </HD>
                    <P>The discussion in this section II.B. of this final rule with comment period is limited to APC changes regarding APCs other than those that violate the 2 times rule and those that represent drugs, biologicals, and transitional pass-through devices, or those that are new technology APCs. The specific APC Panel review and recommendations applicable to those APCs are discussed in sections II.C., IV., III., and II.F., respectively, of the preamble to this final rule with comment period. </P>
                    <HD SOURCE="HD3">4. APC 0018: Biopsy of Skin/Puncture of Lesion </HD>
                    <P>During the February 2004 APC Panel meeting, one presenter recommended moving CPT tracking codes 0046T (Catheter lavage, mammary duct(s)) and 0047T (Each additional duct) from APC 0018 and placing them in an APC that more accurately reflects each of the procedures. The APC Panel recommended that we reassign CPT codes 0046T and 0047T to APC 0021, Level III Excision/Biopsy. </P>
                    <P>In the August 16, 2004 proposed rule, we proposed to accept the APC Panel's recommendation. We did not receive any public comments on our proposal. Therefore, we are adopting as final, without modification, our proposal to reassign CPT codes 0046T and 0047T to APC 0021. </P>
                    <HD SOURCE="HD3">5. Level I and II Arthroscopy </HD>
                    <HD SOURCE="HD3">APC 0041: Level I Arthroscopy </HD>
                    <HD SOURCE="HD3">APC 0042: Level II Arthroscopy </HD>
                    <P>We testified before the APC Panel at its February 2004 meeting regarding a comment that we received in 2003 requesting that we reassign CPT code 29827 (Arthroscopy, shoulder with rotator cuff repair) from APC 0041 to APC 0042, based on its similarity to CPT 29826 (Arthroscopy, shoulder decompression of subacromial space with partial acromioplasty without coracoacromial release). Our clinical staff considered the request and determined that APCs 0041 and 0042 should be reconfigured to improve clinical homogeneity. An APC Panel presenter provided evidence to support moving CPT code 29827 to an APC that would more accurately recognize the complexity of that procedure. We requested the APC Panel's recommendation regarding a total revision of these two APCs. </P>
                    <P>The APC Panel recommended that we reevaluate the codes in APCs 0041 and 0042 and propose restructuring that would improve the clinical homogeneity in the two APCs. </P>
                    <P>In the August 16, 2004 proposed rule, we proposed to accept the APC Panel's recommendation and to revise APCs 0041 and 0042 as presented in Tables 1 and 2 of that proposed rule. We received one public comment on our proposed restructuring. </P>
                    <P>
                        <E T="03">Comment:</E>
                         One commenter requested that we move code 0014T from APC 0041 to APC 0042. The commenter provided information in support of its belief that the procedure more accurately matches the clinical work and resource inputs of APC 0042 than of APC 0041. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We agree with the commenter and are assigning the procedure to APC 0042. The tracking code 0014T is being retired and the successor code is CPT code 29868 (Arthroscopy, knee, surgical, osteochondral autograft(s) meniscal transplantation (including arthrotomy for meniscal insertion, medial or lateral). Placement of this code in APC 0042 is subject to comment in response to this final rule with comment period because the code is a new code for CY 2005. 
                    </P>
                    <P>Accordingly, restructured APCs 0041 and 0042 for CY 2005, as modified based on the public comment received, are shown in Tables 1 and 2 below. </P>
                    <GPH SPAN="3" DEEP="603">
                        <PRTPAGE P="65692"/>
                        <GID>ER15NO04.001</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="316">
                        <PRTPAGE P="65693"/>
                        <GID>ER15NO04.002</GID>
                    </GPH>
                    <BILCOD>BILLING CODE 4120-01-C</BILCOD>
                    <HD SOURCE="HD3">6. Angiography and Venography Except Extremity </HD>
                    <HD SOURCE="HD3">APC 0279: Level II Angiography and Venography Except Extremity </HD>
                    <HD SOURCE="HD3">APC 0280: Level III Angiography and Venography Except Extremity </HD>
                    <HD SOURCE="HD3">APC 0668: Level I Angiography and Venography Except Extremity </HD>
                    <HD SOURCE="HD3">a. February 2004 Panel Meeting </HD>
                    <P>As requested by the APC Panel, at the February 2004 Panel meeting, we presented our proposal for reconfiguring APCs 0279, 0280, and 0668 that reflected changes based on prior input with outside clinical experts. The APC Panel had previously reviewed these APCs during its January 2003 meeting and had recommended that we not restructure these three APCs until we received input from clinical experts in the field. When we updated the APC groups in CY 2003, we accepted the APC Panel's recommendation and made no changes to APCs 0279, 0280, and 0668. </P>
                    <P>A review of these APCs was prompted by a commenter who requested that we move CPT code 75978 (Repair venous blockage) from APC 0668 to APC 0280 and that we move CPT code 75774 (Artery x-ray, each vessel) from APC 0668 to APC 0279. The commenter submitted evidence in support of these requests and testified before the APC Panel regarding the common use of CPT code 75978 for treating dialysis patients and the often required multiple intraoperative attempts to succeed with this procedure for such patients. </P>
                    <P>After receiving input from the clinical experts, we determined that these three APCs should be revised to improve their clinical homogeneity. At the February 2004 meeting, we presented our proposed restructuring of APCs 0279, 0280, and 0668 to the APC Panel. The APC Panel concurred with our proposal. </P>
                    <P>In addition, subsequent to the APC Panel meeting, we discovered several procedures in these APCs that were more appropriately placed in other APCs in order to remedy any 2 times rule violations. We included those modifications in our proposed restructured APCs published in Table 3 in the August 16, 2004 proposed rule. </P>
                    <HD SOURCE="HD3">b. Public Comments Received </HD>
                    <P>
                        <E T="03">Comment:</E>
                         Several commenters requested that CMS postpone or cancel the proposed plans for moving angiography codes 75960 (Transcatheter introduction of intravascular stent(s), (non-coronary vessel) percutaneous and/or open, radiological supervision and interpretation, each vessel), 75962 (Transluminal balloon angioplasty, peripheral artery, radiological supervision and interpretation), 75964 (Transluminal balloon angioplasty, each additional peripheral artery, radiological supervision and interpretation), 75966 (Transluminal balloon angioplasty, renal or other visceral artery, radiological supervision and interpretation), and 75968 (Transluminal balloon angioplasty, each additional visceral artery, radiological supervision and interpretation), which are integral to a number of angioplasty and stent placement procedures, from APC 0280 to APC 0668. One commenter indicated that the proposed decreases in payments for these services that would result from their APC reassignment were inconsistent with CMS' proposal to limit payment decreases for device-dependent APCs. Another commenter was particularly concerned that code 75962, which is used for angioplasty of arterial blockages, may have a wide range of associated procedure costs. The commenters stated that aggregate payment for all services billed for many high volume procedures such as peripheral transluminal angioplasty and single stent placement will decrease by 16 to 21 percent, in large part due to the reassignment of codes 75960, 75962, 75964, 75966, and 75968 to the lower level APC 0668 in the angiography and venography except extremity series and 
                        <PRTPAGE P="65694"/>
                        to their placement on the bypass list. Two commenters were concerned that supervision and interpretation services as part of peripheral atherectomy procedures were assigned to higher paying APC 0279, potentially providing hospitals with an incentive to perform atherectomy instead of angioplasty or stent procedures, or both. Further, the commenters suggested that the lower payment for the supervision and interpretation services moved to APC 0668 for CY 2005 provides an incentive for hospitals to treat patients on an inpatient basis or may limit beneficiaries' access to the outpatient procedures. One commenter indicated that the cost and complexity of performing angiographic procedures for angioplasty are similar, if not more complex, than those of performing angiographic procedures for atheretomy. 
                    </P>
                    <P>The commenters did not understand why CMS reassigned the supervision and interpretation codes from a Level III to a Level I APC and believed that CMS did not take into account the higher level of hospital resources and staffing required for certain therapeutic radiology supervision and interpretation services. Further, they questioned the assumptions CMS adopted in the creation of the bypass list to develop “pseudo”single claims. They suggested that there might be significant differences between the multiple procedure claims that CMS converts to “pseudo” single claims and those that CMS is unable to use. Thus, the commenters questioned the reliability of the claims data and encouraged CMS to use external data as the basis for the decisionmaking. One commenter noted that, of a large number of claims for APC 0668, 79 percent accounted for device costs and 81 percent accounted for room charges, but CMS' single claim methodology had only 4 percent of claims accounting for device costs or room charges. </P>
                    <P>Finally, one commenter, a group of providers, stated that they expected substantial payment decreases to result from the proposed restructuring of APCs 0279, 0280, and 0668. The commenter suggested that CMS should establish a mechanism (such as dampening) to offset large payment swings similar to those anticipated as a result of the CMS proposal. </P>
                    <P>
                        <E T="03">Response:</E>
                         Our analyses of claims data used for the CY 2004 OPPS and several past comments led us to recognize the need to restructure APCs 0279, 0280, and 0668 for the CY 2005 OPPS. There were only two services in APC 0668 for CY 2004, APC 0279 was excepted from the 2 times rule in CY 2004, and the median costs for individual services in APCs 0668, 0279, and 0280 showed significant overlap. The APC Panel also acknowledged the need to reconfigure these APCs. In our proposed rule, we presented the restructured APCs in which the procedures within each APC demonstrated both clinical and resource homogeneity, and our final data confirmed the appropriate assignment of the services. For instance, the peripheral atherectomy supervision and interpretation codes (75992 through 75996) assigned to the Level II APC (0279) consistently had higher median costs than the supervision and interpretation codes for intravascular stent placement or peripheral or visceral artery balloon angioplasty, which are assigned to the Level I APC (0668). For CY 2005, the median costs for the supervision and interpretation codes for stent placement and angioplasty were much lower than the median cost of their prior APC 0280 ($1,181) and were within the range of median costs ($239-$444) for other procedures assigned to APC 0668. As APCs 0668, 0279, and 0280 are not device-dependent APCs because we expect the devices to be reported with the interventional procedures provided (that are in device-dependent APCs), it would be inappropriate to apply the device-dependent APC policy to APCs 0668, 0279, and 0280. In addition, there were no violations of the 2 times rule in the restructured APCs 0668, 0279, or 0280 based on full year 2003 hospital claims data. 
                    </P>
                    <P>The supervision and interpretation codes 75960, 75962, 75964, 75966, and 75968, along with peripheral atherectomy supervision and interpretation CPT codes, were proposed for the bypass list for CY 2005. As the commenters noted, we recognized that angiography and venography services generally involve multiple procedure claims, and less than 10 percent of bills for APCs 0668, 0279, and 0280 were available for ratesetting for CY 2004. We proposed to place a number of radiological supervision and interpretation codes on the bypass list for CY 2005 because we believed that these codes should have little packaging associated with them and we recognized that their addition to the bypass list might enable us to use significantly more data from multiple procedure claims for APCs 0668, 0279, 0280, and others. We did not expect that devices and room charges would generally be packaged with the supervision and interpretation services, but rather would be packaged with the interventional procedures they accompanied. This accounts for the low percentage of device and room costs on the single bills in APC 0668 used for the median calculation. None of the commenters provided any information about why it would be inappropriate to include these codes on the bypass list, other than to point out the decline in proposed payment rates for the services. If packaging appropriately attributable to the supervision and interpretation services through the bypass procedure had been assigned to the interventional procedures that the supervision and interpretation services accompanied (such as angioplasty or stent placement), there should have been increases in the median costs for the interventional procedures. We did not see any such significant increases, and believe that our data do not indicate any specific packaging allocation problems with respect to the supervision and interpretation services. We have no evidence of underreporting of costs used to calculate the median costs for APC 0668. </P>
                    <P>For CY 2005, we had a significantly greater number of single claims available for use in median calculation for APCs 0668, 0279, and 0280. For example, for CY 2005, the median costs for the two supervision and interpretation codes with the highest volume that were of concern to the commenters (codes 75960 and 75962) were based on 20 percent of claims in contrast to only 1 percent used last year. While it is possible, as suggested by the commenters, that there may be differences between the packaging in multiple procedure claims that we were able to convert to “pseudo” single claims and those that we were unable to use, we have no reason to believe that these issues are unique to these APCs or especially problematic for these supervision and interpretation services. Our goal continues to be to use as much of our historical hospital claims data to set payment rates as possible. As we have consistently stated, we are pursuing strategies to improve our ability to utilize multiple procedure claims for median calculation, including discussions with the APC Panel Data Subcommittee. </P>
                    <P>
                        With regard to the commenter's suggestion that we establish a mechanism to offset payment changes from one year to the next, we understand the commenter's desire for a stable system. However, while we are not convinced that an overall dampening policy is required, we continue to work toward improving the hospital claims data through education, data management, and data analyses. We believe that we have achieved significant improvements so far. 
                        <PRTPAGE P="65695"/>
                    </P>
                    <HD SOURCE="HD3">c. Final Policy for CY 2005 </HD>
                    <P>After consideration of the APC Panel's recommendations and the public comments we received on the August 16, 2004 proposal, we are finalizing our proposal for the restructuring of APCs 0668, 0279, and 0280. </P>
                    <P>Tables 3, 4, and 5 reflect the final restructuring of APCs 0668, 0279, and 0280. </P>
                    <BILCOD>BILLING CODE 4120-01-P</BILCOD>
                    <GPH SPAN="3" DEEP="609">
                        <GID>ER15NO04.003</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="374">
                        <PRTPAGE P="65696"/>
                        <GID>ER15NO04.004</GID>
                    </GPH>
                    <BILCOD>BILLING CODE 4120-01-C</BILCOD>
                    <HD SOURCE="HD3">7. Packaged Codes in APCs </HD>
                    <P>As a result of requests from the public, the Packaging Subcommittee of the APC Panel was established to review all the CPT codes with a status indicator of “N.” Status indicator “N” indicates that payment for packaged codes is bundled into the payment that providers receive for separately payable codes for items or services provided on the same day. Providers have often suggested that many codes could be billed alone, without any separately payable service on the claim, and requested that these codes not be assigned status indicator “N.” The Packaging Subcommittee identified areas for change of some packaged CPT codes for items or services that could be provided as the sole service on a given date. During the September 2004 meeting, the APC Panel accepted the report of the Packaging Subcommittee and made the following recommendations: </P>
                    <P>• The Panel recommended that the Packaging Subcommittee review packaged codes individually instead of making a global decision for all packaged codes. </P>
                    <P>• The Panel recommended that CMS assign a modifier to CPT codes 36540 (Collect blood venous device), 36600 (Withdrawal of arterial blood), 51701 (Insert bladder catheter), and 97602 (Wound[s] care, non-selective) to be used when these codes are the only code on that particular claim for the same date of service. The APC Panel indicated that it would revise this subset of codes once data become available. </P>
                    <P>• The Panel recommended that CMS educate providers and intermediaries on the correct billing procedures for the packaged CPT codes 36540, 36600, 51701, and 97602. </P>
                    <P>• The Panel recommended that CMS not change the status indicator for CPT 76397 (Ultrasound guidance for vascular access). The Panel indicated that it would review the data on this code as they become available. </P>
                    <P>• The Panel recommended that the Packaging Subcommittee continue to meet throughout the year to discuss other problematic packaged codes. </P>
                    <P>CMS is considering the recommendation that a modifier be used when certain codes are the only codes on a particular claim for the same date of service. We note that code 97602 is assigned a status indicator of “A” in this final rule with comment period, and is no longer payable under OPPS. Therefore, a modifier, if applicable, would not be assigned for this code. </P>
                    <P>
                        <E T="03">Comment:</E>
                         One commenter asked CMS to review all the packaged codes to determine which codes should become separately payable. Several commenters also requested that codes 36540 (Collect blood venous device), 36600 (Withdrawal of arterial blood), and 97602 (Wound[s] care, nonselective) become separately payable because they are often the only procedure on a bill. In cases where there is no separately payable code on a claim, providers do not receive payment for these packaged services. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We appreciate the commenters' suggestions. As stated above, the APC Panel Packaging Subcommittee recently reviewed all the packaged codes. We are currently 
                        <PRTPAGE P="65697"/>
                        considering whether to create a modifier to be used for CPT codes 36540, 36600, and 51701 when these codes appear on a claim without any separately payable code on the same date of service. As stated above, code 97602 will not be payable under OPPS for CY 2005 and, therefore, is excluded from this discussion. Additional detailed suggestions for the Packaging Subcommittee should be submitted to 
                        <E T="03">APCPanel@cms.hhs.gov</E>
                         with “Packaging Subcommittee” in the subject line.
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         Two commenters requested that code 76937 (Ultrasound guidance for vascular access) be assigned to APC 0268 (Ultrasound Guidance Procedures), with status indicator “S” instead of the proposed status indicator “N.” 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We are accepting the APC Panel's recommendations that code 76937 remain packaged for CY 2005. We are concerned that there will be unnecessary utilization of this procedure if it is separately payable. In addition, because code 76937 only became effective on January 1, 2004, there are currently no claims data for this code. When we review the CY 2004 claims data for the CY 2006 payment rates, we will reexamine the status of code 76937. We also note that the APC Panel Packaging Subcommittee remains active, and additional issues and new data concerning the packaging status of codes will be shared for their consideration as information becomes available. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         Several commenters requested that the following CPT codes become unpackaged: 42550 (Injection for salivary x-ray) and other x-ray injection codes; 75998 (Fluoroscopic guidance for central venous access device placement); 74328 (Endoscopic catheterization of the biliary ductal system, S&amp;I); 74329 (Endoscopic catheterization of the pancreatic ductal system, S&amp;I); 74330 (Combined endoscopic catheterization of the biliary and pancreatic ductal systems, S&amp;I); 36500 (Insert of catheter, vein); 75893 (venous sampling by catheter); 75989 (abscess drainage under x-ray); 76001 (Fluoroscope exam); 76003 (Needle localization by x-ray); 76005 (Fluoroguide for spine inject); 90471 and 90472 (Immunization administration); 94760, 94761, and 94762 (Pulse oximetry); and G0269 (Occlusive device in vein art). The commenters were concerned that the OPPS has denied hospitals reimbursement for these services. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         Hospitals include charges for packaged services on their claims, and the costs associated with these packaged services are then bundled into the costs for separately payable procedures on the claims. Hospitals may use CPT codes to report any packaged services that were performed, consistent with CPT coding guidelines. Because these imaging codes are packaged, their presence on a claim that includes a code for another separately payable service does not necessarily result in the claim being a multiprocedure claim. Payment for these imaging services is packaged in this way into payment for the separately payable services with which the imaging services are billed. 
                    </P>
                    <P>
                        The Packaging Subcommittee reviewed every code that was packaged in CY 2004. The Committee narrowed the list of packaged codes to a list of potentially problematic codes and subsequently reviewed utilization and median cost data for these codes. One of the main criteria evaluated by the Packaging Subcommittee to determine whether a code should become unpackaged was how likely it was for the code to be billed without any other code for separately payable services on the claim. We encourage submission of clinical scenarios involving currently packaged codes to the Packaging Subcommittee for review at future meetings. Submissions should be sent to the 
                        <E T="03">APCPanel@cms.hhs.gov</E>
                         with “Packaging Subcommittee” in the subject line. 
                    </P>
                    <P>We will continue to package CPT codes 42550 and other x-ray injection codes, 75998, 73428, 74329, 74330, 36500, 75893, 75989, 76001, 76003, 76005, 90471, 94472, 94760, 94761, 94762, and G0269 for CY 2005 and will discuss these codes with the APC Panel Packaging Subcommittee. </P>
                    <P>
                        <E T="03">Comment:</E>
                         One commenter requested that the status indicator for code G0102 (Prostate cancer screening; digital rectal examination) be changed from packaged to separately payable. The commenter indicated that the screening is administered as part of the initial preventive physical examination. The commenter stated, “The payment for G0102 will be zero because it is identified with status indicator ‘N' which means it is packaged and not paid for separately.” 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         Currently, under the OPPS, we do not make separate payment for code G0102. Its costs are bundled into the costs of other separately payable services furnished by the hospital on the same day. For example, a digital rectal examination is usually furnished as part of an evaluation and management service, so its payment would generally be bundled into payment for the evaluation and management service when a covered evaluation and management service is furnished on the same day as the digital rectal examination. It is a relatively quick and simple procedure. Likewise, when the examination is performed during the same visit as the initial preventive examination, we would expect that costs associated with the examination would be bundled into the costs for the initial preventive examination. Accordingly, we are continuing to package code G0102. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         One commenter requested that we map code G0168 (Wound closure by adhesive) to an APC instead of assigning status indicator “N” to the code. The commenter was concerned that access to wound adhesives would be reduced if this code is not separately payable. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         Wound adhesives are considered supplies used to repair lacerations and surgical incisions. These products are used instead of sutures to close wounds. We do not make separate payments for sutures under the OPPS. Providers are paid when they use wound adhesives in the same manner as they are paid for other “packaged” procedures. The charges for code G0168 should be packaged into whichever procedure(s) is billed on the same date of service. Payment to the provider reflects the cost of performing the procedure and the related supplies. 
                    </P>
                    <HD SOURCE="HD2">C. Limits on Variations Within APCs: Application of the 2 Times Rule </HD>
                    <P>Section 1833(t)(2) of the Act provides that the items and services within an APC group cannot be considered comparable with respect to the use of resources if the median (or mean) of the highest cost item or service within an APC group is more than 2 times greater than the median of the lowest cost item or service within that same group. However, the statute authorizes the Secretary to make exceptions to this limit on the variation of costs within each APC group in unusual cases such as low volume items and services. No exception may be made in the case of a drug or biological that has been designated as an orphan drug under section 526 of the Federal Food, Drug, and Cosmetic Act. We implemented this statutory provision in § 419.31 of the regulations. Under this regulation, we elected to use the highest median cost and lowest median cost to determine comparability. </P>
                    <P>
                        During the APC Panel's February 2004 meeting, we presented data and information concerning a number of APCs that violate the 2 times rule and asked the APC Panel for its recommendation. We discuss below the APC Panel's recommendations specific to each of these APCs, our proposals in 
                        <PRTPAGE P="65698"/>
                        response to the APC Panel's recommendations that were discussed in the August 2004 proposed rule, and our final policies. 
                    </P>
                    <HD SOURCE="HD3">1. Cardiac and Ambulatory Blood Pressure Monitoring </HD>
                    <HD SOURCE="HD3">APC 0097: Cardiac and Ambulatory Blood Pressure Monitoring </HD>
                    <P>We expressed concern to the APC Panel that APC 0097 appears to violate the 2 times rule. We sought the APC Panel's recommendation on revising the APC to address the violation. Based on clinical homogeneity considerations, the APC Panel recommended that we not restructure APC 0097 for CY 2005. </P>
                    <P>We proposed to accept the APC Panel's recommendation that we make no changes to APC 0097 for CY 2005. We did not receive any public comments on our proposal. Accordingly, in this final rule, we are not making any changes to APC 0097 for CY 2005. </P>
                    <HD SOURCE="HD3">2. Electrocardiograms </HD>
                    <HD SOURCE="HD3">APC 0099: Electrocardiograms </HD>
                    <P>We expressed concern to the APC Panel at its February 2004 meeting that APC 0099 appears to violate the 2 times rule. We asked the APC Panel to recommend options for resolving this violation. Based on clinical homogeneity considerations, the APC Panel recommended that we not alter the structure of APC 0099 for CY 2005. </P>
                    <P>We proposed to accept the APC Panel's recommendation that we make no changes to APC 0099 for CY 2005. We did not receive any public comments on our proposal. Accordingly, in this final rule with comment period, we are not making any changes to APC 0099 for CY 2005. </P>
                    <HD SOURCE="HD3">3. Excision/Biopsy </HD>
                    <HD SOURCE="HD3">APC 0019: Level I Excision/Biopsy </HD>
                    <HD SOURCE="HD3">APC 0020: Level II Excision/Biopsy </HD>
                    <HD SOURCE="HD3">APC 0021: Level III Excision/Biopsy </HD>
                    <P>We expressed concern to the APC Panel at its February 2004 meeting that APC 0019 appears to violate the 2 times rule. We advised the APC Panel that this violation was not evident in CY 2004 because the CY 2002 median cost data used in calculating the CY 2004 APC updates supported moving CPT codes 11404 (Removal of skin lesion) and 11623 (Removal of skin lesion) from APC 0020 and APC 0021. However, based on the CY 2003 data reviewed by the APC Panel, APC 0019 would violate the 2 times rule. Therefore, we asked the APC Panel to recommend an approach to resolve the violation. We asked the APC Panel if we should leave this APC as is; divide APC 0019 into two separate APCs; or move some codes in APC 0019 to higher level excision/biopsy APCs. In making its recommendation, the APC Panel noted that the 2 times violation in APC 0019 was minor, and recommended that we not modify APC 0019. </P>
                    <P>We proposed to accept the APC Panel's recommendation to not make any modifications to APC 0019 for CY 2005. We did not receive any public comments on our proposal. Accordingly, in this final rule with comment period, we are not making any changes to APC 0019 for CY 2005. </P>
                    <HD SOURCE="HD3">4. Posterior Segment Eye Procedures </HD>
                    <HD SOURCE="HD3">APC 0235: Level I Posterior Segment Eye Procedures </HD>
                    <P>We expressed concern to the APC Panel at its February 2004 meeting that APC 0235 appears to violate the 2 times rule. At the August 2003 APC Panel meeting, the APC Panel recommended that we monitor the data for APC 0235 for review at its February 2004 meeting. In order to address the apparent violation, we asked the APC Panel to consider moving a few CPT codes from APC 0235 into a higher level posterior segment eye procedure APC. The APC Panel noted that the 2 times violation in APC 0235 was minor, and recommended that we not change APC 0235. </P>
                    <P>We proposed to accept the APC Panel's recommendation that we make no changes to the structure of APC 0235 for CY 2005. We receive one public comment regarding this proposal. </P>
                    <P>
                        <E T="03">Comment:</E>
                         One commenter urged CMS not to finalize the proposal to keep the CY 2004 structure of APC 0235 for CY 2005. The commenter asked CMS to consider moving codes 67220 (Treatment of choroids lesion), 67221 (Ocular photodynamic therapy), 67225 (Eye photodynamic therapy, add-on), 67101 (Repair detached retina), and 67141 (Treatment of retina) to a higher level Posterior Segment Eye Procedure APC. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         After further analysis, we continue to believe that the resources and clinical characteristics of these codes are most compatible and homogeneous with those services in Level I Posterior Segment Eye Procedures, APC 0235. We plan to discuss the possible restructuring of APCs 0235, 0236, and 0237 (Level I, Level II, and Level III Posterior Segment Eye Procedures, respectively) at the next APC Panel meeting. We invite comments on these APCs. 
                    </P>
                    <P>In this final rule with comment period, we are adopting as final the proposal not to make any changes to APC 0235 for CY 2005. </P>
                    <HD SOURCE="HD3">5. Laparoscopy </HD>
                    <HD SOURCE="HD3">APC 0130: Level I Laparoscopy </HD>
                    <HD SOURCE="HD3">APC 0131: Level II Laparoscopy </HD>
                    <P>We expressed concern to the APC Panel at its February 2004 meeting that APC 0130 appears to violate the 2 times rule. We suggested moving CPT code 44970 (Laparoscopy, appendectomy) from APC 0130 to APC 0131. The APC Panel recommended that we make this change. </P>
                    <P>We proposed to accept the APC Panel's recommendation to move CPT code 44970 from APC 0130 to APC 0131. We did not receive any public comments on our proposal. Accordingly, in this final rule with comment period, we are adopting as final without modification our proposal to move CPT code 44970 from APC 0130 to APC 0131. </P>
                    <HD SOURCE="HD3">6. Anal/Rectal Procedures </HD>
                    <HD SOURCE="HD3">APC 0148: Level I Anal/Rectal Procedure </HD>
                    <HD SOURCE="HD3">APC 0155: Level II Anal/Rectal Procedure </HD>
                    <HD SOURCE="HD3">APC 0149: Level III Anal/Rectal Procedure </HD>
                    <HD SOURCE="HD3">APC 0150: Level IV Anal/Rectal Procedure </HD>
                    <P>We expressed concern to the APC Panel at its February 2004 meeting that APC 0148 appears to violate the 2 times rule. We suggested moving CPT code 46020 (Placement of seton) from APC 0148 to a higher level anal/rectal procedure APC. The APC Panel reviewed the four anal/rectal APCs (APC 0148, 0149, 0150, and 0155) and recommended moving CPT codes 46020 and 46706 (Repair of anal fistula with glue) from APC 0148 to APC 0150. The APC Panel also recommended moving CPT codes 45005 (Drainage of rectal abscess) and 45020 (Drainage of rectal abscess) from APC 0148 to APC 0155. </P>
                    <P>We proposed to accept the APC Panel's recommendations specific to APC 0148. We received one favorable public comment on our proposal. Accordingly, in this final rule with comment period, we are adopting as final without modification our proposal and are moving CPT codes from APC 0148 to APCs 0150 and 0155 as shown in the Table 6 below. </P>
                    <GPH SPAN="3" DEEP="111">
                        <PRTPAGE P="65699"/>
                        <GID>ER15NO04.005</GID>
                    </GPH>
                    <HD SOURCE="HD3">7. Nerve Injections </HD>
                    <HD SOURCE="HD3">APC 0204: Level I Nerve Injections </HD>
                    <HD SOURCE="HD3">APC 0206: Level II Nerve Injections </HD>
                    <HD SOURCE="HD3">APC 0207: Level III Nerve Injections </HD>
                    <HD SOURCE="HD3">APC 0203: Level IV Nerve Injections </HD>
                    <P>We expressed concern to the APC Panel that APC 0203 and APC 0207 appear to violate the 2 times rule. After careful consideration of new data presented during the February 2004 meeting, the APC Panel recommended moving CPTs 64420 (Nerve block injection, intercostal nerve), 64630 (Injection treatment of nerve), 64640 (Injection treatment of nerve), and 62280 (Treatment of a spinal cord lesion) from APC 0207 to APC 0206. The APC Panel also recommended moving CPT code 62282 (Treatment of a spinal canal lesion) from APC 0207 to APC 0203. </P>
                    <P>After reviewing more recent, complete calendar year data that was not available in February 2004, we proposed to accept only the APC Panel's recommendation to move CPTs 64630 and 64640 from APC 0207 to APC 0206 and to make some other changes that we believed were appropriate to improve the nerve injection APCs' clinical and resource homogeneity, as shown in Tables 7, 8, and 9 of the proposed rule.</P>
                    <P>We received two comments regarding our proposed reassignment of four CPT codes from APC 0203 to APC 0207 to address an apparent violation of the 2 times rule. </P>
                    <P>
                        <E T="03">Comment:</E>
                         Commenters urged CMS not to finalize the proposed changes to CPT codes 64620 (Injection treatment of nerve), 64680 (Injection treatment of nerve), 62263 (Lysis epidural adhesions) and 62264 (Epidural lysis on single day), which we proposed to move from APC 0203 to APC 0207. The commenters stated that the proposed payment for these services was well below the cost of the resources required to provide the services at an acceptable standard of care. The commenters requested that we not move these four codes from APC 0203. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         After further analysis, we agree with the commenters that CPT codes 64620, 62263, and 62264 should remain in APC 0203 based on clinical and resource homogeneity with the services in APC 0203. Therefore, in this final rule with comment period, we are not moving these three codes from APC 0203, as displayed in Table 9B below. 
                    </P>
                    <P>However, based on our final CY 2003 hospital data for CPT code 64680, utilizing over half of the several hundred total bills for this service for calculation of median hospital costs, we continue to believe that the resources and clinical characteristics of destruction of the celiac plexus by neurolytic nerve agent are most compatible and homogeneous with those services in Level III Nerve Injections, APC 0207. Therefore, in this final rule with comment period, we are adopting as final the proposed movement of CPT code 64680 from APC 0203 to APC 0207, as displayed in Table 9B below. </P>
                    <P>Accordingly, all of the final APC reassignments of nerve injections codes in this final rule with comment period are displayed below in Tables 7, 8, 9A, and 9B. </P>
                    <GPH SPAN="3" DEEP="449">
                        <PRTPAGE P="65700"/>
                        <GID>ER15NO04.006</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="365">
                        <PRTPAGE P="65701"/>
                        <GID>ER15NO04.007</GID>
                    </GPH>
                    <HD SOURCE="HD3">8. Anterior Segment Eye Procedures</HD>
                    <HD SOURCE="HD3">APC 0232: Level I Anterior Segment Eye Procedures</HD>
                    <HD SOURCE="HD3">APC 0233: Level II Anterior Segment Eye Procedures</HD>
                    <P>We expressed concern to the APC Panel at its February 2004 meeting that APC 0233 appears to violate the 2 times rule. We suggested moving CPT codes 65286 (Repair of eye wound), 66030 (Injection treatment of eye), and 66625 (Removal of iris) from APC 0233 to APC 0232. The APC Panel agreed and recommended that we move CPT codes 65286, 66030, and 66625 from APC 0233 to APC 0232.</P>
                    <P>We proposed to accept the APC Panel's recommendation and to reassign these three codes. We received one public comment on our proposal.</P>
                    <P>
                        <E T="03">Comment:</E>
                         One commenter asserted that the costs for performing the procedures under CPT codes 65286 and 66625 are similar to the costs for performing procedures in APC 0233 and requested that these codes not be moved to APC 0232.
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         After further analysis, we continue to believe that the resources and clinical characteristics of codes 62586 and 66625 are most compatible and homogeneous with those services in Level I Anterior Segment Eye Procedures, APC 0232.
                    </P>
                    <P>Therefore, in this final rule with comment period, we are adopting as final without modification our proposal and are moving CPT codes 65286, 66030, and 66625 from APC 0233 to APC 0232 as shown in the Table 10 below.</P>
                    <GPH SPAN="3" DEEP="125">
                        <GID>ER15NO04.008</GID>
                    </GPH>
                    <PRTPAGE P="65702"/>
                    <HD SOURCE="HD3">9. Pathology</HD>
                    <HD SOURCE="HD3">APC 0343: Level II Pathology</HD>
                    <HD SOURCE="HD3">APC 0344: Level III Pathology</HD>
                    <P>We expressed concern to the APC Panel at its February 2004 meeting that APC 0343 appears to violate the 2 times rule. We suggested moving CPT code 88346 (Immunoflourescent study) from APC 0343 to APC 0344. The APC Panel concurred with our proposal.</P>
                    <P>We proposed to accept the APC Panel's recommendation and to move CPT code 88346 from APC 0343 to APC 0344. We received one public comment on our proposal. </P>
                    <P>
                        <E T="03">Comment:</E>
                         One commenter requested that CMS split APC 0344 into two APCs to create another level for the pathology procedures. The commenter stated that creation of another level would lead to more economically homogenous APCs to provide payment that more closely covers the costs of the procedures. The commenter pointed out that APC 0344, as currently configured, violates the 2 times rule and recommended that CMS split APC 0344 into two APCs and that CMS should assign them to a newly created APC rather than finalize its proposal to assign the new computer-assisted image analysis procedures to APC 0344. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We believe that our proposed reassignment of CPT code 88346 from APC 0343 to 0344, as recommended by the APC Panel, will improve the resource and clinical homogeneity of the APCs. We are reluctant to make further reassignments without hospital cost data to support changes. Several of the codes that the commenter is concerned about, including APC codes 88360 (Morphometric analysis, tumor immunohistochemistry, quantitative or semiquantitative, each antibody; manual), 88368 (Morphometric analysis, in situ hybridization, each probe; manual), and 88367 (Morphometric analysis, in situ hybridization, each probe; using computer assisted technology) were new in CY 2004 and CY 2005 and, as such, we do not have available claims data for analysis. 
                    </P>
                    <P>Given the new codes mentioned by the commenter and the 2 times rule violations in APC 0342 and 0344, we expect that we will want to solicit the advice of the APC Panel regarding the configuration of all the pathology APCs: 0342, 0343, 0344, and 0661, at their next meeting. We will reexamine the APCs for future updates to the OPPS, but will not make other changes to the APCs at this time. </P>
                    <P>In this final rule with comment period, we are adopting as final without modification our proposal and are moving CPT code 88346 from APC 0343 to APC 0344. </P>
                    <HD SOURCE="HD3">10. Immunizations </HD>
                    <HD SOURCE="HD3">APC 0355: Level III Immunizations (for CY 2005: Level I Immunizations) </HD>
                    <HD SOURCE="HD3">APC 0356: Level IV Immunizations (for CY 2005: Level II Immunizations) </HD>
                    <P>We expressed concern to the APC Panel at its February meeting that APCs 0355 and 0356 appear to violate the 2 times rule. In order to eliminate this violation, we suggested moving CPT 90636 (Hepatitis A/Hepatitis B vaccine, adult dose, intramuscular use) from APC 0355 to APC 0356. We also suggested moving CPT codes 90375 (Rabies immune globulin, intramuscular or subcutaneous), 90740 (Hepatitis B vaccine, dialysis or immunosuppressed patient, intramuscular), 90723 (Diphtheria-pertussis-tetanus, Hepatitis B, Polio vaccine, intramuscular), and 90693 (Typhoid vaccine, AKD, subcutaneous) from APC 0356 to APC 0355. </P>
                    <P>The APC Panel recommended moving CPT 90636 from APC 0355 to APC 0356 and CPT codes 90740, 90723, and 90693 from APC 0356 to APC 0355. The APC Panel delayed making a recommendation on CPT 90375 and requested that we collect additional cost data on this procedure for discussion at the next scheduled APC Panel meeting. </P>
                    <P>In the August 16, 2004 proposed rule, we proposed to accept the APC Panel's recommended changes to move CPT code 90740 from APC 0356 to 0355, and to move CPT code 90636 from 0355 to 0356. Based on our review of more recent claims data than were available to the APC Panel, we also determined that the medians for CPT codes 90693 and 90375 are below the $50 drug packaging threshold. Therefore, we also proposed to package both CPT codes 90693 and 90375 and to change the status indicator for CPT code 90723 to “E” because it is not payable by Medicare. </P>
                    <P>We received one public comment relating to CPT code 90740. </P>
                    <P>
                        <E T="03">Comment:</E>
                         One commenter requested that CMS not reassign CPT code 90740 Recombivax 40mcg/mL (a brand name for Hepatitis B vaccine), from APC 0356 (Level II Immunizations) to APC 0355 (Level I Immunizations), as proposed. The commenter stated that the CMS median cost of $5.55 is erroneous and that the lowest published price for Recombivax 40mcg/mL in the Federal Supply Schedule is $79.33. Therefore, the commenter believed that code 90740 does not violate the 2 times rule when assigned to APC 0356. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We are using the CY 2003 hospital claims as the basis for payment and we believe we have adequate claims on which to base payment for CPT code 90740 for CY 2005. We were able to use 99 percent of the claims for CPT code 90740 for median calculation and believe that our assignment of CPT code 90740 for CY 2005 is appropriate. 
                    </P>
                    <P>In this final rule with comment period, we are adopting as final without modification our proposal and are moving CPT code 90740 from APC 0356 to APC 0355 and CPT code 90636 from APC 0355 to APC 0356, as shown in Table 11, and packaging both CPT codes 90693 and 90375. </P>
                    <GPH SPAN="3" DEEP="140">
                        <GID>ER15NO04.009</GID>
                    </GPH>
                    <PRTPAGE P="65703"/>
                    <HD SOURCE="HD3">11. Pulmonary Tests </HD>
                    <HD SOURCE="HD3">APC 0367: Level I Pulmonary Tests </HD>
                    <HD SOURCE="HD3">APC 0368: Level II Pulmonary Tests </HD>
                    <HD SOURCE="HD3">APC 0369: Level III Pulmonary Tests </HD>
                    <P>We expressed concern to the APC Panel at its February 2004 meeting that APC 0369 appears to violate the 2 times rule. We suggested moving CPT code 94015 (Patient recorded spirometry) from APC 0369 to APC 0367. The APC Panel concurred with our proposal. </P>
                    <P>In the August 16, 2004 proposed rule, we proposed to accept the APC Panel's recommendation and to move CPT code 94015 from APC 0369 to APC 0367. In addition, during our analysis of more recent claims data following the APC Panel meeting, we noted that APC 0367 violated the 2 times rule. Therefore, we proposed to reassign CPT codes 94375, 94750, 94450, 94014, 94690, and 93740 to APC 0368. </P>
                    <P>We did not receive any public comments on our proposal. Accordingly, in this final rule with comment period, we are adopting as final without modification our proposal and are moving CPT code 94015 from APC 0369 to APC 0367 and reassigning CPT codes 93740, 94014, 94375, 94450, 94690, and 94750 to APC 0368, as shown in Table 12A. </P>
                    <GPH SPAN="3" DEEP="170">
                        <GID>ER15NO04.010</GID>
                    </GPH>
                    <HD SOURCE="HD3">12. Clinic Visits </HD>
                    <HD SOURCE="HD3">APC 0600: Low Level Clinic Visits </HD>
                    <P>We expressed concern to the APC Panel at its February 2004 meeting that APC 0600 appears to violate the 2 times rule. We suggested moving HCPS code G0264 (Assessment other than CHF, chest pain, asthma) to a higher level clinic visit. The APC Panel recommended that we not make any changes to APC 0600. </P>
                    <P>We proposed to accept this recommendation and not make any changes to APC 0600 for CY 2005. We received one public comment on our proposal from a provider group. </P>
                    <P>
                        <E T="03">Comment:</E>
                         One comment recommended that CMS investigate further the apparent two times violation in APC 0600. The commenter believed that, although the APC Panel did not recommend reassignment of HCPCS code G0264 (Initial nursing assessment of patient directly admitted to observation with diagnosis other than CHF, chest pain or asthma or patient directly admitted to observation with diagnosis of CHF, chest pain or asthma when the observation stay does not qualify for G0244), in order to remedy the apparent violation, CMS should make the reassignment of G0264 to a much higher level clinic visit (APC 0602, High Level Clinic Visit) due to the resources involved in directly admitting a patient to observation. The commenter provided examples of services that the commenter believed are part of the initial observation nursing assessment provided by a hospital, including patient registration, comprehensive nursing clinical admission assessment, initiation of physician orders, coordination and scheduling of ancillary services, administration of medications, and assessment of discharge planning needs. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We do not agree with the commenter's assertion that the services coded using G0264 are necessarily more resource intensive than a low-level clinic visit. The beneficiary whose observation stay would be coded using G0264 presents to the hospital following a physician visit. The beneficiary has already been assessed by the physician who, as a result of the assessment, has decided that observation care is warranted. We are concerned that hospitals may be attributing costs to the initial nursing assessment that are more appropriately attributable to observation services themselves, such as administration of medications, scheduling of tests to be conducted during the period of observation, and discharge planning. It is not apparent why the services provided in the hospital associated with admission to observation care (including some of those listed by the commenter) should require the resources of a High Level Clinic Visit (APC 0602) as the commenter suggested. Thus, we agree with the APC Panel's recommendation to leave G0264 in APC 0600. 
                    </P>
                    <P>Accordingly, in this final rule with comment period, we are adopting as final our proposal not to make any changes to APC 0600 for CY 2005. </P>
                    <HD SOURCE="HD3">13. Other APC Assignment Issues </HD>
                    <P>We received a number of comments about specific APC assignments and payment amounts that were generated by our proposed rates or proposed changes to HCPCS code APC assignments resulting from our revisions to address violations of the 2 times rule. Those changes were not all specifically discussed in the proposed rule, but were open to comment. We respond to these comments in this section of the final rule. </P>
                    <HD SOURCE="HD3">a. Catheters for Brachytherapy Services </HD>
                    <P>
                        <E T="03">Comment:</E>
                         One commenter asked that CMS consider carefully in which APCs to place new CPT codes 19296, 19297, and 19298 (for placement of catheters into the breast for brachytherapy) because the services have, heretofore, been coded under unlisted code 19499, which is assigned to APC 0028 (Level I Breast Surgery) and with a proposed payment amount of $1,081 for CY 2005. The commenter believed that this 
                        <PRTPAGE P="65704"/>
                        proposed amount is too low to appropriately reflect the costs of these services. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We have assigned new CPT codes 19296 and 19298 in New Technology APC 1524 (New Technology-Level XIV ($3,000-$3,500)) with a payment amount of $3,250 and CPT code 19297 in APC 1523 (New Technology-Level XXIII ($2,500-$3,000)) with a payment amount of $2,750 for CY 2005 OPPS. These are new codes and the APC assignments were not included in the proposed rule. Therefore, the APC assignments are subject to comment. 
                    </P>
                    <HD SOURCE="HD3">b. Peripherally Inserted Central Catheters (PICC) </HD>
                    <P>We received one comment regarding our proposed APC reassignment of CPT codes 36568 (Insertion of peripherally inserted central venous catheter (PICC), without subcutaneous port or pump; under 5 years of age) and 36569 (Insertion of peripherally inserted central venous catheter (PICC), without subcutaneous port or pump; age 5 years or older to APC 0187 (Miscellaneous placement/repositioning). We made the proposal based on a recommendation by the APC Panel during its February 2004 meeting. </P>
                    <P>
                        <E T="03">Comment:</E>
                         One commenter requested that we not reassign CPT codes 36568 and 36569 from APC 0032 to APC 0187 as proposed. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We proposed to reassign the PICC lines to APC 0187 based on our agreement with the APC Panel that there are significant differences in the clinical complexity and resource use associated with the procedures assigned to APC 0032 compared to PICC line insertion. We will reevaluate the APC assignment of the PICC line insertion once we have sufficient data to evaluate the assignment. 
                    </P>
                    <HD SOURCE="HD3">c. External Fixation Devices </HD>
                    <P>
                        <E T="03">Comment:</E>
                         One commenter indicated that APC 0046 (Open/Percutaneous Treatment Fracture) contains violations of the two times rules and should be broken into multiple APCs so that CPT codes 20690 (Apply bone fixation device) and 20692 (Apply bone fixation device), which are for application of external fixation devices, could be paid appropriate amounts. Other commenters asked that CMS require that claims for these codes must contain codes for the devices and asked that we revise the definition of C1713 (Anchor/screw for opposing bone to bone or soft tissue to bone (implantable)) to also apply to external fixation devices and to remove the requirement that the device be implantable. One commenter also asked that we instruct providers to bill code 20690 or 20692 when external fixation is provided with the reduction of a fracture and asked that we create a new APC to contain CPT codes 20690 and 20692. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         CPT codes 20690 and 20692 are currently in APC 0050 and no changes were proposed for 2005 OPPS. There are no 2 times violations in the APC in which they are located and each of these codes represents approximately one percent of the volume in the APC. Therefore we see no reason to create a new APC for these codes. The CPT codes for treatment of a fracture often include with or without fixation in the definition of the code. Where fixation is included in the definition of the code, it would be miscoding to also report 20690 or 20692; these codes should be reported if, and only if, fixation is not included in the definition of the CPT code for treatment of the fracture. Providers should review the CPT instructions and look to the AMA's guidance on coding if they have questions about when these codes should be reported. 
                    </P>
                    <HD SOURCE="HD3">d. Apheresis </HD>
                    <P>
                        <E T="03">Comment:</E>
                         Two commenters disagreed with our proposed reassignment of CPT code 36515 (Apheresis, adsorp/reinfuse) to APC 0111 (Blood Product Exchange) and recommended that the code be reassigned to APC 0112 (Apheresis, Photopheresis and Plasmapheresis). One of the commenters, a medical specialty society, indicated that the procedure involves an expensive disposable supply item that costs more than the proposed payment rate for APC 0111. In addition, this commenter stated that the proposed payment rate would be significantly less than the physician's office payment, which the commenter concluded indicated that the charge data used to establish the median cost of the procedure may be incorrect. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         APC assignments are based on clinical homogeneity and comparable resource utilization for all CPT and HCPCS codes within an APC. After careful review, we disagree with the commenters that CPT code 36515 should be reassigned to APC 0112. We believe that the resources required for CPT code 36515 are more similar to the other CPT codes in APC 0111. Thus, for CY 2005, we are adopting as final our proposal to assign CPT code 36515 to APC 0111, effective January 1, 2005. 
                    </P>
                    <HD SOURCE="HD3">e. Imaging for Intravenous Cholangiogram (IVC) Filter Placement and Breast Biopsy </HD>
                    <P>
                        <E T="03">Comment:</E>
                         One commenter requested that we move CPT code 75940 (Percutaneous placement of IVC filter, radiological supervision and interpretation) from APC 0187 (Miscellaneous Placement/Repositioning) to APC 0280 (Level III Angiography and Venography Except Extremity) and CPT code 76095 (Stereotactic localization guidance for breast biopsy or needle placement, each lesion, radiological supervision and interpretation) from APC 0187 (Miscellaneous Placement/Repositioning) to APC 0289 (Needle Localization for Breast Biopsy). The commenter believed that imaging for IVC filter placement and breast biopsy are entirely unrelated services to the central venous access surgical procedures comprising the majority of the codes in APC 0187. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We understand the commenter's concern regarding the clinical inconsistency between the services described by CPT codes 75940 and 76095, which are assigned to APC 0187, and the central venous access (CVA) procedures that are also assigned to APC 0187. However, we disagree with the commenter's recommendation that CPT codes 75940 and 76095 be reassigned. First, if we were to accept the commenter's recommendation to reassign CPT code 75940 to APC 0280 and CPT code 76095 to APC 0289, the resource homogeneity of those two APCs would be compromised, and we would be significantly overpaying CPT code 75940 and underpaying CPT code 76095 based on the median costs of those two codes relative to the median costs of the procedures currently assigned to APCs 0280 and 0289, respectively. Further, we lack data for a number of the CVA codes in APC 0187 because they are new codes that were established in CY 2004. We believe that these new CVA codes are clinically similar to the codes that comprise APC 0187, and we estimate that they are also similar in terms of resource costs, which is why we assigned them to APC 0187. Once we have accumulated data for these new codes, we will review the configuration of APC 0187, and make whatever changes are appropriate in future updates. Therefore, we are maintaining CPT codes 75940 and 76095 in APC 0187 for CY 2005. 
                    </P>
                    <HD SOURCE="HD3">f. Hysteroscopic Endometrial Ablation Procedures </HD>
                    <P>
                        <E T="03">Comment:</E>
                         Some commenters opposed the APC Panel recommendation that both CPT codes 0009T (Endometrial cryoablation) and 58563 (Hysteroscopic endometrial ablation) be assigned to APC 0387 (Level II Hysteroscopy) in CY 2005. The commenters were concerned that adding endometrial cryoablation 
                        <PRTPAGE P="65705"/>
                        (CPT 0009T) to APC 0387 would seriously weaken the clinical homogeneity of APC 0387 because CPT 0009T (Endometrial ablation with ultrasonic guidance) does not use hysteroscopy, and it requires an ultrasound machine and a separate capital unit, or compressor console, to provide cryotherapeutic energy. Instead, the commenters urged CMS not to keep CPT code 58563 in APC 0387, but rather, to assign it to APC 0202, in addition to assigning code 0009T to APC 0202, as we had proposed. One commenter argued that the clinical homogeneity of APC 0202 would be enhanced by grouping the two endometrial ablation procedures that use visualization to monitor and confirm the destruction of the endometrium in the same APC. Moreover, moving both CPT codes 58563 and 0009T to APC 0202 would highlight APC 0202's clinical homogeneity as a more device-intensive family of new technology procedures while better organizing APC 0387 as the group of non-device hysteroscopic procedures involving surgical removal or resection of intrauterine tissue for reasons other than abnormal uterine bleeding (AUB). The same commenter also believed that assigning both codes to APC 0202 would negate any inappropriate incentives to use either treatment because of payment. Other commenters asked that CMS create a new APC for endometrial cryoablation and place that APC on the device-dependent list as it did for cryoablation of the prostate because they have found that the device is 70 percent of the total cost of endometrial cryoablation. The commenters asked that the new APC be paid at least $3,448 to appropriately reflect the hospital's cost of the service. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         After careful consideration of the comments, we have decided to make final for CY 2005 our proposal to retain hysteroscopic endometrial ablation (CPT code 58563) in APC 0387. In addition, we are making final for CY 2005 our proposal to assign endometrial cryoablation with ultrasonic guidance to APC 0202. (We note that CPT code 0009T for endometrial cryoablation with ultrasonic guidance is replaced by new CPT code 58356 for CY 2005.). We believe that the need for a hysteroscope to perform hysteroscopic endometrial ablation makes it similar to the other services in APC 0387. On the other hand, Endometrial cryoablation uses a device but not a hysteroscope and, therefore, is more clinically compatible with APC 0202, which contains other resource intensive gynecologic services that also use a device but not a hysteroscope. Moreover, APC 0202 is a device-dependent APC and, therefore, a more appropriate placement for a procedure that uses a device. 
                    </P>
                    <HD SOURCE="HD3">g. Hysteroscopic Female Sterilization </HD>
                    <P>
                        <E T="03">Comment:</E>
                         One commenter indicated that the AMA intended create a new CPT level III tracking code for hysteroscopic female sterilization for CY 2005 and urged CMS to assign it to APC 0202. The commenter indicated that this new service places implants through a hysteroscope to occlude the fallopian tubes and that, therefore, it should be assigned to APC 0202, which would provide appropriate payment for this new service for which the implants cost $1,000 to $1,500. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         This service is represented by new CPT code 58565 (Hysteroscopic fallopian tube cannulation and micro insert placement), which was created after the issuance of the proposed rule. We are placing this new code to APC 0202 for CY 2005 for the OPPS. The placements of new codes in APCs, such as this code, are subject to comment during the comment period of this final rule with comment period. 
                    </P>
                    <HD SOURCE="HD3">h. Urinary Bladder Residual Study </HD>
                    <P>
                        <E T="03">Comment:</E>
                         One commenter asked us to keep CPT code 78730 (Urinary bladder residual study) in APC 0404 (Renal and Genitourinary Studies Level I) instead of moving it to APC 0340 (Minor Ancillary Procedures). The commenter noted that this code is being misused to report other than urinary bladder residual imaging. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         CPT code 78730 was created and originally valued for the Medicare Physician Fee Schedule as a procedure that required the services of a nuclear medicine technician. Subsequently, the use of the code has changed so that it is now used primarily by urologists. We do not believe that urologists perform services requiring nuclear medicine technicians and so, as the commenter pointed out, it appears that the code may now be utilized for coding a service that is different from that for which it was created. 
                    </P>
                    <P>However, we are not reassigning the code at this time, as requested by the commenter, pending further review. To that end, we would appreciate submission of resource data from other physician specialties that use CPT code 78730 for us to review in the context of our hospital data so that we can examine this issue further.</P>
                    <HD SOURCE="HD3">i. Intracranial Studies, Electrodiagnostic Testing, Autonomic Testing, and EEG</HD>
                    <P>We received one comment relating to the APC assignments for several electrodiagnostic testing, autonomic testing, and EEG codes. </P>
                    <P>
                        <E T="03">Comment:</E>
                         One commenter requested that CPT code 93888 (Intracranial study) be moved from APC 0266 (Level II Diagnostic Ultrasound Except Vascular) and assigned to APC 0267 (Level III Diagnostic Ultrasound Except Vascular) as it was in CY 2002; that CPT codes 95870 (Muscle test, nonparaspinal), 95900 (Motor nerve conduction test), and 95904 (Sensory NCV) be assigned to APC 0218 (Level II Nerve Muscle Tests); that CPT codes 95921, 95922, and 95923 (Autonomic nerve function tests) be assigned to APC 216 (Level III Nerve and Muscle Tests); and that CPT codes 95953 and 95956 (EEG monitoring) be assigned to APC 209 (Extended EEG Studies and Sleep Studies, Level II). 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         Based on our final CY 2003 hospital data for CPT codes 93888, 95870, 95900, 95904, 95921, and 95922, we continue to believe that the resources and clinical characteristics of those codes are most compatible with other services in the APCs to which they are assigned. We made no proposal to change any of those APC assignments. Therefore, in this final rule with comment period, we are finalizing our continued placement of CPT code 93888 in APC 0266; CPT codes 95870, 95900, and 95904 in APC 0215; and CPT codes 95921 and 95922 in APC 0218. We are moving CPT code 95923 from APC 0215 to APC 0218 because the resources for this code are most compatible and homogenous with those services in Level II Nerve and Muscle Tests. 
                    </P>
                    <P>Based on our further review of CPT codes 95953 and 95956, we are moving these two CPT codes, as well as code 95950, to APC 0209 (Extended EEG Studies and Sleep Studies, Level II). Based on our review of clinical and resource use characteristics of these CPT codes, we discovered that 95953, 95956 and 95950 all are more homogenous with procedures assigned to APC 0209 than in their current APCs. Although we did not propose to make these reassignments in the proposed rule, based in part on the comment received and our further review, we are making these reassignments in this final rule with comment period in the interest of clinical and resource use homogeneity.</P>
                    <P>Accordingly, we are reassigning the CPT codes relating to intracranial studies, electrodiagnostics testing, autonomic testing, and EEG to APCs, as displayed below in Table 12B.</P>
                    <GPH SPAN="3" DEEP="154">
                        <PRTPAGE P="65706"/>
                        <GID>ER15NO04.011</GID>
                    </GPH>
                    <HD SOURCE="HD3">j. Therapeutic Radiation Treatment </HD>
                    <P>
                        <E T="03">Comment:</E>
                         Some commenters objected to the proposed movement of CPT code 77370 (Radiation physics consult) from APC 0305 (Level II Therapeutic Radiation Treatment Preparation) to APC 0304 (Level I Therapeutic Radiation Treatment Preparation), with a proposed reduction in the payment rate by 51 percent from the CY 2004 payment rate of $200.60. The commenters indicated that the current CY 2004 payment rate is already inadequate. The commenters expressed concern that the proposed payment of $98.27 would not compensate for the costs incurred to deliver this service and urged that CPT code 77370 remain in APC 0305. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         The median of $134.22 for CPT code 77370 was based on 95 percent of the total CY 2003 claims (33,070 single procedure claims out of 34,792 total claims). Based on these claims data, we believe that the movement of CPT code 77370 from APC 0305 (with a proposed median of $229.92) to APC 0304 (with a proposed median of $99.92) is appropriate. Therefore, we are finalizing our movement of CPT code 77370 from APC 0305 to APC 0304 for CY 2005. 
                    </P>
                    <HD SOURCE="HD3">k. Hyperthermia Procedures </HD>
                    <P>
                        <E T="03">Comment:</E>
                         One commenter expressed concern about the 9-percent decrease in the proposed payment rate for hyperthermia procedures (CPT codes 77600 through 77605) assigned to APC 0314 (Hyperthermic Therapies). The commenter asserted that the hospital charges do not reflect the tremendous capital costs associated with hyperthermia procedures. The commenter suspected that the questionably high utilization for these procedures may be a result of miscoding. The commenter requested that CMS consider the hyperthermia practice expense data submitted through the Practice Expense Advisory Council (PEAC) and Medicare Physician Fee Schedule (MPFS) processes. The commenter urged CMS to maintain the CY 2004 payment rates for hyperthermia through CY 2005 to allow additional time for the commenter to educate providers on the proper coding and cost reporting for hyperthermia. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We believe the data do not support the commenter's concern that a high utilization for these codes is indicative of miscoding, as we do not consider 552 total claims to reflect a high utilization that gives rise to question. The payment rate for APC 0314 for CY 2005 noted in the proposed rule was set using 86 percent of the total claims (that is, 452 single procedure claims out of 522 total claims), which we consider to be sufficiently robust for ratesetting purposes. Therefore, we will not consider practice expense data submitted through the PEAC or MPFS processes. 
                    </P>
                    <HD SOURCE="HD3">l. Physician Blood Bank Services </HD>
                    <P>
                        <E T="03">Comment:</E>
                         One commenter asked that CMS place CPT codes 86077, 86078 and 86079 (Physician blood bank services) into an APC and make payment for them under the OPPS. The commenter indicated that the current assignment of status indicator “A” is assigned to HCPCS codes that are paid under another fee schedule but that these services are not paid under any other fee schedule or payment system and, therefore, the hospital is not being paid for these services. The commenter noted that the services had status indicator “X” for minor services and had APC assignments in the CY 2003 OPPS. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We agree and have assigned these CPT codes to APC 343 with status indicator “X.” These services consist mainly of physician professional services, which are paid through the Medicare Physician Fee Schedule, but we expect there may also be some hospital resources utilized. We have given these codes a condition code of “NI” (new interim) in this interim final rule with comment because they were not paid under the OPPS in CY 2004 and because we were not able to use the data for these codes in the calculation of the median cost for APC 343.
                    </P>
                    <HD SOURCE="HD3">m. Caloric Vestibular Test </HD>
                    <P>
                        <E T="03">Comment:</E>
                         One commenter requested an explanation for the proposed movement of CPT code 92543 (Caloric vestibular test) from APC 0363 (Level I Otorhinolaryngologic Function Tests) to APC 0660 (Level 2 Otohinplaryngologic Function Tests), and CPT codes 92553 (Audiometry, air and bone) and 92575 (Sensorineural acuity test) from APC 0365 (Level II Audiometry) to APC 0364 ((Level I Audiometry). 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We regularly review CPT codes to ensure that they are in appropriate clinical APCs, based on resource use and clinical homogeneity. Upon review, we have found that code 92543 fits more appropriately in a higher-paying APC in the same family of otorhinolaryngologic function test APCs, while codes 92553 and 92575 fit in a lower-paying APC in the same family of audiometry APCs. 
                    </P>
                    <HD SOURCE="HD3">n. APC 0365—Level II Audiometry </HD>
                    <P>
                        <E T="03">Comment:</E>
                         One commenter stated that the services in APC 0365 (Level II Audiometry) are not clinically homogeneous and also violate the 2 times rule, sometimes by a spread of 300 percent. The commenter asked that CMS split the APC into two APCs: one containing CPT codes 92604, 92602, 92603, 92601 and 92561 and a second new APC containing CPT codes 92577, 92579, 92582, 92557. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We agree that revision of this APC would result in improved clinical homogeneity and better grouping of services with similar resources. Therefore, we are establishing a new APC 0366 (Level III Audiometry), and are placing in the new APC those 
                        <PRTPAGE P="65707"/>
                        services that are specific to aural rehabilitation after cochlear implantation: CPT codes 92601, 92602, 92603, and 92604. 
                    </P>
                    <HD SOURCE="HD3">o. Noncoronary Intravascular Ultrasound (IVUS) </HD>
                    <P>
                        <E T="03">Comment:</E>
                         One commenter requested that CMS keep CPT code 37250 (Intravascular ultrasound (non-coronary vessel) during diagnostic evaluation and/or therapeutic intervention; initial vessel) in APC 0670 (Level II Intravascular and Intracardiac Ultrasound and Flow Reserve) and to use only those claims that capture intravascular ultrasound (IVUS) device-related costs to calculate the median cost for this procedure. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We assigned CPT 37250 to APC 0416 (Level I Intravascular and Intracardiac Ultrasound and Flow Reserve) in the proposed rule. We created two levels for IVUS by creating APC 0416 in order to recognize both the clinical and resource use differences between the coronary and noncoronary vessel procedures, as well as the initial vessel and each additional vessel procedures. Prior to creation of APC 0416, all IVUS procedures, coronary and noncoronary, as well as initial vessel and each additional vessel, were assigned to APC 0670. Based on analysis of our CY 2003 hospital claims data, we concluded that the services in APC 0670 had widely varying median costs, with lower median costs for both the each additional vessel (noncoronary and coronary) and initial noncoronary vessel services in APC 0670, as compared with the initial coronary vessel IVUS. We recognized that the additional vessel services would not require a second costly device in most cases. We also noted that the initial vessel coronary IVUS code, CPT 92978, includes imaging supervision and the interpretation and report, while the initial vessel noncoronary IVUS code, CPT 37250, does not include the radiological supervision and interpretation, which is billed using another CPT code. Thus, we believe that the hospital resources utilized to perform initial vessel noncoronary and coronary IVUS are likely to be different because the service elements in the CPT codes vary. Based on this review, we believe CPT 37250, a noncoronary vessel procedure with a median cost of $361, is appropriately assigned to APC 0416 and would be significantly overpaid if assigned to APC 0670. 
                    </P>
                    <P>For CY 2005, we did not have the “C” coded claims to use to identify device-related costs with the level of specificity that was possible for CY 2004. However, we had significantly more claims available for CPT 37250 for ratesetting this year than for CY 2004. We believe that the data on which the assignment to APC 0416 was based were reflective of hospital claims data regarding the resources utilized for the service. As we note elsewhere in this preamble, we will be requiring the use of device codes to report all devices utilized, beginning January 1, 2005. </P>
                    <P>Accordingly, in this final rule we are finalizing the assignment of CPT 37250 to APC 0416 for CY 2005. </P>
                    <HD SOURCE="HD3">p. Electronic Analysis of Neurostimulator Pulse Generators </HD>
                    <P>
                        <E T="03">Comment:</E>
                         One commenter stated that the services in APC 0692 (Electronic Analysis of Neurostimulator Pulse Generators) are not clinically homogeneous and also violate the 2 times rule. The commenter asked that CMS split the APC into two APCs: one containing CPT codes 95972 and 95975, and a second new APC containing CPT codes 95970, 95971, and 95974. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We recognize that there is a violation of the two times rule in APC 0692. Therefore, we are moving CPT code 95970 to APC 0218 (Level II Nerve and Muscle Tests), which places it in a clinical APC that is suitable in terms of resource use for the service and results in APC 0692 conforming to the 2 times rule. 
                    </P>
                    <HD SOURCE="HD3">q. Endoscopic Ultrasound Services </HD>
                    <P>
                        <E T="03">Comment:</E>
                         One commenter asked that CMS create a separate APC for endoscopic ultrasound services because the commenter believed that there are unique costs associated with them. The commenter also believed that ultrasound costs were not packaged into the median for endoscopic ultrasound services because of correct coding edits that define endoscopic ultrasound services as including ultrasound. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We have no reason to believe that the costs for endoscopic ultrasound services do not contain the costs for the ultrasound component of the service. Ultrasound services are included in the definition of the endoscopy CPT codes, and the hospital would include charges for the ultrasound in the charge for endoscopy that uses ultrasound services. We believe that the current APC placement of the codes for endoscopic ultrasound services in APC 0141 (Level I Upper GI Procedures) is valid, both with regard to clinical homogeneity and resource use. 
                    </P>
                    <HD SOURCE="HD3">r. External Counterpulsation (ECP) </HD>
                    <P>
                        <E T="03">Comment:</E>
                         Several commenters requested that G0166 (External Counterpulsation) in APC 0678 (External Counterpulsation) be assigned status indicator “S” rather than “T” and that CMS maintain the payment rate for external counterpulsation at the CY 2004 level. The commenters asserted that external counterpulsation is a stand-alone procedure and that assigning it a status indicator “T” has contributed to declining and inadequate payment rates for the services. The commenters argued that the proposed payment rate for CY 2005 is not reflective of the costs of the service and that the rate should be consistent with other cardiovascular equipment trends such as echocardiography. They contended that the claims data CMS used are erroneous and pointed out that the payment rate has decreased every year since CY 2000, from $112.72 in CY 2004 to a proposed rate of $105.38 for CY 2005. The commenter also speculated that “batching” or “misreporting” of claims also may be contributing to the rate decline trend for external counterpulsation. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We do not believe that the rate decrease for these procedures has anything to do with the “T” status indicator. The rate for external counterpulsation proposed in the August 16, 2004 proposed rule was based on virtually all (35,764) of the 37,565 hospital claims submitted and the APC is comprised of only this one procedure. We are confident that the claims data are representative of actual costs and as such, that the proposed decreased rate is appropriate. 
                    </P>
                    <P>The status indicator only affects the payment rate when external counterpulsation is billed with another procedure that has a status indicator “T.” There are few multiple procedure claims for this procedure in the CY 2003 claims data and, thus, only a very small effect of multiple procedure discounting was possible. </P>
                    <P>In the absence of supporting information from the commenters, it is not clear what the commenters mean by considering the batching of claims as contributing to the payment decrease. It is also not clear whether or not the commenters' belief that misreporting may be contributing to the rate decline trend for external counterpulsation is justified. However, we encourage hospitals to code accurately. </P>
                    <HD SOURCE="HD2">D. Exceptions to the 2 Times Rule </HD>
                    <P>As discussed earlier, the Secretary is authorized to make exceptions to the 2 times limit on the variation of costs within each APC group in unusual cases such as low volume items and services. </P>
                    <P>
                        Taking into account the APC changes that we proposed for CY 2005 based on the APC Panel recommendations discussed in section II.C. of this 
                        <PRTPAGE P="65708"/>
                        preamble and the use of CY 2003 claims data to calculate the median cost of procedures classified in the APCs in the August 16, 2004 proposed rule, we discussed our review of all the APCs to determine which APCs would not meet the 2 times limit. We used the following criteria to decide whether to propose exceptions to the 2 times rule for affected APCs: 
                    </P>
                    <P>• Resource homogeneity. </P>
                    <P>• Clinical homogeneity. </P>
                    <P>• Hospital concentration. </P>
                    <P>• Frequency of service (volume). </P>
                    <P>• Opportunity for upcoding and code fragments. </P>
                    <P>For a detailed discussion of these criteria, refer to the April 7, 2000 OPPS final rule with comment period (65 FR 18457). </P>
                    <P>
                        In the August 16, 2004 proposed rule, we proposed to exempt 54 APCs from the 2 times rule based on the criteria cited above. In cases in which a recommendation of the APC Panel appeared to result in or allow a violation of the 2 times rule, we generally accepted the APC Panel's recommendation because these recommendations were based on explicit consideration of resource use, clinical homogeneity, hospital specialization, and the quality of the data used to determine the APC payment rates that we proposed for CY 2005. The median cost for hospital outpatient services for these and all other APCs can be found at Web site: 
                        <E T="03">http//www.cms.hhs.gov.</E>
                    </P>
                    <P>We received one public comment on our proposal. </P>
                    <P>
                        <E T="03">Comment:</E>
                         One commenter recommended that we use statistical methods to determine variations in the medians of services mapped to an APC. Specifically, the commenter suggested the cost data for an APC should include the standard deviation and the coefficient of variation using the geometric mean as the basis for the measure of dispersion. The commenter recommended that very few APCs be allowed to violate the 2 times rule. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We appreciate the commenter's recommendations. We will consider these recommendations for future recalibrations. We do currently review the range of standard descriptive statistics for all APCs, including, but not limited to, the standard deviation and coefficient of variation. As we stated in the proposed rule, we used multiple criteria to assess whether to propose exceptions to the 2 times rule for affected APCs, including resource and clinical homogeneity, hospital concentration, frequency of services, and opportunities for upcoding and code fragments. Despite an increase in the number of clinical APCs in the OPPS over the last several years, the number of APCs excepted from the 2 times rule has remained relatively stable. 
                    </P>
                    <P>The proposed rule listed exceptions from the 2 times rule based on data from January 1, 2004 through September 30, 2004. For this final rule with comment period, we used data from January 1, 2003 through December 31, 2003. As a result of the additional data, the list of APCs that we are excepting from the 2 times rule has been updated. In this final rule with comment period, we are adopting 57 APCs as excepted from the 2 times rule, as shown in Table 13 below. </P>
                    <BILCOD>BILLING CODE 4120-01-P</BILCOD>
                    <GPH SPAN="3" DEEP="624">
                        <PRTPAGE P="65709"/>
                        <GID>ER15NO04.012</GID>
                    </GPH>
                    <PRTPAGE P="65710"/>
                    <BILCOD>BILLING CODE 4120-01-C</BILCOD>
                    <HD SOURCE="HD2">E. Coding for Stereotactic Radiosurgery Services </HD>
                    <HD SOURCE="HD3">1. Background </HD>
                    <P>In the November 7, 2003 final rule with comment period (68 FR 63403), we discussed the APC Panel's consideration of HCPCS codes G0242 (Cobalt 60-based stereotactic radiosurgery plan) and G0243 (Cobalt 60-based stereotactic radiosurgery delivery). At its August 22, 2003 meeting, the APC Panel discussed combining the coding for these procedures under one code, with the payment for the new code derived by adding together the payments for HCPCS codes G0242 and G0243. The APC Panel recommended that we solicit additional input from professional societies representing neurosurgeons, radiation oncologists, and other experts in the field before recommending changes to the coding configuration for Cobalt 60-based stereotactic radiosurgery planning and delivery. </P>
                    <P>In a correction to the November 7, 2003 final rule with comment period, issued on December 31, 2003 (68 FR 75442), we considered a commenter's request to combine HCPCS codes G0242 and G0243 into a single procedure code in order to capture the costs of this treatment in a single procedure claim because the majority of patients receive the planning and delivery of this treatment on the same day. We responded to the commenter's request by explaining that several other commenters stated that HCPCS code G0242 was being misused to code for the planning phase of linear accelerator-based stereotactic radiosurgery planning. Because the claims data for HCPCS code G0242 represent costs for linear accelerator-based stereotactic radiosurgery planning (due to misuse of the code), in addition to Cobalt 60-based stereotactic radiosurgery planning, we were uncertain of how to combine these data with HCPCS code G0243 to determine an accurate payment rate for a combined code for planning and delivery of Cobalt 60-based stereotactic radiosurgery. </P>
                    <P>In consideration of the misuse of HCPCS code G0242 and the potential for causing greater confusion by combining HCPCS codes G0242 and G0243, we created a planning code for linear accelerator-based stereotactic radiosurgery (HCPCS code G0338) to distinguish this procedure from Cobalt 60-based stereotactic radiosurgery planning. We maintained both HCPCS codes G0242 and G0243 for the planning and delivery of Cobalt 60-based stereotactic radiosurgery treatment, consistent with the use of two G-codes for planning (HCPCS code G0338) and delivery (HCPCS codes G0173, G0251, G0339, G0340, as applicable) of each type of linear accelerator-based treatment. We indicated that we intend to maintain these new codes in their current new technology APCs until the payment rates could be set using medians from this expanded set of codes. We also stated that we would solicit input from the APC Panel at its February 2004 meeting. </P>
                    <P>During the February 2004 APC Panel meeting, several presenters discussed with the APC Panel their rationale for requesting that HCPCS codes G0242 and G0243 be combined into a single procedure code. One presenter explained that the request to combine the codes was made because certain fiscal intermediaries were rejecting claims in which HCPCS codes G0242 and G0243 were reported with a surgery revenue code. Although we have not issued any national instructions to fiscal intermediaries to deny claims for these services if they are billed with a surgery revenue code, the presenter stated that we may have indirectly led some fiscal intermediaries to believe that Cobalt 60-based stereotactic radiosurgery should be reported with a radiation therapy revenue code because the procedure is separated into a planning code and a delivery code, which reflect the coding pattern of a radiation therapy procedure rather than a single code for a surgical procedure. The presenter stated that because of the way that CMS has coded this procedure, some fiscal intermediaries have established local edits to deny claims in which HCPCS codes G0242 and G0243 are reported on a claim with a surgery revenue code. </P>
                    <P>The APC Panel recommended that CMS work with the presenters to determine if any fiscal intermediaries have established local edits to reject claims in which HCPCS codes G0242 and G0243 are reported on a claim, and to determine specific reasons for any such local edits. The APC Panel also recommended that CMS take necessary action to ensure that any such claims are not being denied payment due to local edits. The APC Panel did not agree that the solution to ensuring payment was to combine HCPCS codes G0242 and G0243 into a single code, but rather recommended that CMS educate fiscal intermediaries as to the appropriate procedures for submission of these claims for Medicare payment. </P>
                    <HD SOURCE="HD3">2. Proposal for CY 2005 </HD>
                    <P>In the August 16, 2004 proposed rule, for CY 2005, we proposed to accept the APC Panel's recommendation to work with the presenters to ensure that claims in which HCPCS codes G0242 and G0243 are reported are not being inappropriately denied payment due to local edits established by fiscal intermediaries. In the meantime, for CY 2005, we proposed to maintain HCPCS code G0242 in New Technology APC 1516 (New Technology, Level XVI) at a payment rate of $1,450, and HCPCS code G0243 in New Technology APC 1528 (New Technology, Level XXVIII) at a payment rate of $5,250. These payment rates are the same as those established for CY 2004. </P>
                    <HD SOURCE="HD3">3. Public Comments Received and Departmental Responses </HD>
                    <P>
                        <E T="03">Comment:</E>
                         Numerous comments urged CMS to replace HCPCS codes G0242 (Cobalt 60-based multisource photon SRS, planning) and G0243 (Cobalt 60-based multisource photon SRS, delivery) with one surgical code (that is, CPT code 61793, Stereotactic radiosurgery, one or more lesions) for billing Cobalt 60-based multisource photon stereotactic radiosurgery. These commenters explained that Cobalt 60-based multisource photon SRS is considered to be a one session, neurosurgical procedure and is not separated into planning and delivery sessions. One commenter contended that this procedure is managed and performed exclusively by neurosurgeons. 
                    </P>
                    <P>In response to the OPPS final rule with comment period published on November 7, 2003, one commenter suggested that a combined surgical code representing Cobalt 60-based stereotactic radiosurgery could be appropriately assigned to APC 0222 (Implantation of Neurological Device), APC 0226 (Implantation of Drug Infusion Reservoir), or APC 0227 (Implantation of Drug Infusion Device) to reflect the device costs, the neurosurgical nature of the procedure, and the clinical homogeneity of the other CPT codes that currently reside in these APCs. </P>
                    <P>
                        In response to the OPPS final rule with comment period published on November 7, 2003, and the OPPS proposed rule published on August 16, 2004, several commenters indicated that the current coding structure has resulted in a low volume of single procedure claims for these codes, reflecting the fact that single procedure claims are billed in error for this procedure due to the necessity of billing both HCPCS codes G0242 and G0243 to capture the planning and delivery costs of this procedure. These commenters explained that the concept of planning and delivery is representative of radiation 
                        <PRTPAGE P="65711"/>
                        therapy and, therefore, does not accurately describe Cobalt 60-based multisource photon SRS. The commenters believed that the creation of HCPCS codes G0242 and G0243 has created an unnecessary burden on hospitals because commercial payors do not recognize these codes. One commenter described the burden of reporting the same service using two different coding systems as the costs associated with hiring and training additional staff, preparing individual negotiations with insurers, and addressing the rejection of claims and the delay of treatments. 
                    </P>
                    <P>In contrast, three commenters objected to the use of the term “radiosurgery” to describe Cobalt 60-based multisource photon SRS planning and delivery. One of these commenters indicated that Cobalt 60-based multisource photon SRS is a radiation therapy procedure. This commenter contended that the indirect costs of operating a radiation therapy department are considerably higher than that of a surgery department, when factoring in the cost of a radiation physicist and therapist. The commenter further indicated that the cost-to-charge ratio (CCR) for the radiation therapy cost center more accurately reflects the costs of providing this service relative to a surgical designation. Another commenter objected to our use of the term “radiosurgery” and asserted that this term is a misleading nomenclature because surgery is not involved, except for the placement of an externally attached coordinate reference frame. The commenter explained that this treatment usually consists of one or more high dose radiation treatments delivered by either a linear accelerator or a cobalt 60-based unit and, therefore, should be referred to as “stereotactic radiation therapy.” </P>
                    <P>In response to the OPPS final rule with comment period published on November 7, 2003, one commenter urged that CMS not attempt to label stereotactic radiosurgery as either neurosurgery or external beam radiotherapy, and explained that stereotactic radiosurgery is a unique procedure that combines elements of both neurosurgery and external beam radiotherapy. This commenter recommended that we recognize CPT codes specifically designed for stereotactic radiosurgery. </P>
                    <P>
                        <E T="03">Response:</E>
                         Considering the wide range of conflicting recommendations we received from commenters, we believe that appropriate coding for Cobalt 60-based multisource photon SRS remains a highly contentious and unsettled area of interest among hospitals, neurosurgeons, radiation oncologists, and non-Medicare payors. Based upon our reading of the comments and the observations of CMS staff, we do not believe that Cobalt 60-based multisource photon SRS can be easily classified as either a neurosurgical or radiation therapy procedure specifically. Rather, for the safe and effective delivery of Cobalt 60-based multisource photon SRS to typical patients with brain lesions, the contributions of hospital physician and nonphysician staff with expertise in neurosurgery and radiation therapy are essential for both the planning of the treatment and its delivery. 
                    </P>
                    <P>In the OPPS November 30, 2001 final rule in which we first established payment rates for stereotactic radiosurgery planning and treatment using G-codes in lieu of CPT codes, we noted that, for historical hospital claims for CPT code 61793 (Stereotactic radiosurgery), other combinations of codes from the radiation oncology CPT code section were billed most of the time as well. This confirmed our recognition of the multidisciplinary nature of the service. However, we note that the classification of stereotactic radiosurgery as either neurosurgery or radiation therapy is not relevant to payment for the service under the OPPS. Therefore, for purposes of the OPPS, we have not attributed the service to one specialty or the other. </P>
                    <P>While we consider the adoption of CPT codes that describe this service, we will continue to maintain HCPCS codes G0242 and G0243 as separate codes in their respective new technology APCs 1516 and 1528 for CY 2005. Although we recognize that the single claims data we collect from these codes may include aberrant claims due to the necessity of billing both HCPCS codes G0242 and G0243 on the same date of service for a correctly coded claim, the adoption of CPT code 61793 to replace HCPCS codes G0242 and G0243, as recommended by some commenters, would not resolve the multiple procedure claims dilemma due to the fact that typically hospitals would need to bill additional CPT codes along with CPT code 61793 to report the full range of services that are currently bundled into HCPCS codes G0242 and G0243. For example, in our November 30, 2001 final rule in which we described our determination of the total cost for stereotactic radiosurgery, to model costs for planning, we added the median costs of CPT codes 77295 (the most typical simulation code billed with CPT code 61793), 77300, 77370 (the most common physics consult billed with CPT code 61793), and 77315 (the most common dose plan billed with CPT code 61793). Furthermore, the descriptor for CPT code 61793 describes multiple forms of stereotactic radiosurgery (that is, stereotactic radiosurgery, one or more lesions; particle beam, gamma ray or linear accelerator), rather than Cobalt 60-based multisource photon SRS alone. The adoption of CPT code 61793 under the OPPS would have the effect of nullifying all of the stereotactic radiosurgery G-codes, which we are unwilling to do without cost data supporting an equal payment for all forms of stereotactic radiosurgery. In light of all the above-mentioned reasons, we believe that any stereotactic radiosurgery code changes for CY 2005 would be premature without cost data to support a code restructuring. In the meantime, we will continue to pay HCPCS codes G0242 and G0243 under their current respective new technology APCs 1516 and 1528 for CY 2005, as we continue to analyze new methods for resolving the issue of multiple procedure claims. </P>
                    <P>
                        <E T="03">Comment:</E>
                         In response to the OPPS final rule with comment period published on November 7, 2003, and the OPPS proposed rule published on August 16, 2004, several commenters urged CMS to recognize the surgical nature of Cobalt 60-based multisource photon SRS by mapping the procedure to a surgical revenue code. The commenters claimed that some Medicare fiscal intermediaries continue to reject claims in which HCPCS codes G0242 and G0243 are reported with a surgery revenue code, and encouraged CMS to issue national instructions on the correct billing for stereotactic radiosurgery procedures. The commenters believed that revenue codes are established by the general APC in which the procedure resides. Another commenter stated that the placement of HCPCS codes G0242 and G0243 in new technology APCs labeled as radiation therapy has misled Medicare fiscal intermediaries to assume that a radiation revenue code must be reported with these claims. This commenter indicated that, as a result of providers reporting a radiation revenue code when billing HCPCS codes G0242 and G0243 and Medicare applying a radiation CCR ratio to these codes, the median costs for HCPCS codes G0242 and G0243 were understated, as the CCR for radiation is around 33 percent compared to a 45-percent to 55-percent CCR for surgery cost centers. 
                    </P>
                    <P>
                        In response to the OPPS final rule with comment period published on November 7, 2003, and the OPPS proposed rule published on August 16, 2004, two commenters objected to the 
                        <PRTPAGE P="65712"/>
                        assignment of HCPCS codes G0243 and G0173 to the same new technology APC 1528. The commenters argued that these two procedures should not be grouped into the same APC because they are clinically dissimilar and do not share the same level of resource intensity. The commenter believed that an APC grouping should be determined by the clinical nature of the procedure, its resource cost, the type of physician necessary to perform the procedure, the clinical setting in which the procedure is performed, and the clinical outcomes of the procedure. Another commenter indicated that the cost of Cobalt 60-based SRS multisource photon SRS delivery is 2.45 times the cost of linear accelerator-based SRS delivery, which the commenter believed to be an unacceptable violation of the 2 times rule. In contrast, one commenter reported that its facility has experienced no delays or claims rejections as a result of the current coding structure for stereotactic radiosurgery. The commenter urged CMS to maintain the current coding structure for Cobalt 60-based multi-source photon SRS planning and delivery, asserting that providers who carefully review the code descriptors should experience no delays or claims rejections. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We believe the commenter's concerns regarding the clinical similarity and the application of the 2 times rule to a new technology APC reflect a misunderstanding of the purpose of the new technology APCS. We assign procedures to a new technology APC when we do not have adequate claims data upon which to determine the relative median cost of performing a procedure, and must rely on other sources of information (that is, external data that have been made publicly available) to determine its appropriate payment. New technology APCs do not carry clinical descriptors, such as radiation therapy; rather, the descriptor for each new technology APC represents a particular cost band (for example, $1,400 to $1,500). Payment for items assigned to a new technology APC is the mid-point of the band (for example, $1,450). As we stated in our proposed rule, we have worked together with some of the commenters to identify specific fiscal intermediaries who may be rejecting claims in which HCPCS codes G0242 and G0243 are reported. However, to date, we have been unable to identify any such local edits. Nor have we received examples of rejected claims from providers to enable us to determine why payment was not made for the claims. CMS will continue to work with providers and contractors to clarify coding and billing for all stereotactic radiosurgery procedures through program instructions, Medlearn Matters articles, and other outreach activities. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         One commenter understood that the Advisory Panel on APC Groups is invested with the responsibility of providing correct coding for hospitals, and contended that the Panel should address in more detail the coding issues for stereotactic radiosurgery procedures. This commenter further indicated that the Panel is composed almost entirely of physicians rather than hospital financial personnel or hospital coders, to which the commenter objected as creating a direct conflict with hospital interests. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We do not agree with the commenter's concerns regarding the Advisory Panel on APC Groups. The Panel is governed by the provisions of Pub. L. 92-463, which set forth standards for the formation and use of advisory panels (42 U.S.C. 13951 (t); section 1833(t) of the Act). According to the Charter, the function of the Panel is to review the APC groups and their associated weights and advise the Secretary of Health and Human Services and the Administrator of CMS concerning the clinical integrity of the APC groups and their weights. The subject-matter of the Panel includes to the following issues and related topics: addressing whether procedures are similar both clinically and in terms of resource use; assigning new CPT codes to APCs; reassigning codes to different APCs; and reconfiguring the APCs into new APCs. Responsibility for providing correct coding for hospitals does not fall within the purview of the Panel. Furthermore, we wish to reassure the commenter about the makeup of the Panel. The commenter's understanding that the Panel is almost entirely composed of physicians and lacks representation from hospital financial personnel or hospital coders is not accurate. As required by the Charter, all of the Panel members are currently employed in a full-time status by a hospital and serve as representatives of their hospital employer. Furthermore, only approximately half of the Panel members hold a medical degree, while the other half of the Panel members hold a hospital coding certification or nursing, pharmacy, or business degree(s), or both, or serve as hospital reimbursement officers, or both. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         We received numerous comments suggesting various simplifications of the coding structure for SRS planning and delivery. Some commenters urged that CMS develop one uniform series of treatment codes for the various types of stereotactic radiation therapy, based on the process of care rather than a vendor-specific technology. One commenter suggested that CMS eliminate HCPCS codes G0338 (Linear accelerator-based SRS planning) and G0242 (Multi-source Cobalt 60-based photon SRS planning) and recognize existing CPT codes 77295 or 77301 to describe stereotactic radiation therapy planning, which the commenter believed would more accurately describe the process of care and reduce duplication in codes. Another commenter recommended that CMS eliminate HCPCS code G0242, and recognize HCPCS code G0338 for describing all forms of stereotactic radiosurgery planning by deleting the phrase that restricts the code to linear accelerator-based stereotactic radiosurgery planning. 
                    </P>
                    <P>
                        In contrast, a commenter responding to the OPPS final rule with comment period published on November 7, 2003, suggested that CMS eliminate HCPCS code G0338, and recognize HCPCS code G0242 for all stereotactic radiosurgery planning by deleting the phrase that restricts the code to multisource Cobalt 60-based photon SRS planning. Other commenters recommended that CMS simplify the stereotactic radiosurgery delivery codes as well by eliminating HCPCS codes G0173 (SRS delivery, complete session) and G0251 (Linear accelerator-based SRS delivery, fractionated sessions), and recognizing HCPCS codes G0339 (Image guided, robotic linear accelerator-based SRS, complete or first session) and G0340 (Image guided, robotic linear accelerator-based SRS, second through fifth sessions) for all forms of stereotactic radiosurgery delivery by removing the word “robotic” from their descriptors. Another commenter suggested an alternative option for simplifying the stereotactic radiosurgery delivery codes by eliminating HCPCS codes G0339 and G0340, and recognizing HCPCS codes G0173 and G0251. This commenter recommended that CMS modify the descriptors for HCPCS codes G0173 and G0251 by deleting the linear accelerator specification so the codes apply to all forms of stereotactic radiosurgery delivery and deleting the maximum number of five sessions per course of treatment from the descriptor of HCPCS code G0251. One commenter suggested that CMS eliminate HCPCS codes G0173, G0251, G0339, and G0340 and recognize HCPCS code G0243 as including all stereostactic radiosurgery delivery procedures by deleting the phrase that restricts its use to 
                        <PRTPAGE P="65713"/>
                        multisource Cobalt 60-based photon stereotactic radiosurgery delivery. 
                    </P>
                    <P>In response to the OPPS final rule with comment period published on November 7, 2003, one commenter indicated that HCPCS code G0340 (Image guided, robotic linear accelerator-based SRS, second through fifth sessions) should not be described by radiosurgery, contending that radiosurgery is defined by a single session treatment. The commenter recommended that the descriptor for HCPCS code G0340 be changed to “image-guided, robotic, linear accelerator-based radiation therapy-hypofractionated delivery.” One commenter responded to the OPPS proposed rule by applauding CMS for placing the first fraction of a multiple session treatment delivery of image-guided robotic linear accelerator-based stereotactic radiosurgery (described by HCPCS code G0339) in the same APC as a complete single session treatment delivery of image-guided robotic linear accelerator-based stereotactic radiosurgery, and stated that the resources consumed are identical, regardless of whether additional treatment sessions are delivered. This commenter agreed with CMS' placement of subsequent fractionated sessions in a lower paying APC to reflect the fewer resources consumed during the delivery of subsequent sessions. </P>
                    <P>In response to the OPPS final rule with comment period published November 7, 2003, several commenters supported CMS' decision to assign HCPCS codes G0338 (Linear accelerator-based stereotactic radiosurgery planning) and G0242 (Cobalt 60-based, multi-source photon stereotactic radiosurgery planning) to the same APC, and stated that the resource costs of both types of stereotactic radiosurgery planning are comparable. Another commenter applauded CMS' creation of HCPCS code G0338 to differentiate linear accelerator stereotactic radiosurgery planning from multisource photon stereotactic radiosurgery planning (HCPCS code G0242), due to the differences in their clinical uses and cost resources. </P>
                    <P>In response to the OPPS final rule with comment period published on November 7, 2003, one commenter supported the creation of HCPCS codes G0339 and G0340, as long as these codes are used exclusively for extracranial stereotactic radiosurgery treatments, such as those of the spine, lung, and pancreas. Due to limited cost data and clinical efficacy published on image-guided, robotic stereotactic radiosurgery used to treat extracranial indications, the commenter believed that the costs for this new and emerging technology would be more accurately captured by limiting the use of HCPCS codes G0339 and G0340 to extracranial stereotactic radiosurgery treatments. </P>
                    <P>Several commenters requested that CMS present their recommendations to the Advisory Panel on APC Groups during its next meeting in the event that the stereotactic radiosurgery code descriptors cannot be modified in time for the CY 2005 final rule. </P>
                    <P>
                        <E T="03">Response:</E>
                         For reasons stated in a previous response, we believe that any stereotactic radiosurgery code changes for CY 2005 would be premature without cost data to support a code restructuring. For instance, in preparation of the CY 2006 OPPS Update, we intend to conduct data analysis for the first time for HCPCS codes G0338, G0339, and G0340, which were newly created G-codes for CY 2004. Therefore, until we have completed any such analysis, we will continue to maintain HCPCS codes G0173, G0251, G0338, G0339, G0242, and G0243 in their respective new technology APCs for CY 2005 as we consider the adoption of CPT codes to describe all stereotactic radiosurgery procedures for CY 2006, including the new CPT tracking codes 0082T (Stereotactic body radiation therapy, treatment delivery, one or more treatment areas, per day) and 0083T (Stereotactic body radiation therapy, treatment management, per day) that the AMA intends to make effective January 1, 2005. For CY 2005, we will assign a status indicator of “E” for CPT code 0082T to reflect the fact that the current G-codes for stereotactic radiosurgery treatment delivery include this service, and a status indicator of “N” for CPT code 0083T because we consider the treatment management per session bundled into the current stereotactic radiosurgery treatment delivery G-codes. 
                    </P>
                    <P>In reference to commenters' request that CMS present their recommendations for stereotactic radiosurgery code restructuring to the Advisory Panel on APC Groups, we refer the readers to the discussion above in an earlier response concerning the purview of the Panel's responsibilities. To the extent that the APC assignments for stereotactic radiosurgery codes are an issue, we may bring those to the attention of the Panel. </P>
                    <P>
                        <E T="03">Comment:</E>
                         In response to the OPPS final rule with comment period published on November 7, 2003, several commenters expressed concern that the placement of HCPCS code G0340 (Image-guided robotic linear accelerator-based SRS delivery, fractionated treatment) in a higher paying new technology APC than G0251 (Non-robotic linear accelerator-based SRS delivery, fractionated treatment) creates a financial incentive to use robotic SRS technology over non-robotic stereotactic radiosurgery technology. The commenters urged that HCPCS codes G0251 and G0340 be placed in the same APC until clinical evidence supports an improved clinical outcome using robotic stereotactic radiosrugery as compared to non-robotic stereotactic radiosurgery and sound financial data supports payment differentiation. In addition to placing G0251 and G0340 in the same APC, one commenter urged that CMS remove the language “or first session of fractionated treatment” from the descriptor for G0339 and remove the language “second through fifth sessions” from the descriptor for G0340, so that placement of HCPCS codes G0251 and G0340 in the same APC will result in equal payments for the first session of fractionated therapy, regardless of the type of technology used to deliver fractionated stereotactic radiosurgery. 
                    </P>
                    <P>
                        In response to the OPPS final rule with comment published on November 7, 2003, and the OPPS proposed rule published on August 16, 2004, several commenters asserted that the creation of HCPCS codes G0339 and G0340 was unnecessary, on the premise that all stereotactic radiosurgery and radiotherapy equipment is image guided and robotic. One commenter expressed concern that the creation of HCPCS codes G0339 and G0340, the limitation of HCPCS code G0340 to five fractionated sessions, and the placement of HCPCS code G0340 in a higher paying APC than other SRS modalities inadvertently amount to an endorsement by CMS of the CyberKnife technology. The commenter believed that the current payment rate for CyberKnife therapy results in excessive copayments for beneficiaries and unfairly advantages a technology that has provided insufficient clinical evidence of an improved outcome above existing stereotactic radiosurgery and radiotherapy modalities, and has provided CMS with no convincing cost data to support such an excessive return on investment. The commenter believed that if CMS had consulted the Medicare Coverage Advisory Committee (MCAC) or the Medical Technology Council (MTC), which advise CMS on whether specific medical treatments and technology should receive coverage, neither the MCAC nor the MTC would have recommended coverage for the CyberKnife technology. Other 
                        <PRTPAGE P="65714"/>
                        commenters urged that CMS eliminate what they believe to be an unfair advantage given to HCPCS code G0339 by modifying the descriptor for HCPCS code G0173 (SRS delivery, complete session) to describe a complete session or first session of linear accelerator-based stereotactic radiosurgery delivery, and modifying the descriptor for HCPCS code G0251 to describe second through fifth sessions of linear accelerator-based stereotactic radiosurgery delivery, so that the first session of a multiple session treatment will be paid equal to that of a complete session, regardless of the type of stereotactic radiosurgery technology used. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We disagree with commenters who believe that the creation of HCPCS codes G0339 and G0340, the limitation of HCPCS code G0340 to five fractionated sessions, and the placement of HCPCS code G0340 in a higher paying APC than other stereotactic radiosurgery modalities amount to an endorsement by CMS of a particular technology. We also note that the code descriptors for HCPCS codes G0339 and G0340 do not limit themselves to the CyberKnife technology. As other commenters indicated, the term “image-guided robotic” applies to other types of stereotactic radiosurgery besides CyberKnife. The OPPS payment system establishes payment rates for services based on relative resources utilized by hospitals to provide such services, based primarily on historical claims data if data are available. If hospital claims data are unavailable, we may consider external data to assist us. From 2000 through 2002, the manufacturer of one type of image-guided robotic stereotactic radiosurgery technology (that is, CyberKnife), along with several hospitals, provided CMS with cost data indicating the level of resources utilized in the provision of this form of stereotactic radiosurgery. We believe these data support the current placement of HCPCS codes G0339 and G0340 in their respective new technology APCs 1528 and 1525 for CY 2005. 
                    </P>
                    <P>To date, we have not received such cost data on non-robotic linear accelerator-based stereotactic radoisurgery (that is, on HCPCS codes G0173 and G0251) to aid us in determining if the current payment differentiation is appropriate. Therefore, we will maintain HCPCS codes G0339 and G0340 in APCs 1528 and 1525, respectively, and make no changes to their descriptors for CY 2005. In reference to CMS consulting a medical technology council for advice on new technology coverage, we refer the readers to section II.F.4.,”Public Comments Received Relating to Other New Technology APC Issues,” of this final rule with comment period for a discussion of the recently established Council on Technology and Innovation. </P>
                    <P>
                        <E T="03">Comment:</E>
                         A number of commenters, mostly providers of radiation oncology centers or departments, pointed out that stereoscopic kV x-ray guidance using infrared and/or camera technology is a new and important technology that allows for improved precision in radiation therapy targeting. These commenters indicated that kV x-ray guidance is not described by any current HCPCS or CPT code and requested that CMS create a new HCPCS G-code for payment under the OPPS. In addition, one commenter requested that CMS establish a new HCPCS code necessary for target localization in conjunction with intensity modulated radiation therapy, stereotactic radiotherapy, and stereotactic radiosurgery. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         The kV x-ray guidance using infrared technology came to our attention by means of an application to be considered for assignment to a new technology APC. We have recently concluded that the kV x-ray guidance should receive a temporary “C” code for OPPS payment under certain circumstances described below, and that it should be placed into a new technology APC. Therefore, we are creating the following HCPCS code to describe kV x-ray guidance using infrared technology: 
                    </P>
                    <P>HCPCS code C9722 (Stereoscopic kV x-ray imaging with infrared tracking for localization of target volume) </P>
                    <P>We are assigning the new HCPCS code C9722 to New Technology APC 1502 at a payment of $75, effective on January 1, 2005. </P>
                    <P>While we are assigning a C-code and payment for hospital costs, we are not assigning a G-code because we believe that the interested party should seek a CPT code from the AMA. We believe that the CPT Editorial Panel needs to assess the need for a code for the service, and, if a code is granted, evaluate the resources necessary to provide this service. This technology has been available for more than 2 years. We consider this time period to be sufficient for the interested party to request a CPT code from the AMA. </P>
                    <P>In addition, in our definition and payment instructions for this service, we are limiting additional payment for this service to occasions when kV x-ray is not billed with stereotactic radiosurgery delivery G-codes. As all stereotactic radiosurgery delivery services require guidance, the current payments for the stereotactic radiosurgery delivery G-codes (HCPCS codes G0173, G0243, G0251, G0339, and G0340) bundle payment for guidance services with stereotactic radiosurgery delivery. </P>
                    <HD SOURCE="HD3">4. Final Policy for CY 2005 </HD>
                    <P>We are adopting our proposal to maintain HCPCS codes G0173, G0242, G0243, G0251, G0338, and G0339 in their respective new technology APCs for CY 2005. We will consider the adoption of CPT codes to describe all stereotactic radiosurgery procedures in the future. </P>
                    <HD SOURCE="HD2">F. Movement of Procedures From New Technology APCs to Clinically Appropriate APCs </HD>
                    <HD SOURCE="HD3">1. Background </HD>
                    <P>In the November 30, 2001 final rule (66 FR 59903), we made final our proposal to change the period of time during which a service may be paid under a new technology APC. Beginning in CY 2002, we retained services within new technology APC groups until we acquired adequate data to enable us to assign the service to a clinically appropriate APC. This policy allows us to move a service from a new technology APC in less than 2 years if sufficient data are available. It also allows us to retain a service in a new technology APC for more than 3 years if sufficient data upon which to base a decision for reassignment have not been collected. </P>
                    <P>In the November 7, 2003 final rule with comment period, we implemented a comprehensive restructuring of the new technology APCs to make the payment levels more consistent (68 FR 63416). We established payment levels in $50, $100, and $500 intervals and expanded the number of new technology payment levels. </P>
                    <HD SOURCE="HD3">2. APC Panel Review and Recommendation </HD>
                    <P>
                        During the APC Panel's February 2004 meeting, the APC Panel heard testimony from several interested parties who requested specific modifications to the APCs for the radiation oncology APC. They asked the APC Panel to make several recommendations: (1) That we move CPT code 77418 (Radiation treatment delivery, Intensity-modulated radiation therapy (IMRT)) from APC 0412 (IMR Treatment Delivery) back into a new technology APC; (2) that we dampen, or limit, any possible payment reductions to APC 0301 (Level II Radiation Therapy); (3) that we accept more external data to evaluate costs; and (4) that we identify more claims that are useful for ratesetting. 
                        <PRTPAGE P="65715"/>
                    </P>
                    <P>In response to the testimony presented, the APC Panel recommended that we reassign CPT code 77418 to the new technology APC 1510 for CY 2005 and that we explain to providers any steps we take to limit payment reductions to APC 0301 so that they can better plan for future years during which we may decide not to apply a dampening, or payment reduction limitation, to the rates for APC 0301. </P>
                    <P>In the August 16, 2004 proposed rule, we did not propose to accept the APC Panel's recommendations because we believe that we have ample claims data for use in determining an appropriate APC payment rate for CPT code 77418. Moreover, we believe that the development of median cost for CPT code 77418 based on those data is representative of hospital bills. </P>
                    <P>We have over 255,000 claims for this service, and over 95 percent were single claims that we could use for ratesetting. Moreover, the APC medians have been stable for the last 2 years of data. As indicated by our claims data, returning code 77418 to new technology APC 1510 would result in a payment for the service that is significantly higher than the resources utilized to provide it. </P>
                    <P>We refer the readers to section II.F.4., “Public Comments Received Relating to Other New Technology APC Issues,” of this final rule with comment period for a discussion of the public comments and our final policy regarding the APC placement of CPT code 77418 for CY 2005. </P>
                    <P>
                        <E T="03">Comment:</E>
                         Several commenters objected to the proposed assignment of CPT code 77418 to APC 0412 at a payment rate of $307.78. These commenters disagreed with CMS' conclusion that the significant volume of single claims used to set the payment rate accurately reflects the costs hospitals incur to provide this service, and argued that hospitals are inaccurately coding this service and submitting insufficient charges for delivering this therapy. One commenter raised concerns that some providers are incorrectly billing procedures other than IMRT under CPT code 77418. Commenters urged CMS to accept the recommendation of the Advisory Panel on APC Groups to return CPT code 77418 to a new technology APC with a payment rate comparable to the CY 2003 payment rate of $400. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         As we noted previously, we do not accept the Panel's recommendation to move CPT code 77418 back to a new technology APC. We believe the 2 years (that is, CYs 2002 and 2003) that CPT code 77418 was in new technology APC 0710 allowed ample opportunity for providers to receive proper instruction on correctly coding and billing for this service. The proposed payment rate of $307.78 for CY 2005 was set using 96 percent of the total claims (that is, 246,045 single procedure claims out of 255,020 total claims) for CPT code 77418, which deeply supports its current placement in clinical APC 0412. Therefore, we will maintain CPT code 77418 in APC 0412 for CY 2005. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         Several commenters objected to the proposed movement of CPT code 77301 (Radiotherapy dose plan, IMRT) from new technology APC 1510 (New Technology, Level X) with a payment rate of $850 to clinical APC 0310 (Radiation treatment preparation, Level III) with a payment rate of $811.91. The commenters indicated that this procedure is relatively new and that hospitals appear to be inaccurately reporting the costs of providing this service. The commenters recommended that, until more data can be collected and analyzed, CMS retain CPT code 77301 in new technology APC 1510 at a payment rate of $850. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We move a procedure from a new technology APC to a clinical APC when we have adequate claims data for ratesetting. We believe that the proposed movement of CPT code 77301 from new technology APC 1510 to clinical APC 0310 is appropriate, considering that 88 percent of the total claims (66,076 single procedure claims out of 74,911 total claims) were used to set the payment rate of $811.91 for APC 0301. Furthermore, CPT code 77301 has been placed in a new technology APC for the past 3 years (that is, CY 2002 through CY 2004), which we believe to be ample time for providers to receive proper instruction on correctly coding and billing for CPT code 77301. Therefore, as proposed, we are moving CPT code 77301 from new technology APC 1510 to clinical APC 0310 for CY 2005. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         One commenter requested that new CPT 0073T (Compensator-based beam modulation treatment delivery of inverse planned treatment using three or more high resolution (milled or cast) compensator convergent beam modulated fields, per treatment session) be assigned to APC 0412 with an “S” status indicator. The commenter believed that the assignment of 0073T should be the same as that for CPT 77418. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We agree with the commenter and are assigning CPT 0073T to APC 0412 with status indicator “S” for CY 2005. 
                    </P>
                    <HD SOURCE="HD3">3. Proposed and Final Policy for CY 2005 </HD>
                    <P>There are 24 procedures currently assigned to new technology APCs for which we have data adequate to support assignment into clinical APCs. Therefore, in the August 16, 2004 proposed rule, we proposed to reassign these procedures to clinically appropriate APCs. We proposed to assign 24 of the procedures that were listed in Table 14 of the proposed rule to clinically appropriate APCs using CY 2003 claims data to set medians on which payments would be based. </P>
                    <P>As we did in the proposed rule, we present below a further explanation to provide a fuller understanding of the payment rates for several of the procedures that we proposed to move out of new technology APCs and into clinical APCs. </P>
                    <HD SOURCE="HD3">a. Photodynamic Therapy of the Skin </HD>
                    <P>For CPT code 96567 (Photodynamic therapy of the skin), the impact of the payment decrease between CY 2004 and CY 2005 is actually low, as the CY 2004 payment included the topically applied drug required to perform this procedure and the CY 2005 payment does not. We will now pay separately for the drug billed under HCPCS code J7308 in CY 2005. We have adequate claims data on which to base payment for that procedure in a clinically appropriate APC. Payment based on those data in addition to removal of the drug for separate payment resulted in a lower median cost for the APC. </P>
                    <P>
                        <E T="03">Comment:</E>
                         Several commenters objected to the proposed movement of CPT code 96567 (Photodynamic therapy of the skin) from New Technology APC 1540 (New Technology, Level III) with a payment rate of $150 to clinical APC 0013 (Level II Debridement and Destruction) with a proposed payment rate of $66.15. The commenters recognized that the drug (that is, HCPCS code J7308) used with this procedure is no longer bundled into the payment for CPT code 96567, and agreed that some payment reduction is appropriate. However, the commenters indicated that the proposed payment rate for APC 0013 would not cover the costs of providing this service even after excluding the costs of the drug. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We believe that the resources and the clinical nature of CPT code 96567 are consistent with other codes that are placed in APC 0013. Therefore, in this final rule with comment period, we are finalizing our proposal to move CPT code 96567 from New Technology APC 1540 to clinical APC 0013 for CY 2005. 
                        <PRTPAGE P="65716"/>
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         One commenter brought to our attention that CPT code 96571 (Photodynamic therapy, additional 15 minutes) may have been moved mistakenly from New Technology APC 1541 to clinical APC 0012 (Level I Debridement and Destruction). The commenter suggested that CPT code 96571 be placed in the same clinical APC 0013 (Level II Debridement and Destruction) as CPT code 96570 (Photodynamic therapy, 30 minutes). 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We agree with the commenter that CPT code 96571 was mistakenly moved to APC 0012 in the proposed rule. Because CPT code 96571 is an add-on code for an additional 15 minutes of photodynamic therapy, reported in addition to CPT code 96570, which describes the first 30 minutes of therapy, we believe that both codes, with status indicator “T,” should be placed in APC 0015 (Level III Debridement and Destruction). Therefore, in this final rule with comment period, we are moving CPT code 96571 from New Technology APC 1541 to clinical APC 0015 for CY 2005. 
                    </P>
                    <HD SOURCE="HD3">b. Left Ventricular Pacing, Lead and Connection </HD>
                    <P>Based on a comparison of payment rates for CY 2004 and CY 2005, it appears that there is a large increase in payment that results from reassigning CPT code 33224 (Insertion of left ventricular pacing, lead and connection) from its new technology APC to a clinical APC. The difference is due to the fact that the CY 2005 APC payment includes the cost of the left ventricular lead that was not included in the CY 2004 new technology APC payment. The left ventricular lead was paid as a pass-through device under HCPCS code C1900 in CY 2004, but is not eligible for pass-through payments in CY 2005, and, as such, is now included in the APC for the procedure. </P>
                    <P>Similarly, the CY 2005 payment rate for CPT code 33225 (Left ventricular pacing lead add-on) includes the cost of the ventricular lead. However, for code 33225, the data are still somewhat unstable. Therefore, in the proposed rule, we maintained CPT code 33225 in a new technology APC, but at a higher payment level, to reflect the additional cost of the lead. </P>
                    <P>We received no comments and, therefore, we are reassigning CPT code 33224 to a clinical APC for CY 2005. </P>
                    <HD SOURCE="HD3">c. Positron Emission Tomography (PET) Scans </HD>
                    <HD SOURCE="HD2">PET-FDG (Nonmyocardial) </HD>
                    <P>In the proposed rule, we noted that a number of positron emission tomography (PET) scans currently are classified into APC 1516. We recognized that PET is an important technology in many instances and want to ensure that the technology remains available to Medicare beneficiaries when medically necessary. We believe that we have sufficient data to assign PET scans to a clinically appropriate APC. However, we have been told that if the effect of doing so is to reduce payment significantly for the procedure, it may hinder access to this technology. Therefore, as indicated in the August 16, 2004 proposed rule, we considered three options as the proposed payment for these procedures in CY 2005, based on our review of the 2003 claims data for the PET procedures. We specifically invited comments on each of these options. </P>
                    <P>
                        <E T="03">Option 1:</E>
                         Continue in CY 2005 the current assignment of the scans to New Technology APC 1516 prior to assigning to a clinical APC. 
                    </P>
                    <P>
                        <E T="03">Option 2:</E>
                         Assign the PET scans to a clinically appropriate APC priced according to the median cost of the scans based on CY 2003 claims data. Under this option, we would assign PET scans to APC 0420 (PET Imaging). 
                    </P>
                    <P>
                        <E T="03">Option 3:</E>
                         Transition assignment to a clinical APC in CY 2006 by setting payment in CY 2005 based on a transition payment of a 50-50 blend of the median cost and a New Technology APC payment for CY 2004. We would assign the scans to New Technology APC 1513 for the blended transition payment. 
                    </P>
                    <P>We included the proposed rates for these options in Addendum B of the proposed rule. </P>
                    <P>
                        <E T="03">Comment:</E>
                         Many commenters supported maintaining a number of PET scans in New Technology APC 1516 for CY 2005, as presented under option 1 of the proposed rule. These commenters expressed concern that options 2 and 3 set forth in the proposed rule would greatly impede patient access to PET technology. They stated that options 2 and 3 fail to account for the significant degree of variation in hospital mark-up practices and capital depreciation methods associated with PET procedures and, therefore, underestimate hospitals' costs for performing PET scans. These commenters further explained that the majority of hospitals report PET procedures under an overall diagnostic radiology revenue code rather than distinguishing PET procedures under a diagnostic nuclear medicine revenue code. The commenters expressed concern that PET claims data, when adjusted using a cost to charge ratio not specific to PET, underestimate the relative costs associated with PET imaging procedures. 
                    </P>
                    <P>Another commenter commissioned a time-and-motion study at nine PET facilities in geographically diverse regions of the United States to estimate hospitals' actual costs for providing PET scans. According to the commenter, this cost study concluded that many hospitals could not afford to provide PET scans at a payment rate below $1,450. In addition, the commenter indicated that the cost study suggested that hospitals need to perform three or more scans per day in order to break even at the current payment rate of $1,450 per scan. The commenter pointed out that using a marketing share-weighted average, the cost study found that PET facilities across the United States are performing an average of 2.63 PET scans per day, translating into a loss of $165.18 per scan for most PET providers at the current payment rate of $1,450 per scan. However, the commenter did not clarify whether this national average of performing 2.63 PET scans per day reflects utilization by both hospitals and freestanding PET centers. The commenter urged that PET remain in new technology APC 1516 for CY 2005, and noted that any reductions in payment, including the proposed blended payment rate of $1,150, would significantly impede patient access to this technology, especially in rural settings where the volume of PET scans tends to be lower. Another commenter that provides FDG to 300 PET imaging centers in geographically diverse regions of the United States reviewed their May, June, and July 2004 data for these PET centers and reported an average number of 1.88 PET scans provided per day and a median of 1.3 PET scans provided per day across the 300 PET centers. Again, the commenter did not clarify whether this national average of performing 1.88 PET scans per day reflects utilization by both hospitals and freestanding PET centers. This commenter expressed concern that any reduction in payment for PET scans, with or without a reduction in payment for FDG, may drive many PET centers into an operating deficit and reduce the availability of PET scans for Medicare beneficiaries. </P>
                    <P>
                        <E T="03">Response:</E>
                         We appreciate the many comments we received on this topic and the efforts undertaken by several of the commenters to provide us with additional data concerning the costs of providing the scans. We acknowledge variations in hospital markup practices, capital depreciation and other cost allocation methods, although we note that the CCRs in the various reported cost centers (that is, Nuclear Medicine, 
                        <PRTPAGE P="65717"/>
                        Imaging Department, Radiology) for PET procedures are fairly consistent. The median hospital CCR for these cost centers ranges from 0.3118 to 0.3172, and does not vary greatly from the median overall hospital CCR of 0.33. We believe that the robust number of claims (that is, 55,838 single procedure claims out of 61,492 total claims, representing 91 percent of the total claims) provides sufficient data to assign PET scans to a clinically appropriate APC. However, we received numerous comments indicating that any reduction in payment for PET scans would hinder access by Medicare beneficiaries to this technology. Based on our review of the comments, we are setting the CY 2005 payment for PET scans based on a 50-50 blend of the median cost and the CY 2004 new technology APC payment rate, as presented under option 3 in the proposed rule. PET scans will be assigned to new technology APC 1513 for a blended payment rate of $1,150 for CY 2005. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         One commenter pointed out that the CY 2003 hospital claims data may not account for the current shift to PET/CT technology, which the commenter stated has virtually doubled the cost of launching a viable PET operation, from an average cost of $1,200,000 for a dedicated PET scanner to an average cost of $2,400,000 for a PET/CT scanner. The commenter estimated that approximately 90 percent of the PET systems currently being sold are PET/CT scanners and predicted that the current installed base of approximately 35 percent PET/CT and 65 percent dedicated PET will shift to an overwhelming majority of PET/CT scanners within the next 5 years. The commenter argued that investment in a PET/CT scanner is important to be competitive in the marketplace, due to better capability for detecting malignancies. The commenter stated that the higher capital costs of a PET/CT operation require a patient volume of between four and five patients per day to break even compared to a patient volume of between two and three patients for a dedicated PET operation. According to the commenter, the number of claims for PET remains relatively low compared to MRI and CT scans, comprising less than 1 percent of all imaging procedures performed in the United States. Therefore, the commenter argued that providers would be unlikely to recover significant losses through increased patient volume. 
                    </P>
                    <P>Several commenters indicated that the American Medical Association will be creating three new CPT codes 78814, 78815, and 78816 to describe PET with concurrent CT for anatomical localization for CY 2005. One commenter recommended that CMS assign these new CPT codes for PET/CT scans to three different new technology APCs, while another commenter recommended that CMS place these new CPT codes in new technology APC 1516 at a payment rate of $1,450. </P>
                    <P>
                        <E T="03">Response:</E>
                         The current G code descriptors do not describe PET/CT scan technology, and should not be reported to reflect the costs of a PET/CT scan. At present, we have decided not to recognize the CPT codes for PET/CT scans that the AMA intends to make effective January 1, 2005, because we believe the existing codes for billing a PET scan along with an appropriate CT scan, when provided, preserve the scope of coverage intent of the PET G-codes as well as allow for the continued tracking of the utilization of PET scans for various indications. We plan to issue billing guidance through program instructions and provider education articles for hospitals to use when they provide both a PET and CT scan to patients in their outpatient department. While we acknowledge that PET/CT scanners may be more costly to purchase than dedicated PET scanners, a PET/CT scanner is versatile and may also be used to perform individual CT scans, thereby potentially expanding its use if PET/CT scan demand is limited. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         One commenter supported assigning PET procedures to new technology APC 1513 at a payment rate of $1,150, based on a 50-50 blend of the median cost and the CY 2004 new technology payment, as presented under option 3 of the proposed rule. This commenter stated that option 3 provides the best balance between ensuring continued beneficiary access to this valuable technology and the need for CMS to consistently apply its ratesetting methodology to determine payment rates. Another commenter supported the assignment of PET procedures into a clinically appropriate APC that pays at least $1,200. This commenter believed that a payment of at least $1,200 would compensate adequately for the technology and necessary staffing. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We agree with the commenters that a balance must be reached between ensuring continued beneficiary access to PET scans and the necessity for CMS to apply consistently its rate-setting methodology. Balancing the concern regarding possible adverse effects on patient access that might result from a substantial precipitous reduction in payment with information from thousands of hospital claims and the cost data we received from commenters, we are setting the CY 2005 payment for PET scans based on a 50-50 blend of the median cost and the CY 2004 new technology APC payment rate, as presented under option three in the proposed rule. We believe we have reached this balance for CY 2005 by assigning PET scans to new technology APC 1513 for a blended payment rate of $1,150. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         Another commenter addressed the issue of three new CPT codes 78811, 78812, and 78813 for tumor PET imaging to replace CPT code 78810 (Tumor imaging, positron emission tomography, metabolic evaluation) for CY 2005. The commenter recommended that CMS adopt these new CPT codes in place of the existing G-codes and place them in new clinical APCs, which would result in one level for brain PET scans, two levels for cardiac PET scans, and three levels for tumor PET scans. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         At present, we believe that the existing G-codes for PET scans adequately serve the purpose of tracking utilization of PET scans for various indications. Therefore, CMS will continue to recognize the existing G-codes for PET scans. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         One commenter requested that CMS provide the number of single procedure claims that support assigning FDG-PET scans to a clinically appropriate APC according to the median cost of the scans, as presented under option 2 in the proposed rule. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         The number of single procedure claims used to create the median of $898.64 discussed in the proposed rule under option 2 for APC 0420 (PET imaging) totaled 55,838 single procedure claims out of 61,492 total claims. 
                    </P>
                    <HD SOURCE="HD2">PET (Myocardial) </HD>
                    <P>
                        <E T="03">Comment:</E>
                         One commenter brought to our attention that CPT code 78459 (myocardial imaging, PET, metabolic evaluation) and HCPCS code G0230 (PET imaging; metabolic assessment for myocardial viability following inconclusive SPECT study) are both currently paid under OPPS and describe nearly the same procedure, with the exception that HCPCS code G0230 has a more narrow description. The commenter understood that CMS had intended to replace HCPCS code G0230 with CPT code 78459, but was confused by the payable status indicator for both codes. Two commenters recommended that CMS clarify the proper use of these codes and move CPT code 78459 from APC 0285 (Myocardial Positron Emission Tomography), with a payment rate of $690.61 to APC 1516 with a payment rate of $1,450. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We appreciate the commenter bringing to our attention the 
                        <PRTPAGE P="65718"/>
                        duplication of codes for myocardial PET imaging for metabolic assessment. At present, we will change the status indicator for CPT code 78459 (Myocardial imaging, PET, metabolic evaluation) to “B,” not payable under the OPPS, and move HCPCS code G0230 (PET imaging; metabolic assessment for myocardial viability following inconclusive SPECT study), along with the other PET codes currently assigned to APC 1516, from APC 1516 to APC 1513 for CY 2005. We will seek advice on the APC placement of HCPCS code G0230 from the Advisory Panel on APC Groups during their next meeting. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         Several commenters indicated that the resources, other than the radiopharmaceuticals, required to perform the PET myocardial perfusion imaging studies assigned to APC 0285 (Myocardial Positron Emission Tomography) do not differ significantly from many of the PET tumor imaging procedures contained in new technology APC 1516. These commenters requested an explanation for the payment rate decrease from $1,058.87 in the proposed rule for the CY 2004 update to $772.08 in the final rule for the CY 2004 update, and the further decrease to $690.61 in the proposed rule for the CY 2005 update. The commenters objected to CMS creating an exception to the 2 times rule for APC 0285. The commenters believed that the small volume of these procedures and the complexity of multiple G-codes to describe both single and multiple imaging sessions preclude reasonable conclusions about the cost of providing these services. The commenters recommended that CMS move the 18 G-codes from APC 0285 paying $690.61 to APC 1516 with a payment rate of $1,450. The commenters further recommended that we reduce the complexity of billing for these procedures by collapsing these eighteen G-codes into two CPT codes based on resources for single and multiple studies, replacing HCPCS codes G0030-G0047 with CPT code 78491 (Myocardial imaging, PET, perfusion; single study at rest or stress) and CPT code 78492 (Myocardial imaging, PET, perfusion; multiple studies at rest or stress). 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         The steady decline of the payment rate for APC 0285 since the CY 2004 proposed rule is attributable to the 153-percent increase in the number of single procedure claims used to set the payment rate for APC 0285, which gave rise to better data to more accurately set the payment rate. In the CY 2004 proposed rule, we used 613 single procedure claims out of 1,584 total claims (39 percent of total claims) to set the CY 2004 proposed payment rate of $1,058.87. In the CY 2004 final rule, we used 1,089 single procedure claims out of 1,778 total claims (61 percent of total claims) to set the CY 2004 final payment rate of $772.08. In the CY 2005 proposed rule, we used 1,451 single procedure claims out of 1,946 total claims (75 percent of total claims) to set the CY 2005 proposed payment rate of $690.61. At present, composition of APC 0285 will be maintained for CY 2005 while we collect claims data on HCPCS codes G0030 through G0047. Based on our CY 2003 data for the specific G-codes, we cannot identify a predictable pattern of increased hospital costs associated with multiple studies as compared with single studies. We will present before the Advisory Panel on APC Groups during their next meeting the commenters' recommendation to recognize CPT codes 78491 and 78492 as representing single and multiple myocardial PET studies and movement of these codes from APC 0285 to APC 1516. We note that we will be moving the PET scans currently in APC 1516 to APC 1513 for CY 2005, and will bring that to the Panel's attention as they consider potential APC movement of the myocardial PET studies. 
                    </P>
                    <HD SOURCE="HD3">d. Bard Endoscopic Suturing System </HD>
                    <P>For CY 2005, we proposed to create APC 0422 for Level II Upper GI Procedures and to assign HCPCS code C9703 (the Bard Endoscopic Suturing System), as well as other procedures to APC 0422 based on clinical and resource homogeneity. Currently, HCPCS code C9703 is assigned to New Technology APC 1555, with a payment of $1,650. Our examination of CY 2003 claims data for HCPCS code C9703 revealed that 137 of the 171 single claims were from a single institution with an extremely low and consistent cost per claim. We do not believe that those 137 claims represent the service described by HCPCS code C9703, which includes an upper gastrointestinal endoscopy along with suturing of the esophagogastric junction. Therefore, in establishing the median for APC 0422, we did not use the 137 claims, which we believe were incorrectly coded. </P>
                    <P>
                        <E T="03">Comment:</E>
                         Several commenters opposed the movement of HCPCS code C9703 (Bard Endoscopic Suturing System) from New Technology APC 1555 with a payment rate of $1,650 to clinical APC 0422 (Level II Upper GI Procedures) with a proposed payment rate of $1,274. The commenters indicated that the proposed payment under APC 0422 is inadequate to cover even the equipment costs alone. The commenters contended that the claims data are insufficient to support movement of this procedure out of its new technology APC and into a clinical APC, and urged CMS to maintain HCPCS code C9703 in New Technology APC 1555 with a payment rate of $1,650. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         As we stated in the proposed rule, our examination of the CY 2003 claims data for APC 0422 revealed that 137 of the 171 single claims for HCPCS code C9703 were incorrectly coded. Therefore, the remaining single claims were used in establishing the median for APC 0422. Considering that HCPCS code C9703 has remained in a new technology APC for 2 years with a relatively modest volume, we are not convinced that maintaining HCPCS code C9703 in a new technology APC will necessarily result in a high volume for future ratesetting. Furthermore, the median cost as calculated for HCPCS code C9703, using the subset of single claims, has been relatively stable over the past 2 years and consistent with the median for APC 0422. In addition, in keeping with our practice to use CPT codes, if possible, we will discontinue HCPCS code C9703 and instruct providers to report service with this technology under CPT code 0008T (Upper gastrointestinal endoscopy with suture), which will be payable under the OPPS for CY 2005. In this final rule with comment period, we are finalizing our proposal to move HCPCS code C9703, which will be replaced with CPT code 0008T, from New Technology APC 1555 to clinical APC 0422 for CY 2005. Code 0008T is assigned status indicator “NI” and, as such, is open for public comment during the 60-day comment period associated with this final rule with comment period. 
                    </P>
                    <HD SOURCE="HD3">e. Stretta System </HD>
                    <P>
                        <E T="03">Comment:</E>
                         Several commenters objected to the movement of HCPCS code C9701 (Stretta system) from New Technology APC 1557 with a payment rate of $1,850 to clinical APC 0422 (Level II Upper GI Procedures) with a proposed payment rate of $1,274. The commenters indicated that the proposed payment is inadequate to cover even the equipment costs alone, and urged CMS to maintain HCPCS code C9701 in New Technology APC 1557 with a payment rate of $1,850. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         The single claims volume for HCPCS code C9701 has remained modest for the past 2 years of its placement in a new technology APC. Therefore, we do not believe that maintaining HCPCS code C9701 in a new technology APC will necessarily result in a high volume for future 
                        <PRTPAGE P="65719"/>
                        ratesetting. Furthermore, the median cost for HCPCS code C9701 has been stable over the past 2 years and consistent with the median for APC 0422. Moreover, we can now discontinue HCPCS code C9701 and will instruct providers to report service with this technology under CPT code 43257 (Upper gastrointestinal endoscopy with delivery of thermal energy), a new CPT code that will be payable under OPPS for CY 2005. We are finalizing our proposal to move HCPCS code C9701, which will be replaced with CPT code 43257, from New Technology APC 1557 to clinical APC 0422 for CY 2005. 
                    </P>
                    <HD SOURCE="HD3">f. Gastrointestinal Tract (GI) Capsule Endoscopy </HD>
                    <P>
                        <E T="03">Comment:</E>
                         Several comments opposed our proposal to move CPT code 91110 (GI Capsule Endoscopy) from New Technology APC 1508 with a payment rate of $650 to clinical APC 0141 (Level I Upper GI Procedures) with a proposed payment rate of $464.52 for CY 2005. (CPT code 91110 (Capsule Endoscopy) replaced HCPCS code G0262 in CY 2004. HCPCS code G0262 was mapped to New Technology APC 1508 in CY 2004.) The commenters explained that the cost data for CPT code 91110 are unreliable due to multiple coding changes over the last 3 years and, therefore, believed that the data should not be used to set the payment rate. The commenters indicated that the device costs are $450, and under the proposed payment rate, only $14 would be available to cover the service portion of the procedure. The commenters expressed concern that patient access to care would be hindered by moving the service into clinical APC 0141. The commenters also contended that the proposed assignment of this procedure to APC 0141 is inappropriate because none of the other services that reside in APC 0141 require a device of significant cost and the codes are not clinically homogeneous with CPT code 91110. The commenters urged CMS to maintain CPT code 91110 in New Technology APC 1508 with a payment rate of $650. One commenter suggested that CMS assign a C code to the capsule and instruct providers to bill this C-code along with HCPCS code G0262. One commenter requested that, if CMS does not maintain CPT code 91110 in new technology APC 1508, CMS consider two additional options: (1) Limiting the rate reduction for CY 2005 to 5 percent of the CY 2004 rate; or (2) assign CPT code 91110 to APC 0142 (Small Intestine Endoscopy), which the commenter stated would be a compromise because the payment of $503.20 would still “underpay” the hospital for the costs of providing the procedure. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         Generally, we do not establish C-codes for devices outside of the pass-through process, so we will not assign a C-code to the capsule. We remind providers that they should include the charges for device costs associated with this capsule within the charges reported for CPT code 91110. We agree with the commenters that CPT code 91110 may not belong in APC 0141 based on clinical homogeneity and resource consumption. We had almost 4,000 single claims, about 90 percent of all CY 2003 claims for capsule endoscopy, available for use in calculating the median cost of the service. We have confidence that our median reflects hospital resources needed to perform the service. As one commenter recommended, we believe that the resource costs and clinical nature of CPT code 91110 are more consistent with other codes that reside in APC 0142. Therefore, in this final rule with comment period, we are moving CPT code 91110 from New Technology APC 1508 to clinical APC 0142 for CY 2005, as the commenter suggested. 
                    </P>
                    <HD SOURCE="HD3">g. Proton Beam Therapy </HD>
                    <P>
                        <E T="03">Comment:</E>
                         Several commenters urged CMS to maintain intermediate (CPT code 77523) and complex (CPT code 77525) proton beam therapies in New Technology APC 1511 at a payment rate of $950 for CY 2005. The commenters indicated that the proposed payment rate of $678.31 for CY 2005 does not capture the significant difference in resource consumption and complexity between the simple and the intermediate/complex procedures. These commenters expressed concern that the low volume of claims submitted by only two facilities provides volatile and insufficient data for movement into the proposed clinical APC 0419 (Proton Beam Radiation Therapy) at a payment rate of $678.31. They pointed out that more than four additional centers are currently under construction or in the planning phases in response to the high demand for this technology. The commenters explained that the extraordinary capital expense of between $70-$125 million and high operating costs of a proton beam necessitate adequate payment for this service to protect the financial viability of this emerging technology. They feared that a payment reduction would halt diffusion of this technology and negatively impact patient access to this cancer treatment. 
                    </P>
                    <P>Two commenters explained that the CY 2005 proposed payment rates for CPT codes 77523 (intermediate proton beam treatment) and 77525 (complex proton beam treatment) were based on costs derived by applying CCRs from the most recent Medicare cost reports to charges reported on CY 2003 claims submitted by two hospitals, which were the only two proton therapy centers in operation in the United States at the time. The commenters further indicated that these two hospitals, from which all of the intermediate and complex proton therapies claims were derived, reported the costs and charges of proton therapy along with the costs and charges for all other radiation therapy services on the radiation therapy department line. One commenter calculated an overall radiation therapy department CCR of 0.2442 using CY 2003 data from one of these hospitals. This commenter then calculated a proton beam therapy CCR of 0.4175 by isolating the costs and charges for proton beam therapy from the costs and charges for the overall radiation therapy department. The commenter applied this proton beam therapy CCR of 0.4175 to calculate the costs based on average CY 2003 charges for intermediate and complex proton beam treatments and reported a cost of $1,105.96 for intermediate proton beam treatment and a cost of $1,216.60 for complex proton beam treatment, significantly above Medicare's proposed payment rate of $678.31 for CY 2005. </P>
                    <P>Commenters believed that this understatement of costs in the Medicare cost reports from these two hospitals is largely responsible for the inadequacy of the proposed payment rates for intermediate and complex proton beam treatments. The commenters requested that CMS apply the proton beam therapy CCR of 0.4175, based on proton beam specific cost data provided by one of these commenters, for determining the median costs of proton beam therapy. The commenters believed that the revised costs support the maintenance of CPT codes 77523 and 77525 in New Technology APC 1511 at a payment rate of $950 for CY 2005. The commenters also noted the recommendation of the Advisory Panel on APC Groups to maintain intermediate and complex proton beam therapies in New Technology APC 1511 at a payment rate of $950 for CY 2005 and urged CMS to adopt that recommendation. </P>
                    <P>
                        <E T="03">Response:</E>
                         We will not apply the commenter's calculated CCR to determine the median costs of proton beam therapy because we are unable to replicate the commenter's proton beam therapy CCR calculation of 0.4175 by 
                        <PRTPAGE P="65720"/>
                        isolating the costs and charges for proton beam therapy from the costs and charges for the overall radiation therapy department. However, having considered the concerns of numerous commenters that patient access to proton beam therapy may be impeded by a significant reduction in OPPS payment, we are setting the CY 2005 payment for CPT codes 77523 and 77525 by calculating a 50-50 blend of the median cost of $690.45 derived from 2003 claims and the CY 2004 new technology APC payment rate of $950. We will use the result of that calculation ($820) to assign intermediate and complex proton beam therapies (CPT codes 77523 and 77525) to New Technology APC 1510 for a blended payment rate of $850 for CY 2005. 
                    </P>
                    <P>After consideration of these public comments and based upon our review of the latest claims data available, we are moving the procedures listed in Table 14 from their current new technology APCs to the APCs listed, as we have adequate data on these procedures to enable us to make the necessary APC assignment. </P>
                    <BILCOD>BILLING CODE 4120-01-P</BILCOD>
                    <GPH SPAN="3" DEEP="495">
                        <GID>ER15NO04.013</GID>
                    </GPH>
                    <PRTPAGE P="65721"/>
                    <BILCOD>BILLING CODE 4120-01-C</BILCOD>
                    <HD SOURCE="HD3">4. Public Comments Received Relating to Other New Technology APC Issues </HD>
                    <HD SOURCE="HD3">a. Computerized Reconstruction CT of Aorta </HD>
                    <P>In the August 16, 2004 proposed rule, we proposed to reassign code G0288 (Reconstruction, CTA of aorta for preoperative planning and evaluation post vascular surgery) from New Technology APC 1506 to clinical APC 0417 (Computerized Reconstruction) for CY 2005. </P>
                    <P>
                        <E T="03">Comment:</E>
                         Several commenters expressed concern about our proposal to move G0288 from New Technology APC 1506 to clinical APC 0417. The commenter asserted that the reassignment results in a decreased payment amount from $450 to approximately $247, a rate that commenters believe is too low to cover the costs of providing the service. 
                    </P>
                    <P>The commenters suggested that CMS use external data to calculate rates rather than relying on hospital claims data, that CMS maintain G0288 in its current new technology APC assignment until hospital claims are more accurate, or that CMS go ahead with the reassignment to a clinical APC but continue to base payment on a rate that is consistent with the CY 2004 rate. One commenter provided invoices from hospitals across the country to support its assertion that our proposed payment will be to low. </P>
                    <P>One commenter also requested that CMS change the descriptor for code G0288 to read “Three-dimensional pre-operative and post-operative computer-aided measurement planning and simulation in accordance with measurements and modeling specifications of the Society for Vascular Surgery” in order to ensure that the code is only used for true three-dimensional preoperative and postoperative computer-aided measurement planning and simulation technologies. </P>
                    <P>
                        <E T="03">Response:</E>
                         A predecessor C-code to G0288 had a new technology APC assignment in CY 2002, with a payment level of $625. The C-code was deleted for CY 2003, and G0288, a more general treatment planning code, was then assigned to the same new technology APC for CY 2003, with a payment of $625. For CY 2004, we proposed to move G0288 from a new technology APC to a clinical APC based on over 1,000 claims, with a median cost of $272. Based on hospital data provided by a commenter on the CY 2004 proposed rule and our conclusion that there may have been Medicare claims that understated the costs of the treatment planning software, we placed G0288 in a new technology APC with a payment of $450 for CY 2004, consistent with a 50/50 blend of our data with the analysis of a commenter. For CY 2005, we believe we have adequate claims data on which to base payment for G0288 and to reassign the service to its own clinical APC. We had almost 5,000 total claims for code C9703 (first 3 months of CY 2003 when the C-code was still in the grace period) and G0288, and over half of these were single claims available for APC median calculation. We are confident that the median cost for APC 0417 reflects hospital resource costs, and we are reassured by the consistency of our median cost data over the past several years for this service. 
                    </P>
                    <P>Accordingly, we are adopting as final our proposal to assign code G0288 to APC 0417 for CY 2005. </P>
                    <P>We are not changing the name of G0288 at this time. However, we will take the commenter's suggestion into consideration in the future if the need arises. We revised the descriptor for the code for CY 2004 to clarify that the service can be used for treatment planning prior to surgery and for postsurgical monitoring. We believe that the current G code descriptor appropriately describes the service. </P>
                    <HD SOURCE="HD3">b. Kyphoplasty </HD>
                    <P>
                        <E T="03">Comment:</E>
                         One commenter, a manufacturer of medical devices used to restore spinal function and treat vertebral compression fractures, suggested that CMS should place kyphoplasty, a new procedure to treat vertebral compression fractures, into New Technology APC 1535. The commenter stated that kyphoplasty is currently billed using code 22899 (Unlisted procedure of the spine). The commenter claimed that, according to our policy, because CMS received its application before June 2004, the procedure is eligible for new technology APC payments in October 2004. The commenter was surprised that it did not see a proposal to place kyphoplasty into a new technology APC in our proposed rule or in the October 2004 OPPS update. The commenter stated that using an unlisted code creates problems concerning billing and payment for hospitals. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We have completed our evaluation of the new technology application for kyphoplasty and have assigned new C-codes that describe the procedure. We have assigned these codes to existing clinical APC 0051 rather than to a new technology APC. We believe that APC 0051 is appropriate for kyphoplasty in terms of clinical characteristics and resource costs. Reasonable placement into an existing APC that is appropriate in terms of clinical characteristics and resource costs is one of our criteria in deciding whether a service should be placed into a new technology APC (66 FR 59900, November 30, 2001). 
                    </P>
                    <P>
                        Concerning the commenter's assertion that because CMS received its application before June 2004, the procedure is eligible for payment status as a new technology APC in October 2004, we remind the public that the timing of eligibility for payment, if any, is not bound to when an application is filed with CMS. As we state on the CMS Web site notice at 
                        <E T="03">http://www.cms.gov,</E>
                         if an application is filed by a certain date (for example, by June 1), the earliest date that such an item or service can be considered for new payment status is the following quarter (for example, October 1). This means that any additional coding and payment, if warranted, could begin later than the following quarter. Because it is important that our payment and coding systems do not impede access by Medicare beneficiaries to the best available medical care, we review all applications as quickly as possible, given the complexity of the issues and the thoroughness we believe such reviews require. The timing of completion of our evaluation of any specific application depends on such factors as the complexity of the application, the completeness of all materials submitted, whether the review team requires additional information and the amount of time before we receive additional materials and information. Of course, the service needs to be otherwise eligible for assignment to a new technology APC (or as a pass-through assignment in the case of a new device, drug, or biological). 
                    </P>
                    <P>We note that while we consider these new codes as final, the codes and the placement of the services are subject to comment within 60 days of the publication of this final rule with comment period, as stated elsewhere in this rule. Moreover, the public may comment on our placement of services to the APC Panel, which often hears comments and testimony concerning the placement of new services brought to us by interested parties. </P>
                    <P>Accordingly, the codes for kyphoplasty are:</P>
                    <P>C9718 Kyphoplasty, one vertebral body, unilateral or bilateral injection </P>
                    <P>
                        C9719 Kyphoplasty, one vertebral body, unilateral or bilateral injection; each additional vertebral body (list separately in addition to code for primary procedure)
                        <PRTPAGE P="65722"/>
                    </P>
                    <HD SOURCE="HD3">c. Laser Treatment of Benign Prostatic Hyperplasia (BPH) </HD>
                    <P>In the August 16, 2004 proposed rule, HCPCS code C9713 (Non-contact laser vaporization of prostate, including coagulation control of intraoperative and postoperative bleeding) was assigned to New Technology APC 1525 for CY 2005. The assignment of this code to New Technology APC 1525 was a continuation of the new technology APC placement established on April 1, 2004. </P>
                    <P>
                        <E T="03">Comment:</E>
                         One commenter, the manufacturer of medical equipment used in the treatment of benign prostatic hyperplasia (BPH) stated that its product, the GreenLight Laser, was the only technology available that uses a 532nm or “green” wavelength as an energy source and that CMS had assigned code C9713 in response to an application for a new technology APC assignment from Laserscope. The commenter indicated that other technologies that do not employ the same energy wavelength and the same noncontact vaporization technique should not be billed with code C9713. The commenter expressed concern that the costs of the other techniques are less than those for GreenLight Laser and thus the other techniques should not be paid under New Technology APC 1525. The commenter requested CMS to revise the descriptor of code C9713 to describe only 532nm laser technologies such as the GreenLight Laser. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We acknowledge that HCPCS code C9713 was established following our review of the new technology application from Laserscope. We also agree that code C9713 may be used by hospitals to report such procedures using the Laserscope product, the GreenLight PVP, described in the application for new technology assignment. We established code C9713 based on our understanding of the information provided to us that the service may be different from other services used to treat BPH. We look forward to receiving and assessing the medical review, analysis, and evaluation of the service and technology through the usual AMA coding and payment processes. In general, we do not tailor temporary procedure codes in the “C” series to particular products and have not been persuaded that a redefinition of code C9713 is necessary at this time. With respect to other techniques for treatment of BPH, we would rely on the hospitals to determine which HCPCS code, whether C9713 or one of the CPT codes, most accurately describes the procedure for treatment of BPH for which they are billing. With regards to the commenter's claim that the costs of other techniques described by code C9713 are less than warranted by the New Technology APC 1525, our policy is to review the costs of services assigned to New Technology APCs each year to determine if an alternate placement in another APC is warranted. We continue to believe that placement of code C9713 in a new technology APC is appropriate for CY 2005.
                    </P>
                    <HD SOURCE="HD3">d. Computerized Tomographic Angiography (CTA) </HD>
                    <P>In the August 16, 2004 proposed rule, we included the APC assignment and the payment rate for computed tomographic angiography (CTA). These procedures, coded using one of several CPT codes, depending on the body region under study, involve acquisition of a CT scan with and without contrast material, as well as image post-processing. The assigned CTA CPT codes under APC 0662 had a proposed payment rate of $320.60. That proposed payment rate was slightly lower than that for a CT scan ($323.21) and significantly lower than the sum of the proposed payment for CT scan and image reconstruction, CPT code 76375 ($98), billed separately. </P>
                    <P>
                        <E T="03">Comment:</E>
                         A number of commenters were concerned about the lower payment rates for the CTA procedures and asked CMS to review and revise the proposed payment rate. 
                    </P>
                    <P>The commenters pointed out that, prior to 2001, two codes were used to code for the procedure: one for the CT scan and another for the 3-D reconstruction. The commenters indicated that, in 2001, CPT codes were created to enable specific coding for CTA procedures, including image post-processing in the CTA codes, but those codes were still assigned to the same APC (0333) as CT procedures that did not include image reconstruction. They added that, in CY 2003, the CTA procedures were assigned to their own APC (0662). The commenters asserted that in spite of the creation of an APC specific to CTA procedures, the OPPS payment amounts have not reflected the additional costs for CTA compared to CT. They believed that the low payment rates are due to continuing confusion and conflicting information among providers concerning appropriate billing and charging practices associated with CTA procedures. </P>
                    <P>One commenter performed a number of analyses in an attempt to understand and address the apparent billing problems. In its investigation, the commenter discovered that, in 2002, only 40 percent of all hospitals that performed both CT and CTA charged more for CTA than for CT. The commenter also found in its study of hospital charge structures that there is wide variation in methods employed by hospitals and that only 29 percent of hospitals use costs to set charges. </P>
                    <P>While all commenters recommended that CMS adjust the payment rate for CTA procedures to equal that for APC 0333 plus APC 0282, one commenter recommended that we do this using the adjustment made under the Medicare Physician Fee Schedule for CY 2003 as a model. That commenter suggested that we should ignore CTA claims and instead rely on CT claims (APC 0333) plus reimbursement for image reconstruction (APC 0282) as a basis for setting the rate for CTA services. </P>
                    <P>Other alternative suggestions provided by the commenter include: use only CTA claims that are “logical;” change coding instructions and edits to allow CTA to be billed in addition to image reconstruction; or make an administrative adjustment to increase CTA payment. </P>
                    <P>Finally, the commenters encouraged CMS to investigate alternative methods for calculating CCRs in order to achieve more accurate costs on which to base our rates. </P>
                    <P>
                        <E T="03">Response:</E>
                         Although we understand the commenters' points of view and appreciate the comprehensive analyses they shared with us, we cannot identify any action that would be appropriate for us to take. As the commenters are aware, we rely on hospital claims data to set payment rates and have made clear our intent to rely solely on those claims by CY 2007. If the claims data are inaccurate, especially across a broad spectrum of providers as the commenters believe is evidenced in this case, we have no way to determine which claims are more or less accurate than any others. 
                    </P>
                    <P>
                        To implement the commenters' suggestion that we make the payment rate for CTA (APC 0662) equal to the sum of the rates for CT alone (APC 0333) plus image reconstruction (APC 0282) would require that we have accurate cost information about the cost of image reconstruction for CTA specifically and for CT alone, as utilized with CTA. This is not the case. The image reconstruction code CPT 76375 (coronal, sagittal, multiplanar, oblique, 3-dimensional and/or holographic reconstruction of computed tomography, magnetic resonance imaging, or other tomographic modality) is not limited to image reconstruction performed for CTA and may be used in any number of other procedures. Based on the available CPT codes for CTA, we 
                        <PRTPAGE P="65723"/>
                        would not expect any current utilization of CPT code 76375 to be for CTA post-image processing, unless there was no appropriate CTA code to describe the body region imaged. We believe this would be rare. In addition, our current cost data for CT alone do not necessarily reflect the resources utilized for the CT portion of CTA. 
                    </P>
                    <P>We also do not believe that for the last 3 years there has been conflicting information given to providers concerning appropriate billing and charging practices associated with CTA procedures. The CPT code descriptors clearly include image post-processing for CTA procedures. In response to previous comments, we did provide a separate APC for CTA procedures beginning in CY 2003 in recognition that hospital resources might be different for CTA procedures as compared with CT procedures. From the over 100,000 claims for CTA procedures from CY 2003, we were able to use about 50 percent of the claims to determine hospitals' costs for the services. Our number of claims for CTA procedures increased significantly between CY 2002 and CY 2003. From the 2003 full year of data, we have calculated that median hospital costs for the APCs for CT and CTA services were approximately equal, at $329. Because hospitals set their own charges for services, which we then convert to costs, we see no reason why adding the costs for CT alone plus the costs for image reconstruction would necessarily provide a better estimate of costs for CTA than our analysis of our specific CTA claims. </P>
                    <P>Similarly, in order to make an adjustment akin to that made for the Medicare Physician Fee Schedule for CY 2003, we would need to have accurately coded cost data for the individual components of CTA, performed in the context of CTA, on which to base that change. We do not have that data, and the OPPS system, unlike the Medicare Physician Fee Schedule, relies upon historical hospital claims data to develop relative costs of services. </P>
                    <P>Lastly, we do not agree that we should provide coding guidance that differs from that embodied in the CPT code descriptors in this case. Our current edits that do not allow CTA to be billed in addition to image reconstruction are consistent with the CPT code descriptors for CTA procedures. </P>
                    <P>We created a separately paid, specific APC for those procedures in an attempt to provide an accurate payment for CTA. Moreover, by creating a unique APC for the procedures, we provided the means for hospitals to bill for all of the costs associated with CTA, entirely separate from their billing for CT. We cannot now assume that the claims billed for that APC are incorrect and that those billed for CT alone are correct. </P>
                    <P>We acknowledge the commenters' belief that the claims are flawed and that hospitals' divergent charge structures do not result in consistent charging for CT scans, CTAs or image reconstruction, but note that those claims comprise the data on which the OPPS relies for payment of a wide variety of hospital outpatient services. We must rely on hospitals to manage their charge structures in a manner that accurately and best reflects the services provided. </P>
                    <P>For the reasons stated above, we will not alter the payment rates for CTA, APC 0662, for CY 2005. Once again, we encourage hospitals to take all actions necessary to assure that they are billing accurately and including all resources utilized to deliver services. As discussed in detail in section III. of this preamble, we are continuing our work to refine the CCRs used for ratesetting. </P>
                    <HD SOURCE="HD3">e. Acoustic Heart Sound Services </HD>
                    <P>
                        <E T="03">Comment:</E>
                         Several commenters addressed the need to assign a recently created code for acoustic heart sound services for recording and computer analysis to an APC. One of the commenters indicated that the acoustic heart sound recording can be performed in the first 5 minutes of an emergency department service, together with an ECG, to enable the earliest possible detection of acute cardiac conditions. The commenter related that AMA's CPT Editorial Panel created three new Category III codes for acoustic heart sound recording that correspond to performing the procedure, physician interpretation of results, and recording and interpretation in combination. The commenter contended that one of these codes, CPT Category III code 0069T (Acoustic heart sound recording and computer analysis only) could be payable under the OPPS. The commenters noted that we did not propose an APC assignment for code 0069T in our proposed rule, and they requested an APC assignment effective January 1, 2005. One of the commenters believed that the most appropriate clinical APC to assign this code is APC 0099 (Electrocardiograms). 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         One of the commenters, a manufacturer of the acoustic heart sound system, had previously applied for assignment of these codes to new technology APCs and we have previously evaluated the three acoustic heart sound services. We agree that only code 0069T could be payable under the OPPS. The comment that acoustic heart sound recording can be performed in the first 5 minutes of a visit by an ECG technician, together with an ECG, to enable the earliest possible detection of acute cardiac conditions, demonstrates that there are limited additional facility resources associated with the acoustic heart sound recording in conjunction with an ECG. It is also our understanding that the AMA's coding advice indicates that the acoustic heart sound services are to be used in conjunction with electrocardiography services. We believe it is worthwhile to recognize code 0069T under the OPPS to track its utilization and develop cost data. However, because the service may be performed quickly and is always accompanied by an ECG, we are assigning a packaged status to code 0069T for CY 2005. Although not separately payable under the OPPS, charges for the acoustic heart sound service will be packaged with charges for the separately payable services with which it is performed. With regards to the comment that we did not assign an APC in our proposed rule, we note that we do not recognize under the OPPS new CPT codes on a mid-year basis, even though the AMA may assign new tracking codes mid-year, as it did in this case. We assign new CPT codes on an annual basis, effective with our January 1 updates to the OPPS. Because this is a new code assignment that was not proposed in the CY 2005 proposed rule, interested parties will be able to comment on this new payment assignment in response to this final rule with comment period. This code is included in Addendum B. 
                    </P>
                    <HD SOURCE="HD3">f. Laparoscopic Ablation Renal Mass </HD>
                    <P>
                        <E T="03">Comment:</E>
                         Commenters asked that we move CPT code 50542 (Laparoscopic ablation renal mass) out of APC 0131 (Level II Laparoscopy) and place it in new technology APC 1574 (New Technology, Level XXXVII ($9,500-$10,000) until meaningful data can be obtained for the procedure. The commenter indicated that the procedure, including required devices, might cost approximately $10,000 because of the cost of the cryosurgery device. The commenter indicated that because they did not find any claims for this code that contained the device code for cryoablation probes (C2618), CMS should discard the data as being valid to set the weight for this code. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         Code 50542 represents a service that may or may not be performed with cryoablation equipment. Therefore, the absence of the device code for cryoablation probes on the 
                        <PRTPAGE P="65724"/>
                        claims may be an accurate reflection of the service as it was performed. The median cost for the service appears to be appropriately placed in APC 0131 and the service is clinically coherent with other services in APC 0131. Therefore, we are retaining its placement in APC 0131 for CY 2005. 
                    </P>
                    <HD SOURCE="HD3">g. Intrabeam Intra-Operative Therapy </HD>
                    <P>
                        <E T="03">Comment.</E>
                         One commenter, the manufacturer of the Intrabeam Intra-Operative Therapy System, commented that this procedure, a treatment for women diagnosed with early-stage breast cancer, which is currently assigned to APC 0312 (Radioelement Applications) and is billed using CPT code 77776, is currently underpaid in APC 0312. The commenter claimed that there is no current APC mechanism to capture the cost information specific to this technology, and there are insufficient Medicare claims data at this time to make an appropriate clinical APC assignment. The commenter requested that CMS assign the Intrabeam procedure to a new technology APC. In addition, the commenter requested that CMS create two new level II HCPCS codes with the following descriptors: (1) Surgical placement and removal of intra-operative direct application x-ray source using surgical closure techniques; and (2) Administration of radiation therapy by intra-operative direct application of x-ray source. 
                    </P>
                    <P>
                        <E T="03">Response.</E>
                         We recently received from the manufacturer of the Intrabeam Intra-Operative Radiation Therapy procedure an application for assignment of this procedure to a new technology APC. We are currently engaged in review of that application. 
                    </P>
                    <HD SOURCE="HD3">h. New Technology Process Issues </HD>
                    <P>
                        <E T="03">Comment:</E>
                         In response to the OPPS final rule with comment period published November 7, 2003, one commenter asserted that CMS had failed to establish an acceptable method for evaluating the costs and clinical efficacy of therapeutic medical technologies before assigning a code and New Technology APC payment under the OPPS. The commenter urged CMS to propose evaluation criteria for determining costs and clinical efficacy. In developing such criteria, the commenter encouraged CMS to require that all filings with the FDA be submitted to CMS for review and for CMS to rely heavily on the predicated device in the FDA application, require all privately held companies to provide CMS with a list of investors/owners, utilize generally accepted accounting principles, seek advice from the Medicare Coverage Advisory Committee (MCAC) or the Medical Technology Council (MTC), consider evaluation methods used by other health insurers, and consider recommendations from experts in the field. The commenter believed that if CMS had consulted the MCAC or the MTC, which advise CMS on whether specific medical treatments and technology should receive coverage, neither the MCAC nor the MTC would have recommended coverage for the CyberKnife technology, as an example. 
                    </P>
                    <P>In response to our August 16, 2004 proposed rule, one commenter, a device manufacturer, urged CMS to make changes to the pass-through and new technology application and evaluation processes to provide disclosure of applications filed with CMS and to create an opportunity for the public to comment on the disposition of proposed or final actions on applications. The commenter believed that public processes can be adopted, while retaining CMS' quarterly update capability for coding and payment. </P>
                    <P>
                        <E T="03">Response:</E>
                         As required by section 942(a) of Pub. L. 108-173, we recently established the Council on Technology and Innovation (CTI) which brings together CMS senior leadership to better coordinate coverage, coding and payment policy to support the goal of high quality, high value care. The CTI aims to provide CMS with improved methods for developing practical information about the clinical benefits of new medical technologies to aid in achieving more efficient coverage and payment of these medical technologies. The CTI will also help identify and develop study methods for gathering reliable evidence about the risks and benefits of new and existing medical technologies that can be carried out more easily on a regular basis, such as simple protocols, registries, and other study methods. 
                    </P>
                    <P>The CTI will support CMS' efforts to develop better evidence on the safety, effectiveness, and cost of new and approved technologies to help promote their more effective use. As directed in section 942(a) of Pub. L. 108-173, the CMS Council coordinates the activities of Medicare coverage, coding, and payment for new technologies and the exchange of information on new technologies between CMS and other entities charged with making similar considerations and decisions. </P>
                    <HD SOURCE="HD2">G. Changes to the Inpatient List </HD>
                    <P>At the APC Panel's February 2004 meeting, we advised the APC Panel of a request that we had received to move four codes for percutaneous abscess drainage 44901 (Drain append. abscess, percutaneous), 49021 (Drain abdominal abscess), 49041 (Drain percutaneous abdominal abscess), 49061 (Drain, percutaneous, retroper. abscess)) from the inpatient list and to assign them to appropriate APCs. The APC Panel also recommended that we evaluate other codes on the inpatient list for possible APC assignment and that we consider eliminating the inpatient list. </P>
                    <P>In the August 16, 2004 proposed rule, we proposed to remove the four above-cited codes and assign them to clinically appropriate APCs, as recommended by the APC Panel. We also proposed to assign code 44901 to APC 0037, code 49021 to APC 0037; code 49041 to APC 0037; and code 49061 to APC 0037. We discuss in section VII.E. of this final rule with comment period our response to the APC Panel's recommendation that we either abolish the inpatient list or evaluate it for any appropriate changes, the public comments we received on our proposal, and our responses to those public comments. </P>
                    <HD SOURCE="HD2">H. Assignment of “Unlisted” HCPCS Codes </HD>
                    <HD SOURCE="HD3">1. Background </HD>
                    <P>Some HCPCS codes are used to report services that do not have descriptors that define the exact service furnished. They are commonly called “unlisted” codes. The code descriptors often contain phrases such as: “unlisted procedure,” “not otherwise classified,” or “not otherwise specified.” The unlisted codes typically fall within a clinical or procedural category, but they lack the specificity needed to describe the resources used in the service. For example, CPT code 17999 is defined as “Unlisted procedure, skin, mucous membrane and subcutaneous tissue.” The unlisted codes provide a way for providers to report services for which there is no HCPCS code that specifically describes the service furnished. However, the lack of specificity in describing the service prevents us from assigning the code under the Medicare OPPS to an APC group based on clinical homogeneity and median cost. </P>
                    <P>
                        In the August 16, 2004 proposed rule, we listed in Table 15 our proposed APC reassignments of unlisted HCPCS codes. In most cases, the unlisted codes are assigned to the lowest level, clinically appropriate APC group under the Medicare OPPS. This creates an incentive for providers to select the appropriate, specific HCPCS code to describe the service if one is available. In addition, if there is no HCPCS code that accurately describes the service, placing the unlisted code in the lowest level APC group provides an incentive 
                        <PRTPAGE P="65725"/>
                        for interested parties to secure a code through the AMA's CPT process that will describe the service. Once a code that accurately describes the service is created, we can collect data on the service and place it in the correct APC based on the clinical nature of the service and its median cost. 
                    </P>
                    <P>We do not use the median cost for the unlisted codes in the establishment of the weight for the APC to which the code is assigned because, by definition of the code, we do not know what service or combination of services is reflected in the claims billed using the unlisted code. </P>
                    <P>Our review of HCPCS code assignments to APCs has revealed that there are a number of unlisted codes that are not assigned to the lowest level APC. </P>
                    <HD SOURCE="HD3">2. Proposed and Final Policy for CY 2005 </HD>
                    <P>In the August 16, 2004 proposed rule, we proposed to reassign specified unlisted HCPCS codes for CY 2005 OPPS to the lowest level APC in the clinical grouping in which the unlisted code is located. We displayed a listing of our proposed reassignment of the unlisted HCPCS codes in Table 15 of the proposed rule. </P>
                    <P>We received a number of public comments on our proposals. </P>
                    <P>
                        <E T="03">Comment:</E>
                         Some commenters supported placing all unlisted codes in the lowest paid APC and noted that they believed that there are others, such as CPT code 43999 (Unlisted procedure stomach), which is now in APC 0141, that should be added to the list of those to be placed in the lowest APC. They recommended that CMS review the entire list of CPT codes to find others that should be moved to the lowest level APC. 
                    </P>
                    <P>Some commenters opposed placing “unlisted” or “not otherwise classified” codes in the lowest APC applicable to the category of service. They believed that it is inappropriate for CMS to develop payment policies aimed at forcing stakeholders to seek new HCPCS codes for the services being performed. They indicated that moving these codes to the lowest paying APC would decrease payment for 18 of the 20 procedures by more than 70 percent and would create a barrier to new technology. They indicated that CMS should analyze the costs associated with particular unlisted codes and assign them to APCs that appropriately reflect the cost to perform the services but in the meantime, should retain them in the existing APCs in which they are placed. One commenter urged us to follow the process that is followed for physician payment when unlisted codes are used, with fiscal intermediaries negotiating payment for the unlisted code depending on the actual service provided each time. One commenter indicated that putting the unlisted codes in the lowest level APC provides a disincentive for facilities to adopt new technology because it will not be paid adequately. </P>
                    <P>
                        <E T="03">Response:</E>
                         We appreciate the support of the commenters who agreed with placing unlisted codes in the lowest APC for the clinical category. With respect to the comment that CPT code 43999 should be moved out of APC 0141 and should be placed in the lowest APC for gastrointestinal procedures, we have not moved it from APC 0141 because we believe that APC 0141 is the lowest APC appropriate to the clinical category of services for CPT code 43999. 
                    </P>
                    <P>We have reviewed again the proposed list of unlisted or “not otherwise classified” codes being moved to the lowest APC and based on that re-review have determined that we do not need to make any additional changes to that proposed list in this final rule with comment period. </P>
                    <P>By definition, “unlisted” or “not otherwise classified” codes do not describe the services being performed, and the services coded using “unlisted” codes vary over time as new CPT and HCPCS codes are developed. Therefore, it is impossible for any level of analysis of past hospital data to result in appropriate placement of the service for the upcoming year in an APC in which there is clinical integrity of the groups and weights. Therefore, we believe that the appropriate default, in the absence of a code that describes the service being furnished, is placement in the lowest level APC within the clinical category in which the unlisted code falls. We see no need to expand the process that is followed for physician payment of unlisted codes to the outpatient hospital setting. The assignment of the unlisted codes to the lowest level APC in the clinical category specified in the code provides a reasonable means for interim payment until such time as there is a code that specifically describes what is being paid. It encourages the creation of codes where appropriate and mitigates against overpayment of services that are not clearly identified on the bill. For new technologies that are complete services but may not have yet been granted a specific CPT code, the new technology payment mechanism is available under OPPS. Outlier payments may also be available under the OPPS in a case of an expensive new technology for which a specific code is not available and for which the costs of the new procedure exceed the outlier threshold. </P>
                    <P>
                        <E T="03">Comment:</E>
                         One commenter indicated that the principal problem behind the use of unlisted or not otherwise classified codes is the AMA's bias against giving CPT codes for new services and technologies unless a physician group requests the code to provide a mechanism for increased physician payment for the service. The commenter asked that CMS, as the largest and most powerful licensee of CPT, influence the AMA to reduce the amount of time it takes to release new CPT codes for use in the OPPS so that the need for use of unlisted codes will diminish and the new services can be paid appropriately more quickly after they come onto the market. The commenter also asked that CMS reduce its “barriers” to placement of new services that require new technologies into new technology APCs or to granting of pass through payment status. The commenter indicated that lowering these “barriers” also would eliminate much of the use of the unlisted codes. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         An individual, a physician group, or a manufacturer may submit a request for a new CPT code. CMS works collaboratively with the AMA to establish new CPT codes, recognizing that the process is governed and controlled by the AMA. The AMA CPT process involves methodical consideration of new coding proposals, which may be time consuming. In addition, the payment system changes required by new codes take some time to implement. Under the OPPS, we make available the pass-through and new technology payment mechanisms, using C-codes and G-codes to allow new services, devices, and technologies to be available to clinicians and providers to facilitate appropriate payment for such services. The commenter did not indicate what “barriers” to placement of new services exist. However, to assist the public, we provide further guidance in section IV.C. of the preamble concerning additional comments on the topic of the surgical insertion or implantation criterion for the pass-through device payment mechanism. 
                    </P>
                    <P>In this final rule with comment period, we are adopting as final, without modification, the proposed reassignment of unlisted HCPCS codes to move all unlisted or “not otherwise classified” codes to the lowest level APC that is appropriate to the clinical nature of the service, as displayed in Table 15. </P>
                    <GPH SPAN="3" DEEP="368">
                        <PRTPAGE P="65726"/>
                        <GID>ER15NO04.014</GID>
                    </GPH>
                    <HD SOURCE="HD2">I. Addition of New Procedure Codes </HD>
                    <P>During the first two quarters of CY 2004, we created 85 HCPCS codes that were not addressed in the November 7, 2003 final rule with comment period that updated the CY 2004 OPPS. We have designated the payment status of those codes and added them to the April and July updates of the 2004 OPPS (Transmittals 3144, 3154, 3322, and 3324). We showed these codes in Table 16 of the proposed rule. Thirty of the new codes were created to enable providers to bill for brand name drugs and to receive payments at a rate that differs from that for generic equivalents, as mandated in section 1833(t)(14)(A)(i) of the Act as added by Pub. L. 108-173. In the August 16, 2004 proposed rule, we solicited comment on the APC assignment of these services. Further, consistent with our annual APC updating policy, we proposed to assign the new HCPCS codes for CY 2005 to the appropriate APCs. </P>
                    <P>We did not receive any public comments on our proposal. Accordingly, in this final rule with comment period, we are adopting as final our proposal to assign the new HCPCS codes for CY 2005 to the appropriate APCs, as shown in Addendum B of this final rule with comment period, without modification. </P>
                    <HD SOURCE="HD2">J. OPPS Changes Relating to Coverage of Initial Preventive Physical Examinations and Mammography Services Under Pub. L. 108-173 </HD>
                    <HD SOURCE="HD3">1. Payment for Initial Preventive Physical Examinations (Section 611 of Pub. L. 108-173) </HD>
                    <HD SOURCE="HD3">a. Background </HD>
                    <P>Section 611 of Pub. L. 108-173 provides for coverage under Medicare Part B of an initial preventive physical examination for new beneficiaries, effective for services furnished on or after January 1, 2005. This provision applies to beneficiaries whose coverage period under Medicare Part B begins on or after January 1, 2005, and only for an initial preventive physical examination performed within 6 months of the beneficiary's initial coverage date. </P>
                    <P>Current Medicare coverage policy does not allow for payment for routine physical examinations (or checkups) that are furnished to beneficiaries. Before the enactment of Pub. L. 108-173, all preventive physical examinations had been excluded from coverage based on section 1862(a)(7) of the Act, which states that routine physical checkups are excluded services. This exclusion is specified in regulations under § 411.15(a). In addition, preventive physical examinations had been excluded from coverage based on section 1862(a)(1)(A) of the Act. This section of the Act provides that items and services must be reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member (as implemented in regulations under § 411.15(k)). </P>
                    <P>
                        Coverage of initial preventive physical examinations is provided only under Medicare Part B. As provided in the statute, this new coverage allows payment for one initial preventive physical examination within the first 6 months after the beneficiary's first Part B coverage begins, although that coverage period may not begin before 
                        <PRTPAGE P="65727"/>
                        January 1, 2005. We also note that Pub. L. 108-173 did not make any provision for the waiver of the Medicare coinsurance and Part B deductible for the initial preventive physical examination. Payment for this service would be applied to the required Medicare Part B deductible, which is $110 for CY 2005, if the deductible has not been met, and the usual coinsurance provisions would apply. 
                    </P>
                    <HD SOURCE="HD3">b. Amendments to Regulations </HD>
                    <P>In the August 16, 2004 proposed rule, we proposed to amend our regulations to add a new § 410.16 that would provide for coverage of initial preventive physical examinations in various settings, including the hospital outpatient department, as specified in the statute, and specify the condition for coverage and limitation on coverage. In addition, we proposed to conform our regulations on exclusions from coverage under § 411.15(a)(1) and § 411.15(k) to the provisions of section 611 of Pub. L. 108-173. Specifically, we proposed to specify an exception to the list of examples of routine physical checkups that are excluded from coverage under § 411.15(a) and to add a new exclusion under § 411.15(k)(11). </P>
                    <P>We proposed to amend § 419.21 of the OPPS regulations to add a new paragraph (e) to specify payment for an initial preventive physical examination as a Medicare Part B covered service under the OPPS if the examination is furnished within the first 6 months of the beneficiary's first Medicare Part B coverage. </P>
                    <P>We noted that the initial preventive physical examination was also addressed in detail in our proposed rule to update the Medicare Physician's Fee Schedule for CY 2005 (69 FR 47487, August 5, 2004). However, because we believe the same elements of the initial physical examination furnished in a physician's office would also apply when the examination is performed in a hospital outpatient clinic, we proposed to revise the applicable regulations to reflect this requirement. </P>
                    <P>Section 611(b) of Pub. L. 108-173 defines an “initial preventive physical examination” to mean physicians” services consisting of—</P>
                    <P>(1) A physical examination (including measurement of height, weight, blood pressure, and an electrocardiogram (EKG), but excluding clinical laboratory tests) with the goal of health promotion and disease detection; and </P>
                    <P>(2) Education, counseling, and referral with respect to screening and other preventive coverage benefits separately authorized under Medicare Part B, excluding clinical laboratory tests. </P>
                    <P>Specifically, section 611(b) of Pub. L. 108-173 provides that the education, counseling, and referral services with respect to the screening and other preventive services authorized under Medicare Part B include the following: </P>
                    <P>(1) Pneumococcal, influenza, and hepatitis B vaccine and their administration; </P>
                    <P>(2) Screening mammography; </P>
                    <P>(3) Screening pap smear and screening pap smear and screening pelvic examination; </P>
                    <P>(4) Prostate cancer screening tests; </P>
                    <P>(5) Colorectal cancer screening tests; </P>
                    <P>(6) Diabetes outpatient self-management training services; </P>
                    <P>(7) Bone mass measurements; </P>
                    <P>(8) Screening for glaucoma; </P>
                    <P>(9) Medical nutrition therapy services for individuals with diabetes and renal disease; </P>
                    <P>(10) Cardiovascular screening blood tests; and </P>
                    <P>(11) Diabetes screening tests. </P>
                    <P>Section 611(d)(2) of Pub. L. 108-173 amended sections 1861(s)(2)(K)(i) and (s)(2)(K)(ii) of the Act to specify that the services identified as physicians' services and referred to in the definition of initial preventive physical examination include services furnished by a physician assistant, a nurse practitioner, or a clinical nurse specialist. We refer to these professionals as “qualified nonphysician practitioners.” </P>
                    <P>Based on the language of the statute, our review of the medical literature, current clinical practice guidelines, and United States Preventive Services Task Force recommendations, we proposed (under proposed new § 410.16(a), Definitions) to interpret the term “initial preventive physical examination” for purposes of this new benefit to include all of the following services furnished by a doctor of medicine or osteopathy or a qualified nonphysician practitioner: </P>
                    <P>(1) Review of the beneficiary's comprehensive medical and social history. We proposed to define “medical history” to include, as a minimum, past medical and surgical history, including experience with illnesses, hospital stays, operations, allergies, injuries, and treatments; current medications and supplements, including calcium and vitamins; and family history, including a review of medical events in the patient's family, including diseases that may be hereditary or place the individual at risk. We proposed to define “social history” to include, at a minimum, history of alcohol, tobacco, and illicit drug use; work and travel history; diet; social activities; and physical activities. </P>
                    <P>(2) Review of the beneficiary's potential (risk factors) for depression (including past experiences with depression or other mood disorders) based on the use of an appropriate screening instrument that the physician or qualified nonphysician practitioner may select from various available standardized screening tests for this purpose, unless the appropriate screening instrument is defined through the national coverage determination (NCD) process. </P>
                    <P>(3) Review of the beneficiary's functional ability and level of safety (that is, at a minimum, a review of the following areas: Hearing impairment, activities of daily living, falls risk, and home safety), based on the use of an appropriate screening instrument, which the physician or qualified nonphysician practitioner may select from various available standardized screening tests for this purpose, unless the appropriate screening instrument is further defined through the NCD process. </P>
                    <P>(4) An examination to include measurement of the beneficiary's height, weight, blood pressure, a visual acuity screen, and other factors as deemed appropriate, based on the beneficiary's comprehensive medical and social history and current clinical standards. </P>
                    <P>(5) Performance of an electrocardiogram and interpretation. </P>
                    <P>(6) Education, counseling, and referral, as deemed appropriate, based on the results of elements (1) through (5) of the definition of the initial preventive physical examination. </P>
                    <P>(7) Education, counseling, and referral, including a written plan for obtaining the appropriate screening and other preventive services, which are also covered as separate Medicare Part B benefits; that is, pnuemococcal, influenza, and hepatitis B vaccines and their administration, screening mammography, screening pap smear and screening pelvic exams, prostate cancer screening tests, diabetes outpatient self-management training services, bone mass measurements, screening for glaucoma, medical nutrition therapy services, cardiovascular screening blood tests, and diabetes screening tests. </P>
                    <P>
                        As we indicated in the OPPS proposed rule, we are addressing the public comments that we received on our proposal to revise our regulations to include specific coverage of initial preventive physical examinations under Medicare Part B and finalizing our coverage policy for initial preventive physical examinations in the final rule for the CY 2005 Medicare Physician Fee 
                        <PRTPAGE P="65728"/>
                        Schedule published elsewhere in this issue. 
                    </P>
                    <HD SOURCE="HD3">c. Assignment of New HCPCS Codes for Payment of Initial Preventive Physical Examinations </HD>
                    <P>There was no CPT code that contained the specific elements included in the initial preventive physical examination. Therefore, in the August 16, 2004 proposed rule, we proposed to establish a new HCPCS code to be used to bill for the new service under both the Medicare Physician Fee Schedule and the OPPS. We proposed a code, GXXXX, for the full service, including an EKG, but not including the other previously mentioned preventive services that are currently separately covered and paid under the Medicare Part B screening benefits. When these other preventive services are performed, they should be billed using the existing appropriate HCPCS and CPT codes. </P>
                    <P>For payment under the Medicare Physician Fee Schedule, relative value units were proposed for the new HCPCS code for the initial preventive physical based on equivalent resources and work intensity to those contained in CPT evaluation and management code 99203 (New patient, office or other outpatient visit) and CPT 93000 (Electrocardiogram, complete) (69 FR 47487, August 5, 2004). The “technical component” of the Medicare Physician Fee Schedule (the costs other than those allocated for the physician's professional services and professional liability insurance which are billed and paid for separately, when appropriate) is the portion of the fee schedule payment that is most comparable to what Medicare pays under the OPPS. The estimated “technical component” of the Medicare Physician Fee Schedule payment for GXXXX was between $50 and $100. </P>
                    <HD SOURCE="HD3">d. APC Assignment of Initial Preventive Physical Examination </HD>
                    <P>Given our lack of cost data to guide assignment of the new code to a clinically appropriate APC, in our proposed rule, we proposed assignment of the new code GXXXX (Initial preventive physical examination) to New Technology APC 1539 (New Technology, Level II) with a payment level between $50 and $100. We believed that the proposed temporary assignment to a new technology APC would allow us to pay for the new benefit provided in the OPD while we accrued claims data and experience on which to base a clinically relevant APC assignment in the future. </P>
                    <P>We received a number of public comments regarding the proposed payment for the initial preventive physical examination and its proposed APC placement. </P>
                    <P>
                        <E T="03">Comment:</E>
                         A number of commenters highlighted billing and operational concerns with the definition of a single HCPCS code, GXXXX, for the initial preventive physical examination. The commenters explained that, in hospitals where the EKG was performed in a separate department from the location of the physical examination, the technician charging for the service would have no way of distinguishing an EKG related to the initial preventive physical examination from other EKG tracings performed for diagnostic purposes, for which the hospital would bill for that specific service. The commenters noted that physicians often send their patients to hospitals for the EKG tracing, and if hospitals performed the EKG associated with the initial preventive physical examination in this context, they would have no way to bill for the EKG. The commenters presented various alternative coding possibilities for our consideration to address these situations. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         Section 611 of Pub. L. 108-173 does require a screening EKG to be performed as part of the initial preventive physical examination visit. In view of the different circumstances that may occur when performing the full initial preventive physical examination, we are establishing four new G codes for the initial preventative physical examination for CY 2005. 
                    </P>
                    <P>• G0344: Initial preventive physical examination; face-to-face visit, services limited to new beneficiary during the first 6 months of Medicare Part B enrollment. This code is assigned a status indicator “V” for the OPPS. </P>
                    <P>• G0366: Electrocardiogram, routine EKG with at least 12 leads; performed as a component of the initial preventive physical examination with interpretation and report. This code is assigned a status indicator “B” for the OPPS. </P>
                    <P>• G0367: Electrocardiogram, tracing only, without interpretation and report, performed as a component of the initial preventive physical examination. This code is assigned status indicator “S” for the OPPS. </P>
                    <P>• G0368: Electrocardiogram, interpretation and report only, performed as a component of the initial preventive physical examination. This code is assigned status indicator “A” for the OPPS. </P>
                    <P>In the hospital, performance of the complete initial preventive physical examination service would be coded using both the G0344 and G0367 codes. As required by the statute, the new codes describe the visit and the EKG, but not the other previously mentioned preventive services that are currently separately covered and paid under the Medicare Part B screening benefits. When these other preventive services are performed, they should be billed using the existing appropriate HCPCS and CPT codes. </P>
                    <P>To comply with Pub. L. 108-173, the initial preventive physical examination must include the EKG, regardless of whether a diagnostic EKG had previously been performed. Both components of the initial preventive physical examination, the examination and the EKG, must be performed to fulfill the statutory benefit for either of the components to be paid. Billing instructions for providers will be issued. </P>
                    <P>In addition to our decision to create two codes for hospitals to report for performance of the initial preventive physical examination service, we are assigning the codes to appropriate APCs as follows: G0344 is assigned to APC 0601 (Mid Level Clinic Visits), and G0367 is assigned to APC 0099 (Electrocardiograms). These APC assignments result in a total payment of approximately $78, slightly more than the $75 payment rate proposed for the comprehensive initial preventive physical examination service in the proposed rule. </P>
                    <P>
                        <E T="03">Comment:</E>
                         A few commenters requested that CMS increase the payment for the initial preventive physical examination benefit and stated that the payment rate set is too low to cover the required clinical resources. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         As stated in our proposed rule, the payment rate for the comprehensive initial preventive physical examination service under the OPPS was based on the rate proposed under the Medicare Physician Fee Schedule, which utilized estimates of necessary resources for the initial preventive physical examination benchmarked against the resources required to deliver existing evaluation and management and electrocardiogram services in the physician office. Based on comments concerning the adequacy of our proposed payment for the comprehensive initial preventive physical examination service and our decision to separate the examination service from the EKG for coding and payment purposes, we explicitly compared the resources we anticipated for the examination service delivered in the hospital to the OPPS median cost for the existing new office or other outpatient visit service which was used as a crosswalk. CPT code 99203 (Office 
                        <PRTPAGE P="65729"/>
                        or other outpatient visit for a new patient) is in APC 0601, which has a median cost of $57.66. The AMA/Specialty Society RVS Update Committee survey data for code 99203 showed 51 minutes of staff time, and we believe the initial preventive physical examination will reflect comparable time and consumption of hospital resources. As we expect the hospital resources utilized for code G0344 to be similar to those needed for clinic visits for which we have historical hospital cost data, we will place G0344 in APC 0601 rather than in a new technology APC as we proposed for the initial preventive physical examination comprehensive service. We expect the hospital resources utilized for the screening EKG tracing, code G0367, to be very similar to those necessary for a diagnostic EKG tracing, code 93005 and assigned to APC 0099. Together these APCs (0601 and 0099) will pay approximately $78, several more dollars than we proposed for the comprehensive service. We will monitor our claims data for the initial preventive physical examination services as hospitals gain experience delivering the services. We are finalizing our placement of code G0344 in APC 0601 for CY 2005 and code G0367 in APC 0099 for 2005. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         Several commenters asked that CMS provide explicit instructions and guidelines, respectively, to providers and beneficiaries regarding the details of what will be included in the new initial preventive physical examination benefit, the eligibility requirements, and how providers should bill Medicare for the new service. One commenter asked if the preventive physical examination will be subject to the evaluation and management guidelines. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We will release appropriate manual and transmittal instructions and information from the CMS educational components for the medical community, including a MedLearn Matters article and fact sheets such as the “2005 Payment Changes for Physicians and Other Providers: News From Medicare for 2005”. The medical community can join this effort in educating physicians and beneficiaries by their own communications, bulletins, or other publications. In addition, we have specifically included information on the new initial preventive physical examination benefit in the 2005 version of the 
                        <E T="03">Medicare and You Handbook</E>
                         and revised booklet, 
                        <E T="03">Medicare's Preventive Services</E>
                        . A new 2-page fact sheet on all of the new preventive services, including the initial preventive physical examination benefit, will be available this Fall, and a bilingual brochure for Hispanic beneficiaries will also be available in the near future. Information will be disseminated by CMS regional offices, State Health Insurance Assistance Programs (SHIPs), and various partners at the national, State, and local levels. Information on the new benefit will also be made available to the public through Web site, 
                        <E T="03">http://www.medicare.gov</E>
                        , the partner Web site to 
                        <E T="03">http://www.cms.hhs.gov</E>
                        , the toll free number 1-800-MEDICARE, numerous forums hosted by CMS, and conference exhibits and presentations. 
                    </P>
                    <P>The initial preventive physical examination will not be subject to each hospital's internal set of evaluation and management guidelines that hospitals were instructed to develop at the implementation of the OPPS in the August 7, 2000 final rule (65 FR 18451) because we have defined one explicit service, without levels. </P>
                    <P>
                        <E T="03">Comment:</E>
                         Several commenters asked how providers of initial preventive physical examination services will know if a particular beneficiary is eligible to receive the new benefit due to the statutory time and coverage frequency (one-time benefit) limitations. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         The statute provides for coverage of a one-time initial preventive physical examination that must be performed for new beneficiaries by qualified physicians or certain specified nonphysician practitioners within the first 6 month period following the effective date of the beneficiary's first Medicare Part B coverage. Because physicians or qualified nonphysician practitioners may not have the complete medical history for a particular new beneficiary, including information on possible use of the one-time benefit, these clinicians are largely relying on their own medical records and the information the beneficiary provides to them in establishing whether or not the initial preventive physical examination benefit is still available to a particular individual and has not been performed by another qualified practitioner. Because a second initial preventive physical examination will always fall outside the definition of the new Medicare benefit, an advance beneficiary notice (ABN) need not be issued in those instances where there is doubt regarding whether the beneficiary has previously received an initial preventive physical examination. The beneficiary will always be liable for a second initial preventive physical examination, no matter when it is conducted. However, for those instances where there is sufficient doubt as to whether the statutory 6-month period has lapsed, the physician or qualified nonphysician practitioner should issue an ABN to the beneficiary that indicates that Medicare may not cover and pay for the service. If the physician or qualified nonphysician practitioner does not issue an ABN to the beneficiary and Medicare denies payment for the service because the statutory time limitation for conducting the initial preventive physical examination has expired, the physician or qualified nonphysician practitioner may be held financially liable. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         One commenter recommended that CMS compare the requirements of the initial preventive physical examination to the contemplated requirements for similar but not-yet-disclosed facility-specific evaluation and management level definitions. The commenter wanted to ensure that the technical requirements are comparable between the new benefit and similar evaluation and management service definitions being contemplated by CMS. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We will take the commenter's recommendation into consideration in our ongoing work to develop new evaluation and management codes for the OPPS. 
                    </P>
                    <HD SOURCE="HD3">2. Payment for Certain Mammography Services (Section 614 of Pub. L. 108-173) </HD>
                    <P>Section 614 of Pub. L. 108-173 amended section 1833(t)(1)(B)(iv) of the Act to provide that screening mammography and diagnostic mammography services are excluded from payment under the OPPS. This amendment applies to screening mammography services furnished on or after December 8, 2003 (the date of the enactment of Pub. L. 108-173), and in the case of diagnostic mammography, to services furnished on or after January 1, 2005. As a result of this amendment, both screening mammography and diagnostic mammography will be paid under the Medicare Physician Fee Schedule. </P>
                    <P>In the August 16, 2004 proposed rule, we proposed to amend § 419.22 of the regulations by adding a new paragraph(s) to specify that both screening mammography and diagnostic mammography will be excluded from payment under the OPPS, in accordance with section 614 of Pub. L. 108-173. We received a few public comments on our proposal. </P>
                    <P>
                        <E T="03">Comment:</E>
                         A few commenters expressed support for the movement of payment for diagnostic mammograms from the OPPS to the Medicare Physician Fee Schedule. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We appreciate the commenters' support. Additional 
                        <PRTPAGE P="65730"/>
                        discussion of section 614 of Pub. L. 108-173 can be found in the final rule for the CY 2005 Medicare Physician Fee Schedule published elsewhere in this issue. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         A few commenters recommended that the payment rates for mammography be increased. The commenters stated that beneficiary access to mammography is being limited due to a growing number of radiologists who refuse to read mammograms due to low payment and high malpractice rates and recent closure of a large number of centers across the country. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We set the payment rates for diagnostic mammography based on hospital claims data, consistent with the payment methodology for OPPS services. In fact, in accordance with section 614 of Pub. L. 108-173, which requires that diagnostic mammography be paid now under the Medicare Physician Fee Schedule, payment is set using an entirely different process. This statutory change in the payment process results in a somewhat increased payment for mammography procedures from that under the OPPS. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         One commenter asked CMS to clarify that the increase in payment for diagnostic mammography furnished in the hospital outpatient department does not “come out of the [Medicare Physician Fee Schedule] budget.” 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         The increase in payment for diagnostic mammography furnished in the hospital outpatient department has no effect on payment for Medicare Physician Fee Schedule services. We are using the Medicare Physician Fee Schedule rate to set Medicare payment for diagnostic mammography furnished in the hospital outpatient department, as required by statute. Further, we are not including diagnostic mammography in our model for setting the relative weights under the OPPS. Thus, the increase in payment for diagnostic mammography furnished in the hospital outpatient department also has no effect on payment for any other OPPS services. 
                    </P>
                    <P>In this final rule, we are adopting, as final without modification, our proposed revision of § 419.22 to incorporate the provisions of section 614 of Pub. L. 108-173. </P>
                    <HD SOURCE="HD1">III. Recalibration of APC Relative Weights for CY 2005 </HD>
                    <HD SOURCE="HD2">A. Database Construction </HD>
                    <P>Section 1833(t)(9)(A) of the Act requires that the Secretary review and revise the relative payment weights for APCs at least annually, beginning in CY 2001 for application in CY 2002. In the April 7, 2000 OPPS final rule (65 FR 18482), we explained in detail how we calculated the relative payment weights that were implemented on August 1, 2000, for each APC group. Except for some reweighting due to APC changes, these relative weights continued to be in effect for CY 2001. This policy is discussed in the November 13, 2000 interim final rule (65 FR 67824 through 67827).) </P>
                    <P>In the August 16, 2004 OPPS proposed rule, we proposed to use the same basic methodology that we described in the April 7, 2000 final rule to recalibrate the relative APC weights for services furnished on or after January 1, 2005, and before January 1, 2006. That is, we proposed to recalibrate the weights based on claims and cost report data for outpatient services. We proposed to use the most recent available data to construct the database for calculating APC group weights. We provide a complete description of the data processes we proposed to use for the creation of the CY 2005 OPPS payment rates in the August 16, 2004 proposed rule (69 FR 50448). </P>
                    <P>For the purpose of recalibrating APC relative weights for CY 2005 displayed in this final rule with comment period, we used the most recent available claims data, which were the approximately 132 million final action claims for hospital OPD services furnished on or after January 1, 2003, and before January 1, 2004. Of the 132 million final action claims for services provided in hospital outpatient settings, 106 million claims were of the type of bill potentially appropriate for use in setting rates for OPPS services (but did not necessarily contain services payable under the OPPS). Of the 106 million claims, we were able to use 51 million whole claims (from which we created 84 million single procedure claim records) to set the final OPPS CY 2005 APC relative weights. We used claims from this period that had been processed before June 30, 2004, to calculate the APC weights and payments contained in Addenda A and B of this final rule with comment period. </P>
                    <P>We received one general public comment on our proposed OPPS database construction for CY 2005 discussed in the August 16, 2004 proposed rule. </P>
                    <P>
                        <E T="03">Comment:</E>
                         One commenter suggested that CMS use a nationally representative sample of hospitals from which cost data could be collected for purposes of setting relative weights. The commenter suggested that such a sample could be used to validate findings from the larger claims data set or to establish median costs that more accurately reflect the costs of providing device-related procedures and other outpatient services, or both. As an alternative, the commenter suggested conducting a demonstration project using a sample of hospitals that would receive small grants for set up and training to test the feasibility of collecting a valid reliable and manageable data set from which to develop payment rates. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We believe that the Medicare hospital outpatient claims and hospital cost reports are the best, nationally representative database of such information at present. Nevertheless, we acknowledge that an approach that would involve the collection of additional hospital data from a representative sample could have some merit. However, in addition to the resources that would be required for us to pursue such an approach, we also are concerned about the costs to hospitals associated with such an additional data collection effort. Nevertheless, we remain interested and invite additional suggestions from hospitals and other stakeholders on ways to enhance the data we now use to set relative weights for services paid under the OPPS. 
                    </P>
                    <HD SOURCE="HD3">1. Treatment of Multiple Procedure Claims </HD>
                    <P>For CY 2005, we proposed to continue to use single procedure claims to set the medians on which the weights would be based (69 FR 50474). As indicated in the August 16, 2004 proposed rule, we received many requests that we ensure that the data from claims that contain charges for multiple procedures were included in the data from which we calculate the CY 2005 relative payment weights (69 FR 50474). Requesters believe that relying solely on single procedure claims to recalibrate APC relative weights fails to take into account data for many frequently performed procedures, particularly those commonly performed in combination with other procedures. They believe that, by depending upon single procedure claims, we base relative payment weights on the least costly services, thereby introducing downward bias to the medians on which the weights are based. </P>
                    <P>
                        We agree that, optimally, it is desirable to use the data from as many claims as possible to recalibrate the relative payment weights, including those with multiple procedures. As discussed in the explanation of single procedure claims below, we have used the date of service on the claims and a list of codes to be bypassed to create “pseudo” single claims from multiple procedure claims. We refer to these newly created single procedure claims 
                        <PRTPAGE P="65731"/>
                        as “pseudo” singles because they were submitted by providers as multiple procedure claims. 
                    </P>
                    <HD SOURCE="HD3">2. Use of Single Procedure Claims </HD>
                    <P>We use single procedure claims to set the median costs for APCs because we are, so far, unable to ensure that packaged costs can be correctly allocated across multiple procedures performed on the same date of service. However, bypassing specified codes that we believe do not have significant packaged costs enables use of more data from multiple procedure claims. For CY 2003, we created “pseudo” single claims by bypassing HCPCS codes 93005 (Electrocardiogram, tracing), 71010 (Chest x-ray), and 71020 (Chest x-ray) on a submitted claim. However, we did not use claims data for the bypassed codes in the creation of the median costs for the APCs to which these three codes were assigned because the level of packaging that would have remained on the claim after we selected the bypass code was not apparent and, therefore, it was difficult to determine if the medians for these codes would be correct. </P>
                    <P>For CY 2004, we created “pseudo” single claims by bypassing these three codes and also by bypassing an additional 269 HCPCS codes in APCs. We selected these codes based on a clinical review of the services and because it was presumed that these codes had only very limited packaging and could appropriately be bypassed for the purpose of creating “pseudo” single claims. The APCs to which these codes were assigned were varied and included mammography, cardiac rehabilitation, and level I plain film x-rays. To derive more “pseudo” single claims, we also broke claims apart where there were dates of service for revenue code charges on that claim that could be matched to a single procedure code on the claim on the same date. </P>
                    <P>As in CY 2003, we did not include the claims data for the bypassed codes in the creation of the APCs to which the 269 codes were assigned because, again, we had not established that such an approach was appropriate and would aid in accurately estimating the median cost for that APC. For CY 2004, from about 16.3 million otherwise unusable claims, we used about 9.5 million multiple procedure claims to create about 27 million “pseudo” single claims. For the CY 2005 OPPS rates in this final rule with comment period, from about 24 million otherwise unusable claims, we used about 18 million multiple procedure claims to create about 52 million “pseudo” single claims. </P>
                    <P>For CY 2005, we proposed to continue using date of service matching as a tool for creation of “pseudo” single claims and take a more empirical approach to creating the list of codes that we would bypass to create “pseudo” single claims. The process we proposed for CY 2005 OPPS resulted in our being able to use some part of 89 percent of the total claims eligible for use in OPPS ratesetting and modeling in developing this final rule with comment period. In CY 2004, we used some part of the data from 82 percent of eligible claims. This process enabled us to use, for CY 2005, 84 million single bills for ratesetting: 52 million “pseudo” singles and 33 million “natural” single bills. </P>
                    <P>We proposed to bypass the 383 codes, which we published in Table 17 of the proposed rule (69 FR 50476 through 50486), to create new single claims and to use the line-item costs associated with the bypass codes on these claims in the creation of the median costs for the APCs into which they are assigned (69 FR 50474 through 50486). Of the codes on this list, only 123 (32 percent) were used for bypass in CY 2004. </P>
                    <P>We developed the proposed bypass list using four criteria: </P>
                    <P>a. We developed the following empirical standards by reviewing the frequency and magnitude of packaging in the single claims for payable codes other than drugs and biologicals. We proposed to use these standards to determine codes that could be bypassed to create “pseudo” single claims for median setting. (More explanation regarding the use of these standards is provided in our August 16, 2004 OPPS proposed rule (69 FR 50475).) </P>
                    <P>• There were 100 or more single claims for the code. </P>
                    <P>• Five percent or fewer of the single claims for the code had packaged costs on that single claim for the code. </P>
                    <P>• The median cost of packaging observed in the single claim was equal to or less than $50. </P>
                    <P>• The code is not a code for an unlisted service. </P>
                    <P>b. We examined APCs relying on a low volume of single claims, and it became apparent that several radiological supervision and interpretation codes were commonly billed with the procedural codes in the APCs. We then reviewed all radiological supervision and interpretation codes to assess their viability as bypass codes. For the codes included on the proposed list published in Table 17, we determined that, generally, the packaging on claims, including these radiological supervision and interpretation codes, should be associated with the procedure performed. </P>
                    <P>c. We examined radiation planning and related codes provided by a professional organization. In the organization's opinion, the codes could safely be bypassed and used without packaging to set medians for the APCs into which these codes are assigned. Many of the codes the organization recommended met our criteria under item a., and the remaining codes were close. Therefore, after reviewing such codes, we proposed to adopt as bypass codes all radiation planning and related codes as provided by the organization. </P>
                    <P>d. We included HCPCS codes 93005 and 71010. These codes have been bypassed for the past 3 years and generate a significant amount of new single claims because they are very commonly done on the same date of surgery. They have low median packaged costs and a low percentage of single claims with any packaged costs, 6 percent and 18 percent, respectively. </P>
                    <P>In the August 16, 2004 proposed rule, we invited public comment on the “pseudo” single process, including the bypass list and the criteria. We received a number of public comments on our proposals. </P>
                    <P>
                        <E T="03">Comment:</E>
                         Some commenters stated that CMS should provide an impact analysis by medical specialty and APC for the bypass list. Commenters indicated that 26 radiation oncology codes, which represent over 40 percent of the radiation oncology codes, are on the proposed list and that it is not clear what impact the inclusion of these codes will have on payment for radiation oncology procedures. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         The OPPS pays hospitals for the hospital services they furnish and, therefore, we focus our impact analysis on the providers who provide services and to whom the payment is made. It is impractical to do an impact analysis by hospital category, much less medical specialty and APC, for each and every step of the process we use to establish medians on which we base our payment rates. 
                    </P>
                    <P>
                        However, to facilitate the public's ability to do specialized detailed analyses beyond what is practical for us to do, we make available the claims we use to set median costs. Specifically, the claims we used to set the payment rates for CY 2004 OPPS and CY 2005 OPPS are available to the public for public use in extended and focused analysis at any level of interest. Moreover, exhaustive discussion of our process is contained in both the CY 2004 and CY 2005 OPPS final rule with comment period claims accounting documents that are available on 
                        <E T="03">
                            www.cms.hhs.gov/providers/
                            <PRTPAGE P="65732"/>
                            hopps.asp,
                        </E>
                         to facilitate the use of such claims for further analysis. Therefore, we provide to the public the data needed for a focused exhaustive analysis of impact by medical specialty or on any basis on which any party with a special interest has a particular concern. 
                    </P>
                    <P>The 383 bypass codes presented in Table 17 of the proposed rule represent the result of an empirical and clinical analysis that identified HCPCS codes for which we could not observe significant packaged costs in the CY 2003 claims data and for which there was no clinical reason that a procedure or service should have significant packaged costs. These criteria are detailed in the proposed rule and were carefully chosen to avoid the inaccurate redistribution of packaged costs (69 FR 50474 through 50475). Inclusion of a HCPCS code on the bypass list is not predicated on the median impact, but rather empirical evidence or clinical arguments that these procedures do not contain significant packaged costs that would call into question their appropriateness for inclusion on the bypass list. </P>
                    <P>
                        <E T="03">Comment:</E>
                         Most commenters supported the use of a bypass list and date of service matching as a way to use more data from multiple claims. One commenter was concerned that the bypass list may inappropriately break multiple claims into single procedure claims by assuming that the amount and frequency of packaging on procedures found on single bills was the same as would exist on multiple procedure claims. The commenter stated that claims involving multiple APCs are by their nature the most complex combinations of services requiring many more resources than if they were performed singly and that, therefore, CMS may be incorrect to generalize that the packaging found on single bills would also be present for the same procedure done as a multiple procedure. Another commenter opposed the use of the bypass list, citing it as a “bandaid” and as not a satisfactory way to deal with the presence of multiple procedure claims over the long run. The commenter indicated that, given the OPPS experience gained over the past years, CMS should be able to perform a study of multiple procedure claims that provides a mechanism for using them. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We have retained and used the proposed bypass methodology in creating the median costs used to set the CY 2005 OPPS relative payment weights in this final rule with comment period. We believe that the use of the bypass list gives us considerably more single claims for ratesetting than had we not used it and that it is a valid representation of codes for which there is seldom any packaging and for which the packaging that exist, is minimal. Given the inability of any concrete processes that provide a way to attribute packaging on multiple bill claims, we believe that the best and only alternative available is for us to use the packaging on single bill claims to determine whether a code can be safely bypassed in the creation of “pseudo single” claims for median setting. We continue to examine the means by which we could use all multiple procedure claims and to invite additional recommendations from the public on how we might do so. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         One commenter strongly objected to any method of using multiple procedure claims that would rely in any way on payment weights because the commenter believed that any such method would compound problems in the data by carrying them forward into future years. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We expect to examine a number of different ways of using the data from multiple procedure claims and will evaluate each carefully before we discard any particular process. As we have in the past for updating the OPPS, if we decide to pursue any particular process change, we will discuss our findings and any proposed changes to the OPPS median development process in the proposed rule and consider public comments on the proposal before we change the process. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         Some commenters indicated that the use of single procedure claims means that the most typical correctly coded claims are not used for many services. They added that many of the procedures that implant a device are actually replacing an existing device, which means that the removal of the device is billed with one code while the implant is billed with another code on the same claim on the same date of service, thereby creating a multiple procedure claim that will become two “pseudo” single claims under the CMS process. The commenters also stated that services that are provided only in addition to other services, such as noncoronary intravascular ultrasound, can never be correctly coded as a single procedure claim. They contended that such correctly coded claims will be multiple major procedure claims and thus will not be used for median cost setting. The commenters stated that the nature of some services being routinely performed in combination with other services means that, under the current CMS methodology, only small percentages of the claims will be used to set the medians and that those claims are likely to be the incorrectly coded claims. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We recognize that there are categories of service that are typically done in combination with other services at such frequency that acquiring valid single procedure claims is very difficult, if not impossible. We are planning to explore these services for which the medians are set based on a small percentage of the claims that are submitted with the APC Panel in the future to determine what methods may be available to deal effectively with these situations. 
                    </P>
                    <P>In the August 16, 2004 proposed rule, we also discussed suggestions that we had received for creating “pseudo” single claims, which included recommendations that the costs in packaged revenue codes and packaged HCPCS codes be allocated separately to paid HCPCS codes based on the prior year's payment weights or payment rates for the single procedures. Still other suggestions recommended that we allocate the packaged costs in proportion to the charges or to the costs for the major procedures based on the current year's claims. We are concerned that using a prior year's median costs, relative weights or payment rates as the basis to allocate current year's packaged costs to current year costs for payable HCPCS codes may not be appropriate. For example, if two procedures are performed and one uses an expensive device, this methodology would split the costs of the device between the service that uses the device and a service that does not use the device, thus resulting in an incorrect allocation of the packaged costs. For this reason, we did not propose to incorporate these suggestions in our ratesetting methodology. However, we stated in our proposed rule that we intended to examine them more thoroughly. </P>
                    <P>We did not propose a methodology beyond use of dates of service and the expanded bypass list. However, we solicited specific proposals that would be provided as comments on how multiple procedure claims can be better used in calculating the relative payment weights. </P>
                    <P>
                        <E T="03">Comment:</E>
                         One commenter asked that CMS clarify whether the “pseudo” single claims data for CPT codes 93307 (Echo exam of heart), 93303 (Echo transthoracic), and 93320 (Doppler echo exam, heart) were used in setting APC relative weights and, if so, the impact of this proposal. Another commenter asked that CMS clarify whether HCPCS codes for drugs, radiopharmaceuticals, and blood products were bypassed to create “pseudo” singles. The commenter 
                        <PRTPAGE P="65733"/>
                        believed that packaged costs are never associated with these items; therefore, they should always be bypassed. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         The claims data for the three referenced CPT codes were used in setting the APC relative weights for these services. They were included in the list of bypass codes because they met the criteria for inclusion, which focused on selecting only claims that often did not include packaged services and for which packaging on the single bills was very modest. 
                    </P>
                    <P>We agree with the commenter that drugs, radiopharmaceuticals, and blood products would rarely be expected to have associated packaged costs. Presence of codes for these items on a claim does not result in a multiple claim, as we do not consider the items to be major procedures. </P>
                    <P>
                        <E T="03">Comment:</E>
                         One commenter asked that CMS add CPT codes 76362 (Computed tomography guidance for, and monitoring of, visceral tissue ablation), 76394 (Magnetic resonance guidance for, and monitoring of, visceral tissue ablation), and 76940 (Us guide, tissue ablation) to the bypass list because they are often billed with CPT code 47382 (Radiofrequency ablation procedures of the liver) and CPT code 20982 (Radiofrequency ablation procedures of the bone). The commenter believed that this approach would create more single claims for those codes. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         The three CPT codes that the commenter requested we add to the bypass list did not have sufficient claims volume at the time the bypass list was created to meet the criteria for inclusion. When we next review the bypass list, we will examine these codes for inclusion on any future bypass list. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         One commenter objected to use of data-based criteria as the only determinant of whether services are included on the bypass list. Specifically, the commenter objected to the inclusion of CPT evaluation and management codes 99213 and 99214 on the bypass list even though CPT codes 99211, 99212, and 99215 are not included on the list. The commenter believed that CMS should not assume that these codes do not typically have packaged costs associated with them because less than 5 percent of the claims with the code appeared on a claim with packaged charges. The commenter believed that all codes that “meet the 5 percent data test” should be qualitatively reviewed to determine whether clinical practice and charging methods support the assertion that packaged dollars are not related to the service proposed for the bypass list. The commenter also recommended that CMS include on the bypass list “add-on” CPT codes that have a status indicator of “N” so that the remaining packaged services on the claim would be packaged to the main procedure if that were the only other APC reported on the claim. The commenter recommended that “add-on” CPT codes with APC payment should be accepted as bypass codes if the only other CPT code on the claim is the main procedure. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         The commenter is incorrect in believing that the only criterion used to determine if a code were suitable for inclusion on the bypass list was whether 5 percent of the claims for the code appeared with packaged charges. As we discussed above, there were a number of criteria that had to be met which were focused on ensuring that packaging did not occur often or in significant amounts when it did occur. We reviewed the clinical appropriateness of the codes that were derived from applying the criteria, and did not remove any as a result of the review. Given the large volume of evaluation and management services, we believe that the evaluation and management codes we included on the bypass list were appropriate for inclusion. As we discussed with regard to the radiological supervision and evaluation codes and the simple EKG and chest x-ray codes, clinical practice and charging methods were also factors in determining inclusion on the bypass list. 
                    </P>
                    <P>With respect to the add-on codes, those that have a status indicator of “N” would not cause a claim to be a multiple procedure claim (because they are not separately paid). Thus it would not be useful to add them to the bypass list (which is intended to break multiple procedure claims into two single claims). Those add-on codes that are paid separately may or may not have packaging associated with them. Thus, it would be incorrect to assume that all packaging on the claim would be associated with the core procedure to which the add-on code is an appendage. For example, insertion of a left ventricular pacing lead as an add-on procedure to the insertion of a cardioverter-defibrillator carries considerable packaged costs with the add-on service, such as the device, significant additional operating room time, and extra drugs and medical supplies, and, therefore, it would not be suitable for inclusion on the bypass list. </P>
                    <P>After carefully reviewing all public comments received, we are adopting as final the bypass codes listed in Table 16 below. </P>
                    <BILCOD>BILLING CODE 4120-01-P</BILCOD>
                    <GPH SPAN="3" DEEP="622">
                        <PRTPAGE P="65734"/>
                        <GID>ER15NO04.015</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="492">
                        <PRTPAGE P="65735"/>
                        <GID>ER15NO04.016</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="492">
                        <PRTPAGE P="65736"/>
                        <GID>ER15NO04.017</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="491">
                        <PRTPAGE P="65737"/>
                        <GID>ER15NO04.018</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="491">
                        <PRTPAGE P="65738"/>
                        <GID>ER15NO04.019</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="492">
                        <PRTPAGE P="65739"/>
                        <GID>ER15NO04.020</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="490">
                        <PRTPAGE P="65740"/>
                        <GID>ER15NO04.021</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="490">
                        <PRTPAGE P="65741"/>
                        <GID>ER15NO04.022</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="490">
                        <PRTPAGE P="65742"/>
                        <GID>ER15NO04.023</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="433">
                        <PRTPAGE P="65743"/>
                        <GID>ER15NO04.024</GID>
                    </GPH>
                    <BILCOD>BILLING CODE 4120-01-C</BILCOD>
                    <HD SOURCE="HD2">B. Calculation of Median Costs for CY 2005 </HD>
                    <P>
                        In this section of the preamble, we discuss the use of claims to calculate the OPPS payment rates for CY 2005. (The hospital outpatient prospective payment page on the CMS Web site on which this final rule with comment period is posted provides an accounting of claims used in the development of the final rates: 
                        <E T="03">http://www.cms.hhs.gov/hopps.)</E>
                         The accounting of claims used in the development of the final rule with comment period is included under supplemental materials for this final rule with comment period. That accounting provides additional detail regarding the number of claims derived at each stage of the process. In addition, we note that below we discuss the files of claims that comprise the data sets that are available for purchase under a CMS data user contract. Our CMS Web site, 
                        <E T="03">http://www.cms.hhs.gov/providers/hopps</E>
                         includes information about purchasing the following two OPPS data files: “OPPS limited data set” and “OPPS identifiable data set.” 
                    </P>
                    <P>In this final rule with comment period, we are using the same methodology as proposed in the August 16, 2004 proposed rule to establish the relative weights that we used in calculating the OPPS payment rates for CY 2005 shown in Addenda A and B to this final rule with comment period. This methodology is as follows: </P>
                    <P>We used outpatient claims for full CY 2003 to set the relative weights for CY 2005. To begin the calculation of the relative weights for CY 2005, we pulled all claims for outpatient services furnished in CY 2003 from the national claims history file. This is not the population of claims paid under the OPPS, but all outpatient claims (for example, critical access hospital (CAH) claims, and hospital claims for clinical laboratory services for persons who are neither inpatients nor outpatients of the hospital). </P>
                    <P>We then excluded claims with condition codes 04, 20, 21, and 77. These are claims that providers submitted to Medicare knowing that no payment will be made. For example, providers submit claims with a condition code 21 to elicit an official denial notice from Medicare and document that a service is not covered. We then excluded claims for services furnished in Maryland, Guam, and the U.S. Virgin Islands because hospitals in those geographic areas are not paid under the OPPS. </P>
                    <P>
                        We divided the remaining claims into the three groups shown below. Groups 
                        <PRTPAGE P="65744"/>
                        2 and 3 comprise the 106 million claims that contain hospital bill types paid under the OPPS. 
                    </P>
                    <P>1. Claims that were not bill types 12X, 13X, 14X (hospital bill types), or 76X (CMHC bill types). Other bill types, such as ASCs, bill type 83, are not paid under the OPPS and, therefore, these claims were not used to set OPPS payment. </P>
                    <P>2. Bill types 12X, 13X, or 14X (hospital bill types). These claims are hospital outpatient claims. </P>
                    <P>3. Bill type 76X (CMHC). (These claims are later combined with any claims in item 2 above with a condition code 41 to set the per diem partial hospitalization rate determined through a separate process.) </P>
                    <P>In previous years, we have begun the CCR calculation process using the most recent available cost reports for all hospitals, irrespective of whether any or all of the hospitals included actually filed hospital outpatient claims for the data period. However, in developing the proposed rule and this final rule with comment period, we first limited the population of cost reports to only those for hospitals that filed outpatient claims in CY 2003 before determining whether the CCRs for such hospitals were valid. This initial limitation changed the distribution of CCRs used during the trimming process discussed below. </P>
                    <P>We then calculated the CCRs at a departmental level and overall for each hospital for which we had claims data. We did this using hospital specific data from the Hospital Cost Report Information System (HCRIS). As indicated in the proposed rule, we used the same CCRs as those used in calculating the relative weights that we used in developing the proposed rule. We did not recalculate CCRs to reflect updated cost report data. </P>
                    <P>We then flagged CAHs, which are not paid under the OPPS, and hospitals with invalid CCRs. These included claims from hospitals without a CCR; those from hospitals paid an all-inclusive rate; those from hospitals with obviously erroneous CCRs (greater than 90 or less than .0001); and those from hospitals with CCRs that were identified as outliers (3 standard deviations from the geometric mean after removing error CCRs). In addition, we trimmed the CCRs at the departmental level by removing the CCRs for each cost center as outliers if they exceeded +/−3 standard deviations of the geometric mean. In prior years, we did not trim CCRs at the departmental level. However, for CY 2005, as proposed, we trimmed at the departmental CCR level to eliminate aberrant CCRs that, if found in high volume hospitals, could skew the medians. We used a four-tiered hierarchy of cost center CCRs to match a cost center to a revenue code with the top tier being the most common cost center and the last tier being the default CCR. If a hospital's departmental CCR was deleted by trimming, we set the departmental CCR for that cost center to “missing,” so that another departmental CCR in the revenue center hierarchy could apply. If no other departmental CCR could apply to the revenue code on the claim, we used the hospital's overall CCR for the revenue code in question. </P>
                    <P>We then converted the charges on the claim by applying the CCR that we believed was best suited to the revenue code indicated on the line with the charge. (We discussed in greater detail the allowed revenue codes in the proposed rule (69 FR 50487).) If a hospital did not have a CCR that was appropriate to the revenue code reported for a line-item charge (for example, a visit reported under the clinic revenue code but the hospital did not have a clinic cost center), we applied the hospital-specific overall CCR, except as discussed in section V.H. of this final rule with comment period, for calculation of costs for blood. </P>
                    <P>Thus, we applied CCRs as described above to claims with bill types 12X, 13X, or 14X, excluding all claims from CAHs and hospitals in Maryland, Guam, or the U.S. Virgin Islands, and flagged hospitals with invalid CCRs. We excluded claims from all hospitals for which CCRs were flagged as invalid. </P>
                    <P>We identified claims with condition code 41 as partial hospitalization services of CMHCs and removed them to another file. These claims were combined with the 76X claims identified previously to calculate the partial hospitalization per diem rate. </P>
                    <P>We then excluded claims without a HCPCS code. We also removed claims for observation services to another file. We removed to another file claims that contained nothing but flu and pneumococcal pneumonia (“PPV”) vaccine. Influenza and PPV vaccines are paid at reasonable cost and, therefore, these claims are not used to set OPPS rates. We note that the two above mentioned separate files containing partial hospitalization claims and the observation services claims are included in the files that are available for purchase as discussed above. </P>
                    <P>We next copied line-item costs for drugs, blood, and devices (the lines stay on the claim but are copied off onto another file) to a separate file. No claims were deleted when we copied these lines onto another file. These line-items are used to calculate the per unit median for drugs, radiopharmaceuticals, and blood and blood products. The line-item costs were also used to calculate the per administration cost of drugs, radiopharmaceuticals, and biologicals (other than blood and blood products) for purposes of determining whether the cost of the item would be packaged or paid separately. Section 1833(t)(16)(B) of the Act, as added by section 621(a)(2) of Pub. L. 108-173, requires the Secretary to lower to $50 the threshold for separate payment of drugs and biologicals and the per administration cost derived using these line-item cost data would be used to make that decision for CY 2005. As discussed in the November 7, 2003 OPPS final rule with comment period (68 FR 63398), we had also applied a $50 threshold to these items for the CY 2004 update to the OPPS. </P>
                    <P>We then divided the remaining claims into five groups. </P>
                    <P>
                        1. 
                        <E T="03">Single Major Claims:</E>
                         Claims with a single separately payable procedure, all of which would be used in median setting. 
                    </P>
                    <P>
                        2. 
                        <E T="03">Multiple Major Claims:</E>
                         Claims with more than one separately payable procedure or multiple units for one payable procedure. As discussed below, some of these can be used in median setting. 
                    </P>
                    <P>
                        3. 
                        <E T="03">Single Minor Claims:</E>
                         Claims with a single HCPCS code that is not separately payable. These claims may have a single packaged procedure or a drug code. 
                    </P>
                    <P>
                        4. 
                        <E T="03">Multiple Minor Claims:</E>
                         Claims with multiple HCPCS codes that are not separately payable without examining dates of service. (For example, pathology codes are packaged unless they appear on a single bill by themselves.) The multiple minor file has claims with multiple occurrences of pathology codes, with packaged costs that cannot be appropriately allocated across the multiple pathology codes. However, by matching dates of service for the code and the reported costs through the “pseudo” single creation process discussed earlier, a claim with multiple pathology codes may become several “pseudo” single claims with a unique pathology code and its associated costs on each day. These “pseudo” singles for the pathology codes would then be considered a separately payable code and would be used like claims in the single major claim file. 
                    </P>
                    <P>
                        5. 
                        <E T="03">Non-OPPS Claims:</E>
                         Claims that contain no services payable under the OPPS are excluded from the files used for the OPPS. Non-OPPS claims have codes paid under other fee schedules, for example, durable medical equipment or clinical laboratory. 
                        <PRTPAGE P="65745"/>
                    </P>
                    <P>We note that the claims listed in numbers 1, 2, and 4 above are included in the data files that can be purchased as described above. </P>
                    <P>We set aside the single minor claims and the non-OPPS claims (numbers 3 and 5 above) because we did not use either in calculating median cost. </P>
                    <P>We then examined the multiple major and multiple minor claims (numbers 2 and 4 above) to determine if we could convert any of them to single major claims using the process described previously. We first grouped items on the claims by date of service. If each major procedure on the claim had a different date of service and if the line-items for packaged HCPCS and packaged revenue codes had dates of service, we broke the claim into multiple “pseudo” single claims based on the date of service. </P>
                    <P>After those single claims were created, we used the list of “bypass codes” in Table 16 of this final rule with comment period to remove separately payable procedures that we determined contain limited costs or no packaged costs from a multiple procedure bill. A discussion of the creation of the list of bypass codes used for the creation of “pseudo” single claims is contained in section III.A.2. of this preamble. </P>
                    <P>When one of the two separately payable procedures on a multiple procedure claim were on the bypass code list, the claim was split into two single procedure claims records. The single procedure claim record that contained the bypass code did not retain packaged services. The single procedure claim record that contained the other separately payable procedure retained the packaged revenue code charges and the packaged HCPCS charges. </P>
                    <P>We excluded those claims that we were not able to convert to singles even after applying both of the techniques for creation of “pseudo” singles. We then packaged the costs of packaged HCPCS (codes with status indicator “N” listed in Addendum B to this final rule with comment period) and packaged revenue codes into the cost of the single major procedure remaining on the claim. The list of packaged revenue codes is shown in Table 17 below. </P>
                    <P>After removing claims for hospitals with error CCRs, claims without HCPCS codes, claims for immunizations not covered under the OPPS, and claims for services not paid under the OPPS, 56 million claims were left. This subset of claims is roughly one-half of the 106 million claims for bill types paid under the OPPS. Of these 56 million claims, we were able to use some portion of 52 million (91 percent) whole claims to create the 84 million single and “pseudo” single claims for use in the CY 2005 median payment ratesetting. </P>
                    <P>We also excluded claims that either had zero costs after summing all costs on the claim or for which CMS lacked an appropriate provider wage index. For the remaining claims, we then wage adjusted 60 percent of the cost of the claim (which we determined to be the labor-related portion), as has been our policy since initial implementation of the OPPS, to adjust for geographic variation in labor-related costs. We made this adjustment by determining the wage index that applied to the hospital that furnished the service and dividing the cost for the separately paid HCPCS code furnished by the hospital by that wage index. As proposed, we used the final pre-reclassified wage indices for IPPS and any subsequent corrections. We used the pre-reclassified wage indices for standardization because we believe that they better reflect the true costs of items and services in the area in which the hospital is located than the post-reclassification wage indices, and would result in the most accurate adjusted median costs. </P>
                    <P>We then excluded claims that were outside 3 standard deviations from the geometric mean cost for each HCPCS code. We used the remaining claims to calculate median costs for each separately payable HCPCS code; first, to determine the applicability of the “2 times” rule, and second, to determine APC medians as based on the claims containing the HCPCS codes assigned to each APC. As stated previously, section 1833(t)(2) of the Act provides that, subject to certain exceptions, the items and services within an APC group cannot be considered comparable with respect to the use of resources if the highest median (or mean cost, if elected by the Secretary) for an item or service in the group is more than 2 times greater than the lowest median cost for an item or service within the same group (“the 2 times rule”). Finally, we reviewed the medians and reassigned HCPCS codes to different APCs as deemed appropriate. Section III.B. of this preamble includes a discussion of the HCPCS code assignment changes that resulted from examination of the medians and for other reasons. The APC medians were recalculated after we reassigned the affected HCPCS codes. </P>
                    <P>A detailed discussion of the medians for blood and blood products is provided at section V.I. of this preamble. We provide a discussion of the medians for APC 0315 (Level II Implantation of Neurostimulator), and APC 0651 (Complex Interstitial Radiation Application), at sections III.C.2.a. and III.C.2.b., respectively, of this preamble. </P>
                    <P>A discussion of the medians for APCs that require one or more devices when the service is performed is provided at section III.C. of this preamble. A discussion of the median for observation services is provided at section VII.D. of this preamble and a discussion of the median for partial hospitalization is provided at section X.C. of this preamble. </P>
                    <P>We received a number of public comments concerning our proposed data processes for calculating the CY 2005 OPPS relative weights and median costs. </P>
                    <P>
                        <E T="03">Comment:</E>
                         Some commenters requested that CMS provide specialty-specific and APC-specific impact tables that provide additional information and analysis of its proposal to trim CCRs on a departmental basis. The commenters stated that CMS should justify why it trimmed departmental CCRs at ±3 standard deviations from the geometric mean and explain the impact of the change. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We chose to trim at ±3 standard deviations from the geometric mean because cost and charge data are traditionally log normal distributed and because the 3 standard deviations threshold is standard policy for identifying outliers in CMS' payment systems. We do not believe that an impact analysis for the departmental-level CCR trim is necessary because the overall number of cost-centers trimmed were minimal relative to the number of hospitals and because this trim only removed extreme department CCRs, both low and high. We fully expect that, had we chosen not to trim at the department-level, extreme cost estimates would have been removed during our trim at the HCPCS-level performed later in the data development process. 
                    </P>
                    <P>For example, we trimmed the most department CCRs, 68, from cost center 5500, Medical Supplies Charged to Patients. The low CCRs that were trimmed ranged from 0.00008 to 0.0281. The high CCRs that were trimmed ranged from 0.39530 to 6069.17. Even after the department-level trim, only 7 percent of the hospitals in our data set defaulted to the overall CCR for services mapped to this cost center. </P>
                    <P>
                        <E T="03">Comment:</E>
                         One commenter stated that the CCRs fell between 1996 and 2002 because charges were increasing faster than costs and that this change resulted in a significant payment decrease for hospitals for which we used the default CCR. The commenter urged CMS to instruct fiscal intermediaries to work with these hospitals in determining 
                        <PRTPAGE P="65746"/>
                        CCRs that will provide accurate cost estimates.
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         The commenter misunderstood the source of the CCRs used to adjust hospital costs to charges for OPPS median setting. We do not use the CCRs that fiscal intermediaries calculate for purposes of outlier payments, and cost reimbursement. Instead, we use hospital specific data from the health care cost reporting information system and independently calculate CCRs for each standard and nonstandard cost center in which the costs of outpatient services are to be found as well as an overall CCRs for the costs of outpatient care. Hence, intermediaries have no role in the calculation of the CCRs used to reduce charges to approximate costs for OPPS median cost setting. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         One commenter asked that CMS justify why did it not use cost-to-charge data from all hospitals for CY 2005 OPPS calculations when, in the past, CMS used cost report data from all hospitals without regard to whether the hospital had filed data during a specified period. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         In the past, we first calculated CCRs for all providers, trimmed the overall hospital CCRs, and then compared the providers for which we had valid CCRs to the providers for which we had claims data. For CY 2005 OPPS, we first determined the providers for which we had claims data and we then calculated the CCRs for those hospitals so that the trimming would occur only across the hospitals for which we had claims data because a CCR is of value only if there are claims to which to apply it. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         One commenter urged CMS to greatly expand the outpatient code editor (OCE) edits to return to providers claims that fail edits that are appropriate to the type of service being billed. The commenter cited as examples, the creation of edits that return claims for chemotherapy administration procedures if anti-neoplastics (cancer chemotherapy) are not also billed on the same day and edits that return claims for services that require the use of contrast agents if no contrast agent were billed. The commenter believed that this would greatly improve the data on which median costs are set. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We do not intend, at this time, to greatly expand the OCE edits to force correct coding as the commenter recommends beyond the edits for correct coding of device procedures that are discussed in section III.C.4 of this final rule with comment period. While we recognize that these kinds of edits would likely result in better coding, they would also impose a significant burden on hospitals. We do, however, encourage hospitals to review their claims completion processes carefully and to edit their claims before they are submitted to maximize the likelihood that the claims are correct and complete. Such a practice would both assist us in developing better OPPS rates, but more importantly, ensure that hospitals are being correctly paid for all of the services they furnish to our beneficiaries. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         One commenter noted the prevalence of drug billing and charging errors and recommended that CMS revise its median trimming methodology for drugs from ±3 standard deviations from the geometric mean to a trim by provider by drug based on the correlation of units and charges. This approach assumes that hospitals engaged in accurate and consistent unit coding and billing will demonstrate a strong correlation between units and per unit charges. The commenter noted that CMS' current trim is very conservative, especially for low costs per unit because it will only eliminate negative cost values, which do not exist in the data. The commenter further suggested that CMS' trim of department-level CCR's and the use of C-code only claims to set device medians are comparable to this proposal. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We agree that billing accurate units has proven challenging for some hospitals in light of various differences in packaged versus delivered units, changing drug pricing, and unit changes in HCPCS codes. Clearly, our goal in conducting the current trim at ±3 standard deviations from the geometric mean is to remove aberrant per unit costs, or costs that are so far removed from the geometric mean that the probability of their occurrence is less than 1 percent. However, even after this trim is conducted, we remain concerned about the per unit cost estimates for some drug codes. 
                    </P>
                    <P>We believe, however, that the current trim of drug costs, while conservative, is not as limiting as suggested in the comment. The natural logarithm of costs per unit less than $1 will be negative. The trim compares the natural logarithm of the cost to the geometric mean, ±3 standard deviations and removes low and high cost observations. The low trim threshold may also be negative if costs are less than $1. In addition to using a trim, we also rely on a median cost rather than an average cost. Averages are subject to the influence of extreme outliers. Using a median instead of a mean eliminates this concern. Assuming most line-items for any given drug are coded correctly, using a trim and the median should provide a robust per unit cost estimate. Nonetheless, we do recognize that for selected low-volume or complex products, this approach is still not sufficient to remove all errors. </P>
                    <P>We are concerned, however, about implementing systematic trimming at the provider-level as suggested by the commenter for several reasons. First, this approach would remove the data for multiple providers from any given median calculation, making the assumption that their data were inaccurate, when, in fact, a few instances of poor coding may adversely impact the provider's correlation coefficient. Thus, a provider may actually be coding and charging accurately in many cases. In rare instances, we have removed a specific provider when it is more than obvious that the data are erroneous, but we only do this after a careful review of the provider's claims data. It is our preference to remove aberrant line-items rather than a provider's entire data for any given drug. Second, correlation coefficients for a provider may fluctuate if they are based on very low-volume, even if the majority of line-items appear accurate. Third, the commenter's proposed correlation coefficient approach lacks a generally accepted threshold when a providers' data should be removed, unlike the widely accepted trim of 3 standard deviations from the mean. Finally, this approach assumes that a negative correlation coefficient implies that a provider erred in setting its charging practices. </P>
                    <P>
                        While we agree that the proposed trim seeks to improve the accuracy of the claims data, which is the goal of all trimming, we disagree that the commenter's proposed trim is necessarily comparable to the use of a department-level CCR trim and the limitation of claims to those with C-codes for estimating medians for device-dependent APCs. The department-level trim does not eliminate a provider entirely, it eliminates the department-level CCR for a specific hospital and replaces this CCR with the overall CCR for that hospital. Relying on C-coded claims to calculate device-dependent medians assures us that the device was used with the device-dependent procedure. The specific cost associated with the device code is not considered in subsetting claims and the subsetting is done by claim, not by provider. While the commenter's proposed methodology is not appropriate for use at this time, we nonetheless believe that the commenter's suggested approach can serve as a useful tool in helping us begin the process of identifying providers 
                        <E T="03">Comment:</E>
                         One commenter indicated that using the overall CCR where the 
                        <PRTPAGE P="65747"/>
                        departmental CCR cannot be used may skew the costs derived from application of CCRs to charges. The commenter suggested that CMS develop a method for replacing departmental CCRs similar to that used for blood and blood products whereby the CCR that would apply would not be the overall CCR but a national CCR calculated based on the departmental CCRs of hospitals that do report the more pertinent specific cost centers on their cost reports. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We will consider whether doing so is practical and whether it would yield more accurate cost estimates. However, there were very specific characteristics of the reporting of blood such as a very specific cost center and very specific revenue codes that may not exist for other services. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         One commenter asked that CMS undertake a study to improve the reporting of costs in conjunction with the CCR development. The commenter stated that a more timely process should be implemented so that currently accurate CCRs are used to translate hospital charges to costs and that consideration should be given to attaining greater detail from the hospitals to calculate the CCRs to better reflect the full line of services being offered by hospitals. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We study means by which we could improve the development of cost-to-charge ratios annually. We also use the most current cost report data from the HCRIS system to calculate the cost to-charge-ratios and we use charges from the most current claims data. However, hospitals have great latitude in the way they organize their costs and complete their cost reports. We have no plans to alter the existing instructions to require cost report detail that is not currently provided. We will, instead, continue to examine how the data currently submitted by hospitals can be used to secure the most accurate estimates of cost for the full range of services furnished by hospitals. 
                    </P>
                    <P>After carefully reviewing all comments, we are adopting as final, for OPPS services furnished on or after January 1, 2005, the process for calculating median costs that we described in this section and the list of packaged services shown in Table 17 below. This table contains the list of packaged services by revenue code that we used in developing the APC weights and medians listed in Addenda A and B of this final rule with comment period. </P>
                    <BILCOD>BILLING CODE 4120-01-P</BILCOD>
                    <GPH SPAN="3" DEEP="607">
                        <PRTPAGE P="65748"/>
                        <GID>ER15NO04.025</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="159">
                        <PRTPAGE P="65749"/>
                        <GID>ER15NO04.026</GID>
                    </GPH>
                    <BILCOD>BILLING CODE 4120-01-C</BILCOD>
                    <HD SOURCE="HD2">C. Adjustment of Median Costs for CY 2005 </HD>
                    <HD SOURCE="HD3">1. Device-Dependent APCs </HD>
                    <P>Table 19, which we published in the proposed rule (69 FR 50492), contains a list of APCs consisting of HCPCS codes that cannot be provided without one or more devices. For CY 2002 OPPS, we used external data in part to establish the medians used for weight setting. At that time, many devices were eligible for pass-through payment. For that year, we estimated that the total amount of pass-through payments would far exceed the limit imposed by statute. To reduce the amount of a pro rata adjustment to all pass-through items, we packaged 75 percent of the cost of the devices (using external data furnished by commenters on the August 24, 2001 proposed rule) into the median cost for the APCs associated with these pass-through devices. The remaining 25 percent of the cost was considered to be pass-through payment. (Section VI. of this preamble includes a discussion of the pro rata adjustment.) </P>
                    <P>For CY 2003 OPPS, which was based on CY 2001 claims data, we found that the median costs for certain device-dependent APCs when all claims were used were substantially less than the median costs used for CY 2002. We were concerned that using the medians calculated from all claims would result in payments for some APCs that would not compensate the hospital even for the cost of the device. Therefore, we calculated a median cost using only claims from hospitals that had separately billed the pass-through device in CY 2001 (that is, hospitals whose claims contained the C-code for the pass-through device). Furthermore, for any APC (whether device-dependent or not) where the median cost would have decreased by 15 percent or more from CY 2002 to CY 2003, we limited decreases in median costs to 15 percent plus half of the amount of any reduction beyond 15 percent (68 FR 47984). For a few particular device-dependent APCs for which we believed that access to the service was in jeopardy, we blended external data furnished by commenters on the August 9, 2002 proposed rule (67 FR 57092) with claims data to establish the median cost used to set the payment rate. For CY 2003, we also eliminated the HCPCS C-codes for the devices and returned to providers those claims on which the deleted device codes were used. (The November 1, 2002 OPPS final rule (67 FR 66750) and section III.C.4 of this preamble contain a discussion regarding the required use of C-codes for specific categories of devices.) </P>
                    <P>For CY 2004 OPPS, which was based on CY 2002 claims data, we used only claims on which hospitals had reported devices to establish the median cost for the device-dependent APCs in Table 18. We did this because we found that the median costs calculated when we used all claims for these services were inadequate to cover the cost of the device if the device was not separately coded on the claim. Using only claims containing the code for the device (a C-code) provided costs that were closer to those used for CY 2002 and CY 2003 for these services. For a few particular APCs in which we believed that access to the service was in jeopardy, we used external data provided by commenters on the August 12, 2003 proposed rule in a 50 percent blend with claims data to establish the device portion of the median cost used to set the payment rate (68 FR 63423). We also reinstated for CY 2004, but on a voluntary basis, the reporting of C-codes for devices. </P>
                    <P>Thus, in developing the median costs for device-dependent APCs for CYs 2002, 2003, and 2004, we applied certain adjustments to our claims data as provided under the authority of section 1833(t)(9)(A) of the Act to ensure equitable payments to the hospitals for the provision of such services. As stated in the August 16, 2004 proposed rule, we have continued to receive comments from interested parties as part of the APC Panel process urging us to determine whether the claims data that would be used in calculating the median costs for device-dependent APCs for payment in CY 2005 would represent valid relative costs for these services (69 FR 50490). Careful analysis of the CY 2003 data that we used in calculating the median costs for the CY 2005 OPPS payment rates revealed problems similar to those discussed above in calculating device-dependent APC median costs based solely on claims data. Calculation of the CY 2005 median costs for the device-dependent APCs indicated that some of the medians appeared to appropriately reflect the costs of the services, including the cost of the device, and others did not. Of the 41 device-dependent APCs analyzed, 27 have median costs that are lower than the medians on which the OPPS payments were based in CY 2004. In contrast, 14 device-dependent APCs have median costs that are higher than the medians on which OPPS payments were based in CY 2004. </P>
                    <P>
                        The differences between the CY 2004 payment medians and the proposed CY 2005 median costs using CY 2003 claims data are attributable to several factors. As discussed above, the CY 2004 payment medians were based on a subset of claims that contained the codes for the devices without which the procedures could not be performed, and several APCs were adjusted using external data. The CY 2005 OPPS median costs on which the proposed payment rates in the August 16, 2004 proposed rule were based, were calculated based on all single bills, including “pseudo” single bills, for the services in the APCs and (not a subset 
                        <PRTPAGE P="65750"/>
                        of claims containing device codes) and were not adjusted using external data. In fact, as stated previously, we eliminated device coding requirements for hospitals in CY 2003. Consequently, there were no device codes reported for almost all devices in the CY 2003 claims data. Thus, it was not possible to use only the CY 2003 claims data containing device codes to calculate APC device-dependent medians as was done in CY 2004. Similarly, it was not possible to calculate a percentage of the APC cost attributed to device codes based on CY 2003 claims data. 
                    </P>
                    <P>In light of these data issues for CY 2005, we examined several alternatives to using CY 2003 claims data to calculate the proposed median costs for device-dependent APCs. As discussed in the August 16, 2004 proposed rule, we considered using CY 2004 OPPS medians with an inflation factor, as recommended by the APC Panel and by several outside organizations. We rejected this option because it would not recognize any changes in relative costs for these APCs and would not direct us towards our goal of using all single claims data as the basis for payment weights for all OPPS services. </P>
                    <P>We also considered using the medians we calculated from all single bills with no adjustments. However, the results of using this approach without increasing the payments for some important high cost services for CY 2005 could result in the closing of hospital programs that provide these services thus, jeopardizing access to needed care. Therefore, we did not adopt this approach. </P>
                    <P>In addition, we considered subsetting claims based on the presence of charges in certain revenue codes. These revenue codes include: 272, sterile supplies; 275, pacemakers; 278, other implants; 279, other supplies/devices; 280, oncology; 289, other oncology; and 624, investigational devices. We determined that the medians increased for some device-dependent APCs when we used only claims with a charge in at least one of these revenue codes, but our analysis provided no reliable evidence that the charges that would be found in these revenue codes were necessarily for the cost of the device. </P>
                    <P>Further, we considered using CY 2002 claims to calculate a ratio between the median calculated using all single bills and the median calculated using only claims with HCPCS codes for devices on them, and applying that ratio to the median calculated using all single bills from CY 2003 claims data. We rejected this option because it assumes that the relationship between the costs of the claims with and without codes for devices is a valid relationship not only for CY 2002 but CY 2003 as well. It also assumes no changes in billing behavior. We have no reason to believe either of these assumptions is true and, therefore, we did not choose this option. </P>
                    <P>In summary, we considered and rejected all of the above options. We have given special treatment to the device-dependent APCs for the past 3 years, recognizing that, in a new payment system, hospitals need time to establish correct coding processes and, considering the need to ensure continued access to these important services. After 3 years of such consideration, we believe that it is time to begin a transition to the use of pure claims data for these services (reflected in these APCs) to ensure the appropriate relativity of the median costs for all payable OPPS services. Our goal is to establish payment rates that provide appropriate relative payment for all services paid under the OPPS without creating payment disincentives that may reduce access to care. </P>
                    <P>Therefore, we proposed to base median costs for device-dependent APCs in CY 2005 on the greater of (1) median costs calculated using CY 2003 claims data, or (2) 90 percent of the APC payment median for CY 2004 for such services. We proposed this adjustment because we believe that some variation in median costs is to be expected from year to year, and we believe that recognizing up to a 10 percent variation in our payment approach is a reasonable limit. In the August 16, 2004 proposed rule, we solicited comments on all aspects of theses issues and particularly on steps that can be taken in the future to transition from the historic payment medians to claims based median costs for OPPS ratesetting for these important services. In addition, we discussed this issue with the APC Panel at its September 1 through 2, 2004 meeting. The Panel recommended that we base median costs for these APCs on no less than 95 percent of the CY 2004 median not to exceed 105 percent of the CY 2004 payment median. </P>
                    <P>We received numerous public comments on our proposals. </P>
                    <P>
                        <E T="03">Comment:</E>
                         A number of commenters objected to the proposal to set the payment medians for device APCs at 90 percent of the CY 2004 payment median for the APC. They indicated that many of these APCs had already been reduced substantially over the past few years and that permitting them to be reduced another 10 percent would mean that some hospitals may close their programs and send patients to other hospitals for these services. Some commenters recommended that the median costs for these APCs be set at 100 percent of the CY 2004 payment median. Some commenters recommended that CMS use the CY 2004 payment median plus an update amount as the median cost for the CY 2005 OPPS. Commenters also recommended that instead of using median costs from claims data with any adjustment, that we collect actual hospital acquisition data or use cost data provided by manufacturers and other stakeholders and substitute that data for the device portion of the median costs. They indicated that we used external data in the past and that we should do so this year also. They cited APCs 0081, 0107, 0108, 0225, 0229, 0259, 0385, and 0386 as cases in which the proposed APC payment rates were less than the cost of the devices and as those for which CMS should use external data in setting the payment rates for CY 2005. A commenter supported the proposal to pay the greater of the CY 2005 claims based median or 90 percent of the CY 2004 payment median. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         For the reasons discussed below, we set the adjusted CY 2005 OPPS device-dependent median at the greater of the CY 2005 OPPS unadjusted median or 95 percent of the CY 2004 OPPS adjusted final payment median rather than the greater of the CY 2005 unadjusted median or 90 percent of the CY 2004 OPPS adjusted final median as we proposed in the August 16, 2004 proposed rule. We view this as a transition to the full use of claims data to set the medians for these services. The integrity of a prospective payment system lies heavily in its reliance on a standardized process applied to a standardized data source. The use of external data can, as some commenters point out, unfairly unbalance the payments and result in inequities in payment. (Section III.C.5. of this preamble includes a discussion on the use of external data.) 
                    </P>
                    <P>
                        We considered setting the medians at the CY 2004 adjusted final payment medians with and without further inflation, but we think a certain amount of fluctuation in costs from year to year is to be expected as the costs of services decline after they have been on the market for some time. Moreover, we considered our proposal to pay the greater of the CY 2005 unadjusted median or 90 percent of the CY 2004 OPPS adjusted final payment median, but acknowledged the concerns of the commenters who believe that setting the comparison at 95 percent of the CY 2004 OPPS final adjusted payment median was more appropriate and less likely to impede access to these important services. We recognize that adjustments 
                        <PRTPAGE P="65751"/>
                        to median costs derived from claims data may be necessary yet again in the CY 2006 OPPS due to the voluntary nature of the reporting of device codes in CY 2004. However, as discussed further below at section III.C.4. of this preamble in our discussion of mandatory coding for devices, we expect that reporting of device codes in the CY 2005 claims will enable us to rely upon the claims data for setting the median costs without adjustment in CY 2007. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         Some commenters opposed the APC Panel's recommendation to limit increases in median costs for device APCs to 5 percent over the CY 2004 payment median because the commenters believe such a limit would be arbitrary and would be a hindrance to the improvement of cost data. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We agree and we have not limited the extent to which the median costs for device-dependent APCs may increase for the CY 2005 OPPS. We believe that in a number of cases, providers are reporting the charges for the devices and have otherwise greatly improved coding of their services, resulting in increases in median costs that appear to appropriately reflect the costs of the services furnished. We have no indication that the increases do not otherwise properly reflect the costs of services and, therefore, see no reason to constrain the increases that have resulted. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         Some commenters stated that CMS should look long term to determining a factor through regression analysis that enables CMS to adjust the charges for high cost devices so that the methodology will result in more accurate costs for high cost devices. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We will review and consider the results of credible studies of the possible compression of all charges, both for high cost services and low cost services. Studies that focus only on part of the spectrum of hospital charges, for example, those which look at low markup of high cost items but not at high markup of low cost items, would not be useful in a relative weight system. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         Some commenters indicated that hospitals typically markup high cost items and services less than they markup low cost items and services and that CMS' cost finding methodology does not recognize this because it applies a uniform cost-to-charge ratio (for the department or hospital overall) to the charges, which then yields distorted costs. They recommended that CMS resolve this problem using external data from manufacturers and other stakeholders until such time that CMS can comply with the GAO study that recommended that CMS “analyze variation in hospital charge setting to determine if the OPPS payment rates uniformly reflect hospitals' costs of provided outpatient services and if they do not, to make appropriate changes to the methodology.” The commenters asked that CMS provide explicit instructions to hospitals regarding how to adequately capture and charge for high cost devices. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         As we discussed previously, we have decided not to use external data to adjust the APC payment rates for CY 2005 OPPS. We do, however, reassess our existing methodology each year to determine how we can best create rates that uniformly reflect hospitals' cost of providing outpatient services. We will not provide instructions to hospitals regarding how to capture and charge for high cost devices. As a matter of policy, we do not tell hospitals how to set their charges for their services. However, we will continue to inform hospitals of the importance of their charge data in future ratesetting and encourage them to include all appropriate charges on their Medicare claims. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         One commenter objected to us applying the wage index adjustment to the cost of a device in a device-dependent APC because, as the commenter stated, the wage index is intended to address the identified differential in wages across localities. The commenter contends that there is no demonstration of a similar differential in the costs of devices across localities. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         Previous studies have shown that across the entirety of all services paid under OPPS, approximately 60 percent of total cost is labor related. Therefore we believe it is appropriate to apply the wage index to 60 percent of the payment for each service. The application of the wage index to the payment for the device-dependent APC can either inflate the total payment for the device-dependent APC or reduce it depending on whether the hospital is in a high cost or low cost area. In many cases, if we ceased to apply the wage index adjustment to 60 percent of the APC payment, the payment to the hospital for the APC would be significantly reduced. We will, however, consider whether it is appropriate to continue to apply the wage index adjustment as we currently do. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         One commenter asked that we add CPT codes 47382, (Radiofrequency ablation procedures of the liver) and CPT code 20982, (Radiofrequency ablation procedures of the bone) to the list of device-dependent APCs because they require the use of devices. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We will consider whether these services should be added to the list of device-dependent APCs in the future. However, it is unclear to us what proportion of total cost of each of these procedures is the cost of the device because codes are not reported for the devices. We do not agree that the cost of the devices could be derived from charges reported in particular revenue codes because there is no identification of the items charged under any revenue code. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         Some commenters indicated that the reductions in APC payments following termination of pass-through status for devices have resulted in the elimination of programs at hospitals that have chosen to no longer implant prosthetic devices. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We share the concern that beneficiaries should have access to services covered under Medicare and believe that our payment policies under OPPS have consistently taken this concern into account. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         Some commenters indicated that the proposed payment rates for APCs 0081, 0107, 0108, 0222, 0229, 0385, and 0386 are inadequate and do not cover the cost of the device; therefore, they do not provide payment for the facility services. The commenters stated that hospitals have taken a loss on these services for several years and cannot continue to provide the services at a loss. The commenters developed alternative cost estimates using external data and urged CMS to use these data rather than its claims data as the basis for developing median costs. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         As stated, for device-dependent APC in general, we have not used external data to adjust any median costs for CY 2005 OPPS. Instead, we set the medians for these APCs at the greater of the median cost for CY 2005 derived using claims data or 95 percent of the CY 2004 OPPS adjusted payment median. Beginning in CY 2005, we will also require that the claims containing codes assigned to these APCs also contain a code for an appropriate device for the claim to be paid, so that in CY 2007 we will have correctly coded claims to help us in setting the payment weights. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         Some commenters stated that the proposed payment for cryoablation of the prostate (CPT code 55873) is insufficient to cover the cost for the procedure. They further stated that CMS should factor in external data that shows hospital costs to exceed $9,000, eliminate or adjust claims for APC 0674 in which the charges for 
                        <PRTPAGE P="65752"/>
                        cryoablation probes are less than $7500, or discard all claims containing CPT code 55873 in the Medicare database for which the total hospital costs are less than $6500. The commenters indicated that access to this care would be impeded if the APC payment is not sufficient to pay the full cost of the service. The commenters believed that APC payment at less than full costs for the service will give rise to the use of alternative means of treating prostate cancer. These commenters indicated that the charges hospitals report on their claims are seldom sufficient to result in the full cost of all of the supplies and equipment needed to furnish the service. The commenters also indicated that when the only claims used to set the median are those for which the code for cryoablation probes is found, the median increases significantly. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         The codes for the cryoablation probes used in providing cryoablation of the prostate were billed in CY 2003 because they were paid as pass-through payments in CY 2003. Therefore, they exist in the claims data and we used them to screen for correctly coded claims in setting the median cost for APC 0674. The median derived using the subset of claims is $6,562.69, a decrease of 5.10 percent from the CY 2004 final payment median for APC 0674. Therefore, based on the device-dependent APC policy that we are finalizing for CY 2005, we set the median for APC 0674 at 95 percent of the CY 2004 final payment median, or $6,569.33. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         Some commenters supported the increased payment for cochlear implant services (CPT code 69930 in APC 0259) even though they indicated that they believe that the Medicare payment continues to be insufficient to fully pay for the costs of both the device and the procedure. One commenter provided an independent statistical analysis of the Medicare claims data and invoice data that the commenter indicated revealed hospital costs of $27,954 based on a screen of claims that contained HCPCS code L8614 and asked that CMS set the payment at that amount. Some commenters stated that they believe that some hospitals are using the cochlear implant codes to code implantation of less expensive implantable hearing aid devices. The commenter also asked that CMS provide education and develop a guidance document for hospitals specific to coding and billing for cochlear implant surgery. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         The device code for cochlear implants remained active in CY 2003 because Medicare uses it for purposes other than the OPPS. In developing the CY 2005 OPPS medians, we created a subset of claims for implantation of cochlear implants that contained the device code and calculated the median for the CY 2005 OPPS using only those correctly coded claims. This yielded a median cost of $26,006.74, which we used as the basis for the APC 0259 payment weight for the CY 2005 OPPS. While it is certainly possible that some hospitals are misusing the code for cochlear implantation to bill for less costly implanted hearing aid devices, we have no way to make that determination using the claims data. However, we note that hospitals billing in such a manner do so at their own risk of being found to have filed a false claim. We will consider what general education activities we need to undertake with regard to all devices but we are disinclined to focus on specific devices to the exclusion of others. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         One commenter indicated that the proposed decrease in payment rates for APC 0039 (Level I Implantation of Neurostimulator) is not acceptable as it would not enable hospitals to cover the cost of the service. Moreover, the commenter stated that hospitals have failed to code and bill correctly for this service and that there are no disincentives for incorrect coding and billing. The commenter further stated that the only diagnosis on the claims for APC 0039 should be that for epilepsy because that is the fundamental reason for implanting the device. However, according to the commenter, examination of the claims for APC 0039 revealed that only 12 percent of those claims contained an epilespsy diagnosis; therefore, the remaining claims caused the median to incorrectly represent the implantation of the device for treatment of epilepsy. The commenter recommended that CMS use external data to ensure that the costs of the device and procedure are adequate to avoid discouraging hospitals from providing the care. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         As with other device-dependent APCs, the absence of device codes on the claims for CY 2003 means that we were unable to screen the claims to positively identify which claims include the neurostimulator device costs and we are not confident that screening only for the diagnosis of epilepsy will resolve the coding problem. Therefore, we have set the median for APC 0039 at 95 percent of the CY 2004 final adjusted payment median. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         Some commenters objected to the assignment of status indicator “T” to APC 0229 (Transcatheter Placement of Intravascular Stent) because they believe it should not be subject to the multiple procedure reduction due to its dependence on a device. They believed that the payment for the services is undervalued because it is typically done with other procedures and that it is further underpaid by the application of the multiple procedure reduction. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We have not changed the status indicator for APC 0229 because the cost of the device for services in this APC is less than 50 percent of the total cost of the service. Therefore, the multiple procedure reduction of 50 percent does not result in the APC payment being less than the device cost. Moreover, there are efficiencies when multiple services are performed on the same day that we believe justify applying the multiple procedure reduction to the services in this APC. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         One commenter asked that CMS require hospitals to show the actual acquisition cost for devices on the bill using a UB92 value code and the amount. The commenter recommended that where 50 percent or more of the APC is attributable to packaged device cost, CMS should obtain actual device information and use it to determine if APC cost calculations are reasonable. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We do not believe the imposition of an additional reporting requirement would be effective. Such a requirement would be both burdensome and unlikely to provide the actual hospital acquisition cost because hospitals have the ability to reflect general rebates and discounts on a per device basis. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         One commenter asked that we make separate payments for CRT-Ds (pacemaker-defibrillators) for which there was a new technology add-on payment under the IPPS for FY 2005, so that payment for this service under the IPPS and the OPPS would be better aligned. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         CRT-Ds were paid on a pass-through basis under the OPPS in CYs 2001 and 2002. Their OPPS pass-through status expired in CY 2003 and their component services were packaged into clinical APC 0107 (Insertion of Cardioverter-Defibrillator) and APC 0108 (Insertion/Replacement/Repair of Cardioverter-Defibrillator Leads) and. Accordingly, no separate additional payment is appropriate for these devices. 
                    </P>
                    <P>
                        After carefully reviewing the comments, considering the APC Panel recommendations and examining the claims data, we are adjusting the medians for device-dependent APCs based on comparison of the CY 2005 median costs and the CY 2004 final payment median costs. Specifically, we decided to set the median costs for these 
                        <PRTPAGE P="65753"/>
                        APCs at the higher of the CY 2005 median cost from our claims data or 95 percent of the CY 2004 final adjusted median cost used to set the payment in CY 2004 rather than 90 percent of the CY final adjustment median cost as we proposed. 
                    </P>
                    <P>We believe that this adjustment methodology provides an appropriate transition to eventual use of all single bill claims data without adjustment, and that the methodology moves us towards the goal of using all single bill data without adjustment by CY 2007. It is a simple and easily understood methodology for adjusting median costs. Where reductions occur compared to CY 2004 OPPS, we believe that, under this methodology, the reductions will be sufficiently modest that providers will be able to accommodate them without ceasing to furnish services that Medicare beneficiaries need. </P>
                    <P>In addition, beginning in CY 2005, as proposed, we are requiring hospitals to bill all device-dependent procedures using the appropriate C-codes for the devices. We believe that this approach mitigates against the reduction of access to care while encouraging hospitals to bill correctly for the services they furnish. We intend this requirement to be the first step towards use of all available single bill claims data to establish medians for device-dependent APCs. Our goal is to use all single bills for device-dependent APCs in developing the CY 2007 OPPS, which we expect to base on data from claims for services furnished in CY 2005. We further discuss our coding requirement in section III.C.4. of this preamble. </P>
                    <P>Table 18 below, which is sorted by APC, contains the CY 2004 OPPS payment medians, the CY 2005 OPPS final adjusted medians using single bill claims from January 1, 2003, through December 31, 2003), and the medians derived from the adjustment processes discussed further below. </P>
                    <BILCOD>BILLING CODE 4120-01-P</BILCOD>
                    <GPH SPAN="3" DEEP="603">
                        <PRTPAGE P="65754"/>
                        <GID>ER15NO04.027</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="623">
                        <PRTPAGE P="65755"/>
                        <GID>ER15NO04.028</GID>
                    </GPH>
                    <PRTPAGE P="65756"/>
                    <BILCOD>BILLING CODE 4120-01-C</BILCOD>
                    <P>We also note that as a result of our initial data analysis for device-dependent APCs, we proposed to make the following additional adjustments to specific device-dependent APCs for the reasons specified: </P>
                    <HD SOURCE="HD2">a. APC 0226: Implantation of Drug Infusion Reservoir </HD>
                    <P>We proposed to remove APC 0226 (Implantation of Drug Infusion Reservoir) from the list of device-dependent APCs and to use its unadjusted single bill median of $2,793.30 as the basis for the payment weight. CPT code 62360 (Implantation or replacement of device for intrathecal or epidural drug infusion, subcutaneous reservoir) is assigned to APC 0226. In CY 2002, when we packaged 75 percent of the cost of the device into the payment for the procedure with which the device was billed to reduce the pro rata adjustment, we inadvertently packaged the cost of an implantable infusion pump (C1336 and C1337) rather than that of a drug reservoir. Our data indicated that the reservoir used in performing CPT code 62360 costs considerably less than an implantable infusion pump, and we believe that the median cost for APC 0226 appropriately reflects the relative cost of the service and the required device. </P>
                    <P>We did not receive any public comments on this proposal. Accordingly, we have removed APC 0226 from the device-dependent APC list and used its unadjusted single bill median of $2,541.43 as the basis for its CY 2005 relative payment weight. </P>
                    <HD SOURCE="HD2">b. APC 0048: Arthroscopy With Prosthesis </HD>
                    <P>In addition, we proposed to delete APC 0048 (Arthroplasty with Prosthesis) from the list of device-dependent APCs for CY 2005 and to not adjust the median costs for this APC because we believe that the CY 2005 median cost for this APC as restructured is reasonable and appropriate. Based on our careful analysis of the CY 2003 claims data for this APC, we believe the difference between the CY 2004 and CY 2005 median cost is attributable to the migration of certain high cost CPT codes (23470, 24361, 24363, 24366, 25441, 25442, 25446) from APC 0048 to new APC 0425 (Level II Arthroplasty with Prosthesis) and, as such, this change would not adversely limit beneficiary access to this important service. Therefore, we did not propose to apply a device-dependent adjustment to the median cost for APC 0048. </P>
                    <P>We did not receive any public comments on this proposal. Accordingly, for CY 2005 we are removing APC 0048 from the device-dependent list and are not adjusting the median cost for this APC. </P>
                    <HD SOURCE="HD2">c. APC 0385: Level I Prosthetic Urological Procedures </HD>
                    <P>We proposed to move CPT code 52282 (Cystourethroscopy, insert urethral stent), from APC 0385 (Level I Prosthetic Urological Procedure) and assign it to APC 0163 (Level IV Cystourethoscopy and other Genitourinary Procedures), for clinical homogeneity. As titled, APC 0385 was intended for the assignment of certain urological procedures that require the use of prosthetics. However, CPT code 52282 requires the use of a stent rather than a urological prosthetic. Therefore, we proposed to reassign CPT code 52282 to APC 0163. Recalculation of the median cost for APC 0385 after reassigning CPT code 52282 yielded a median cost for that APC that is consistent with its CY 2004 median payment. Thus, we did not propose a device-dependent adjustment for the median cost for APC 0385. </P>
                    <P>
                        <E T="03">Comment:</E>
                         Some commenters asked that we keep CPT code 52282 in APC 0385 and not move it to APC 0163. These commenters believed that placement of CPT code 52282 in APC 0385 would maintain clinical coherence and resource similarity. They also supported the APC Panel's recommendation that all three codes, which we proposed to move from APC 0385 to 0386 (CPT codes 53440, 53444, and 54416) should be retained in APC 0385 for CY 2005 OPPS because they are dissimilar in terms of the nature of the surgical procedure and the sophistication of the prosthetic urology device that is implanted. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We have moved CPT code 52282 from APC 0385 to APC 0163 because we believe that this service is more compatible from a clinical and resource perspective with the other cystourethroscopy services assigned to APC 0163 than with services assigned to APC 0385. We have retained CPT codes 53440 and 53444 to APC 0385 because the median costs for these procedures in the CY 2003 data that were used to develop this final rule with comment period indicate that the resources required for them are similar to those for CPT code 54400, which is also assigned to APC 0385. However, we have placed CPT code 54416 in APC 0386 because the median cost shows that the resources are much more like those for services assigned to APC 0386 than the median costs for services in APC 0385. CPT code 54416 requires removal and replacement of a non-inflatable or inflatable prosthesis and our resource data demonstrate relatively high costs for the service, most typically associated with replacement of an inflatable prosthesis. Thus, the nature of the services are sufficiently similar such that CPT code 54416 is clinically coherent with the services in APC 0386. 
                    </P>
                    <HD SOURCE="HD2">d. APC 0119: Implantation of Infusion Device and APC 0115: Cannula/Access Device Procedures </HD>
                    <P>We proposed to remove CPT code 49419 (Insert abdom cath for chemo tx), from APC 0119 (Implantation of Infusion Pump) and assign it to APC 0115 (Cannula/Access Device Procedures) to achieve clinical homogeneity within APC 0115. Unlike all the other codes assigned to APC 0115, HCPCS code 49419 does not require the use of an infusion pump. Rather, this code is used when inserting an intraperitoneal cannula or catheter with a subcutaneous reservoir. Thus, we believed it would be more appropriate clinically to reassign HCPCS code 49419 to APC 0115 that includes procedures that require the use of devices similar to that required for CPT code 49419. </P>
                    <P>
                        <E T="03">Comment:</E>
                         One commenter recommended that we move the CPT code 36260 (Insertion of infusion pump) and CPT code 36563 (Insert tunneled cv catheter) from APC 0119 to APC 0227 (Implantation of Drug Infusion Device), which is also for implantation of infusion pumps. The commenter indicated that all of these services are for implantation of infusion pumps and that the external cost data on the pumps are not dissimilar. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We have not combined the codes in these APCs because they are not clinically homogeneous. Specifically, the services in APC 0227 are for the insertion of spinal infusion pumps and those in APC 0119 are for insertion of vascular infusion pumps. We see no clinical reason to move these codes as suggested by the commenter. 
                    </P>
                    <HD SOURCE="HD3">2. Treatment of Specified APCs </HD>
                    <HD SOURCE="HD2">a. APC 0315: Level II Implantation of Neurostimulator </HD>
                    <P>
                        As stated in the August 16, 2004 proposed rule, CPT code 61866 (Implant neurostim arrays) was brought to our attention by means of an application for a new device category for transitional pass-through payment for the Kinetra
                        <E T="51">®</E>
                         neurostimulator, a dual channel neurostimulator currently approved and used for Parkinson's disease. We denied approval for a new device category for the Kinetra
                        <E T="51">®</E>
                         neurostimulator because the device is described by a previously 
                        <PRTPAGE P="65757"/>
                        existing category, C1767 (Generator, neurostimulator (implantable)). 
                    </P>
                    <P>
                        The manufacturer of Kinetra
                        <E T="51">®</E>
                         stated that the AMA created CPT 61886 to accommodate implantation of the Kinetra
                        <E T="51">®</E>
                         neurostimulator and that no services other than implantation of the Kinetra
                        <E T="51">®</E>
                         are currently described by that CPT code. Even though the Kinetra
                        <E T="51">®</E>
                         did not receive full FDA pre-market approval until December 2003, hospital outpatient claims were reported in CYs 2002 and 2003 (289 total claims in CY 2003) for this device. The manufacturer asserted that these claims must have been miscoded because the Kinetra
                        <E T="51">®</E>
                         could not have been used in performing CPT code 61886 before obtaining FDA approval in December 2003. Therefore, the manufacturer did not believe that the device cost could be included in the median for CPT code 61886, which has been assigned to APC 0222. 
                    </P>
                    <P>
                        In examining the CY 2003 claims for CPT code 61866, we noted that many of the claims also contained codes for procedures related to treatment with cranial nerve stimulators, including the placement of electrodes for cranial nerve stimulation. The placement of the cranial neurostimulator electrodes used with the Kinetra
                        <E T="51">®</E>
                         is currently an inpatient rather than outpatient procedure. Therefore, we would not expect patients being prepared for cranial nerve stimulation to also have a Kinetra
                        <E T="51">®</E>
                         neurostimulator for deep brain stimulation for Parkinson's disease placed at the same time. Thus, it seems possible that the CY 2003 claims for CPT code 61886, generally, are incorrectly coded and do not include the dual chamber neurostimulator in the reported charges. 
                    </P>
                    <P>
                        Prior to the availability of the dual channel neurostimulator Kinetra
                        <E T="51">®</E>
                         for bilateral deep brain stimulation, it is our understanding that patients diagnosed with Parkinson's disease had two single channel neurostimulator generators implanted in the same operative session. According to the Kinetra
                        <E T="51">®</E>
                         manufacturer, this device will now replace the insertion of two single channel neurostimulators and the cost of the Kinetra
                        <E T="51">®</E>
                         is equivalent to the cost of two single channel neurostimulators. Given this information, we examined our CY 2003 claims data and found that 69 single claims were reported for patients with a diagnosis of Parkinson's disease and that 2 single channel neurostimulator pulse generators (CPT code 61885) were implanted on the same day. The median cost for these claims was $20,631. Other than the device costs, we believe the procedural costs for the insertion of two single channel devices or one dual channel device should be roughly comparable. Therefore, we proposed to establish a new APC 0315, Level II Implantation of Neurostimulator, for CPT code 61886, and assign it a median cost of $20,631. Because of our concern that hospitals correctly code OPPS claims for CPT code 61886, we also proposed to require device coding (C-code) for APC 0315 to improve the coding on all claims for placement of a dual channel cranial neurostimulator pulse generator or receiver, as we proposed for APC 0039, Implantation of Neurostimulator, for placement of a single channel cranial neurostimulator, discussed in section III. C. of this preamble. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         We received one comment in support of our proposed median cost for APC 0315. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We appreciate the commenter's support. Accordingly, we are finalizing our CY 2005 proposal to assign CPT code 61886 to APC 0315 with an assigned median cost of $20,633.70. 
                    </P>
                    <HD SOURCE="HD2">b. APC 0651: Complex Interstitial Radiation Application </HD>
                    <P>For CY 2003, APC 0651 included CPT code 77778 (Complex interstitial radiation source application). This code was not to be used for prostate brachytherapy because we created HCPCS codes G0256 (Prostate brachytherapy with palladium sources) and G0261 (Prostate brachytherapy with iodine sources) in which we packaged the cost for placement of needles or catheters and sources into a single APC payment for each G code (67 FR 66779). When we calculated the median from all single bills for CPT code 77778 from CY 2003 data for CY 2005 OPPS, we found that 73 percent of the single bills for this APC were for prostate brachytherapy and, therefore, were miscoded. The median for APC 0651, using all single bills, including those miscoded for prostate brachytherapy, was $2,641.67. When we removed the incorrectly coded claims for prostate brachytherapy, which we believed to contain brachytherapy sources and which are paid separately for CY 2004 and will be paid separately for CY 2005, the median was $1,491.39. This is the amount that we proposed for payment for CY 2005 OPPS for APC 0651. The proposed median was considerably higher than the median cost of $589.72 for CY 2004 OPPS (from CY 2002 claims data). </P>
                    <P>We believed that this adjusted median was appropriate for APC 0651 when used for prostate brachytherapy because the service described by CPT code 77778 is only one of several components of the payment for the service in its entirety. When it is used for prostate brachytherapy, hospitals should also bill for the placement of the needles and catheters using CPT code 55859 and should also bill the brachytherapy sources separately. Hospitals will be paid for both APCs and for the cost of sources. </P>
                    <P>Section 621(b)(1) of Pub. L. 108-173 specifically provides separate payment in CY 2005 “* * * for a device of brachytherapy, consisting of a seed or seeds (or radioactive source) * * *” at the hospital's charge adjusted to cost. We proposed to package the cost of other services such as the needles or catheters into the payment for the brachytherapy APCs and not to pay on the same basis as the brachytherapy sources because the law does not include needles and catheters in its definition of brachytherapy sources to be paid on charges adjusted to cost. </P>
                    <P>We also recognized that APC 0651 is used for brachytherapy services other than prostate brachytherapy and that, in some of those cases, there are no other separate procedure codes for placement of the needles or catheters. In those cases, which are represented in the claims we used to calculate the proposed median (once the miscoded claims for prostate brachytherapy were excluded), we believed that the charges for CPT code 77778 may have included the placement of the needles or catheters and, therefore, the median may be somewhat overstated when used as the basis for payment for prostate brachytherapy and the other forms of brachytherapy that have procedure codes for placement of needles and catheters. Similarly, we believed that the median may be understated when used to pay for brachytherapy services for which there are no separate HCPCS codes for needle or catheter placement. We considered whether to create new G codes for the placement of catheters and needles for the brachytherapy services for which such codes do not exist, but we were concerned that doing so might create unneeded complexity and that the existing data may not support establishing medians for the new codes. We requested comments on how to address those services for which there are currently no HCPCS codes for placement of needles and catheters for brachytherapy applications. </P>
                    <P>
                        <E T="03">Comment:</E>
                         Commenters indicated that the absence of codes for brachytherapy needle/catheter placement is problematic because hospitals are forced to use existing “not otherwise classified” codes that makes claims analysis difficult for ratesetting. They asked that we create three “not otherwise classified” HCPCS codes for the placement of needles and catheters 
                        <PRTPAGE P="65758"/>
                        for application of brachytherapy sources other than prostate brachytherapy so that they can be billed and paid appropriately. Specifically, they asked (1) that CMS create a code for 1-4 needles/catheters and place it in APC 1507; (2) that CMS create a code for placment of 5-10 catheters and place it in New Technology APC 1513; and (3) that CMS create a new code for more than 10 needles/catheters and place it in New Technology APC 1522. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We have not created HCPCS codes for needle/catheter placement for CY 2005 as suggested by the commenters. We do not believe that the requested new, “not otherwise classified” codes would be any more meaningful for OPPS ratesetting than the existing “not otherwise classified” codes. 
                    </P>
                    <P>As explained in the November 30, 2001 final rule (66 FR 59897), new Technology APCs are for complete procedures, not devices or drugs or biologicals, but such items may be part of the cost of the complete service. To qualify for OPPS payment under the new technology APCs, a service must meet the following criteria: </P>
                    <P>• Service must be a complete service. </P>
                    <P>• Service must not be described by an existing HCPCS code or combination of codes. </P>
                    <P>• Service could not have been adequately represented in the claims data used for the most current annual OPPS payment update. </P>
                    <P>• Service does not qualify for additional payment under pass-through payment provisions. </P>
                    <P>• Service cannot reasonably be placed in an existing APC group that is appropriate in terms of clinical characteristics and resource costs. </P>
                    <P>• Service is medically reasonable and necessary. </P>
                    <P>• Service falls within scope of Medicare benefits. </P>
                    <P>
                        Processes and requirements for pass-through and new technology service APC applications are provided in more detail on the OPPS Web site: 
                        <E T="03">http://www.cms.hhs.gov/poviders/hopps/.</E>
                    </P>
                    <P>Implicit in the criteria is that there exists a meaningful description of the services for which new technology status is being requested. We do not believe the “not otherwise classified” codes proposed by the commenters are sufficiently specific that they could satisfy the criteria. We believe that CPT already contains sufficient “not otherwise classified” codes for the coding of placement of brachytherapy needles and catheters in locations of the body for which specific codes do not now exist. We are unable to specify the “not otherwise classified” codes that should be used because the “not otherwise classified” codes are generally categorized by body part or function, and, therefore, the code that would apply depends on the location in the body in which the needles and catheters are being placed. For example, placement of needles or catheters in a shoulder muscle would be coded differently from placement of needles or catheters in the pancreas. </P>
                    <P>
                        <E T="03">Comment:</E>
                         Some commenters supported the proposed payment for APC 0651 (Complex Interstitial Radiation Source Application). They indicated that, together with separate payment for the brachytherapy sources and the placement of needles and catheters, the proposed payment would provide adequate payment for these important services. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We appreciate the commenters' support. Further discussion regarding the payment for APC 0651 is provided at III.C.2.b. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         One commenter indicated that there are many supplies and devices other than needles and catheters that are used in providing brachytherapy and asked that CMS develop codes for them so that they could be billed as coded items because such coding would facilitate capture of all the costs associated with performing the services. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We have not created new device codes for the supplies and equipment that the commenter requested because such items are incidental to the service. We do not believe that such incidental items justify development of new device codes. 
                    </P>
                    <P>In this final rule with comment period, the median cost for APC 0651 is $1,283.44, resulting in a national unadjusted payment rate of $1,248.93. There were fewer CY 2003 final action claims for this service in the database that was constructed from the most current claims data and used to develop the weights and median costs for this final rule with comment period. Twelve hospitals whose claims had appeared in the CY 2003 claims data used to calculate the proposed weights and median costs withdrew their claims before we pulled the data for this final rule with comment period. This may have been because they realized that they had billed incorrectly and withdrew the claims to bill correctly. </P>
                    <P>Our examination of the claims data set for this final rule with comment period reveals that the claims largely appear to not include charges for brachytherapy sources. The unadjusted median cost that resulted from use of these claims is $1,283.44, a 117 percent increase over the median cost for CY 2004 for this APC. As we noted previously, the median should reflect accurately the appropriate claims for the APC. We have no reason to believe that this median is flawed. Therefore, we have used it as the basis for the CY 2005 OPPS unadjusted payment rate of $1,248.93. </P>
                    <HD SOURCE="HD3">c. APC 0659: Hyperbaric Oxygen Therapy </HD>
                    <P>
                        In the August 16, 2004 proposed rule, we stated that over the past year, we have received a number of questions about billing and payment for HCPCS code C1300 (Hyperbaric oxygen under pressure, full body chamber, per 30 minute interval). In light of these issues, we carefully examined the CY 2003 single procedure claims data that we proposed to use to calculate the CY 2005 median for APC services. Based on our examination of single procedure claims filed for HCPCS code C1300 in CY 2003, we believe that the claims for these services were either miscoded or the therapy was aborted before its completion. The claims that we examined reflected a pattern that is inconsistent with the clinical delivery of this service. Hyperbaric oxygen therapy (HBOT) is prescribed for clinical conditions such as promoting the healing of chronic wounds. It is typically prescribed on average for 90 minutes and, therefore, you would expect hospitals to bill multiple units of HBOT to achieve full body hyperbaric oxygen therapy. In addition to the therapeutic time spent at full hyperbaric oxygen pressure, treatment involves additional time for achieving full pressure (descent), providing air breaks to prevent neurological and other complications from occurring during the course of treatment, and returning the patient to atmospheric pressure (ascent). Our examination of the claims data revealed that providers who billed multiple units of C1300 reported a consistent charge for each “30 minute” unit. Conversely, providers who billed only a single unit of C1300, suggesting either a miscoded or aborted service, reported a charge that was 3 to 4 times greater than the per “30 minute” unit reported by providers billing multiple units of HCPCS code C1300. While it appears that many of the single procedure HBOT claims that we examined represented billing for a full 90 to 120 minutes of HBOT (including ascent, descent, and air break time), they were improperly billed as 1 unit rather than as 3 or 4 units of HBOT. Consequently, this type of incorrect coding would result in an inappropriately high per 30 minute median cost for HBOT or a median cost 
                        <PRTPAGE P="65759"/>
                        for HBOT of $177.96 derived using single service claims and “pseudo” single service claims. This is a significant issue because HBOT is the only procedure assigned to APC 0659. 
                    </P>
                    <P>Our initial analysis of the HBOT claims data further revealed that about 40 percent of all HBOT claims included packaged costs. To confirm our belief that these packaged costs were not associated with HBOT, we examined the other major payable procedures billed in conjunction with HBOT. As a result, we identified billed services such as drug administration and wound debridement that we would typically expect to have associated packaged services. We also looked at the magnitude of packaged costs in our single bills and found the majority of these costs were small, less than $30, and concentrated in revenue codes 25X, Pharmacy, and 27X, Medical/Surgical Supplies. </P>
                    <P>As a result of these coding anomalies, we proposed to calculate a “30 minute” median cost for APC 0659, using a total of 30,736 claims containing multiple units or multiple occurrences of HBOT, about 97 percent of all HBOT claims. Based on our finding, we proposed to exclude claims with only one unit of HBOT. We estimated costs on these claims using the respiratory therapy cost center CCR when one was available. Otherwise we used the hospital's overall CCR. Using this proposed methodology, the proposed median cost per unit of C1300 was $82.91. Based on hospitals' charges on correctly coded claims, we believe this estimate is much more accurate for 30 minutes of HBOT. Thus, we proposed a median cost for APC 0659 of $82.91 for CY 2005. </P>
                    <P>We received many public comments on this proposal. </P>
                    <P>
                        <E T="03">Comment:</E>
                         Overall, commenters expressed concern about the proposed reduction in payment for HBOT. There also was great consistency in the comments. Almost all the commenters cited a recent research report by The Lewin Group (Lewin) that examined our methodology for calculating a payment rate for APC 0659 and offered us several alternatives for identifying a median for HBOT. In their evaluation of our proposed change for calculating a median for HBOT, The Lewin Group ultimately concluded that, while our proposed use of claims with multiple units of C1300 in lieu of the clams with a single unit of C1300 was appropriate for calculating the median cost, we used an inappropriate cost-to-charge ratio to estimate costs from charges on those multiple unit claims. 
                    </P>
                    <P>Lewin surveyed the majority of hospitals billing Medicare for HBOT, requesting specific pages from each hospital's cost report to determine where HBOT services are reported and the associated CCR. Lewin received completed responses from 120 hospitals, a 30 percent response rate. The majority of responding hospitals, 63 percent, frequently broke out the costs of hyperbaric/wound care in a subscripted cost center on their cost report. In addition, 24 percent included their costs in the respiratory therapy cost center, and the remainder included their costs in disparate cost centers including emergency room and physical therapy. For those hospitals reporting separate line-items for hyperbaric/wound care, Lewin used CMS claims data to estimate a median CCR of 0.400 as compared with the median CCR for respiratory therapy of 0.248. Lewin also sought to establish the generalizability of their sample findings by demonstrating that responding hospitals were geographically diverse and that the respiratory therapy CCR for the responding hospitals was comparable to that observed in the claims data. Finally, Lewin used their survey findings to estimate a proportional difference in CCRs between respiratory therapy and the observed, hyperbaric-related CCRs of 1.411 and, applying this adjustment to the CMS claims data, they calculated a payment rate of $118.21. </P>
                    <P>Practically all commenters offered four possible alternatives to our proposed methodology. First, commenters suggested that CMS leave HBOT reimbursement at its CY 2004 level until CMS can accurately estimate costs and charges for HBOT. Second, commenters suggested that CMS apply The Lewin Group methodology in estimating median cost. Third, commenters suggested that CMS adopt The Lewin Group's estimated median of $118.21 per 30 minutes. With regard to this specific recommendation, several commenters stated that they thought that the $118 rate was appropriate, and one commenter believed a rate of $120 or greater would be acceptable. Finally, commenters suggested that CMS default to the overall CCR of 0.47 in lieu of using the respiratory therapy CCR. </P>
                    <P>
                        <E T="03">Response:</E>
                         We agree with the commenters that The Lewin Group analysis provides sufficient evidence that the CCR for HBOT is not reflected solely in the respiratory therapy cost center. With regard to the first recommended alternative, we do not believe it is appropriate to maintain the CY 2004 HBOT payment rate for CY 2005. We have clearly demonstrated that the single procedure claims are inappropriate for calculating a median cost, and the submitted research did not dispute our median calculation methodology. We cannot undertake the recommended second alternative and replicate The Lewin Group's methodology because the hyperbaric/wound care cost report cost center line-items are neither standard nor non-standard cost centers. We presume that these line-items for hyperbaric/wound care are subscripted cost centers that are ultimately rolled-up in to a standard cost center on the electronic cost report data. Without the specific subscripted information, we cannot calculate a cost-to-charge ratio specific to HBOT. 
                    </P>
                    <P>We also do not believe it is appropriate to adopt the $118.21 estimate made by Lewin using its survey results and our data, the third recommended alternative. The Lewin survey indicates diversity among hospitals in the subscripted location of reported hyperbaric oxygen costs on the cost report. In addition, the $118.21 is based on an adjustment to the CCR that assumes all nonresponding hospitals report their costs in the hospital-specific hyperbaric oxygen-related cost centers, even though roughly one-fourth of hospitals in the Lewin sample were demonstrated to report costs in the respiratory therapy cost center and 13 percent reported costs in other cost centers. The submitted research further indicates fairly substantial variation in the CCRs for the responding hospitals in the HBOT-related cost centers. In light of this, we agree to adopt the last recommended alternative, which is to calculate the median using the overall CCR. As several commenters noted, defaulting to the hospital's overall CCR is standard OPPS policy when an appropriate cost center cannot be assigned to a revenue code. We estimate an overall, hospital-weighted, median CCR for all hospitals of 0.33 and a hospital-weighted, median CCR for respiratory therapy for all hospitals of 0.27. Using the overall CCR to estimate costs from charges associated with HCPCS code C1300, we calculated a median cost of $93.26 using 38,505 claims in the final rule data. We used this median to set the final CY 2005 payment for APC 0659. </P>
                    <P>
                        <E T="03">Comment:</E>
                         One commenter conducted an internal study of 11 member hospitals and reported a median total cost of $126.42. The study findings acknowledged that we found billing anomalies in the claims with single units, but noted that our proposed approach will have unintended financial consequences. The commenter requested that we review our claims data to ensure HBOT rates that reflect the full cost of providing HBOT services. 
                        <PRTPAGE P="65760"/>
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         As discussed above, we agree that the proposed cost for HBOT was too low because it relied solely on the respiratory therapy CCR. However, based on the volume and consistency of claims for HBOT, we still believe that the claims data are correct. As already discussed, we will base payment for HBOT on a median calculated using the overall hospital CCR. Further, the purpose of OPPS is not to pay the full cost of a service for any given hospital, but rather to proportionally redistribute total OPPS dollars in a manner that reflects relative resource use. APC payment rates are based on the median cost of a group of services, or in this case, one service, to achieve the averaging effect of a prospective payment system and are not intended to reimburse the full cost to a specific hospital. The costs for these 11 member hospitals may fall above the median cost for all hospitals billing HBOT. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         One commenter reviewed CMS claims with multiple units and found an overall average of 15 units of HBOT per claim. This commenter recommended that CMS review a sample of medical records. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We expect that this finding is the result of outlier claims and unit coding errors. In our analyses of HBOT claims for the proposed rule, we found that the vast majority of claims, 93 percent, were for 3 to 5 units of service. Further, The Lewin Group analysis reviewed above did not dispute the appropriateness of using claims with multiple units for calculating a median cost. As discussed above, we believe that the appropriate concern in estimating a median cost for HBOT is the disparity in charging and cost reporting practices among hospitals and not with the claims themselves, a finding that mitigates the need for medical record review. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         One commenter recommended that CMS continue to compile claims data on HBOT and refer this issue to the APC Panel before making changes. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         By using claims with multiple units, we believe that we have ample claims data. However, the APC Panel is an official public forum designed to consider and advise us on APC-related issues. If this is a particular concern to the public, the public is invited to present this concern at the next APC Panel meeting. 
                    </P>
                    <P>After carefully reviewing all comments received, we are basing payment for HBOT on a median calculated using the overall hospital CCR rather than the respiratory therapy CCR as proposed. As discussed above, using the overall CCR to estimate costs from charges associated with HCPCS code C1300, we calculated a final CY 2005 payment for APC 0659 of $90.75. </P>
                    <HD SOURCE="HD3">3. Other APC Median Cost Issues</HD>
                    <HD SOURCE="HD3">a. APC 0312 Radioelement Applications </HD>
                    <P>
                        <E T="03">Comment:</E>
                         Some commenters stated that the payment rate for APC 0312 (Radioelement Applications) is inadequate to pay for the staff, supplies and appliances that are needed to furnish the service. The commenters further stated that the APC payment should be similar to that for APC 0651. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         The median for APC 0312 has increased significantly from the CY 2004 payment median of $199.90 to the CY 2005 OPPS final rule with comment period median of $326.65. Moreover, we were able to use 28 percent of the total claims in CY 2003 for this APC to set the median cost for the CY 2005 OPPS. Therefore, we see no reason to adjust the median for this APC to the level of APC 0651.
                    </P>
                    <HD SOURCE="HD3">b. Percutaneous Radiofrequency Ablation of Liver Tumors </HD>
                    <P>
                        <E T="03">Comment:</E>
                         Some commenters objected to the proposal to move CPT code 47382 (Percutaneous radiofrequency of liver tumors), from a New Technology APC to clinical APC 0423 (Level II Percutaneous Abdominal and Biliary Procedures) because they believe that there is an inadequate number of claims on which to base median costs, and that median costs are inappropriately low because device costs associated with performing this procedure are underreported. They indicated that the proposed reimbursement does not cover the costs of the single use catheters used in performing the service. The commenters stated that revenue codes should be used to screen for appropriately coded claims. They contended that if CMS cannot complete this analysis for this final rule with comment period, CMS should retain CPT code 47382 in a new technology APC at the CY 2004 payment rate until more representative cost data are available. They argued that this latter approach is consistent with how CMS has handled APC payments for PET services since CY 2001. The commenters also recommended that CPT codes 76362 (CT guidance for and monitoring of visceral tissue ablation), 76394 (Magnetic resonance imaging for and monitoring of visceral tissue ablation), and 76940 (Ultrasound guidance for and monitoring of visceral tissue ablation) be added to the bypass list so that more single bills could be used to set the median for CPT code 47382. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We believe that the claims volume is sufficiently adequate to remove CPT code 47382 from New Technology APC 1557 and place it in a clinical APC. Moreover, the median cost, $1,801.84, derived from the CY 2003 claims data for APC 0423, is very close to the payment that was made for New Technology APC 1557 of $1,850. Therefore, as proposed, this service will be placed in clinical APC 0423 and paid based on its historic claims data for services furnished for the CY 2005 OPPS. 
                    </P>
                    <P>In addition, the three CPT codes that the commenter recommended we add to the bypass list do not meet the CY 2005 criteria for inclusion on the list. However, we will consider their inclusion when we next review items for inclusion in CY 2006.</P>
                    <HD SOURCE="HD3">c. Heparin Coated Stents </HD>
                    <P>
                        <E T="03">Comment:</E>
                         One commenter objected to CMS' policy that heparin coated stents should be coded under C1874 (Stent, coated/cov w/del sys) because the commenter believes that to do so will adversely affect the median cost of the stents. The commenter urged us to create a unique C-code if HCPCS codes G0290 and G0291, which are used for placement of drug eluting stents, are retired. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         HCPCS codes G0290 and G0291 will remain active codes for CY 2005 and we see no reason to create another C-code at this time. We will determine whether there is a need for another C-code to differentiate between stents if and when HCPCS codes G0290 and G0291 are retired.
                    </P>
                    <HD SOURCE="HD3">d. Aqueous Drainage Assist Device </HD>
                    <P>
                        <E T="03">Comment:</E>
                         One commenter asked that CMS ensure that the costs of code C1783 (Aqueous drainage assist device) are packaged with the costs of the procedures with which the device is most commonly billed. The commenter stated that codes C1783, L8610 and L8612 would usually be billed with procedures that are in APC 0673. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We package the costs of devices that are billed on the same claim with the procedural APCs into the cost of the procedural APC. Thus, the extent to which the costs of these devices are packaged into the median cost for the procedure depends upon the extent to which the hospitals include the charges for the devices on the claim, with or without including the code for the device. To the extent that hospitals included charges for these devices on the claims for the procedures in which they were used, those charges would be converted to costs and packaged into the median cost for the procedure. 
                        <PRTPAGE P="65761"/>
                    </P>
                    <HD SOURCE="HD3">4. Required Use of C-Codes for Devices </HD>
                    <P>An important ancillary issue in regard to using hospital outpatient claims data to calculate median costs for a device-dependent APC is whether to require that hospitals bill the HCPCS codes for the devices that are required for use in the provision of the services in these APCs. We deleted HCPCS codes for devices in CY 2003 because hospitals objected to the complexity of this coding, and we believed that hospitals would charge for the devices in appropriate revenue codes. Our review of the claims data does not support this belief. Hospitals do not appear to routinely include the charges for the devices they use when they bill for all of the related services in the device-dependent APCs. Therefore, as discussed in the August 16, 2004 proposed rule, we proposed requiring hospitals to code devices for APCs to improve the quality of the claims data in support of our transition to the use of all single claims to establish payment rates for those APCs. We made this proposal cautiously, as we realize that it imposes a burden on hospitals to code the devices. </P>
                    <P>For the CY 2005 OPPS, we proposed to require coding of devices required for APCs for which we proposed to adjust the median costs for the CY 2005 OPPS. The APCs and the devices that were proposed for device coding were published in Table 20 of the August 16, 2004 proposed rule (69 FR 50497 through 50499). Specifically, if one device is shown for one APC, that device would have to be billed on the claim for a service in that APC or the claim would be returned to the provider for correction. If more than one device is shown for one APC, the provider would be required to bill one of the device codes shown on the same claim with the service in that APC for the claim to be accepted. </P>
                    <P>We also proposed to require coding of C1900 (Left ventricular lead) required to perform the service described in APC 0418, Left Ventricular Lead, because the service cannot be done without the lead, and because the device has been billed separately for pass-through payment in CYs 2003 and 2004. We believe that continued coding of the device would not impose a burden on hospitals. Similarly, because of our concerns regarding the correct coding of claims for CPT code 61886 (Implant neurostim arrays), assigned to APC 0315 (discussed in greater detail in section III.C.2.a. of this preamble), we proposed to require device coding for APC 0315 (Level II Implantation of Neurostimulator) to improve the coding on claims for placement of a dual channel cranial neurostimulator pulse generator or receiver, just as we proposed to require device coding for APC 0039 (Implantation of Neurostimulator) for placement of a single channel cranial neurostimulator as noted below. </P>
                    <P>We solicited comments on the proposed C-code requirements. </P>
                    <P>In addition, we announced in the proposed rule that we are considering expanding the device coding requirements in the future. We believed that, by requiring device coding for a small subset of device-dependent APCs each year, we would minimize the marginal annual coding burden on hospitals and begin to improve data for these APCs, which have consistently proven to be problematic. We believed coding of devices was essential if we were to improve the accuracy of claims data sufficiently to better calculate the correct relative costs of device-dependent APCs in relation to the other services paid under the OPPS. </P>
                    <P>
                        We asked that the public inform us of the device codes that are essential to the procedures contained in the device-dependent APCs listed in Table 20 of the proposed rule. The alphanumeric HCPCS codes for devices that were reactivated for CY 2004 OPPS can be found on the CMS Web site at 
                        <E T="03">http://www.cms.hhs.gov/providers</E>
                         under coding. They are in the section of alphanumeric codes that begin with the initial letter “C.” 
                    </P>
                    <P>We received a number of comments regarding our request. </P>
                    <P>
                        <E T="03">Comment:</E>
                         In general, commenters supported a requirement for mandatory device coding for all devices, not only those for which CMS proposed mandatory reporting. However, they had different views regarding what the requirement should contain and how it should be enforced. Some commenters asked that we require that all procedures for device-dependent APCs contain a C-code to identify the device used in the procedure. They indicated that they believed that this requirement is crucial to acquiring valid cost data for these services. Some commenters were concerned about the administrative burden that required C-coding imposes on hospitals and urged CMS to reassess the burden within 2 years if it imposes mandatory C-coding for devices. Other commenters urged CMS to implement a grace period of no less than 90 days after implementation of the CY 2005 OPPS to enable hospitals to be sure that they are prepared for device code edits. During this period, the commenters wanted intermediaries to accept the codes and not return incorrectly coded claims. The commenters indicated that the edits should be included in this final rule with comment period so that hospitals can begin to work on them as soon as possible. Those commenters suggested that the device codes for which edits will not be implemented in CY 2005 should not be required until CY 2006. The commenters indicated that both OCE and intermediary systems must be ready to handle this change, and that no edits should be implemented if they are not and if providers have not had at least 30 days notice. Some commenters urged CMS to base any edits or list of required device codes on CPT codes, not APCs, because in some cases, not all codes in an APC require the same device. One commenter objected to the use of edits to return to providers claims that contain a procedure code that cannot be done without a device but which contain no device code. The commenter indicated that CMS has been inconsistent in its policies governing coding of devices since the inception of the OPPS and should provide some greater period of stability in coding before it edits for the presence of the device codes. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We appreciate the comments, but continue to believe coding of devices is vital to enhancing the device-dependent APC claims data. Therefore, as proposed, effective for services provided on or after January 1, 2005, we will require hospitals to include device category codes on claims when such devices are used in conjunction with procedures billed and paid for under the OPPS. While we are requiring use of these device codes for reporting all such devices effective January 1, 2005, we will not implement the edits contained in Table 19 until April 1, 2005, to provide time for further review and for hospitals to prepare for them. The edits will not apply to claims that contain a procedure code reported with a modifier 73 or 74 to signify an interrupted procedure because we recognize that in those cases, the procedure might have been interrupted before the device was implanted.
                    </P>
                    <P>
                        We will apply the edits at the CPT/HCPCS code level to be as precise as possible. Table 19 includes the edits that we expect to go into effect April 1, 2005. The table of edits and the definitions of the C-codes (Table 20 of this preamble) will be posted on the CMS Web site on the OPPS page. As noted on Table 19, there are some CPT codes for which edits cannot be established, for example, because of the optional nature of the use of a device when performing the service. Although there is no official comment period 
                        <PRTPAGE P="65762"/>
                        associated with implementation of the edits, we welcome comments on the edits to be implemented on April 1, 2005, particularly from hospitals to whose claims the edits will apply and from medical specialties whose physicians use the devices in the procedures performed in hospital outpatient settings. Comments may be sent to 
                        <E T="03">OutpatientPPS@cms.hhs.gov</E>
                         if possible, by December 1, 2004. 
                    </P>
                    <P>In the future, we will consider edits for additional procedure codes in other device-dependent APCs. We will post all final edits on the CMS Web site with an announcement of the calendar quarter in which we expect to implement them. We will also provide them in a Medlearn Matters article. Any future edits will be implemented as always as part of the quarterly OCE release. We intend to expand the editing of device-dependent procedure codes for appropriate device C-codes as expeditiously but also as carefully as possible. The next group of device procedures for which we will consider edits will include those procedures in APCs for which we set the median cost at 95 percent of the CY 2004 payment median but for which we did not propose edits in the August 16, 2004 proposed rule. </P>
                    <P>
                        <E T="03">Comment:</E>
                         One commenter asked that CMS encourage manufacturers to put the applicable HCPCS device C-code on the device package and that CMS work with FDA to expedite placement of C-codes on device packages. The commenter also urged CMS to simplify the C-codes to be consistent with the information routinely reported by physicians in operative reports. The commenter gave, as an example, the seven device codes used with APC 0087 (Noncoronary Angioplasty or Atherectomy), all of which could be reported using only one code for “transluminal catheter”. The commenter stated that such simplification would greatly improve the likelihood that the device is coded on the claim because the description that distinguishes one of the seven codes from another is typically not documented in the hospital's record and is not information the coder would know. Other commenters asked that CMS actively undertake a program designed to educate providers on how to bill for devices and how to set charges for high cost devices so that future updates to the OPPS will more accurately reflect the costs of these services. Some commenters urged CMS to create and maintain a file on the CMS Web site that contains a complete crosswalk of devices codes to CPT codes in the device APCs. Some commenters asked that CMS provide a detailed revenue code to device code crosswalk so that hospitals will promote more uniformity in billing for devices. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We will carefully examine how we can facilitate correct coding of devices, including possible communication with the FDA. We will also consider the extent to which we can simplify the HCPCS codes for devices to facilitate straightforward coding. Finally, we will determine the extent to which we can improve provider education regarding correct coding for devices. However, we will not undertake any activity designed to advise hospitals on how to set charges for their services or to designate what revenue codes hospitals should use on a device-specific basis. 
                    </P>
                    <P>The edits that we created to ensure the coding of devices for the selected APCs that are listed in Table 19 of this preamble are also available as an Excel file in the supporting documentation of this final rule with comment period that will be posted on the CMS Web site and will also be contained in the transmittals for the January 2005 OPPS update and OCE release. Moreover, as described above, we will post any added edits for device coding on the OPPS page of the CMS Web site so that providers can have ready access to them. </P>
                    <P>
                        <E T="03">Comment:</E>
                         Some commenters asked that we add particular device and procedure combinations to the table of edits. Specifically, a commenter asked that we add APC 0259 (Cochlear Implant Surgery) as paired with device code L8614 (Cochlear implant), and APC 0040 paired with both device codes C1778 (Lead neurostimulator) and C1883 (Adapter/extension packing lead or neurostimulator lead). Another commenter asked that we add code C1787 (Patient programmer, neurostimulator) to the required devices for APC 0222. Another commenter asked that the same device codes be required for the CPT codes in APC 0087 as we proposed to require for APC 0085 because the commenter believes that the same devices are used in both APCs. Other commenters asked that we include edits for other APCs, for example, APC 0385 (Level I Prosthetic Urological Procedures) and APC 0386 (Level I Prosthetic Urological Procedures). 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         Except as discussed below, we have not added any APCs to the list that we proposed be edited for device codes at this time. Although our policy to require hospitals to code all devices is effective January 1, 2005, we will not implement edits until April 1, 2005. We will consider the comments regarding additional edits for later implementation. We believe that it is preferable to focus first on the APCs most affected and to add subsequent edits after careful deliberation. In this manner we can minimize the potential for adverse effects on claims processing and hospitals' cash flow. 
                    </P>
                    <P>However, we have added one CPT code to the list of codes that will be edited for device codes. We inadvertently omitted a proposed edit for CPT code 33225 (Left ventricular pacing lead add-on), which we proposed to place in New technology APC 1525. This procedure uses the device code C1900 (Left ventricular lead), whose pass-through status expires in January 2005. We proposed that when the lead is implanted as a stand-alone procedure using CPT code 33224 (Insert pacing lead and connect), we would edit for the presence of the device code for the lead on the claim. However, we believe that it is also appropriate to edit for the presence of the lead on a claim for the add-on code, CPT code 33225, and that it should pose no additional burden on hospitals because hospitals have been required to bill the device code C1900 for pass-through payment since CY 2004. </P>
                    <P>Summary of provisions related to required use of C-codes for devices that we are making final beginning in CY 2005: </P>
                    <P>1. Hospitals are required to report device category codes on claims when such devices are used in conjunction with procedure(s) billed and paid for under the OPPS in order to improve the claims data used annually to update the OPPS payment rates. </P>
                    <P>2. Beginning April 1, 2005, the OCE will include edits to ensure that certain procedure codes are accompanied by an associated device category code. </P>
                    <P>3. CMS will post the OCE edits that are to be implemented beginning April 1, 2005 on the CMS Web site to give hospitals and the provider community ample opportunity to review them and provide feedback prior to implementation. </P>
                    <P>4. Edits will apply at the CPT/HCPCS code level rather than the APC level. </P>
                    <P>5. Edits will not apply when a procedure code is reported with a modifier −73 or −74 to designate an incomplete procedure. </P>
                    <P>
                        6. CMS will add edits as needed in future quarterly updates of the OCE to ensure that hospitals are reporting device category codes appropriately with associated procedure codes. CMS will post future device category and procedure code edits on the CMS Web site to give hospitals and the provider 
                        <PRTPAGE P="65763"/>
                        community ample opportunity for input prior to implementation. 
                    </P>
                    <BILCOD>BILLING CODE 4120-01-P</BILCOD>
                    <GPH SPAN="3" DEEP="390">
                        <GID>ER15NO04.029</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="590">
                        <PRTPAGE P="65764"/>
                        <GID>ER15NO04.030</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="574">
                        <PRTPAGE P="65765"/>
                        <GID>ER15NO04.031</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="607">
                        <PRTPAGE P="65766"/>
                        <GID>ER15NO04.032</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="587">
                        <PRTPAGE P="65767"/>
                        <GID>ER15NO04.033</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="324">
                        <PRTPAGE P="65768"/>
                        <GID>ER15NO04.034</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="611">
                        <PRTPAGE P="65769"/>
                        <GID>ER15NO04.035</GID>
                    </GPH>
                    <BILCOD>BILLING CODE 4120-01-C</BILCOD>
                    <HD SOURCE="HD3">5. Submission of External Data </HD>
                    <P>
                        In the August 16, 2004 proposed rule, we stated that we would consider external data submitted with respect to any APC to the extent that such data enable us to verify or adjust claims data where we are convinced that such an adjustment to the median cost is appropriate. Further, we stated that all comments and any data we use would be available for public inspection and commenters should not expect that any data furnished as part of the comment 
                        <PRTPAGE P="65770"/>
                        would be withheld from public inspection. We also stated that parties who submit external data for devices should also submit a strategy that can be used to determine what part of the median cost represents the device to which the external data applies. We stated in the proposed rule that external data that are likely to be of optimal use should meet the following criteria: 
                    </P>
                    <P>• Represent a diverse group of hospitals both by location (for example, rural and urban) and by type (for example, community and teaching). We preferred that commenters identify each hospital, including location with city and State, nonprofit vs. for profit status, teaching vs. nonteaching status, and the percent of Medicare vs. non-Medicare patients receiving the service. A pseudo identifier could be used for the hospital identification. Data should be submitted both “per hospital” and in the aggregate. </P>
                    <P>• Identify the number of devices billed to Medicare by each hospital as well as any rebates or reductions for bulk purchase or similar discounts and identify the characteristics of providers to which any such price rebates or reductions apply. </P>
                    <P>• Identify all HCPCS codes with which each item would be used. </P>
                    <P>• Identify the source of the data. </P>
                    <P>• Include both the charges and costs for each hospital for CY 2003. </P>
                    <P>Meeting the criteria would help enable us to compare our CY 2003 claims data to the submitted external data and help us determine whether the submitted data are representative of hospitals that submit claims under the OPPS. </P>
                    <P>We noted in the proposed rule that information containing beneficiary-specific information (for example, medical records, and invoices with beneficiary identification on it) must be altered, if necessary, to remove any individually identifiable information, such as information that identifies an individual, diagnoses, addresses, telephone numbers, attending physician, medical record number, and Medicare or other insurance number. Moreover, individually identifiable beneficiary medical records, including progress notes, medical orders, test results, and consultation reports must not be submitted to us. Similarly, photocopies of checks from hospitals or other documents that contain bank routing numbers must not be submitted to us. </P>
                    <P>We received a number of public comments concerning the submission of external data. </P>
                    <P>
                        <E T="03">Comment:</E>
                         Some commenters supported use of claims data and strongly opposed use of data from external sources to set the OPPS payment rates. They believed that claims data more accurately reflects the costs hospitals incur to provide outpatient services. They strongly opposed use of external data because they believe that item specific adjustments will make OPPS unduly complex and result in unfair imbalances in payments. They believed that CMS should remain committed to the principles of prospective payment and the use of the averaging process rather than seeking to pay actual cost for one element of costs (for example, new technology) at the expense of all other items, which would result after application of mandated budget neutrality adjustments. Conversely, other commenters indicated that CMS should rely on external data in lieu of claims data for procedures that require high cost devices because the CMS methodology of applying a cost-to-charge ratio to charges to acquire costs will always result in costs that are below the actual acquisition cost of the device and that, barring a significant change in CMS' cost finding process, external data are the only means by which valid cost data for high cost devices can be introduced into the OPPS. Some commenters provided external data on the devices of interest to them and some provided specific amounts calculated using external data, which they asked that we substitute for claims data in setting the weight for the APC of interest to them. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We have not applied numbers from external data in our adjustments of median costs for the CY 2005 OPPS. While recognizing that external data aids in our general analysis of determining payment rates, we believe that generally such use of external data is not the optimal way to set payment rates for services in a relative weight system. As we discussed in section III.C.5. of this preamble, we believe that using external data has a significant potential for creating an unfair imbalance in a prospective payment system. However, we appreciate the efforts of some commenters in providing us with external data.
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         Some commenters urged us to use external data in the construction of APC rates and urged us to use confidential data for this purpose. Some commenters are concerned about the criteria CMS proposed for external data and urged us to expand the use of confidential external data to calculate future payment rates whenever such data are indicated and proven reliable based on the data's merits. The commenter did not suggest criteria for determining if confidential proprietary external data are reliable. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         As we indicated in the August 16, 2004 proposed rule, all information sent in response to comments will be made available to the public for review. We believe that all parties who are affected by the payment rates set under this system should have access to the information on which the rates are set. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         One commenter indicated that CMS should use external data for all device APCs in which the device cost exceeds 5 percent of the total APC cost because to do otherwise would unfairly benefit some categories of services compared to other categories of services. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We have not used external data to adjust any medians for the CY2005 OPPS. As discussed above, we applied the same adjustment rules to all device medians. 
                    </P>
                    <P>After carefully reviewing all public comments received, we have decided not to use any external data to adjust the median costs for the CY 2005 OPPS for the reasons discussed above. </P>
                    <HD SOURCE="HD2">D. Calculation of Scaled OPPS Payment Weights </HD>
                    <P>Using the median APC costs discussed previously, we calculated the relative payment weights for each APC for CY 2005 shown in Addenda A and B to this final rule with comment period. As in prior years, we scaled all the relative payment weights to APC 0601 (Mid-Level Clinic Visit) because it is one of the most frequently performed services in the hospital outpatient setting. We assigned APC 0601 a relative payment weight of 1.00 and divided the median cost for each APC by the median cost for APC 0601 to derive the relative payment weight for each APC. Using CY 2003 data, the median cost for APC 0601 is $57.32 for CY 2005. </P>
                    <P>
                        Section 1833(t)(9)(B) of the Act requires that APC reclassification and recalibration changes, wage index changes, and other adjustments be made in a manner that assures that aggregate payments under the OPPS for CY 2005 are neither greater than nor less than the aggregate payments that would have been made without the changes. To comply with this requirement concerning the APC changes, we compared aggregate payments using the CY 2004 relative weights to aggregate payments using the CY 2005 proposed relative weights. Based on this comparison, we proposed to make an adjustment to the weights for purposes of budget neutrality. The unscaled weights were adjusted by 0.984667135 for budget neutrality. The CY 2005 
                        <PRTPAGE P="65771"/>
                        relative weights, which incorporate the recalibration adjustments explained in this section, are listed in Addendum A and Addendum B to this final rule with comment period. 
                    </P>
                    <P>Section 1833(t)(14)(H) of the Act, as added by section 621(a)(1) of Pub. L. 108-173, states that “Additional expenditures resulting from this paragraph shall not be taken into account in establishing the conversion factor, weighting and other adjustment factors for 2004 and 2005 under paragraph (9) but shall be taken into account for subsequent years.” Section 1833(t)(14) provides the payment rates for certain specified covered outpatient drugs. Therefore, the incremental cost of those specified covered outpatient drugs (as discussed in section II.J. of this final rule with comment period) is excluded from the budget neutrality calculations but the base median cost of the drugs continues to be a factor in the calculation of budget neutrality. Accordingly, we calculated median costs for the specified covered outpatient drugs to which this section applies and used those medians and the frequencies in the calculation of the scaler for budget neutrality. </P>
                    <P>Under section 1833(t)(16)(C) of the Act, as added by section 621(b)(1) of Pub. L. 108-173, payment for devices of brachytherapy consisting of a seed or seeds (or radioactive source) is to be made at charges adjusted to cost for services furnished on or after January 1, 2004 and before January 1, 2006. As we stated in our January 6, 2004 interim final rule, charges for the brachytherapy sources will not be used in determining outlier payments and payments for these items will be excluded from budget neutrality calculations, consistent with our practice under the OPPS for items paid at cost. (We provide a discussion of brachytherapy payment issues at section VII.G. of this final rule with comment period.) </P>
                    <HD SOURCE="HD1">IV. Payment Changes for Devices </HD>
                    <HD SOURCE="HD2">A. Pass-Through Payments for Devices </HD>
                    <HD SOURCE="HD3">1. Expiration of Transitional Pass-Through Payments for Certain Devices </HD>
                    <P>Section 1833(t)(6)(B)(iii) of the Act requires that, under the OPPS, a category of devices be eligible for transitional pass-through payments for at least 2, but not more than 3 years. This period begins with the first date on which a transitional pass-through payment is made for any medical device that is described by the category. In our November 7, 2003 final rule with comment period (68 FR 63437), we specified six device categories currently in effect that would cease to be eligible for pass-through payment effective January 1, 2005. </P>
                    <P>The device category codes became effective April 1, 2001, under the provisions of the BIPA. Prior to pass-through device categories, we paid for pass-through devices under the OPPS on a brand-specific basis. All of the initial category codes that were established as of April 1, 2001, have expired; 95 categories expired after CY 2002 and 2 categories expired after CY 2003. All of the categories listed in Table 21, along with their expected expiration dates, were created since we published the criteria and process for creating additional device categories for pass-through payment on November 2, 2001 (66 FR 55850 through 55857). We based the expiration dates for the category codes listed in that table on the date on which a category was first eligible for pass-through payment. </P>
                    <P>There are six categories for devices that would have been eligible for pass-through payments for at least 2 years as of December 31, 2004. In our November 7, 2003 final rule with comment period, we finalized the December 31, 2004 expiration dates for these six categories. (Three other categories listed in Table 21, as proposed, C1814, C1818, and C1819, will expire on December 31, 2005.) As indicated in Table 21, as proposed, the six categories that will expire as of December 31, 2004, are: C1783, C1884, C1888, C1900, C2614, and C2632. Each category includes devices for which pass-through payment was first made under the OPPS in CY 2002 or CY 2003. </P>
                    <P>In the November 1, 2002 final rule, we established a policy for payment of devices included in pass-through categories that are due to expire (67 FR 66763). For CY 2003, we packaged the costs of the devices no longer eligible for pass-through payments into the costs of the procedures with which the devices were billed in CY 2001. There were few exceptions to this established policy (brachytherapy sources for other than prostate brachytherapy, which is now also separately paid in accordance with section 621(b)(2) of Pub. L. 108-173). For CY 2004, we continued to apply this policy for categories that expired on January 1, 2004. </P>
                    <HD SOURCE="HD3">2. Proposed and Final Policy for CY 2005 </HD>
                    <P>In the August 16, 2004 proposed rule, we proposed to continue to base the expiration date for a device category on the earliest effective date of pass-through payment status of the devices that populate the category. This basis for determining the expiration date of a device category is the same as that used in CY 2003 and CY 2004. </P>
                    <P>We also proposed that payment for the devices that populate the six categories that would cease to be eligible for pass-through payment after December 31, 2004, would be made as part of the payment for the APCs with which they are billed. This methodology for packaging device cost is consistent with the packaging methodology that we describe in section III. of this final rule with comment period. To accomplish this, we proposed to package the costs of devices that would no longer be eligible for pass-through payment in CY 2005 into the HCPCS codes with which the devices are billed. </P>
                    <P>In the proposed rule, we noted that category C1819 (Tissue localization excision device) was added subsequent to our proposed rule for CY 2004. We first announced the start date and the proposed expiration date for this device category in our November 7, 2003 final rule with comment period. Therefore, we proposed to maintain the category's December 31, 2005 expiration date. We invited specific comments on the proposed expiration date for category C1819. </P>
                    <P>We received a number of public comments on our proposals relating to the expiration dates for transition pass-through devices. </P>
                    <P>
                        <E T="03">Comment:</E>
                         One commenter noted that C1884 (Embolization protection system) is used for carotid stenting. The commenter recommended that CMS continue paying pass-through payment for C1884 until carotid stenting APC costs are established. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         Carotid stenting procedures are on the inpatient list for the OPPS and, therefore, are not paid by Medicare when performed in the outpatient hospital setting. To the extent that C1884 has been used with other procedures payable under the OPPS, we packaged the costs of C1884 into the APCs that include the procedures with which this device code was billed. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         One commenter objected to our proposal to remove HCPCS code C1884 from pass-through status, effective January 1, 2005. The commenter believed that the service had been unfairly subjected to the device offset because it was totally new and did not replace any existing device. The commenter claimed that, for CY 2003, code C1884 inappropriately received very little pass-through payment when the device was used. The commenter indicated that CMS subsequently recognized its error by changing the offset policy for CY 2004, the second year of the device's pass-through status, 
                        <PRTPAGE P="65772"/>
                        and, therefore should give the device a third year of pass-through payment. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We disagree with the commenter that we inappropriately made little pass-through payments for C1884. The commenter is correct that, for CY 2004, following notice and comment rulemaking, we changed the policy for applying offsets. As of January 1, 2004, we apply offsets, on a device-category-specific basis, when we determine that an APC contains costs associated with the device. Under the policy in effect prior to CY 2004, we applied offsets when a device category was billed with any of the APCs on our device offset list. This policy change affected all the categories in effect in CYs 2003 and 2004, including C1884. Some of these categories went into effect as of January 1, 2003; thus their pass-through status will expire after exactly 2 years. Other categories began receiving pass-through payments in the middle of 2002. Therefore, their categories will have more than 2, but less than 3 years with pass-through payment. We would not be able to extend pass-through payment for the second group of categories for an additional year, because they would then have greater than the statutory maximum of 3 years of pass-through payment. 
                    </P>
                    <P>We see no reason to adopt the commenter's suggestions to only change the status for code C1884. In CY 2003, C1884, like all our other pass-through categories, was subject to the same offset policy. Therefore, we are not changing the expiration date of device category C1884. </P>
                    <P>This device will cease to be a pass-through device effective January 1, 2005, at which time it will have had 2 years of pass-through payment. </P>
                    <P>We note that the expiration dates of C1884 and most other categories (the exception being C1819, discussed below) that were in effect at the time of our final rule for CY 2004 (68 FR 63437) were made final in that same rule, having been proposed in the proposed rule for CY 2004. We are now merely reaffirming that policy. </P>
                    <P>A few commenters supported our proposal to remove the six device categories from further pass-through payments and our proposal to package the costs of these devices into the cost of the APCs with which they are billed. The commenters indicated that incorporating these technologies into the APC system will minimize special payment incentives to use certain devices over others. </P>
                    <P>
                        <E T="03">Comment:</E>
                         One commenter was concerned that pass-through payment for a brachytherapy-related solution (C2632, Brachytherapy solution, Iodine-125, per mCi) would expire from pass-through payment after December 31, 2004, under our proposal, and requested a third year of pass-through payment, until December 31, 2005, because pass-through payment has been made only since January 1, 2003. The commenter claimed that this category still qualifies for another year of pass-through payment. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         Because the brachytherapy solution in question, C2632, is a brachytherapy source separately payable under the OPPS according to section 621(b) of Pub. L. 108-173, it will continue to receive cost-based payment as of January 1, 2005, based on those statutory provisions, rather than on the pass-through payment provisions. Section VII.G. of this final rule with comment period explains those provisions and includes code C2632 for cost-based payment in CY 2005. As indicated, in regard to other comments concerning expired categories, this brachytherapy device will have had 2 years of pass-through status on January 1, 2005. Our policy is that pass-through devices are removed from pass-through status as soon as permitted under the statute. Therefore, this device will cease to be a pass-through device effective January 1, 2005, at which time it will have had 2 years of pass-through payment. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         A few commenters were concerned that pass-through payment for C2614 (Probe, percutaneous lumbar diskectomy) in APC 0220 (Level I Nerve Procedures) would expire from pass-through payment after December 31, 2004, under our proposal, and requested that CMS continue to pay for this device category separately on a pass-through basis. The commenters were under the impression that the methodology used to determine whether or not a device category would continue to be eligible for payment in CY 2005 was if it showed “that there were no close or identifiable costs associated with the devices relating to the respective APCs that are normally billed with them.” 
                    </P>
                    <P>One commenter indicated that the payment for APC 0220 is not sufficient to cover the cost of the high end disposable RF lumbar probe coded under C2614. The commenter was also concerned that this device, which is used in performing CPT code 62287 (Percutaneous diskectomy), and which costs $1,150, will cease to be eligible for pass-through payments effective January 2005. The commenter stated that the device has increased effectiveness and reduced recovery time for patients but unless CMS increases the payment for APC 0220 for which we proposed to pay $996.69, hospitals will be forced to cease using it in 2005. The commenter urged that CMS continue pass-through payment for C2614 until such time as the payment rate for APC 0220 is adequate to cover the cost of the probe. </P>
                    <P>
                        <E T="03">Response:</E>
                         The commenters are incorrect in their understanding of our criteria for proposing to expire device categories. We proposed to expire C2614 because it has received pass-through payment for at least 2 years, which is also the basis for our proposal to expire the other five device categories listed for expiration in CY 2005 in our proposed rule. A device with no close or identifiable costs associated with the devices relating to the respective APCs that are normally billed with them is actually a factor in determining whether to apply an offset, which would reduce the pass-through payment amount, as explained in the August 16, 2004 proposed rule (69 FR 50501). As indicated, similar to other responses in regard to other comments concerning other categories due to expire, this disc decompression device will have had 2 years of pass-through status on January 1, 2005. Our policy is that pass-through devices are removed from pass-through status as soon as permitted under the statute. Therefore, this device will cease to be a pass-through device effective January 1, 2005, at which time it will have had 2 years of pass-through payment. 
                    </P>
                    <P>We have considered the commenter's concern regarding placement of code C2614, the code for a device that is used in performing CPT code 62287, in APC 0220 and find that the resource costs for CPT code 62287 may be more appropriate for APC 0221 (Level II Nerve Procedures). Therefore, we have reassigned CPT code 62287 to APC 0221, for which the CY 2005 payment rate is $1,635.87. </P>
                    <P>
                        <E T="03">Comment:</E>
                         One commenter recommended that CMS continue to pay for C2614 as a pass-through device category until CMS determines how the procedure, percutaneous lumbar diskectomy, is coded for determination of accurate APC cost weighting. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         As explained previously, we packaged costs of the C-code devices into the APCs that include the procedures with which the device codes were billed. We are packaging the costs related to code C2614 in this manner. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         One commenter, a device manufacturer, recommended that CMS extend the expiration date for pass-through payment of C1819 (Tissue localization excision device) until December 31, 2006, instead of ending pass-through payment after CY 2005. The commenter claimed that CMS will have only a partial year of data for the 
                        <PRTPAGE P="65773"/>
                        CY 2006 year, unless it extends the date that the category is effective for pass-through payment. This commenter claimed that the proposed payment for APC 0028, in which therapeutic breast cancer procedures, CPT codes 19125 and 19160, are placed, increased by only $100 and does not represent any device codes. The commenter asserted that CMS needs to collect data over 2 years and increase payment for APC 0028 to at least $1,345 starting in CY 2007. The commenter also pointed out that two categories set to expire after December 31, 2005, C1814 (Retinal tamonade device, silicone oil) and C1818 (Integrated keratoprosthesis), would be paid as pass-through devices several months longer than C1819, resulting in a greater amount of data for ratesetting than will be available for C1819. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We believe it is premature to make any conclusions and recommendations concerning the payment rate for APC 0028 for CY 2006 or CY 2007. Presumably, after the pass-through period ends, the device costs of category code C1819 will be included in the median costs of APC 0028 if the device is billed with procedures that are included in that APC. We reiterate that, as with other categories due to expire, this tissue localization device will have had 2 years of pass-through status on January 1, 2006. Our policy is that pass-through devices are removed from pass-through status as soon as permitted under the statute. Therefore, this device will cease to be a pass-through device effective January 1, 2006. 
                    </P>
                    <P>In this final rule with comment period, we are finalizing the proposed expiration dates for device categories as specified in the proposed rule, as indicated in Table 21 below. </P>
                    <GPH SPAN="3" DEEP="176">
                        <GID>ER15NO04.036</GID>
                    </GPH>
                    <HD SOURCE="HD2">B. Provisions for Reducing Transitional Pass-Through Payments to Offset Costs Packaged into APC Groups </HD>
                    <HD SOURCE="HD3">1. Background </HD>
                    <P>In the November 30, 2001 final rule, we explained the methodology we used to estimate the portion of each APC rate that could reasonably be attributed to the cost of the associated devices that are eligible for pass-through payments (66 FR 59904). Beginning with the implementation of the CY 2002 OPPS update (April 1, 2002), we deducted from the pass-through payments for the identified devices an amount that reflected the portion of the APC payment amount that we determined was associated with the cost of the device, as required by section 1833(t)(6)(D)(ii) of the Act. In the November 1, 2002 final rule, we published the applicable offset amounts for CY 2003 (67 FR 66801). </P>
                    <P>For the CY 2002 and CY 2003 OPPS updates, to estimate the portion of each APC rate that could reasonably be attributed to the cost of an associated pass-through device eligible for pass-through payment, we used claims data from the period used for recalibration of the APC rates. Using those claims, we calculated a median cost for every APC without packaging the costs of associated C-codes for device categories that were billed with the APC. We then calculated a median cost for every APC with the costs of the associated device category C-codes that were billed with the APC packaged into the median. Comparing the median APC cost without device packaging to the median APC cost including device packaging enabled us to determine the percentage of the median APC cost that is attributable to the associated pass-through devices. By applying those percentages to the APC payment rates, we determined the applicable amount to be deducted from the pass-through payment, the “offset” amount. We created an offset list comprised of any APC for which the device cost was at least 1 percent of the APC's cost. </P>
                    <P>
                        As first discussed in our November 1, 2002 final rule (67 FR 66801) the offset list that we publish each year is a list of offset amounts associated with those APCs with identified offset amounts developed using the methodology described above. As a rule, we do not know in advance which procedures and APCs may be billed with new categories. Therefore, an offset amount is applied only when a new device category is billed with an APC appearing on the offset list. The list of potential offsets for CY 2004 is currently published on the CMS Web site: 
                        <E T="03">http://www.cms.hhs.gov,</E>
                         as “Device-Related Portions of Ambulatory Payment Classification Costs for 2004.” 
                    </P>
                    <P>
                        For CY 2004, we modified our policy for applying offsets to device pass-through payments. Specifically, we indicated that we would apply an offset to a new device category only when we could determine that an APC contains costs associated with the device. We continued our existing methodology for determining the offset amount, described above. We were able to use this methodology to establish the device offset amounts for CY 2004 because providers reported device codes (C-codes) on the CY 2002 claims used for CY 2004 OPPS. However, for the CY 2005 update to the OPPS, we proposed to use CY 2003 claims that do not include device coding. (Section III. of this final rule with comment period contains a fuller discussion of our proposed and final requirement for use 
                        <PRTPAGE P="65774"/>
                        of C-codes for CY 2005.) In the CY 2004 OPPS update, we reviewed the device categories eligible for continuing pass-through payment in CY 2004 to determine whether the costs associated with the device categories are packaged into the existing APCs. Based on our review of the data for the categories existing in CY 2004, we determined that there were no close or identifiable costs associated with the devices relating to the respective APCs that are normally billed with them. Therefore, for those device categories, we set the offset to $0 for CY 2004. 
                    </P>
                    <HD SOURCE="HD3">2. Proposed and Final Policy for CY 2005 </HD>
                    <P>As we proposed in the August 16, 2004 proposed rule, in this final rule with comment period for CY 2005, we are continuing to review each new device category on a case-by-case basis as we did in CY 2004 to determine whether device costs associated with the new category are packaged into the existing APC structure. We are setting the offsets to $0 for the currently established categories that would continue for pass-through payment into CY 2005. If, during CY 2005, we create a new device category and determine that our data contain identifiable costs associated with the devices in any APC, we will adjust the APC payment if the offset is greater than $0. If we determine that device offsets greater than $0 are appropriate for any new category that we create during CY 2005, we will announce the offset amounts in the program transmittal that announces the new category. </P>
                    <P>
                        Further, as we proposed, in this final rule with comment period for CY 2005, we are using the device percentages (portion of the APC median cost attributable to the packaged device) that we developed for potential offsets in CY 2004 and apply these percentages to the CY 2005 payment amounts to obtain CY 2005 offset amounts, in cases where we determine that an offset is appropriate. As proposed, we are using the device percentage developed for CY 2004 because, as noted above, for the CY 2005 update to the OPPS, we are using CY 2003 claims that do not include device codes. Therefore, we are not easily able to determine the device portions of APCs for CY 2003 claims data. We have posted the list of device-dependent APCs and their respective device portions on the CMS Web site: 
                        <E T="03">http://www.cms.hhs.gov</E>
                         for CY 2004 We will update the device portions as a percentage of final CY 2005 APC payments and post these on the CMS Web site. 
                    </P>
                    <P>We did not receive any public comments on our proposed policy for reducing transitional pass-through payments to offset costs packaged into APC groups. </P>
                    <HD SOURCE="HD2">C. Criteria for Establishing New Pass-Through Device Categories </HD>
                    <P>
                        <E T="03">Comment:</E>
                         Several commenters from the medical device community asked that CMS revise the criteria under which it evaluates applications for pass-through status for new device categories. The commenters specifically requested that CMS eliminate the current requirement that items that are included in new pass-through device categories must be surgically inserted or implanted through a surgically created incision. The commenters expressed concern that the current requirement may prevent access to innovative and less invasive technologies, particularly in the areas of gynecologic, urologic, colorectal and gastrointestinal procedures. These commenters asked that CMS change the surgical insertion or implantation criterion to allow pass-through payment for potential new device categories that include items introduced into the human body through a natural orifice, as well as through a surgically created incision. 
                    </P>
                    <P>Several of the commenters recommended that CMS allow the creation of a new pass-through category for items implanted or inserted through a natural orifice, as long as the other existing criteria are met. The commenters do not believe that such an expansion of the criteria would significantly increase the amount spent on pass-through device categories and asked that CMS implement this change in January 2005. A few commenters predicted that this modification would result in expenditures of less than one quarter of the total amount available for pass-through payments. A few commenters further asked that CMS allow new categories, even if the name or terminology associated with the requested category resembles an expired category, even if that entails modifying the description of the expired category. One commenter claimed that manufacturers of technologies that are implanted through a surgically created opening have two options for incremental payment: (1) Pass-through payment; and (2) new technology APC, and that those not requiring a surgical incision have only one option for additional payment (the new technology APC). </P>
                    <P>
                        <E T="03">Response:</E>
                         We share the views of the commenters about the importance of ensuring access for Medicare beneficiaries to new technologies that offer substantial clinical improvement in the treatment of their medical conditions. We also recognize that, since the initial implementation of the OPPS, there have been beneficial changes in the methods by which some conditions are treated. These are issues that the agency takes very seriously and considers in the context of both pass-through device categories and payment for new, complete procedures through assignment to either a new technology APC or an existing clinical APC. 
                    </P>
                    <P>We note that other payment mechanisms exist within the OPPS for complete procedures that use new technology. These other payment mechanisms (establishment of a new code, where appropriate, and assignment to either a new technology APC or to a clinical APC) are already available, and do not require the implantation of a device through a surgical incision. </P>
                    <P>
                        We are also interested in hearing the views of other parties and receiving additional information on these issues. While we appreciate and welcome additional comments on these issues from the medical device makers, we are also interested in hearing the views of Medicare beneficiaries, of the hospitals that are paid under the OPPS and of physicians and other practitioners who attend to patients in the hospital outpatient setting. For that reason, we are soliciting additional comments on this topic within the 60-day comment period for this final rule with comment period. (See the 
                        <E T="02">ADDRESSES</E>
                         section of this preamble for information on submitting comments. When submitting comments on this issue, please include the caption “Device Categories” at the beginning of your comment.) In framing their comments, commenters are asked to consider the following questions: 
                    </P>
                    <P>1. The comments discussed above refer to devices introduced into the body through natural orifices. We are seeking comments on whether this includes orifices that are either naturally or surgically created, as in the case of ostomies? If you believe this includes only natural orifices, why do you distinguish between natural and surgically created orifices? </P>
                    <P>2. How would you define “new,” with respect to time and to predecessor technology? What additional criteria or characteristics do you believe distinguish “new” devices that are surgically introduced through an existing orifice from older technology that also is inserted through an orifice? </P>
                    <P>
                        3. What characteristics do you consider to distinguish a device that might be eligible for a pass-through category even if inserted through an 
                        <PRTPAGE P="65775"/>
                        existing orifice from materials and supplies such as sutures, clips or customized surgical kits that are used incident to a service or procedure? 
                    </P>
                    <P>4. Are there differences with respect to instruments that are seen as supplies or equipment for open procedures when those same instruments are passed through an orifice using a scope? </P>
                    <P>Concerning the request that we allow new categories for new devices by modifying the descriptors of existing categories, we note there are systems difficulties with changing a descriptor of an existing HCPCS code, such as payment considerations of claims prior to when a modification would be made. Moreover, both hospitals and manufacturers have informed us in the past that coding changes have led to confusion on the part of hospital coders. Modifying established device category C-codes would only exacerbate any such coding confusion. Therefore, we note that we are not inclined to change the descriptors of existing C-codes at this time. </P>
                    <P>
                        <E T="03">Comment:</E>
                         One commenter recommended that CMS revise the cost significant criterion for establishing new device categories for pass-through payment. The commenter stated that medical devices are sometimes used as part of procedures that are secondary to a primary procedure, and in these cases the cost significance threshold of at least 25 percent of the APC rate associated with the services performed with the device should be adjusted downward to reflect the lower APC payment made for the secondary service. The commenter provided as an example those cases when the secondary procedure would be subject to the multiple procedure discount, thus lowering the APC payment associated with the procedure by 50 percent. The commenter indicated that this scenario happens infrequently. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We disagree that our cost significance criterion for a proposed new device category for pass-through payment requires revision or adjustment. The criterion commented on requires that the estimated average reasonable cost of devices in a proposed new device category exceeds 25 percent of the applicable APC payment amount for the service associated with the device category (67 FR 66785). Very few new device category applications are denied for pass-through payment because they do not meet this cost criterion. If the proposed category of devices can be billed with more than one APC, we generally use the lowest APC payment rate applicable for use with the nominated device when we test against this cost criterion, thus increasing the probability the device will pass the cost significance criterion. We do not believe any further adjustment is needed for this cost criterion. 
                    </P>
                    <P>Therefore, we are not making any additional changes to our policy for CY 2005. </P>
                    <HD SOURCE="HD1">V. Payment Changes for Drugs, Biologicals, Radiopharmaceutical Agents, and Blood and Blood Products </HD>
                    <HD SOURCE="HD2">A. Transitional Pass-Through Payment for Additional Costs of Drugs and Biologicals </HD>
                    <HD SOURCE="HD3">1. Background </HD>
                    <P>Section 1833(t)(6) of the Act provides for temporary additional payments or “transitional pass-through payments” for certain drugs and biological agents. As originally enacted by the BBRA, this provision required the Secretary to make additional payments to hospitals for current orphan drugs, as designated under section 526 of the Federal Food, Drug, and Cosmetic Act (Pub. L. 107-186); current drugs and biological agents and brachytherapy used for the treatment of cancer; and current radiopharmaceutical drugs and biological products. For those drugs and biological agents referred to as “current,” the transitional pass-through payment began on the first date the hospital OPPS was implemented (before enactment of BIPA (Pub. L. 106-554), on December 21, 2000). </P>
                    <P>Transitional pass-through payments are also required for certain “new” drugs, devices and biological agents that were not being paid for as a hospital OPD service as of December 31, 1996, and whose cost is “not insignificant” in relation to the OPPS payment for the procedures or services associated with the new drug, device, or biological. Under the statute, transitional pass-through payments can be made for at least 2 years but not more than 3 years. In Addenda A and B to this final rule with comment period, pass-through drugs and biological agents are identified by status indicator “G.” </P>
                    <P>
                        The process to apply for transitional pass-through payment for eligible drugs and biological agents can be found on pages of our CMS Web site: 
                        <E T="03">http://www.cms.hhs.gov.</E>
                         If we revise the application instructions in any way, we will post the revisions on our Web site and submit the changes to the Office of Management and Budget (OMB) for approval, as required under the Paperwork Reduction Act (PRA). Notification of new drugs and biological application processes is generally posted on the OPPS Web site at: 
                        <E T="03">http://www.cms.hhs.gov/hopps.</E>
                    </P>
                    <HD SOURCE="HD3">2. Expiration in CY 2004 of Pass-Through Status for Drugs and Biologicals </HD>
                    <P>Section 1833(t)(6)(C)(i) of the Act specifies that the duration of transitional pass-through payments for drugs and biologicals must be no less than 2 years and no longer than 3 years. The drugs whose pass-through status will expire on December 31, 2004, meet that criterion. In the August 16, 2004 proposed rule, Table 22 listed the 13 drugs and biologicals for which we proposed that pass-through status would expire on December 31, 2004. </P>
                    <P>
                        <E T="03">Comment:</E>
                         One commenter, a national hospital association, supported our proposal to remove these 13 drugs from the pass-through status on December 31, 2004. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We appreciate the commenters' support for our proposal. 
                    </P>
                    <P>For this final rule with comment period, in Table 22 below, we are specifying the drugs and biologicals for which pass-through status will expire on December 31, 2004. This listing is the same as that published in the proposed rule. </P>
                    <GPH SPAN="3" DEEP="353">
                        <PRTPAGE P="65776"/>
                        <GID>ER15NO04.037</GID>
                    </GPH>
                    <HD SOURCE="HD3">3. Drugs and Biologicals With Pass-Through Status in CY 2005 </HD>
                    <P>As we proposed in the August 16, 2004 proposed rule, we are continuing pass-through status for CY 2005 for 18 drugs and biologicals listed in Table 23 of this final rule with comment period. The APCs and HCPCS codes for drugs and biologicals that will have pass-through status in CY 2005 are assigned status indicator “G” in Addendum A and Addendum B, respectively, to this final rule with comment period. </P>
                    <P>Section 1833(t)(6)(D)(i) of the Act sets the payment rate for pass-through eligible drugs (assuming that no pro rata reduction in pass-through payment is necessary) as the amount determined under section 1842(o) of the Act. Section 303(c) of Pub. L. 108-173 amended Title XVIII of the Act by adding new section 1847A. This new section establishes the use of the average sales price (ASP) methodology for payment for drugs and biologicals described in section 1842(o)(1)(C) of the Act furnished on or after January 1, 2005. Therefore, as we proposed in the August 16, 2004 proposed rule, in CY 2005, we will pay under the OPPS for drugs and biologicals with pass-through status consistent with the provisions of section 1842(o) of the Act as amended by Pub. L. 108-173 at a rate that is equivalent to the payment these drugs and biologicals will receive in the physician office setting, and established in accordance with the methodology described in the CY 2005 Physician Fee Schedule final rule published elsewhere in this issue. </P>
                    <P>Section 1833(t)(6)(D)(i) of the Act also sets the amount of additional payment for pass-through eligible drugs and biologicals (the pass-through payment amount). The pass-through payment amount is the difference between the amount authorized under section 1842(o) of the Act, and the portion of the otherwise applicable fee schedule amount (that is, the APC payment rate) that the Secretary determines is associated with the drug or biological. </P>
                    <P>In this final rule with comment period, we are adopting as final our proposal to amend § 419.64 of the regulations to conform this section to these changes. Specifically, we are revising paragraph (d) to provide that, subject to any reduction determined under § 419.62(b), the payment for a drug or biological with pass-through status equals the amount determined under section 1842(o) of the Act, minus the portion of the APC payment amount that we determine is associated with the drug or biological. </P>
                    <P>
                        As we explained in the August 16, 2004 proposed rule, we will make separate payment, beginning in CY 2005, for new drugs and biologicals with an HCPCS code consistent with the provisions of section 1842(o) of the Act, as amended by Pub. L. 108-173, at a rate that is equivalent to the payment they would receive in a physician office setting, whether or not we have received a pass-through application for the item. Accordingly, beginning in CY 2005, the pass-through payment amount for new drugs and biologicals that we determine have pass-through status equals zero. That is, when we subtract the amount to be paid for pass-through drugs and biologicals under section 1842(o) of the Act, as amended by Pub. L. 108-173, from the portion of the otherwise applicable fee schedule amount, or the APC payment rate associated with the drug or biological that would be the amount paid for drugs and biologicals under section 1842(o) of the Act as 
                        <PRTPAGE P="65777"/>
                        amended by Pub. L. 108-173, the resulting difference is equal to zero. 
                    </P>
                    <P>
                        We have used the second quarter ASP numbers for budget neutrality estimates, impact analysis, and for completing Addenda A and B because those were the most recent numbers available to us in time for publication. Changes in program payments due to quarterly updates of ASP for pass-through drugs are factored into our budget neutrality estimates. To be consistent with the ASP-based payments that will be made when these drugs and biologicals are furnished in physician offices, we plan to make any appropriate adjustments to the amounts shown in Addendum A and B if later quarter ASP submissions indicate that adjustments to the payment rate are necessary. We will announce such changes in our program instructions to implement quarterly releases and post any revisions to the Addenda on the 
                        <E T="03">http://cms.hhs.gov</E>
                         Web site. 
                    </P>
                    <P>
                        In the proposed rule, we listed in Table 23 the drugs and biologicals for which we proposed pass-through status continuing in CY 2005. We also included in Addendum B to the proposed rule the proposed CY 2005 rates for these pass-through drugs and biologicals based on data reported to CMS as of April 30, 2004. Since publication of the proposed rule on August 16, 2004, we have approved two additional drugs and biologicals for pass-through payment beginning on or after October 1, 2004. These products are Vidaza that has been assigned HCPCS code C9218 (Injection, azacitidine, per 1 mg) and Myfortic that has been assigned HCPCS code J7518 (Mycophenolic acid, oral, per 180 mg). (
                        <E T="03">See</E>
                         Change Request 3420, Transmittal 290 issued August 27, 2004.) In addition, three more products have been approved for pass-through status beginning or after January 1, 2005. They are Orthovice (HCPCS code C9220, Sodium Hyaluronate per 30 mg dose, for intra-articular injection), GraftJacket (Repair)(HCPCS code C9221, Acellular dermal tissue, matrix per 16cm2), and GraftJacket (Soft Tissue)(HCPCS code C9222, Decellularized Soft Tissue Scaffold, per 1 cc). These new eligible pass-through items are listed in Table 23 below. 
                    </P>
                    <P>We received several public comments on the proposed listing and payment rates for drugs and biologicals for pass-through status continuing in CY 2005. </P>
                    <P>
                        <E T="03">Comment:</E>
                         Two commenters stated that the proposed payment rate for HCPCS code C9203 (Injection, Perflexane lipid microsphere, per single use vial) is inappropriate and should be re-examined. They state that the methods used to price the drug are inconsistent with the Pub. L. 108-173, which requires that payments for pass-through drugs be based at either 106 percent of reported average sales price (ASP) or 83 percent of the average wholesale price (AWP). Pricing at 95 percent of AWP for C9203 creates a competitive disadvantage for contrast agents no longer being paid as pass-through drugs. 
                    </P>
                    <P>One commenter suggests that CMS create a class of echocardiography contrast agents similar to the class established for anti-emetic drugs. This allows for a uniform methodology to price drugs and ensures patient access to all drugs in the same therapeutic class. An alternative proposal identified by the commenter, is to base the payment for Imagent on the method applicable to the pricing for all other specified covered outpatient drugs (that is, 83 percent of the AWP). Yet another proposal included either maintaining pass-through status for all contrast agents or removing Imagent from pass-through designation. Another commenter recommended that the payment rate for all contrast agents be based on median costs reflected in hospital outpatient claims data. </P>
                    <P>
                        <E T="03">Response:</E>
                         Whereas separate payment was already being made for the contrast agents, either as a pass-through item or as a “specified covered outpatient drug,” the 5HT3 anti-emetic products varied in their payment status, that is, some were packaged and some were paid separately. Although we are making final our proposal to pay separately for the 5HT3 anti-emetic products in CY 2005 in this final rule with comment period, the intent of this policy discussed in section IV.B.2. of this preamble is not to standardize payment for already separately payable drugs. For this reason, the policy does not apply to the echocardiography contrast agents. Therefore, we are not accepting the commenter's recommendation that we create a class of echocardiography contrast agents similar to the class for anti-emetic drugs. 
                    </P>
                    <P>Other proposals to: (1) Change the pass-through payment status for Imagent to a “specified covered outpatient drug,” (2) extend the pass-through payment status for other contrast agents, or (3) use hospital claims data to establish payment for Imagent are not provided for under the statute. Imagent obtained pass-through status effective on April 1, 2003, and will remain a pass-through drug for CY 2005. </P>
                    <P>Since the ASP for contrast agents was not reported in time for use in developing the APC payments for this final rule with comment period, the CY 2005 first quarter APC payment for Imagent is based on 95 percent of the AWP reported as of May 1, 2003. As previously stated, we plan to update payments for pass-through drugs on a quarterly basis. Beginning in April 2005, payment for Imagent will be based on 106 percent of the reported ASP. </P>
                    <P>
                        <E T="03">Comment:</E>
                         Several commenters wrote in support of our proposal to remove 13 drugs and biologic agents from the pass-through table as the pass-through period for these items will end on January 1, 2005. Many commenters were very much in favor of our proposal for setting the pass-through payment portion of drugs. They wrote that zero pass-through payments ensures pass-though drugs and biologicals receive the full payment while at the same time eliminates the risk of a pro-rata reduction from occurring. Other commenters urged CMS to update ASP based payment rates for therapies with transitional pass-through status on a quarterly basis as is done for the drugs and biologicals administered in physician offices and paid for in accordance with the same statutory requirements as the drugs and biologicals with pass-through status under the OPPS. Otherwise, they argued, patient access to innovative drug and biological therapies in appropriate outpatient settings could be jeopardized. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We appreciate the comments that support our decision to remove 13 drugs pass-through and biologicals for which pass-through status expires at the end of CY 2004 from the table. With respect to those drugs and biologicals that will continue to be on pass-through status or that may be granted pass-through status in CY 2005, we agree that our payment rules and amounts should be consistent with the ASP-based payments that will be made when these drugs and biologicals are furnished in physician offices since payment for both settings is governed by the same provisions of the Act. Therefore, we plan to make any appropriate adjustments to the amounts shown in Addendum A and B if later quarter ASP submissions indicate that adjustments to the payment rate are necessary. Changes in total payments due to quarterly updates of ASP for pass-through drugs are factored into our budget neutrality estimates. 
                    </P>
                    <P>
                        In this final rule with comment period, we are not making any changes to the listing as a result of public comments. Table 23 below lists the drugs and biologicals that will have pass-through status in CY 2005. Addendum B of this final rule with 
                        <PRTPAGE P="65778"/>
                        comment period lists the final CY 2005 rates for these pass-through drugs and biologicals, which are assigned status indicator “G” based on data reported to CMS as of July 30, 2004. 
                    </P>
                    <BILCOD>BILLING CODE 4120-01-P</BILCOD>
                    <GPH SPAN="3" DEEP="521">
                        <GID>ER15NO04.038</GID>
                    </GPH>
                    <BILCOD>BILLING CODE 4120-01-C</BILCOD>
                    <HD SOURCE="HD2">B. Drugs, Biologicals, and Radiopharmaceuticals Without Pass-Through Status </HD>
                    <HD SOURCE="HD3">1. Background </HD>
                    <P>
                        Under the OPPS, we currently pay for drugs, biologicals including blood and blood products, and radiopharmaceuticals that do not have pass-through status in one of two ways: packaged payment and separate payment (individual APCs). We explained in the April 7, 2000 final rule (65 FR 18450) that we generally package the cost of drugs and radiopharmaceuticals into the APC payment rate for the procedure or treatment with which the products are usually furnished. Hospitals do not receive separate payment from Medicare for packaged items and supplies, and hospitals may not bill beneficiaries separately for any packaged items and supplies whose costs are recognized and paid for within the national OPPS payment rate for the associated 
                        <PRTPAGE P="65779"/>
                        procedure or service. (Program Memorandum Transmittal A-01-133, issued on November 20, 2001, explains in greater detail the rules regarding separate payment for packaged services.) 
                    </P>
                    <P>Packaging costs into a single aggregate payment for a service, procedure, or episode of care is a fundamental principle that distinguishes a prospective payment system from a fee schedule. In general, packaging the costs of items and services into the payment for the primary procedure or service with which they are associated encourages hospital efficiencies and also enables hospitals to manage their resources with maximum flexibility. Notwithstanding our commitment to package as many costs as possible, we are aware that packaging payments for certain drugs, biologicals, and radiopharmaceuticals, especially those that are particularly expensive or rarely used, might result in insufficient payments to hospitals, which could adversely affect beneficiary access to medically necessary services. As discussed in the November 7, 2003 OPPS final rule with comment period (68 FR 63445), in CY 2004 we packaged payment for drugs, biologicals, and radiopharmaceuticals into the APCs with which they were billed if the median cost per day for the drug, biological, or radiopharmaceutical was less than $50. We established a separate APC payment for drugs, biologicals, and radiopharmaceuticals for which the median cost per day exceeded $50. Our rationale for establishing a $50 threshold was also discussed in the November 7, 2003 OPPS final rule with comment period (68 FR 63444 through 63447). </P>
                    <HD SOURCE="HD3">2. Criteria for Packaging Payment for Drugs, Biologicals, and Radiopharmaceuticals </HD>
                    <P>Section 621(a)(2) of Pub. L. 108-173 amended section 1833(t)(16) of the Act by adding a new subparagraph (B) to require that the threshold for establishing separate APCs for drugs and biologicals be set at $50 per administration for CYs 2005 and 2006. For CY 2005, we proposed to continue our policy of paying separately for drugs, biologicals, and radiopharmaceuticals whose median cost per day exceeds $50 and packaging the cost of drugs, biologicals, and radiopharmaceuticals whose median cost per day is less than $50 into the procedures with which they are billed. </P>
                    <P>We calculated the median cost per day using claims data from January 1, 2003, to December 31, 2003, for all drugs, biologicals, and radiopharmaceuticals that had an HCPCS code during this time period and were paid (via packaged or separate payment) under the OPPS. Items such as single indication orphan drugs, certain vaccines, and blood and blood products were excluded from these calculations and our treatment of these is discussed separately in sections V.F., E., and I., respectively, of this preamble. In order to calculate the median cost per day for drugs, biologicals, and radiopharmaceuticals to determine their packaging status in CY 2005, in the August 16, 2004 proposed rule, we proposed to use the methodology that was described in detail in the CY 2004 OPPS proposed rule (68 FR 47996 through 47997) and finalized in the CY 2004 final rule with comment period (68 FR 63444 through 63447). We requested comments on the methodology we proposed to continue to use to determine the median cost per day of these items. </P>
                    <P>We proposed to apply an exception to our packaging rule to one particular class of drugs, the injectible and oral forms of anti-emetic treatments. The HCPCS codes to which our exception to the packaging rule for CY 2005 would apply were listed in Table 24 of the proposed rule (69 FR 50506). Our calculation of median cost per day for these products showed that, if we were to apply our packaging rule to these items, two of the injectible products would be packaged and one would be separately payable. In addition, two of the oral products would be separately payable and one would be packaged. Chemotherapy is very difficult for many patients to tolerate as the side effects are often debilitating. In order for beneficiaries to achieve the maximum therapeutic benefit from chemotherapy and other therapies with side effects of nausea and vomiting, anti-emetic use is often an integral part of the treatment regimen. We wanted to ensure that our payment rules did not impede a beneficiary's access to the particular anti-emetic that is most effective for him or her as determined by the beneficiary and his or her physician. Therefore, we proposed to pay separately for all six injectible and oral forms of anti-emetic products in CY 2005. </P>
                    <P>We received several public comments on our proposed criteria for packaging payment for drugs, biologicals, and radiopharmaceuticals. </P>
                    <P>
                        <E T="03">Comment:</E>
                         Many commenters supported our proposal to continue paying separately for drugs, biologicals, and radiopharmaceuticals whose median costs per day exceed $50. The commenters encouraged CMS to continue to maintain the threshold at $50 after CY 2006 and recommended that any additional packaging threshold be examined carefully prior to future implementation so that beneficiary access to therapies will not be compromised as a result. One of the commenters, however, remained concerned about the packaging of other drugs and biologicals that fell below the $50 threshold and recommended that CMS make separate payments for drugs and biologicals that meet one or both of the following criteria: products with median cost per day of at least $50; or products that are eligible for separate payment in other outpatient sites of care and that received a separate payment previously under the OPPS. Another commenter expressed concern about the site of service incentives presented by some drugs being paid when furnished in the physicians' offices, while being packaged in the hospital setting. The commenter urged CMS to consider several options, including: Making separate payment for all drugs in CY 2005 that were separately paid under a previous OPPS payment rate and are separately paid for in physicians' offices; lowering the packaging threshold, for example, to $10 or $20; paying separately for all drugs for which the 106 percent of ASP payment amount in the physicians' office is at least $10; or establishing procedures to ensure that drugs used for similar indications (including off-label uses) are either all packaged or all paid separately. MedPAC, to the contrary, expressed concern about the use of an arbitrary cut-off of $50 per administration for separate payment of drugs. It stated that separate payment for certain more expensive drugs gave hospitals an incentive to use those drugs rather than those that are packaged, and the threshold also gave manufacturers an incentive to price their drugs to ensure that they are above $50 per administration. MedPAC recommended that CMS should carefully analyze alternative thresholds or the creation of larger bundles to allow for alternative approaches once the MMA provision requiring a $50 threshold expires in CY 2007. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We appreciate the support of many commenters for our packaging policy for CY 2005. Section 621(a)(2) of Pub. L. 108-173 requires that the threshold for establishing separate APCs for drugs and biologicals be set at $50 per administration for CYs 2005 and 2006. Therefore, we cannot change the threshold amount for CY 2005 as some of the commenters have suggested. We will take all of the commenters' recommendations into consideration as 
                        <PRTPAGE P="65780"/>
                        we work on our packaging proposal for the CY 2007 OPPS.
                    </P>
                    <P>However, in light of the commenters' concerns, we have decided to apply our equitable adjustment authority to establish several exceptions to the packaging threshold. We note that there were seven drugs and biologicals that we proposed to pay separately for in our proposed rule. However, when we recalculated their median costs per day using all of the hospital claims used for this final rule with comment period, their median costs per day were less than $50. We considered several payment options for these drugs and biologicals, such as packaging all of the items in CY 2005 or paying separately for all of them as we had proposed. However, after evaluating these drugs carefully, we decided to finalize the following payment policy for these items: </P>
                    <P>• Drugs and biologicals that were paid separately in CY 2004 and have median costs per day less than $50 based on the hospital claims data being used for the CY 2005 final rule with comment period would continue to receive separate payment in CY 2005. </P>
                    <P>• Those drugs and biologicals that are packaged in CY 2004 and that have median costs per day less than $50 based on the hospital claims data being used for the CY 2005 final rule with comment period would remain packaged in CY 2005. </P>
                    <P>We believe these policies are the most equitable for this particular set of drugs given the fluctuations in median hospital cost relative to the $50 threshold and their status in CY 2004. </P>
                    <P>Table 24 lists the seven drugs and biologicals to which this policy will apply along with their CYs 2004 and 2005 payment status indicator. The four items that will be separately paid under this policy meet the definition of sole source “specified covered outpatient drugs” and will be paid between 83 percent and 95 percent of their AWP in CY 2005. </P>
                    <GPH SPAN="3" DEEP="245">
                        <GID>ER15NO04.039</GID>
                    </GPH>
                    <P>
                        <E T="03">Comment:</E>
                         One commenter indicated that CMS was proposing a packaging policy that appeared to be different from the MMA requirement because a particular drug may be administered more than once per day. Therefore, the commenter added, a drug with a cost per administration of less than $50 that is administered more than once per day would qualify for separate payment under CMS' proposed policy, but would not qualify for separate payment under the MMA requirement. The commenter indicated that the overall impact of this discrepancy is that there will be less packaging of drugs under the OPPS than Congress intended. The commenter was unclear as to whether CMS had the authority to deviate from the statute in this way. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We note that the hospital claims data do not indicate whether there were multiple administrations of the same drug on a single day. Accordingly, we must assume that for all cases there was only a single administration of each drug per day. For packaging purposes, the median cost per day for each drug and biological must, therefore, serve as a proxy for its cost per administration. We will, however, continue to explore ways to distinguish single versus multiple drug administrations for future OPPS updates. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         Numerous commenters, including several manufacturers of pharmaceutical products, individual hospitals, and hospital associations, strongly supported CMS' proposed exception to exclude the six injectible and oral forms of 5HT3 anti-emetic products from the packaging threshold and allow separate payment for all of them. One commenter indicated that CMS' claims data used to determine median cost per day may not be a reliable source for accurate median costs for these products and may understate their actual acquisition and related costs. Another commenter stated that if the $50 threshold were applied to this class of drugs, it would have created an incentive for hospitals to choose therapies based on the opportunity for payment and not their appropriateness for each individual patient. The commenters agreed that this policy would help to ensure beneficiary access to the most appropriate anti-emetic drug for cancer care. Several commenters also urged CMS to give careful thought to the effects of packaging on patient access to other types of drugs and biological therapies. However, one commenter indicated that, in recent months, the 
                        <PRTPAGE P="65781"/>
                        wholesale acquisition cost for one of the injectible anti-emetic drugs specified in the proposed exception was reduced by the manufacturer by seventy-three percent. If the proposed exception were applied to this drug, the payment would provide a margin of over one hundred dollars for each dose administered and the outcome would be contrary to the stated intent of the proposal. The commenter believed that CMS could not have anticipated the perverse payment situation that would result under such an exception and recommended that CMS reconsider and withdraw the exception to the packaging rule for this class of drugs. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We appreciate the commenters' support of our proposal to pay for the six 5HT3 products separately. We also recognize the concerns raised by a commenter informing us of the price reduction for one of the injectible products. However, we firmly believe that packaging some of the 5HT3 anti-emetic products and paying separately for others may negatively impact a beneficiary's access to the particular anti-emetic that is most effective for him or her as determined by the beneficiary and his or her physician. Therefore, we are finalizing our policy to pay separately for all six injectible and oral forms of anti-emetic products in CY 2005. We note that this policy only affects drugs of a particular class (in this case, 5HT3 anti-emetic products) that vary in their payment status (that is, packaged or paid separately), and our intent is not to generally standardize payment methodologies for separately payable drugs of the same class. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         One commenter expressed operational concerns about billing for oral anti-emetics associated with chemotherapy. The commenter indicated that it will be extremely difficult to bill for these drugs when the same HCPCS codes are used for the drugs' use in nausea not associated with chemotherapy and requested that CMS consider establishing a separate HCPCS code or an edit that will only allow payment when a cancer diagnosis is on the claim. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         The following HCPCS codes are those hospitals use to report the six 5HT3 products irrespective of their use: J1260 (Injection, Dolasetron, Mesylate, 10 mg), Q0180 (Dolasetron Mesylate, 100 mg, oral), J1626 (Injection, Graniestron Hydrochloride, 100 mcg), Q0166 (Granisetron Hydrochloride, 1 mg, oral), J2405 (Injection, Ondansetron Hydrochloride, per 1 mg), and Q0179 (Ondansetron Hydrochloride 8 mg, oral). The policy discussed above applies only to the packaging status of these products, not to their coverage status. Hospitals should continue billing in accordance with existing coverage rules. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         We received comments on the packaging status of several drugs, biologicals, and radiopharmaceutical agents where the commenters indicated that the items were incorrectly packaged and should be paid separately as sole source “specified covered outpatient drugs.” Specific items mentioned in the comments were HCPCS codes A9524, Q3010, J2790, and J7525. The commenters asserted that the median cost per day calculations for these products were based on inaccurate and incomplete hospital claims data because the hospitals were not likely to have been charging appropriately for the products or billing the correct number of units. One of the commenters also cited changes in HCPCS code descriptors and the lag time in hospitals updating their charge masters to reflect revised code descriptors as possible reasons for why the hospital claims data may be skewed and may not be reflective of hospitals' actual acquisition costs. Another commenter asserted that since many of these drugs were packaged in CY 2003, the claims data did not capture the drugs' actual costs. Commenters urged CMS to review only the “correctly coded” claims when determining median cost per day for these products, use external data to help determine appropriate payment rates, or pay for the drugs separately as sole source “specified covered outpatient drugs” since these items meet that definition. Another commenter requested that CMS retain the CY 2004 payments until there is enough data to accurately determine payment rates. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We understand commenters' concerns about the median cost per day for these particular items. To determine which claims for drugs, biologicals and radiopharmaceuticals are “correctly coded” would require that we attempt to assess which claims indicate that the number of units billed were or were not clinically reasonable. Given variations among patients with respect to the appropriate doses, the variety of indications with different dosing regimens for some agents, our lack of information about how many doses were administered on a given day, the possibility of off-label uses, and our desire not to question the clinical judgment of the prescribing providers on these issues, we do not believe that an approach that attempts to identify and use only “correctly coded” claims is feasible. The hospital claims database is the best and most complete source of data we have for establishing median hospital costs for the services and items paid for under the OPPS. 
                    </P>
                    <P>In section III.B. of this final rule with comment period, we discuss comments concerning our methodology for units trimming. It is possible that some other approaches to units trimming could increase the derived cost per day for some drugs but could also result in decreases for some. For others, it could result in no difference for the drug in relation to the $50 threshold. As a test, we applied several different unit trim approaches to one of the codes for which we received comments and still did not achieve a median cost per day above $50. Nevertheless, we appreciate the thoughtful comments we have received on this topic and will consider the issue of units trimming in later development of our OPPS payment rates. For our final policy for CY 2005, however, we retain the methodology that we proposed. We will also encourage hospitals to carefully consider the descriptions of each HCPCS code when determining the number of units to bill for drugs, biologicals and radiopharmaceuticals. We will consider special efforts related to particular items. We would note, also, that the payment hospitals receive for a particular drug is based on the number of units billed. If a hospital underreports the number of units administered to a patient due to a misunderstanding about the definition of the code, the hospital will not receive the full amount to which it is entitled. Conversely, hospitals should not report more units than appropriate based on the coding description and the amount required to treat the patient. </P>
                    <HD SOURCE="HD3">3. Payment for Drugs, Biologicals, and Radiopharmaceuticals Without Pass-Through Status That Are Not Packaged </HD>
                    <HD SOURCE="HD3">a. Payment for Specified Covered Outpatient Drugs </HD>
                    <P>Section 621(a)(1) of Pub. L. 108-173 amended section 1833(t) of the Act by adding a new subparagraph (14) that requires special classification of certain separately paid radiopharmaceutical agents and drugs or biologicals and mandates specific payments for these items. Under section 1833(t)(14)(B)(i), a “specified covered outpatient drug” is a covered outpatient drug, as defined in section 1927(k)(2) of the Act, for which a separate APC exists and that either is a radiopharmaceutical agent or is a drug or biological for which payment was made on a pass-through basis on or before December 31, 2002. </P>
                    <P>
                        Under section 1833(t)(14)(B)(ii) of the Act, certain drugs and biologicals are designated as exceptions and are not 
                        <PRTPAGE P="65782"/>
                        included in the definition of “specified covered outpatient drugs.” These exceptions are: 
                    </P>
                    <P>• A drug or biological for which payment is first made on or after January 1, 2003, under the transitional pass-through payment provision in section 1833(t)(6) of the Act. </P>
                    <P>• A drug or biological for which a temporary HCPCS code has not been assigned. </P>
                    <P>• During CYs 2004 and 2005, an orphan drug (as designated by the Secretary). </P>
                    <P>Section 1833(t)(14)(A)(i) of the Act, as added by section 621(a)(1) of Pub. L. 108-173, specifies payment limits for three categories of specified covered outpatient drugs in CY 2004. Section 1833(t)(14)(F) of the Act defines the three categories of specified covered outpatient drugs based on section 1861(t)(1) and sections 1927(k)(7)(A)(ii), (k)(7)(A)(iii), and (k)(7)(A)(iv) of the Act. The categories of drugs are “sole source drugs,” “innovator multiple source drugs,” and “noninnovator multiple source drugs.” The definitions of these specified categories for drugs, biologicals, and radiopharmaceutical agents under Pub. L. 108-173 were discussed in the January 6, 2004 OPPS interim final rule with comment period (69 FR 822), along with our use of the Medicaid average manufacturer price database to determine the appropriate classification of these products. Because of the many comments received on the January 6, 2004 interim final rule with comment period, the classification of many of the drugs, biologicals, and radiopharmaceuticals changed from that initially published. These changes were announced to the public on February 27, 2004, Transmittal 112, Change Request 3144. Additional classification changes were implemented in Transmittals 3154 and 3322. </P>
                    <P>We received 25 public comments associated with the January 6, 2004 interim final rule with comment period. These public comments are summarized under section V.B.4. of this preamble. </P>
                    <P>Section 1833(t)(14)(A) of the Act, as added by section 621(a)(1) of Pub. L. 108-173, also provides that payment for these specified covered outpatient drugs is to be based on its “reference average wholesale price,” that is, the AWP for the drug, biological, or radiopharmaceutical as determined under section 1842(o) of the Act as of May 1, 2003 (section 1833(t)(14)(G) of the Act). Section 621(a) of Pub. L. 108-173 also amended the Act by adding section 1833(t)(14)(A)(ii), which requires that: </P>
                    <P>• A sole source drug must, in CY 2005, be paid no less than 83 percent and no more than 95 percent of the reference AWP. </P>
                    <P>• An innovator multiple source drug must, in CY 2005, be paid no more than 68 percent of the reference AWP. </P>
                    <P>• A noninnovator multiple source drug must, in CY 2005, be paid no more than 46 percent of the reference AWP. </P>
                    <P>Section 1833(t)(14)(G) of the Act defines “reference AWP” as the AWP determined under section 1842(o) as of May 1, 2003. We interpreted this to mean the AWP set under the CMS single drug pricer (SDP) based on prices published in the Red Book on May 1, 2003. </P>
                    <P>For CY 2005, we proposed to determine the payment rates for specified covered outpatient drugs under the provisions of Pub. L. 108-173 by comparing the payment amount calculated under the median cost methodology as done for procedural APCs (described previously in the preamble) to the AWP percentages specified in section 1833(t)(14)(A)(ii) of the Act. </P>
                    <P>Specifically, for sole source drugs, biologicals, and radiopharmaceuticals, we compared the payments established under the median cost methodology to their reference AWP. We proposed to determine payment for sole source items as follows: If the payment falls below 83 percent of the reference AWP, we would increase the payment to 83 percent of the reference AWP. If the payment exceeds 95 percent of the reference AWP, we would reduce the payment to 95 percent of the reference AWP. If the payment is no lower than 83 percent and no higher than 95 percent of the reference AWP, we would make no change. </P>
                    <P>
                        <E T="03">Comment:</E>
                         A few commenters strongly opposed the decrease in the payment floor for sole source specified covered outpatient drugs from 88 percent of AWP in CY 2004 to 83 percent of AWP in CY 2005. The commenters believed that the decrease was inappropriate and lacked sound policy justification. The commenters recommended that for CY 2005 the payment floor for sole source specified covered outpatient drugs be maintained at 88 percent of AWP. One commenter, however, was concerned about the proposed payment rate for HCPCS code J9395 (Injection, Fulvestrant, 25 mg), which is based on 83 percent of AWP instead of 85 percent of AWP that is the CY 2004 payment level. The commenter asserted that CMS's use of median cost data to establish appropriate payment rates for specified covered outpatient drugs is faulty for this drug because of concerns about the accuracy of the hospital median cost data. The commenter also indicated that several payment changes affecting this drug were likely to have created a significant degree of confusion among hospitals that may have negatively skewed hospital median cost data and led CMS to correlate the data to an AWP-based payment percentage that is too low. Another commenter urged CMS to create an exceptions process that would provide for appropriate adjustments within the MMA-specified payment corridor upon submission of data documenting potential access problems or a payment rate significantly lower than the acquisition cost of the drug. The commenter indicated that creating such an approach would help to minimize disruption to patient access to drugs in the hospital outpatient setting. To the contrary, several commenters were pleased with the payment rates for certain products at 83 percent of their AWPs. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         Section 621(a) of Pub. L. 108-173 is very specific in requiring that a sole source drug must be paid no less than 83 percent and no more than 95 percent of the reference AWP in CY 2005. We used the 83 percent of AWP as the payment floor to set payment rates for sole source drugs, unless payments based on median costs were higher, as we lack any data to determine what would be the appropriate payment level between 83 percent and 95 percent of AWP for all sole source drugs. We set up a payment floor to avoid paying for these drugs at different arbitrarily determined payment levels. We note that if data show that the payment rate for a drug falls between the 83 percent floor and 95 percent ceiling, the drug is paid at the payment rate. 
                    </P>
                    <P>
                        We have responded to comments about the relative hospital data from our claims above and in other sections of this preamble. While we certainly share the desire to provide beneficiaries with access to the drugs that are reasonable and necessary for the treatment of their conditions, we do not agree with the comments that we should pay above the 83 percent floor established by the MMA for sole source drugs if the median hospital cost falls below this floor. We believe the intent of the law is to use hospital cost data as the best available information in setting the payment rates for most items paid for under the OPPS. In the case of sole source specified covered outpatient drugs, the MMA provides for a floor of 83 percent of the reference AWP for those items for which the payment based on relative hospital costs would fall below 83 percent of the AWP and a ceiling of 95 percent of the reference AWP for items where the relative 
                        <PRTPAGE P="65783"/>
                        hospital costs from our claims data exceed that amount. We are not convinced that the 83 percent AWP floor is a barrier to appropriate treatment. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         One commenter, the manufacturer of AGGRASTAT
                        <E T="51">®</E>
                        , requested that CMS convert the current temporary outpatient HCPCS code C9109 (Injection, Tirofiban HCl, 6.25 mg) to a permanent national HCPCS code with a base dose of 5 mg and continue to maintain the permanent national HCPCS code J3245 (Injection, Tirofiban HCl, 12.5 mg). The commenter asserted that HCPCS codes with units of 5 mg and 12.5 mg would properly reflect the actual doses of AGGRASTAT
                        <E T="51">®</E>
                         that currently exist in the market. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         For 2005, the National HCPCS Panel decided to delete HCPCS codes C9109 and J3245 and create a new HCPCS code J3246 (Injection, Tirofiban HCl, 0.25 mg). We hope that the creation of this new HCPCS code will ameliorate the commenter's concerns about appropriate coding for this product. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         We received a number of comments on the packaging status of HCPCS codes J7505 (Muromonab-CD3, parenteral, 5 mg) and J9266 (Pegaspargase, single dose vial). The commenters stated that these two products were incorrectly packaged because the data used to determine packaging status were flawed and requested that both products be paid separately as sole source drugs at a rate between 83 percent and 95 percent of their AWPs. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         There were several drugs and biologicals that we proposed to package in the proposed rule, including the two products mentioned in the comments. However, when we recalculated their median costs per day using all of the hospital claims from CY 2003 used for this final rule with comment period, we determined that their median costs per day were greater than $50. Therefore, for CY 2005, we will pay for these drugs and biologicals separately. Items that meet the definition of “specified covered outpatient drugs” (SCOD) will be paid according to the payment methodologies established in the MMA, and payment for items that do not meet the definition will be based on their median unit cost. Table 25 lists the drugs and biologicals that were proposed as packaged drugs and biologicals but will be paid separately in CY 2005. The table also indicates the methodology that will be used to determine their APC payment rates in CY 2005. 
                    </P>
                    <GPH SPAN="3" DEEP="218">
                        <GID>ER15NO04.040</GID>
                    </GPH>
                    <P>
                        <E T="03">Comment:</E>
                         One commenter was concerned about the proposed payment rates for HCPCS codes A9502 (Supply of radiopharmaceutical diagnostic imaging agent, technetium Tc 99m tetrofosmin, per unit dose) and Q3005 (Supply of radiopharmaceutical diagnostic imaging agent, technetium Tc-99m mertiatide, per mci). The commenter indicated that payment corrections made for these two products in the February 27, 2004 CMS Transmittal 113 resulted in significant payment reductions. The commenter was concerned that significant payment fluctuations and reductions were counter-productive to the provision of quality care and will negatively impact the operational viability of nuclear medicine departments. Therefore, the commenter urged CMS to reconsider their proposed payments for these two products. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We understand the commenter's concern about the impact of fluctuations in payment rates for HCPCS codes A9502 and Q3005. However, we note that the payment rates that were listed in the January 6, 2004 interim final rule with comment period for these products were calculated using incorrect reference AWPs as indicated in the February 27, 2004 CMS Transmittal 113. Therefore, we made corrections to the AWPs for these products and recalculated their payment rates according to the payment methodology required by the MMA for sole source “specified covered outpatient drugs”. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         One commenter requested that CMS support a decision by the HCPCS Alpha-Numeric Editorial Panel to issue separate permanent and universal drug codes for echocardiography contrast agents for which applications have been submitted. Specifically, the commenter recommended that CMS support the application submitted for the creation of a J-code for Definity, which is currently being reported as HCPCS code C9112 (Injection, perflutren lipid microsphere, per 2 ml vial). 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         Decisions regarding the creation of permanent HCPCS codes are coordinated by the National HCPCS Panel. Comments related to the HCPCS code creation process and decisions made by the National HCPCS Panel are 
                        <PRTPAGE P="65784"/>
                        outside the scope of this rule; therefore, we will not respond to this comment. We note that until a J-code is established for this product, hospitals can continue to bill for this product using the HCPCS code C9112. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         Several commenters expressed concern about the proposed payment for intravenous immune globulin. They were concerned that CMS calculated the reference AWP for this code using AWPs for one or more products that were no longer commercially available. For example, Carimune and Panglobulin were removed from the market and replaced with Carimune NF and Panglobulin NF, respectively. The commenters requested that CMS review the current pricing data on the brand products that are currently in the market place and recalculate payment for IVIG as a sole source specified covered outpatient drug. Another commenter was concerned about the proposed payment rate for HCPCS code J7198 (Anti-inhibitor, per IU). The commenter indicated CMS calculated the reference AWP for this code using an AWP for a product called Autoplex that was discontinued from the market in May 2004 and recommended that CMS calculate payment for this HCPCS code using cost data associated with the product Feiba VH that currently exists in the market. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We agree with the comments and accordingly recalculated the base AWP for HCPCS code J1563 (Immune globulin, intravenous, 1 g) excluding AWPs for the two discontinued products, Panglobulin and Carimune. Similarly, we excluded the AWP for the discontinued product, Autoplex, when redetermining the base AWP for HCPCS code J7198 (Anti-inhibitor, per IU). We then recalculated their payment rates as sole source “specified covered outpatient drugs.” We note that these changes resulted in an increase in the base AWPs for both products. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         One commenter, the maker of the product billed under HCPCS code C9201 (Dermagraft, 37.5 cm2), requested that CMS set its CY 2005 payment rate under the OPPS identical to the payment rate in the physician office setting. The commenter anticipated a payment rate of $574.41 (third quarter ASP plus 6 percent) when it is used in the physician office setting during CY 2005; however, the proposed payment rate as a sole source drug under the OPPS was $529.54. The commenter indicated that Dermagraft's cost to all customers is identical regardless of the site of service and establishing a payment rate under the OPPS below the cost of the product to hospitals would hinder their access to medical technologies for which they will not recover their costs. Additionally, we received comments from an association representing a group of specialty hospitals and a professional association expressing concern about the proposed payment level for HCPCS code J3395 (Injection, verteporfin, 15 mg). The commenters indicated that the payment rate for this product is significantly less than the acquisition cost for outpatient facilities and requested that CMS pay for it at a rate that covers the cost of acquiring the drug. The commenter also stated that accurate pricing information for the drug should be available when CMS receives final data from the manufacturer on October 31, 2004 and that the final OPPS payment rate should be reflective of the pricing data. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         The products described by HCPCS codes C9201 and J3395 meet the definition of sole source “specified covered outpatient drugs.” The MMA specifies the methodology that determines payment for this group of drugs under the OPPS where, for CY 2005, sole source drugs must be paid between 83 percent and 95 percent of their reference AWP. Since payments for these two products based on the median cost methodology were less than 83 percent of their AWPs, their CY 2005 payment levels were established at 83 percent of their AWP. In these cases, we believe the statute specifically addresses the payment methodology for these drugs. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         A few commenters were concerned about the proposed payment rates for some separately payable drugs and biologicals that did not fall under the category of “specified covered outpatient drugs.” These products would be either paid as pass-through items or their payment rates were based on median cost data; however, the commenters requested that the products be paid as sole source “specified covered outpatient drugs.” One of the commenters requested that external data be used to correct the payment rate for their product. Several rationales were cited for this request to change the payment methodology, such as the use of inaccurate and incomplete hospital claims data to determine payment rates that are lower than actual hospital acquisition costs and eliminating payment differentials between drugs of the same class. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We believe that the MMA defines the items that are to be considered “specified covered outpatient drugs” for payment purposes under the OPPS, and these drugs do not meet the definition. We also recognize that classifying these products as sole source “specified covered outpatient drugs” would increase their payments; however, we are not convinced that the payment rates for these products calculated under current methodologies are insufficient. 
                    </P>
                    <P>In developing our August 16, 2004 proposed rule, there was one sole source item, Co 57 cobaltous chloride (HCPCS code C9013), for which we could not find a reference AWP amount. However, we had CY 2003 claims data for HCPCS code C9013, and therefore, we proposed to derive its payment rate using its median cost per unit. We requested comments on our proposed methodology for determining the payment rate for HCPCS code C9013. We received a few comments in response to our proposal. </P>
                    <P>
                        <E T="03">Comment:</E>
                         The manufacturer of the product billed under HCPCS code C9013 (Supply of Co 57 cobaltous chloride, radiopharmaceutical diagnostic imaging agent), Rubatrope, along with other commenters, indicated that Rubatrope is an FDA-approved radiopharmaceutical and a sole source drug that meets the definition of a “specified covered outpatient drug;” therefore, it should be paid between 83 percent and 95 percent of AWP. The manufacturer of Rubatrope indicated that it had experienced problems with the production of this product in the past 2 years and thus production was discontinued. However, the product will be commercially available from November 2004. The commenter also indicated that it would send CMS an AWP for this product once it becomes available. Therefore, for CY 2005, the commenters strongly urged CMS to establish payment for C9013 as a sole source drug at 83 percent of AWP. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We understand the commenters' concern about the payment rate for this product and note that HCPCS code C9013 was considered a sole source “specified covered outpatient drug” in the proposed rule. However, as we were not able to determine a reference AWP for this product, we based its proposed payment rate on its median cost from the claims data. At the time of the publication of this final rule, we were still unable to find an AWP for this product, and thus, in the absence of an AWP for this product, as proposed we will use the product's median cost to base its CY 2005 payment rate. However, if we determine an AWP for HCPCS code C9013, we will issue a change to its payment accordingly in a quarterly update of the OPPS. 
                    </P>
                    <P>
                        We note that there are three radiopharmaceutical products for which 
                        <PRTPAGE P="65785"/>
                        we proposed a different payment policy in CY 2005. These products are represented by HCPCS codes A9526 (Ammonia N-13, per dose), C1775 (FDG, per dose (4-40 mCi/ml), and Q3000 (Rubidium-Rb-82). Radiopharmaceuticals are classified as a “specified covered outpatient drug” according to section 1833(t)(14)(B)(i)(I) of the Act and their payment is dependent on their classification as a single source, innovator multiple source, or noninnovator multiple source product as defined by sections 1927 (k)(7)(A)(iv), (ii), and (iii) of the Act. Upon further analysis of these items, we determined that these three products do not meet the statutory definition of a sole source item or a multiple source item. Pub. L. 108-173 requires us to pay for “specified covered outpatient drugs” using specific payment methodologies based on their classification and does not address how payment should be made for items that do not meet the definition of a sole source or multiple source item. Therefore, in the August 16, 2004 proposed rule, we proposed to set the CY 2005 payment rates for these three products based on median costs derived from CY 2003 hospital outpatient claims data, which would reflect hospital costs associated with these products. With regard to HCPCS code A9526, we have no hospital outpatient cost data for this HCPCS code. We received correspondence from an outside source stating that Rubidium-Rb-82 (HCPCS code Q3000) is an alternative product used for procedures for which Ammonia N-13 is also used and these two products are similar in cost. Therefore, we proposed to establish a payment rate for Ammonia N-13 that is equivalent to the payment rate for Rubdium Rb-82. 
                    </P>
                    <P>We listed the proposed CY 2005 payment rates for these three items in Table 25 of the proposed rule (69 FR 50507), requested comments on the proposed payment rates and invited commenters to submit external data if they believe the proposed CY 2005 payment rates for these items do not adequately represent actual hospital costs. </P>
                    <P>We received many public comments on the proposed payment rates for the three items. </P>
                    <P>
                        <E T="03">Comment:</E>
                         Many commenters were concerned about the proposed reduction in the payment rate for FDG in CY 2005. They stated that FDG meets the definition of “specified covered outpatient drugs,” and the MMA requires that “specified covered outpatient drugs” be classified as sole source drugs, innovator multiple source drugs, or noninnovator multiple source drugs, and be reimbursed according to a percentage of the reference AWP during CY 2005. Several commenters understood the difficulty CMS had in classifying FDG into one of the three categories of “specified covered outpatient drugs.” However, one of the commenters was concerned that CMS abandoned the methodology prescribed by the MMA and created another payment category for “specified covered outpatient drugs,” which the commenter believed is outside the scope of the MMA. 
                    </P>
                    <P>A commenter suggested that CMS assign FDG to the category that most closely reflects the underlying regulatory and economic environment for the production of FDG, which is the innovator multiple source drug category. The commenter explained that the production and sale of FDG is unusual in that the FDA does not yet require an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA). The commenter also stated that the FDA is currently drafting special criteria to govern NDAs and ANDAs for the production and marketing of FDG, and eventually, manufacturers will be required to submit either an NDA or ANDA in order to sell FDG. Right now, there are no approved ANDAs or “generics” for FDG, and none of the FDA approved products is therapeutically equivalent. The commenter indicated that FDG is sold commercially by at least three manufacturers and is produced by numerous hospitals and academic medical centers for their own use, thus making it a multiple source drug. However, until the FDA finalizes its requirements for NDAs and ANDAs for FDG and all manufacturers have an opportunity to comply with those regulations, all FDG marketed in the United States should be considered a “brand” version. Although the different FDG products distributed are not rated as equivalent by the FDA, FDG was originally marketed under an NDA, and currently there are multiple distributors. Thus, although FDG does not meet all aspects of the multiple source innovator drug definition, given the inaccuracies of the hospital outpatient claims data, this commenter, along with several others, recommended that FDG be paid under the MMA at 68 percent of its AWP. Alternatively, some commenters requested that CMS keep the CY 2005 payment for FDG at its CY 2004 level until the completion of the GAO hospital acquisition cost survey, which will allow for a more reliable basis for setting payment based on average acquisition cost. One commenter stated that CMS should use external data submitted by hospitals to determine the true costs of this product. External data from a survey of 2002 nuclear medicine costs reported by hospitals were submitted, and the results indicated that median cost to hospitals for one dose of FDG is $425. Another commenter stated that their current cost for administering one dose of FDG to patients receiving PET scans is $450 and that CMS should research real market costs for this product before reducing payment by $126 from the current CY 2004 payment rate </P>
                    <P>The commenters all agreed that CMS should not use CY 2003 hospital claims data to calculate payment for FDG in CY 2005 because the reported data fails to accurately capture the actual acquisition cost to hospitals along with all the reasonable costs needed to safely prepare, store, administer, and dispose of the product. Commenters indicated that the HCPCS code descriptor for C1775 is written in a way that requires hospitals to use the same code to report FDG with a concentration of 4mci/ml as they use to report FDG with a concentration of 40 mci/ml, thus making the claims data unreliable, and also, hospitals did not have clear billing and charging guidance. Thus, the commenters claimed that the FDG data from CY 2003 are a flawed basis upon which to make a payment determination and would significantly underpay hospitals. Commenters noted that a reduction in payment for FDG to the proposed payment rate would limit utilization and access to FDG PET because of the financial losses the providers will suffer. </P>
                    <P>
                        <E T="03">Response:</E>
                         We appreciate these thoughtful comments on our proposed payment rate for FDG. Based on the unique regulatory processes that affect the manufacturing and marketing of FDG, we believe that it is reasonable for us to classify FDG as an innovator multiple source drug. Therefore, we will not reinstate the HCPCS code C9408 (FDG, brand, per dose), which we inadvertently deleted as stated in the October 2004 Update of the OPPS (CMS Transmittal 290). In CY 2005, hospitals should use C1775 to bill for all FDG products. 
                    </P>
                    <P>
                        With respect to calculating payment for FDG in CY 2005, the MMA requires that an innovator multiple source drug must be paid no more than 68 percent of the reference AWP. The MMA sets forth a payment ceiling for the brand innovator multiple source drugs, but does not provide a payment floor for them. We believe that the intent of the statute is to use available hospital 
                        <PRTPAGE P="65786"/>
                        claims to set payment rates for most items paid under OPPS; therefore, we apply the ceiling only when the payment for an item based on the median hospital cost for the drug exceeds the ceiling. As we described in section V.A.3.a. of this final rule with comment period, for innovator multiple source drugs, we set the payment rate at the lower of the payment rate calculated under the standard median cost methodology or 68 percent of the AWP. We have applied this methodology to all of the other innovator multiple source drugs; therefore, we do not believe that it would be appropriate for us to exempt FDG from this methodology and pay for it at 68 percent of AWP, the ceiling for innovator products. We believe that basing payment for this item on relative hospital costs, with the application as appropriate of the previously mentioned ceiling, not only meets the intent but also the requirements of the MMA. The payment rate for C1775 in CY 2005 will be $221.11. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         The manufacturer of CardioGen-82, also known as Rubidium Rb-82, along with other commenters asserted that this product does meet the classification of a sole source drug as defined by the MMA. The commenters indicated that FDA approval for this product was received under an NDA, and there is currently only one manufacturer of the Cardiogen-82 generators used to produce Rubidium Rb-82. Also, there is no FDA-approved generic product for Rubidium Rb-82. One of the commenters indicated that a survey was conducted to obtain data on actual hospital costs for Rubidium Rb-82, which showed that the median per dose cost to hospitals was $244.73. Thus, the commenter believed that CMS hospital cost data were flawed and do not represent true hospital costs; therefore, the hospital claims cost data should not be used to set the payment rate for Rubidium Rb-82 in CY 2005. Other commenters indicated that median cost data used by CMS to calculate the payment rate for Rubidium Rb-82 underreport the actual and reasonable hospital costs needed to safely prepare, store, administer, and dispose of the product. The commenters urged CMS to recognize HCPCS code Q3000 (Supply of radiopharmaceutical diagnostic imaging agent, Rubidium Rb-82, per dose) as a sole source drug and set its payment at 83 percent of its AWP, or at minimum, retain the CY 2004 payment rate. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We appreciate these comments. Based on further evaluation of the appropriate classification for this product, we agree with the commenters that Rubidium Rb-82 should be classified as a sole source product. Therefore, payment for Q3000 will be made at 83 percent of AWP as its payment based on the median cost methodology is less than 83 percent of AWP. The payment rate for Rubidium Rb-82 in CY 2005 will be $153.39 per dose. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         Numerous commenters were concerned about the proposed payment rate for HCPCS code A9526 (Ammonia N-13, per dose). Some of the commenters stated that CMS proposed to treat HCPCS codes Q3000 (Rubidium Rb-82, per dose) and A9526 under a “presumptive functional equivalence” in setting the same payment rate for these products when they are not functionally equivalent. It was also stated that Rubidium Rb-82 and Ammonia N-13 are used for similar procedures, but they have different costs, clinical composition, and utilization patterns. Another commenter indicated that Rubidium Rb-82 significantly differs from the other PET radiopharmaceuticals as it is produced by a radionuclide generator system, compared to FDG and Ammonia N-13 that are made in cyclotrons. A commenter also stated that Ammonia N-13 has no commercial vendors; whereas, Rubidium Rb-82 is produced and distributed by one commercial vendor. Some commenters suggested that CMS pay for A9526 separately, similar to other “specified covered outpatient drugs.” On the other hand, other commenters recommended that, in the absence of reliable cost data or a published AWP, CMS should use the cost of FDG as a proxy for the cost of Ammonia N-13, since these products have equivalent production costs. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We recognize the concerns raised by commenters about our proposal to pay for Ammonia N-13 at the same payment rate as Rubidium Rb-82. We acknowledge that Ammonia N-13 meets the definition of “specified covered outpatient drugs;” however, we have not been able to determine an AWP for this product. Thus, we cannot set a payment rate for this product based on a percentage of its AWP. While some of the commenters recommended that we set the payment rate for Ammonia N-13 at the same level as that for FDG, we are aware this would give rise to the same concerns raised by commenters regarding payment for Ammonia N-13 and Rubidium Rb-82. Therefore, we are not adopting our proposed payment policy for Ammonia N-13. Based on the complete CY 2003 hospital claims data that were used for this final rule with comment period, we were able to identify claims submitted for Ammonia N-13; therefore, for CY 2005, we will use median cost derived from the claims data to set the payment for this product. The CY 2005 payment rate for A9526 will be $109.86 per dose. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         A number of commenters, including several cancer research centers and trade associations representing the radionuclide and radiopharmaceutical industry, biomedical science, and the biotechnology industry, as well as the manufacturers of Bexxar (billed using HCPCS codes C1080, C1081, and G3001) and Zevalin (billed using HCPCS codes C1082 and C1083), expressed concern that 83 percent of AWP is insufficient to reimburse hospitals for the cost of acquiring Zevalin and Bexxar. Several commenters, including the manufacturer of Zevalin, were concerned that the proposed payment rates for Zevalin are inadequate to facilitate patient access to this critical therapy. One commenter stated that, because Zevalin is a radioimmunotherapy, its purchase and use are subject to state regulatory safeguards that limit its availability in the oncology practices; therefore, its access in the hospital outpatient setting is crucial. The commenter urged CMS to maintain the 2004 payment rates for Zevalin, which are at 88 percent of AWP, into CY 2005, and indicated that this stability would make treatment with Zevalin more economically feasible for hospitals. 
                    </P>
                    <P>One commenter, the manufacturer of Bexxar, expressed concern about what they identified as several “inequities” in the coding and proposed payments for Bexxar and Zevalin. Specifically, the commenter pointed out that the payment proposed for Bexxar in CY 2005 is more than $1500 less than the payment proposed for Zevalin. This commenter further recommended that payment for Bexxar be set at its wholesale acquisition cost, which is $19,500, or 95 percent of the RAWP, which would be $22,230. Several commenters indicated that CMS has the option to exceed the floor of 83 percent of AWP established under the MMA for sole source specified covered outpatient drugs, which would enable CMS to set a rate for Bexxar and Zevalin commensurate with their cost. </P>
                    <P>Two commenters recommended that CMS consider external data where available to supplement its payment determinations for Bexxar and Zevalin. </P>
                    <P>
                        <E T="03">Response:</E>
                         We share the commenters' concerns that Medicare payment rates not be a barrier to beneficiary access to radioimmunotherapy for the treatment of non-Hodgkins lymphoma. However, we do not agree with the comments that we should set the OPPS payment rates 
                        <PRTPAGE P="65787"/>
                        for Zevalin and Bexxar based on their CY 2004 payment levels, on external data, on their WAC, or on any payment amount other than that which is consistent the designation of radiopharmaceuticals in the MMA as specified covered outpatient drugs. 
                    </P>
                    <P>Zevalin and Bexxar are radiopharmaceuticals, and the MMA includes them as “specified covered outpatient drugs” for the OPPS payment purposes. Each meets the definition of a sole source drug. We believe the intent of the law is that we set payment rates for most items paid for under the OPPS using hospital cost data from the best and most recent information available, unless the statute directs otherwise, as in the case of drugs with pass-through status or new drugs without HCPCS codes. The MMA provides a floor of 83 percent of the reference AWP in CY 2005 for sole source specified covered outpatient drugs for which payment based on relative hospital costs would be less. Similarly, the MMA provides a cap of 95 percent of the reference AWP in CY 2005 for sole source specified covered outpatient drugs for which payment based on relative hospital costs would be higher. The statute provides a payment floor and ceiling for sole source “specified covered outpatient drugs,” at no lower than 83 percent of AWP or higher than 95 percent of AWP; the statute does not require a payment at some intermediate level that falls between 83 percent and 95 percent of AWP. </P>
                    <P>Payment for Zevalin based on relative hospital costs drawn from CY 2003 claims data would fall below 83 percent of the reference AWP. As we did in the case of other sole source drugs for which payment based on hospital claims would be lower than 83 percent of AWP, we proposed to set payment for Zevalin at 83 percent of the reference AWP. We also proposed to set payment for Bexxar in CY 2005 as a sole source radiopharmaceutical at 83 percent of AWP because, like Zevalin, it is a radiopharmaceutical and, therefore, a sole source specified covered outpatient drug under the MMA. We discuss in section V.G. of this final rule with comment period that we are making final our proposal to treat radiopharmaceuticals the same as we treat drugs and biologicals for purposes of ratesetting, with two exceptions: We will set payment for new radiopharmaceuticals for which we have no claims data, and for new radiopharmaceuticals with pass-through status effective on or after January 1, 2005, based on the MMA CY 2005 payment requirements for specified covered outpatient drugs. We have no ASP for Bexxar because it is a radiopharmaceutical, and manufacturers have not been required to submit ASP for radiopharmaceuticals. We have no claims data from which to calculate relative hospital costs for Bexxar because of the newness of the product. Therefore, we are setting payment for Bexxar in accordance with the MMA requirement that a sole source specified covered outpatient drug be paid no less than 83 percent of AWP in CY 2005. </P>
                    <P>
                        <E T="03">Comment:</E>
                         A number of commenters, including several cancer centers and a nuclear medicine trade association, asked that CMS provide payment to hospitals for the cost of compounding each patient-specific dose of Bexxar, noting that the compounding costs amount to several thousand dollars in addition to the cost of the drug itself. One of these commenters recommended that the cost of compounding Bexxar be included in the payment for the product and that C1080 and C1081 be assigned to a new technology APC to reflect the total cost of the product plus compounding. One commenter, the manufacturer of Bexxar, is concerned because the payment proposed for Bexxar in CY 2005 does not include payment for the cost of compounding that is required to prepare patient specific doses of diagnostic and therapeutic I-131 tositumomab, whether done by the hospital's own radiopharmacy or by a commercial radiopharmacy. The commenter estimates that hospitals incur a compounding cost of $2,000-$3,000 to furnish Bexxar to a single patient when a commercial radiopharmacy does the compounding. The commenter recommends that CMS either base payment for Bexxar on 95 percent of AWP, continue payment for Bexxar at the CY 2004 level, or establish a new code to enable hospitals to bill separately for Bexxar compounding costs. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         Because Zevalin and Bexxar are radiopharmaceuticals that fall under the category of sole source specified covered drugs established by the MMA, the payment rates for these products are based on AWP, as required by the MMA. To the extent that compounding costs are reflected in the AWP, the payment rate includes these costs. If hospitals incur additional compounding costs for the radiolabeled monoclonal antibodies, those costs could be reported as a separate line item charge with an appropriate revenue code or packaged into the charge for CPT codes 78804 and 79403, which could result in an outlier payment if the outlier threshold for those services was exceeded. The MMA requires that MedPAC submit a report to the Secretary by July 1, 2005 on adjustment of payment for ambulatory payment classifications for specified covered outpatient drugs to take into account overhead and related expenses, such as pharmacy services and handling costs. We look forward to receiving this report in anticipation that the data collected by MedPAC will enable us to address drug-related overhead costs in future OPPS updates. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         Several commenters expressed concerns that the payment rates proposed for Bexxar could result in clinicians having to make treatment decisions based upon payment considerations rather than medical considerations, and could result in physicians having to deny patients a potential life-saving therapy. The same commenters were concerned that the payment proposed for Zevalin and Bexxar does not recognize all of the additional costs associated with the provision of radiolabeled antibody therapy or radioimmunotherapy (RIT) for the treatment of non-Hodgkins lymphoma. These commenters urged CMS to consider all of the costs associated with this therapy when setting payment rates for each component of the regimen and recommended that CMS ensure that total payment to hospitals be commensurate with all of the actual costs that hospitals incur to acquire, prepare, and administer radiolabeled antibodies and to perform all of the additional procedures associated with RIT, thereby ensuring that patient access to these vital therapies will not be jeopardized. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We share the commenters' concerns about the extent to which payment considerations influence treatment decisions. However, we believe that to the extent that radioimmunotherapy proves to be an efficacious treatment for patients with certain forms of non-Hodgkins lymphoma, payment in the aggregate for the full array of procedures and services associated with this new form of treatment affords hospitals sufficient flexibility to ensure that payment is not a barrier to beneficiary access when it is deemed reasonable and necessary. 
                    </P>
                    <P>Table 26 below lists the final APC payment rates for sole source drugs, biologicals, and radiopharmaceuticals effective January 1, 2005 to December 31, 2005. </P>
                    <BILCOD>BILLING CODE 4120-01-P</BILCOD>
                    <GPH SPAN="3" DEEP="331">
                        <PRTPAGE P="65788"/>
                        <GID>ER15NO04.041</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="578">
                        <PRTPAGE P="65789"/>
                        <GID>ER15NO04.042</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="580">
                        <PRTPAGE P="65790"/>
                        <GID>ER15NO04.043</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="605">
                        <PRTPAGE P="65791"/>
                        <GID>ER15NO04.044</GID>
                    </GPH>
                    <P>
                        In order to determine the payment amounts for innovator multiple source and noninnovator multiple source forms of the drug, biological, or radiopharmaceutical, we compared the payments established under the median cost methodology to their reference AWP. For innovator multiple source items, we proposed to set payment rates at the lower of the payment rate calculated under our standard median cost methodology or 68 percent of the reference AWP. For noninnovator multiple source items, we proposed to set payment rates at the lower of the 
                        <PRTPAGE P="65792"/>
                        payment rate calculated under our standard median cost methodology or 46 percent of the reference AWP. We followed this same methodology to set payment amounts for innovator multiple source and noninnovator multiple source “specified covered outpatient drugs” that were implemented by the January 6, 2004 interim final rule with comment period. We listed the proposed payment amounts in Table 26 of the proposed rule. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         One commenter, an association of cancer centers, indicated that CMS proposed the same payment rate for both the brand name and generic versions of a drug. Given that CMS does not have separate HCPCS code level data for brand versus generic drugs in the CY 2003 claims data, the commenter indicated that it did not understand how CMS could use claims data to justify equivalent payment levels for both brand and generic versions of a drug. The commenter was also concerned about the adequacy of using the CY 2003 claims data to calculate the costs of these products and making comparisons to the payment rate ceilings set forth by the MMA for multi-source drugs, especially for the brand name drugs. Therefore, the commenter requested that CMS pay for all brand name drugs at 68 percent of AWP and pay for generics by comparing the calculated cost using the claims data to the 46 percent of AWP threshold and selecting the lower of the two as the payment rate. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         For CY 2005, as for the current year, the MMA sets forth different payment ceilings for the brand and generic versions of the drug. The MMA does not provide a payment floor for either the brand or generic versions of such items. Only sole source drugs have a payment floor and ceiling. As stated elsewhere in this final rule with comment period, the CY 2005 payment rate for innovator multiple source (brand name) drugs may not exceed 68 percent of the reference AWP. The payment for noninnovator multiple source (generic) drugs may not exceed 46 percent of the reference AWP. In determining payment rates, we apply those ceilings only when the payment for an item based on the median hospital cost for the drug exceeds one of these ceilings. In some cases, the payment based on the median hospital cost falls below the 46 percent ceiling for generic drugs. In such cases, the payment rate would be the same for brand and generic versions. However, we believe that basing payment for these items on relative hospital costs, with the application as appropriate of the previously mentioned ceilings not only meets the intent but also the requirements of the MMA. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         A few commenters indicated that the proposed payment rate of $410.45 for HCPCS code A9600 (Supply of therapeutic radiopharmaceutical, Strontium-89, per mci) would underpay hospitals for this product since the payment rate was based on flawed CMS median cost data that do not accurately reflect the real acquisition cost of this drug by hospitals. The commenters believed that hospital costs for A9600 are approximately $800 per mci and requested that CMS adjust the payment accordingly. One commenter, who was the manufacturer of this product, asserted that the product is expensive and difficult to manufacture since it is produced in small quantities. The commenter also indicated that the reduction in the payment rate for this product is driving the underutilization of this product and increasing the use of costly narcotic analgesics, thus resulting in a decrease in quality of life and a rise in the cost of health care. Another commenter stated that the HCPCS codes for diagnostic and therapeutic iodine products (C1064, C1065, C1188, C1348, A9528, A9529, A9530, A9531, A9517 and A9518) all describe in various years and forms diagnostic and therapeutic Iodine 131 and that these codes have had varying descriptions that have resulted in flawed cost data. The commenter submitted data indicating that the cost for I-131 in the capsule form is higher than for solution, and recommended that CMS use external data to restore and correct payment rates for the Iodine 131 product so that the payment more accurately reflects actual hospital costs. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We understand the commenters' concerns about establishing appropriate payment rates for these products. We believe that the intent of the statute is to use available hospital claims to set payment rates for most items paid under the OPPS. In the case of multiple source drugs such as these products, the MMA requires that innovator and noninnovator multiple source drugs be paid no more than 68 percent and 46 percent of their AWP, respectively. 
                    </P>
                    <P>As previously stated, for innovator multiple source drugs, we set the payment rate at the lower of the payment rate calculated under the standard median cost methodology or 68 percent of the AWP; and for noninnovator multiple source drugs, we set the payment rate at the lower of the payment rate calculated under the standard median cost methodology or 46 percent of the AWP. Using the most recent available data, we determined that the payment rates based on median cost for these drugs were lower than both 68 percent and 46 percent of their AWPs; therefore, the payment rates for both the innovator and noninnovator forms of these products were based on their median costs. </P>
                    <P>
                        <E T="03">Comment:</E>
                         One commenter, the maker of one of the viscosupplement drugs, was concerned that the proposed payment rates for the four competitive products are inequitable and will harm beneficiary access to these therapies. The commenter indicated that currently two of the products, Hyalgan and Supartz, are billed using HCPCS code J7317 (Sodium Hyaluronate, per 20 to 25 mg dose for intra-articular injection), and this HCPCS code has been classified as a multi-source drug. The commenter assumed that another product, Orthovisc, would also be billed under HCPCS code J7317. However, the fourth product, Synvisc, is classified as a sole source drug and billed under HCPCS code J7320 (Hylan G-F20, 16 mg, for intra-articular injection). The commenter strongly believed that classifying these products differently resulted in payment rates that will create significant payment inequities and unjustified market distortions. To correct the payment inequity across the class of viscosupplements, the commenter recommended that CMS create separate HCPCS codes for these products and treat each product as a sole source drug. Another commenter strongly recommended that Orthovisc, a new product, be recognized as a pass-through under the OPPS, and be assigned a separate C-code for payments under that system. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We recognize the commenter's concern about payment for these viscosupplement drugs under the OPPS. The National HCPCS Panel coordinates decisions regarding the creation of permanent HCPCS codes; therefore, comments related to the HCPCS creation process and decisions made by the National HCPCS Panel are outside the scope of this rule. However, we note that the product Orthovisc received approval for pass-through status under the OPPS effective January 1, 2005, and a new temporary C-code has been established to allow hospitals to receive pass-through payments for this product. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         A commenter requested that CMS show three separate tables for the nonpass-through drugs; that is, one for sole source drugs, one for innovator multiple source drugs, and one for noninnovator multiple source drugs. 
                        <PRTPAGE P="65793"/>
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We have accepted the commenter's suggestion and created three distinct tables listing the sole source drugs, innovator multiple sources drugs, and noninnovator multiple source drugs. 
                    </P>
                    <P>Tables 27 and 28 below list the final payment amounts for innovator and noninnovator multiple source drugs, biologicals, and radiopharmaceuticals, respectively, effective January 1, 2005 to December 31, 2005. </P>
                    <BILCOD>BILLING CODE 4120-01-P</BILCOD>
                    <GPH SPAN="3" DEEP="613">
                        <GID>ER15NO04.045</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="548">
                        <PRTPAGE P="65794"/>
                        <GID>ER15NO04.046</GID>
                    </GPH>
                    <BILCOD>BILLING CODE 4120-01-C</BILCOD>
                    <HD SOURCE="HD3">b. Treatment of Three Sunsetting Pass-Through Drugs as Specified Covered Outpatient Drugs </HD>
                    <P>As we discussed in the August 16, 2004 proposed rule, there are 13 drugs and biologicals whose pass-through status will expire on December 31, 2004. Table 29 below lists these drugs and biologicals. </P>
                    <P>
                        Pass-through payment was made for 10 of these 13 items as of December 31, 2002. Therefore, these 10 items now qualify as specified covered outpatient drugs under section 1833(t)(14) of the Act, as added by section 621(a) of Pub. L. 108-173, as described above. However, pass-through status for three of the pass-through drugs and biologicals that will expire on December 31, 2004 (C9121, Injection, Argatroban; J9395, Fulvestrant; and J3315, Triptorelin pamoate), was first made effective on January 1, 2003. These items are specifically excluded from the definition of “specified covered outpatient drugs” in section 1833(t)(14)(B)(ii) of the Act, because they are not drugs or biologicals for which pass-through payment was first made on or before December 31, 2002. Pub. L. 108-173 does not address how 
                        <PRTPAGE P="65795"/>
                        to set payment for items whose pass-through status expires in CY 2004, but for which pass-through payment was not made as of December 31, 2002. 
                    </P>
                    <P>Therefore, we proposed to pay for the three expiring pass-through items for which payment was first made on January 1, 2003, rather than on or before December 31, 2002 using the methodology described under section 1833(t)(14) of the Act for specified covered outpatient drugs. We believed that this methodology would allow us to determine appropriate payment amounts for these products in a manner that is consistent with how we pay for drugs and biologicals whose pass-through status was effective as of December 31, 2002, and that does not penalize those products for receiving pass-through status beginning on or after January 1, 2003 and expiring December 31, 2004. In Table 27 in the proposed rule, we listed the CY 2005 OPPS payment rates that we proposed for these three drugs and biologicals. </P>
                    <P>Of the 13 products for which we proposed that pass-through status expire on December 31, 2004, we proposed to package two of them (C9113, Inj. Pantoprazole sodium and J1335, Ertapenum sodium) because their median cost per day falls below the $50 packaging threshold. We proposed to pay for the remaining 11 drugs and biologicals as sole source items according to the payment methodology for sole source products described above. </P>
                    <P>We note that darbepoetin alfa (Q0137) will be considered a “specified covered outpatient drug” in CY 2005. Payment for these drugs is governed under section 1833(t)(14) of the Act. Specifically, we proposed that darbepoetin alfa would be paid as a sole source drug at a rate between 83 percent and 95 percent of its reference AWP. Accordingly, we specifically solicited comments on whether we should again apply an equitable adjustment, made pursurant to section 1833(t)(2)(E) of the Act, to the price for this drug. </P>
                    <P>
                        <E T="03">Comment:</E>
                         Numerous commenters applauded CMS for proposing a fair and consistent payment methodology for drugs and biologicals whose pass-through status expires on December 31, 2004, and supported the proposal to treat these three therapies as specified covered outpatient drugs. They also encouraged CMS to expand this treatment to all separately paid drugs and biologicals in the future. A few commenters, including MedPAC, disagreed with our proposal to pay for the three expiring pass-through items for which payment was first made on January 1, 2003, as “specified covered outpatient drugs.” One commenter indicated that because these three drugs were excluded from the statutory definition of “specified covered outpatient drug,” it did not believe that CMS had the authority to treat newer drugs expiring out of pass-through status as specified covered outpatient drugs. Therefore, the commenter believed that CMS should pay for newer drugs expiring from pass-through status at 106 percent ASP, the rate applicable to the physician setting. MedPAC expressed concern about treating these 3 expiring pass-through drugs differently from the older, historically packaged drugs that are now eligible for separate payment and whose payments will be based on the median cost from the claims data. MedPAC indicated that the purpose of the pass-through payments is to allow time to accumulate data on costs and that there seemed to be no reason to believe that claims data are more accurate for one category of drugs that the other. Therefore, the drugs coming off pass-through, which do not fall under the SCOD category, and the older drugs should be paid consistently. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We appreciate the commenters' support for our proposal to treat the three items for which pass-through status expires on December 31, 2004, but that were approved for pass-through status effective January 1, 2003, similar to the other drugs and biologicals whose pass-through status expires December 31, 2004, but that were approved for pass-through status on or before December 31, 2002. The statute does not address payment for drugs and biologicals that had pass-through status effective on January 1, 2003, but not on or before December 31, 2002. These items are newer drugs than the older products that never received pass-through status. We have accumulated cost data for these three drugs throughout the same 2-year period during which we accumulated cost data for the other drugs and biologicals whose pass-through status expires on December 31, 2004. Therefore, noting that the statute does not address drugs whose pass-through status likewise expires on December 31, 2004, but was approved on January 1, 2003, we believe it is reasonable to pay for these three drugs in a manner consistent with how we pay for the other drugs whose pass-through status likewise sunsets on December 31, 2004. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         We received a number of comments concerning our proposal to pay for both epoetin alfa (marketed under trade name of Procrit) and darbepoetin alfa (marketed under the trade name of Aranesp
                        <E T="51">®</E>
                        ) based on 83 percent of their individual reference AWPs. A number of commenters also wrote in response to our solicitation for comments concerning the application of our equitable adjustment authority in determining the payment rate for darbepoetin alfa. Commenters acknowledged that both biologicals meet the MMA definition of specified covered outpatient drug (SCOD) and that the pass-through status of darbepoetin alfa ends on January 1, 2005. One of the commenters supported the proposal to establish payment for darbepoetin alfa as a SCOD, to base CY 2005 payment on its reference AWP, and to discontinue the application of an equitable adjustment to reduce the statutorily mandated payment for any product paid under the OPPS in CY 2005. This commenter stated the proposed payment for darbepoetin alfa as a sole source SCOD is fully consistent with section 621 of the MMA and that this is consistent with the method of payment for all other sole source SCODs. The commenter further stated that when drafting the language for section 622 of the MMA, Congress intended to ensure that considerations of functional equivalence were not applied to darbepoetin alfa after its pass-through status expired. This commenter acknowledges that section 1833(t)(2)(E) of the Act permits CMS to make “adjustments as determined to be necessary to ensure equitable payments.” However, this commenter stated that payments for the two products are already inherently equitable at the proposed rates because they are comparably priced and because CMS proposed to set the payment rates for the two products using the same methodology. The commenter noted that when CMS first applied the equitable adjustment for darbepoetin alfa, in CY 2003, CMS had only three choices for establishing drug payments under the OPPS: (1) Packing payment with related services; (2) using charges from outpatient claims to derive median cost; and (3) paying separately under the pass-through provisions, at 95 percent of AWP. The commenter notes the new payment methodology for all sole source “specified covered outpatient drugs” and argues that by applying this methodology to both of these biologicals, CMS would establish a level playing field and assure that market-based forces remain operable. This commenter also provided data concerning the clinical efficacy of darbepoetin alfa. 
                    </P>
                    <P>
                        Many of the other commenters stated that CMS' application of its equitable adjustment authority deviated from the MMA's intent to pay for sole source 
                        <PRTPAGE P="65796"/>
                        products and multi-source products under separate payment methodologies. The commenters were concerned about the significant impact that application of such authority may have on a company's decision to continue developing innovator products. The commenters also argued that applying such a policy could inject CMS into clinical decisions based solely on economic considerations and create payment incentives that distort patient decisions properly entrusted to treating physicians. One commenter recommended that if CMS plans to utilize this authority again, then CMS should hold a public forum and provide interested parties with an opportunity to submit written comments about the standards that will be used to determine equitable adjustment. Other commenters argued that CMS should comply with the MMA and protect patient access to innovative therapies by not applying functional equivalence or a similar standard to any drug in 2005 or future years. 
                    </P>
                    <P>One commenter on this topic also provided detailed results of clinical studies that the commenter believes support the necessity of a continuation of the equitable payment adjustment. This commenter further stated that the clinical data support the use of a particular conversion ratio in making such an adjustment. The commenter noted that without an equitable adjustment policy, both drugs would be paid at 83 percent of each product's AWP. The commenter estimated weekly payments for the two drugs under four scenarios: an equitable adjustment based on three different conversion ratios and the proposed policy of treating each drug independently without application of an equitable adjustment. According to this commenter, overall Medicare expenditures and beneficiary coinsurance payments would increase for the treatment of chemotherapy-induced anemia in the absence of an equitable payment adjustment. The commenter's estimates assume a 50 percent market share for each of the two drugs and estimated 2005 spending based on 2003 OPPS claims data with anemia market unit growth assumptions of 35 percent in 2004 and 22 percent in 2005. The commenter also noted that the MMA did not remove the Secretary's authority to establish adjustments to ensure equitable payments and that the Secretary retains the authority to determine the CY 2005 payment rate for darbepoetin alfa using the equitable payment policy applied in CY 2003 and CY 2004. This commenter also argued that the MMA prohibition on the use of a functional equivalence standard applies only to pass-through drugs and only to future implementation. </P>
                    <P>
                        A comment from MedPAC on this issue indicated that as costs to the Medicare program continue to grow, the program will need to examine tools for obtaining value in its purchasing. MedPAC believed that, absent evidence that the CMS' use of its equitable adjustment to set equivalent payment rates for Procrit and Aranesp
                        <E T="51">®</E>
                         denied beneficiaries' access to needed treatments, CMS should pursue value-based purchasing where possible. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         As the commenters noted, while we proposed a payment rate for darbepoetin alfa as a sole source SCOD based on its reference AWP, we also specifically solicited comments on whether we should again apply an equitable adjustment, made pursuant to section 1833(t)(2)(E) of the Act, to establish the payment for this drug in CY 2005. After careful consideration of the thoughtful and well-documented comments concerning this issue, we have concluded that it is still appropriate to apply an adjustment to the payment for darbepoetin alfa under our authority in section 1833(t)(2)(E) of the Act to ensure that equitable payments for these two products under the OPPS continue in CY 2005. We agree with those commenters that argued that section 1833(t)(2)(E) of the Act was not affected by the provisions of the MMA and that we retain our authority to make such adjustments to payments under the OPPS. As we have done previously, we will reassess the need to exercise our adjustment authority when we next review the payment rates under the OPPS. 
                    </P>
                    <P>
                        To apply an equitable adjustment for CY 2005, we reviewed the analysis we conducted during 2003 and the additional data we received in 2004. As we discussed in further detail in our November 7, 2003 final rule with comment period for the 2004 update to the OPPS (68 FR 63455) and our November 1, 2002 final rule with comment period for the 2003 update (67 FR 66758), because darbepoetin alfa has two additional carbohydrate side-chains, it is not structurally identical to epoetin alfa. The addition of these two carbohydrate chains affects the biologic half-life of the compound. This change in turn affects how often the biological can be administered, which yields a different dosing schedule for darbepoetin alfa by comparison to epoetin alfa. Amgen has FDA approval to market darbepoetin alfa under the trade name 
                        <E T="51">®</E>
                         for treatment of anemia related to chronic renal failure (including patients on and not on dialysis) and for treatment of chemotherapy-related anemia in cancer patients. Epoetin alfa, which is marketed by Ortho Biotech under the trade name Procrit, is approved by FDA for marketing for the following conditions: (1) Treatment of anemia of chronic renal failure (including for patients on and not on dialysis); (2) treatment of Zidovudine-related anemia in HIV patients; (3) treatment of anemia in cancer patients on chemotherapy; and (4) treatment of anemia related to allogenic blood transfusions in surgery patients. 
                    </P>
                    <P>The two biologicals are dosed in different units. Epoetin alfa is dosed in Units per kilogram (U/kg) of patient weight and darbepoetin alfa in micrograms per kilogram (mcg/kg). The difference in dosing metric is due to differences in the accepted convention at the time of each product's development. At the time epoetin alfa was developed, biologicals (such as those like epoetin alfa that are produced by recombinant DNA technology) were typically dosed in International Units (or Units for short), a measure of the product's biologic activity. They were not dosed by weight (for example, micrograms) because of a concern that weight might not accurately reflect their standard biologic activity. The biologic activity of such products can now be accurately predicted by weight, however, and manufacturers have begun specifying the doses of such biologicals by weight. No standard formula exists for converting amounts of a biologic dosed in Units to amounts of drug dosed by weight. </P>
                    <P>The process that we used in 2003 to define the payment conversion ratio between the two biologicals for CY 2004 is described in the November 7, 2003 final rule with comment period. We refer readers to that discussion, found at 68 FR 63455, for more complete details on that process and the data received and reviewed by CMS during the process. At the conclusion of the 2003 process, we established a conversion ratio of 330 Units of epoetin alfa to 1 microgram of darbepoetin alfa (330:1) for establishing the CY 2004 payment rate for darbepoetin alfa. </P>
                    <P>
                        During the comment period, each company presented additional data concerning their products. Based upon our analysis to date, we continue to believe that the conversion ratio used for CY 2004 is appropriate for purposes of establishing equitable payment under the OPPS for both epoetin alfa and darbepoetin alfa for CY 2005. Initial review of new information submitted by the commenters provides no compelling 
                        <PRTPAGE P="65797"/>
                        evidence that the conversion ratio of 330:1 is unreasonable. Therefore, for this final rule with comment period, we have established payment for darbepoetin alfa by applying the conversion ratio of 330:1 to 83 percent of the AWP for epoetin alfa. The resulting payment rate for darbepoetin alfa is $3.66 per microgram. We will continue to assess the data we have received thus far and invite the submission of additional information. In order to fully evaluate and assess this issue in determining whether any further adjustment of the conversion ratio is necessary, additional analysis will be required. If, after additional review and analysis, we determine that a different conversion ratio is more appropriate, we will make a change in the payment rate for darbepoetin alfa to reflect the change in ratio as soon as possible. 
                    </P>
                    <P>We do not believe that our application of an equitable adjustment will create a barrier to treatment for the conditions for which these products are prescribed or to the product of choice of the beneficiary and his or her treating physician. According to the most recent average sales price (ASP) information collected by CMS and available in time for this final rule with comment period, 106 percent of ASP for darbepoetin alfa is $3.69 per microgram. This amount would have been the basis for payment under the OPPS on January 1, 2005 if pass-through status did not expire and if we did not apply an equitable adjustment. Furthermore, as we have emphasized in prior rulemaking on this topic, our conversion of amounts of a biologic dosed in Units to amounts of a drug dosed by weight strictly for the purpose of calculating a payment rate should not in any way be viewed as a statement regarding the clinical use of either product. The method we use to convert Units to micrograms in order to establish equitable payments is not intended to serve as a guide for dosing individual patients in clinical practice. By using a conversion ratio solely for the purpose of establishing equitable payments, CMS is not attempting to establish a lower or upper limit on the amount of either biological that a physician should prescribe to a patient. We expect that physicians will continue to prescribe these biologicals based on their own clinical judgment of the needs of individual patients. </P>
                    <P>Table 29 below lists the final CY 2005 OPPS payment rates for the three sunsetting pass-through drugs and biologicals that will be treated as specified covered outpatient drugs. </P>
                    <GPH SPAN="3" DEEP="135">
                        <GID>ER15NO04.047</GID>
                    </GPH>
                    <HD SOURCE="HD3">c. CY 2005 Payment for Nonpass-through Drugs, Biologicals, and Radiopharmaceuticals With HCPCS Codes, But Without the OPPS Hospital Claims Data </HD>
                    <P>Pub. L. 108-173 does not address the OPPS payment in CY 2005 for new drugs and biologicals that have assigned HCPCS codes, but that do not have a reference AWP or approval for payment as pass-through drugs or biologicals. Because there is no statutory provision that dictates payment for such drugs and biologicals in CY 2005, and because we have no hospital claims data to use in establishing a payment rate for them, we investigated other possible options to pay for these items in CY 2005. Clearly, one option is to continue packaging payment for these new drugs and biologicals that have their own HCPCS codes until we accumulate sufficient claims data to calculate median costs for these items. Another option is to pay for them separately using a data source other than our claims data. The first option is consistent with the approach we have taken in prior years when claims data for new services and items have not been available to calculate median costs. However, because these new drugs and biologicals may be expensive, we are concerned that packaging these new drugs and biologicals may jeopardize beneficiary access to them. In addition, we do not want to delay separate payment for a new drug or biological solely because a pass-through application was not submitted. </P>
                    <P>Therefore, for CY 2005, we proposed to pay for these new drugs and biologicals with HCPCS codes but which do not have pass-through status at a rate that is equivalent to the payment they would receive in the physician office setting, which would be established in accordance with the methodology described in the CY 2005 Medicare Physician Fee Schedule proposed rule (69 FR 47488, 47520 through 47524). We noted that this payment methodology is the same as the methodology that will be used to calculate the OPPS payment amount that pass-through drugs and biologicals will be paid in CY 2005 in accordance with section 1842(o) of the Act, as amended by section 303(b) of Pub. L. 108-173, and section 1847A of the Act. Thus, we proposed to treat new drugs and biologicals with established HCPCS codes the same, irrespective of whether pass-through status has been determined. We also proposed to assign status indicator “K” to HCPCS codes for new drugs and biologicals for which we have not received a pass-through application. </P>
                    <P>
                        In light of our August 16, 2004 proposal, we understood that manufacturers might be hesitant to apply for pass-through status. However, we did not believe there would be many instances in CY 2005 when we would not receive a pass-through application for a new drug or biological that has an HCPCS code. To avoid delays in setting an appropriate payment amount for new drugs and biologicals and to expedite the processing of claims, we strongly encouraged manufacturers to continue submitting pass-through applications for new drugs and biologicals when FDA 
                        <PRTPAGE P="65798"/>
                        approval for a new drug or biological is imminent to give us advance notice to begin working to create an HCPCS code and APC. The preliminary application would have to be augmented by FDA approval documents and final package inserts once such materials become available. However, initiating the pass-through application process as early as possible would enable us to expedite coding and pricing for the new drugs and biologicals and accelerate the process for including them in the next available OPPS quarterly release. 
                    </P>
                    <P>In the August 16, 2004 proposed rule, we discussed how we proposed to pay in CY 2005 for new drugs and biologicals between their FDA approval date and assignment of an HCPCS code and APC. We shared the desire of providers and manufacturers to incorporate payment for new drugs and biologicals into the OPPS as expeditiously as possible to eliminate potential barriers to beneficiary access and to minimize the number of claims that must be processed manually under the OPPS interim process for claims without established HCPCS codes and APCs, and we solicited public comments on our proposal. </P>
                    <P>
                        <E T="03">Comment:</E>
                         Several commenters commended CMS's proposal to set payment rates for new drugs with HCPCS codes using the same methodology proposed to set payment for drugs with pass-through status, regardless of whether a pass-through application has been submitted for the new drug. They applauded CMS for acknowledging that packaging payment for these new therapies might jeopardize beneficiary access to them. However, a comment from MedPAC indicated that CMS's proposal to pay 106 percent of ASP for this particular group of drugs and biologicals represented a change in policy where drugs of this nature were previously packaged until sufficient claims data were accumulated to calculate payment rates, unless they received pass-through status via an application process. MedPAC was concerned that the newly approved drugs and biologicals that do not go through the pass-through payment mechanism will be added to the OPPS system without any control on spending since this policy does not have a budget neutrality provision, similar to pass-through payments. Given that the pass-through policy existed as a controlled mechanism for introducing new drugs into the OPPS, these drugs should either be treated through the pass-through process or continue to be packaged under the previous policy. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We appreciate the commenters' support for our proposal to pay for new drugs with HCPCS codes, but without pass-through status and hospital claims data under the same methodology that will be used to pay for them in the physician office setting. We also understand MedPAC's concern about budget neutrality associated with this policy. Our intent in paying for new drugs and biologicals with HCPCS codes, but without pass-through status and hospital claims data, separately, was that we recognized that some of these new products would be important new therapies in treatment of such diseases as cancer. We also believe that the MMA provision that requires CMS to pay for new drugs and biologicals before a code is assigned indicates that Congress intended for us to pay separately for new items until we have hospital claims data that would allow us to determine whether the product should be packaged. We are concerned that packaging their payments may prevent hospitals from acquiring these products and in turn harm beneficiaries' access to them. We do not expect the volume of new drugs and biologicals to which we would apply this policy in CY 2005 to be so significant as to have an effect on budget neutrality. Moreover, we would not expect this policy to have a differential impact on budget neutrality any more than payment for the drugs would affect pass-through spending had the drugs been approved for pass-through status. We also believe (and strongly encourage) that stakeholders will continue to apply for pass-through status for new drugs, biologicals and radiopharmaceuticals as a means of ensuring that we have all of the information required to establish accurate payments for these items as quickly as possible. At the same time, if we were to package all such items, we are concerned that it would provide a disincentive for manufacturers to come forward and request codes for new items. Under the MMA provision described above, we are required to pay for new drugs and biologicals without HCPCS code at 95 percent of AWP, which we would expect to generally be higher than 106 percent of ASP. We also believe the MMA provision regarding drugs without HCPCS codes indicates that Congress clearly intended that we pay separately for new drugs and biologicals. Therefore, for CY 2005 we will finalize the policy that we proposed to pay separately for new drugs and biologicals with HCPCS codes but without pass-through status and hospital claims data based on the payment for the same new products in a physician office. 
                    </P>
                    <P>
                        We will, however, monitor this carefully during the course of CY 2005 and reassess the policy for CY 2006. In CY 2005, payment for these new drugs and biologicals will be based on 106 percent of ASP. In the absence of ASP data, we will use wholesale acquisition cost (WAC) for the product to establish the initial payment rate. If WAC is also unavailable, then we will calculate payment at 95 percent of the May 1, 2003 AWP or the first reported AWP for the product. We have used the second quarter ASP data from CY 2004 because those were the most recent numbers available to us in time for the publication for this rule. To be consistent with the ASP-based payments that will be made when these drugs and biologicals are furnished in the physician offices, we plan to make any appropriate adjustments to the amounts shown in Addendum A and B if later quarter ASP submissions indicate that adjustments to the payment rates are necessary. We will announce such changes in our program instructions to implement quarterly releases and post any revisions to the addenda on the 
                        <E T="03">www.cms.hhs.gov</E>
                         Web site. We will similarly adjust payment for items for which we used AWP or WAC because ASP was not available if ASP becomes available from later quarter submissions. 
                    </P>
                    <P>For CY 2005, we will apply this policy to three drugs and biologicals that are new effective January 1, 2005 and do not have pass-through status and hospital claims data. These drugs will be separately payable under the OPPS, and thus, we have assigned them to status indicator “K”. Table 30 below lists these drugs and biologicals and the payment methodologies used to calculate their APC payments listed in Addendum A and B of this rule. </P>
                    <GPH SPAN="3" DEEP="129">
                        <PRTPAGE P="65799"/>
                        <GID>ER15NO04.048</GID>
                    </GPH>
                    <P>We have also identified several drugs and biologicals with new HCPCS codes created effective January 1, 2004, that do not meet the definition of “specified covered outpatient drugs” and for which we would not have CY 2003 hospital claims data. These items are packaged in CY 2004, and we also proposed to package them for CY 2005 in the proposed rule. To avoid negatively impacting beneficiary access to these new products by packaging them, we will be paying for these drugs in CY 2005 under the same methodology that will be used to pay for them in the physician office setting. The rules for determining payment for these drugs will be the same as the rules for new drugs with HCPCS codes but without pass-through status in CY 2005. In CY 2005, these drugs will be separately payable under the OPPS, and thus, we have assigned status indicator “K” to these drugs. Table 31 below lists these drugs and biologicals and the payment methodologies used to calculate their APC payments listed in Addendum A and B of this rule. </P>
                    <P>We note that CPT 90715 (Tdap vaccine &gt; 7 im) was newly created in 2004; however, we will not apply this payment policy to this code because all of the vaccines similar to this product are packaged in CY 2004 and will remain packaged in CY 2005. This payment policy also will not apply to new radiopharmaceuticals since all radiopharmaceuticals meet the definition of “specified covered outpatient drugs”. Therefore, payment for new radiopharmaceuticals will be made according to the payment methodologies established for “specified covered outpatient drugs” under section 1833(t)(14)(A)(ii) of the Act. </P>
                    <GPH SPAN="3" DEEP="219">
                        <GID>ER15NO04.049</GID>
                    </GPH>
                    <P>
                        <E T="03">Comment:</E>
                         One commenter noted that CMS historically had declined to process pass-through applications prior to FDA approval, consequently many manufacturers have ceased submitting early applications. The commenter stated that manufacturers may be uncomfortable submitting the detailed information required for the pass-through application prior to securing FDA approval. The commenter suggested that a more realistic expectation of the timeframe for pass-through application would be at or subsequent to FDA approval, when the product launch is imminent. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We recognize that some manufacturers may be concerned about submitting detailed information for pass-through application in advance of FDA's approval for their product. However, we reiterate that we strongly encourage manufacturers to continue submitting pass-through applications when FDA approval for a new drug or biological is imminent to give us advance notice to begin working to create a HCPCS code and an APC for their product. While we will not be able to give final approval to the pass-through application prior to FDA approval, early notification about the product prior to FDA approval can expedite the granting of a new product-specific code and implementation of 
                        <PRTPAGE P="65800"/>
                        that code and appropriate payment rate within our system. 
                    </P>
                    <HD SOURCE="HD3">d. Payment for Separately Payable NonPass-Through Drugs and Biologicals </HD>
                    <P>As discussed in section V.B.2. of the August 16, 2004 proposed rule, for CY 2005, we used CY 2003 claims data to calculate the proposed median cost per day for drugs, biologicals, and radiopharmaceuticals that have an assigned HCPCS code and are paid either as a packaged or separately payable item under the OPPS. Section 1833(t)(14) of the Act, as added by section 621(a) of Pub. L. 108-173, specified payment methodologies for most of these drugs, biologicals, and radiopharmaceuticals. However, this provision did not specify how payment was to be made for separately payable drugs and biologicals that never received pass-through status and that are not otherwise addressed in section 1833(t)(14) of the Act. Some of the items for which such payment is not specified are (1) those that have been paid separately since implementation of the OPPS on August 1, 2000, but are not eligible for pass-through status, and (2) those that have historically been packaged with the procedure with which they are billed but, based on the CY 2003 claims data, their median cost per day is above the legislated $50 packaging threshold. Because Pub. L. 108-173 does not address how we are to pay for such drugs and biologicals (any drug or biological that falls into one or the other category and that has a per day cost greater than $50), we proposed to set payment based on median costs derived from the CY 2003 claims data. Because these products are generally older or low-cost items, or both, we believe that the payments will allow us to provide adequate payment to hospitals for furnishing these items. In the proposed rule, we listed in Table 28 the drugs and biologicals to which the proposed payment policy would apply. </P>
                    <P>We received numerous public comments on our proposal. </P>
                    <P>
                        <E T="03">Comment:</E>
                         A commenter expressed concern about the proposed payment rate for HCPCS code J7342 (Dermal tissue, of human origin, with or without other bio-engineered or processed elements, with metabolically active elements, per square centimeter) when billed by Maryland-based hospitals and comprehensive outpatient rehabilitation facilities (CORFs). 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We understand the commenter's concern; however, Maryland-based hospitals and CORFs are excluded from payment under the OPPS and the OPPS payment rates do not apply to them. This final rule with comment period addresses only the providers that are paid under the OPPS. Therefore, this comment is outside the scope of this rule. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         An association for manufacturers of contrast agents supported CMS' proposal to pay separately for certain MRI contrast agents (for example, HCPCS codes A4643 and A4647). However, the commenter was concerned that the payment rates for these products were based on CY 2003 hospital claims data and that the overall accuracy of the hospital median cost data is questionable; therefore, the commenter recommended that CMS review the proposed payment rates for MRI contrast agents and requested that such review include a confirmation that the median cost data used as the basis for calculating the payment rates are correct. The commenter also indicated that the proposed rule did not have unit descriptors for the HCPCS codes A4643 and A4647 and requested that CMS add the unit descriptor, “up to 20 ml” to HCPCS codes A4643 and A4647 in order to provide further clarity and facilitate more accurate coding and billing by hospitals. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We understand the commenter's concern about setting appropriate payment rates for these products. These products do not meet the definition of “specified covered outpatient drugs” as defined in the MMA; however, we do have a significant number of CY 2003 hospital claims data for these products. It is our general policy under the OPPS to use the most recent available hospital claims data in setting the OPPS payment rates. For CY 2005, both of these products will be separately payable items. The payment rate for A4643 will be based on approximately 14,200 claims for approximately 27,000 services, and payment for A4647 will be based on approximately 87,600 claims for approximately 155,000 services. 
                    </P>
                    <P>We believe that the CY 2003 claims data contain a sufficiently robust set of claims for both products on which to base the payment rates for these items using the methodology that will be used for other separately payable non-pass-through drugs and biologicals. With respect to adding unit descriptors to A4643 and A4647, we suggest that the commenter pursue these changes through the process set up by the National HCPCS Panel. </P>
                    <P>
                        <E T="03">Comment:</E>
                         A commenter expressed concern that CMS may have inappropriately packaged low osmolar contrast material (LOCM) drugs into APCs based on a determination that the drugs do not meet CMS's packaging rule because they are below the $50 threshold required for separate payment. The commenter questioned the accuracy of the median cost data used as the basis for CMS's decision as CMS' paid claims files for LOCM do not include unit descriptors for the HCPCS codes A4644, A4645, and A4646. The commenter is concerned that this makes it difficult to interpret the data in any meaningful way for purposes of determining what the payment rates for these drugs should be and whether they should be paid separately, in particular, because the dose administered per procedure can range from 10 ml to 200 ml. The commenter also believed that CMS should pay for LOCM drugs separately in the hospital outpatient setting because they are paid as such in the physician office setting. Therefore, the commenter recommended that CMS exercise its discretion to apply an exception to the packaging rule to LOCM as it did with the anti-emetics and allow separate payment for LOCM drugs in CY 2005. The commenter also suggested that CMS assign the unit descriptor “per 10 ml” to HCPCS codes A4644, A4645, and A4646. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We recognize that the commenter is concerned about the packaging of the three LOCM products. Based on the methodology used to calculate median cost per day for drugs and biologicals, as explained in section V.B.2. of the preamble, we determined that the per day costs of these products were below $50. Therefore, these items were packaged. We note that the LOCM products are a unique class of drugs that have always been packaged from the beginning of the OPPS in August 1, 2000, and this is the first year that we looked into the cost data for these drugs to determine whether they should be paid separately. We realize that for CY 2005 these drugs will be packaged under the OPPS, but will receive separate payment in the physician office setting. However, based upon the statutory packaging threshold for drugs and biologicals as per administration cost less than $50, we believe that it is appropriate for us to package the LOCM drugs under the OPPS. With respect to adding unit descriptors to HCPCS code A4644, A4645, and A4646, we suggest that the commenter pursue these changes through the process set up by the National HCPCS Panel. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         We received comments concerning the new Part D prescription drug benefit mandated by the MMA and the intersection between drugs covered by Part D and Part B. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         Because such issues are not within the scope of this CY 2005 OPPS 
                        <PRTPAGE P="65801"/>
                        final rule with comment period, we will not respond to those comments in this document. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         We received many comments from makers of drug and biological products, national trade associations, and an association for cancer centers suggesting that CMS should expand the future rate-setting methodology for “specified covered outpatient drugs” to include all drugs and biologicals that either are or were previously paid separately under the OPPS, regardless of whether the drugs meet or exceed the $50 threshold. The commenters also recommended that CMS also work with GAO and MedPAC to ensure that their respective studies of the acquisition costs and pharmacy service and overhead costs include all of these drugs and biologicals and that the studies are thorough and will contain all the information CMS needs to set proper payment rates in the future. Many of these commenters were concerned about CMS' use of claims, other data, and the methodologies used to establish the OPPS payments for drugs and biologicals that do not meet the definition of “specified covered outpatient drugs” and therefore, are not statutorily required to be included in these studies. The commenters suggested that CMS should not implement different methodologies for “specified covered outpatient drugs” and other separately paid drugs in CY 2006; instead, CMS should ensure appropriate payment for all Medicare covered drugs by applying the acquisition cost-based payment methodology to all separately paid drugs. One commenter believed that Congress fully intended for all separately paid drugs and biologicals to be paid based on hospital acquisition costs, as informed by these studies. Another commenter recommended that CMS continue to accept external cost data that may be submitted by knowledgeable stakeholders, such as manufacturers, providers, or patients to provide verification of hospital acquisition costs for specific drugs and biologicals. One commenter indicated that it would like to work with CMS as it prepares the hospital acquisition cost survey for the CY 2006 rates. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We appreciate the interest expressed by many of the commenters regarding the MMA-mandated surveys that will be conducted by the GAO and MedPAC of hospital acquisition cost for drugs and biologicals and their overhead and related costs, respectively. However, we note that these provisions of the MMA affect payment for drugs and biologicals in CY 2006, and thus, these comments fall outside the scope of this rule. Therefore, we will not be responding to these comments at this time. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         A commenter requested that CMS examine every HCPCS J-code for drugs to ensure that the dosage definitions for the HCPCS codes are set at the lowest available manufacturers' dosage and match the customary dispensing packaging. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         Changes to the HCPCS J-codes are made by the National HCPCS Panel; therefore, this comment is outside the scope of this OPPS final rule. We suggest that the commenter pursue these changes through the process established by the National HCPCS Panel. 
                    </P>
                    <BILCOD>BILLING CODE 4120-01-P</BILCOD>
                    <GPH SPAN="3" DEEP="627">
                        <PRTPAGE P="65802"/>
                        <GID>ER15NO04.050</GID>
                    </GPH>
                    <BILCOD>
                        BILLING CODE 4120-01-C
                        <PRTPAGE P="65803"/>
                    </BILCOD>
                    <HD SOURCE="HD3">e. CY 2005 Change in Payment Status for HCPCS Code J7308 </HD>
                    <P>Since implementation of the OPPS on August 1, 2000, HCPCS code J7308 (Aminolevulinic acid HCI for topical administration, 20 percent single unit dosage form) has been treated as a packaged item and denoted as such using status indicator “N”. Thus, historically we have not allowed separate payment for this drug under the OPPS and it does not meet the statutory definition of a specified covered outpatient drug. For CY 2005, we proposed to allow separate payment for this drug at 106 percent of ASP, which is equivalent to the payment rate that it would receive under the Medicare Physician Fee Schedule. We proposed a CY 2005 ASP and payment under the OPPS for HCPCS code J7308 of $88.86. We solicited comments on our proposed payment methodology for HCPCS code J7308 for CY 2005. </P>
                    <P>We did not receive any comments on our proposed policy. However, we did receive a comment on this policy in response to the January 6, 2004 interim final rule with comment period, which we discuss below. </P>
                    <P>
                        <E T="03">Comment:</E>
                         One commenter requested that HCPCS code J7308 be paid separately under the OPPS because its cost is in excess of the $50 median cost per day threshold, and the drug is also paid separately under the Medicare Physician Fee Schedule in CY 2004. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We agree with the commenter and will finalize our policy to pay separately for J7308 at the payment rate that it would receive under the Medicare Physician Fee Schedule. The payment rate listed in Addenda A and B of the August 16, 2005 proposed rule was based on the second quarter ASP submission for CY 2004. As stated in section V.A. 3. of this final rule with comment period, we plan to make any appropriate adjustments to the amount shown in Addenda A and B if later quarter ASP submissions indicate that adjustments to the payment rate for this drug is necessary. 
                    </P>
                    <HD SOURCE="HD3">4. Public Comments Received on the January 6, 2004 Interim Final Rule With Comment Period and Departmental Responses </HD>
                    <P>
                        As discussed in section V.B.3. of this final rule with comment period, on January 6, 2004, we published in the 
                        <E T="04">Federal Register</E>
                         an interim final rule with comment period (69 FR 822) that implemented section 621(a)(1) of Pub. L. 108-173. Section 621(a)(1) specified payment limits on three categories of specific covered outpatient drugs and defined these three categories of drugs. 
                    </P>
                    <P>We received many pieces of correspondence that contained public comments associated with the January 6, 2004 interim final rule with comment period. Many of the comments expressed concerns about the following issues: treating radiopharmaceuticals as “drugs;” establishing mechanisms to pay for drugs without HCPCS codes at 95 percent of AWP; correcting the classification of specific items to sole source “specified covered outpatient drugs;” eliminating the use of “equitable adjustments” to the OPPS payment for drugs and biologicals or applying any functional equivalence standards; paying separately for drugs that are either packaged or whose payment is based on median cost as “specified covered outpatient drugs”; expanding the list of items that will be studied in the MMA-mandated GAO and MedPAC surveys of certain OPD services; using the cost-to-charge methodology and the hospital outpatient claims data to set payment rates for certain drugs and biologicals; identifying and establishing appropriate payment rates for innovator and noninnovator multiple source drugs; and changing HCPCS code descriptors for radiopharmaceuticals to reflect the products as administered to patients. </P>
                    <P>We will not address these comments separately in this section because these issues are discussed in detail throughout this entire section (section V.) of this final rule with comment period. However, for those public comments that are not specifically addressed in section V., a summary of them and our responses to those comments follow: </P>
                    <P>
                        <E T="03">Comment:</E>
                         A commenter suggested that CMS create separate HCPCS codes for Neoral, Sandimmune, and the other cyclosporine products. The commenter indicated that currently all of these products are being billed using HCPCS code J7502 (Cyclosporine, oral, 100 mg). The commenter stated that the payment rates for the brand name products should not be linked to the payment rates for the non-innovator products because this situation creates access issues to the branded products, and CMS should not limit patient access to the specific formulation deemed medically appropriate for the individual needs of the specific patients. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We note that for both CYs 2004 and 2005, hospitals can use HCPCS code C9438 to bill for the brand name forms of oral cyclosporine. As stated V.A.3.a. of this final rule with comment period, the MMA set forth different payment ceilings for the brand and generic versions of a drug where the CY 2005 payment rate for innovator multiple source (brand name) drugs may not exceed 68 percent of the reference AWP and the payment for generic versions may not exceed 46 percent of the reference AWP. We explained previously that we apply those ceilings only where the payment for an item based on the median hospital cost for the drug exceeds one of these ceilings. In some cases, the payment based on the median hospital cost falls below the 46 percent ceiling for generic drugs. In such cases, the payment rate would be the same for brand and generic versions. We believe that basing payment for these items on relative hospital costs, with the application as appropriate of the previously mentioned ceilings not only meets the intent but also the requirements of the MMA. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         A commenter recommended that CMS consider pricing information from several authoritative sources when determining the reference AWP, including Red Book and First Data Bank, on a case-by-case basis since such pricing information can be used to resolve outstanding payment issues and ensure greater accuracy in calculating the OPPS payment rates. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We appreciate this comment and will consider this recommendation when we reassess the OPPS payment rates. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         Several commenters noted that CMS changed the classification for many of the biologicals products to sole source “specified covered outpatient drugs” in the February 27, 2004 CMS Transmittal 113 without discussing why the changes were made. One of the commenters indicated that the definition for sole source “specified covered outpatient drugs” in the MMA is different from the Medicaid rebate definition. The commenter stated that the MMA defined sole source drugs as: (1) A biological product (as defined under section 1861(t)(1) of the Act); or (2) a single source drug (as defined in section 1927(k)(7)(A)(iv) of the Act). The commenters requested that CMS clarify that it intends to treat all biological products as sole source drugs in the future as the law requires. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We agree with the commenters that biologicals products are defined as sole source “specified covered drugs” in the MMA, and we will determine payment rates for these products accordingly. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         We received several comments on the mechanism for establishing payment rates for innovator and noninnovator multiple source drugs. One commenter urged CMS to set the payment rates closer to the actual 
                        <PRTPAGE P="65804"/>
                        costs for all products and services and provide differential reimbursement for innovator multiple source products only if their actual acquisition costs were markedly higher than that for the noninnovator multiple source products. Another commenter indicated that innovator and noninnovator multiple source drugs were discounted very similarly, and therefore, differential payments were not necessary. A commenter also requested that CMS obtain legislative approval to price these innovator and noninnovator multiple source drugs using a blended payment rate set halfway between 46 percent and 68 percent of their reference AWPs. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We appreciate these suggestions and note that the methodology that will be used to determine payment rates for innovator and noninnovator multiple source drugs in CY 2005 is described in detail in  section V.A.3.a. of this final rule with comment period. 
                    </P>
                    <HD SOURCE="HD2">C. Coding and Billing for Specified Outpatient Drugs </HD>
                    <P>As discussed in the January 6, 2004 interim final rule with comment period (69 FR 826), hospitals were instructed to bill for sole source drugs using the existing HCPCS code, which were priced in accordance with the provisions of newly added section 1833(t)(14)(A)(i) of the Act, as added by Pub. L. 108-173. However, at that time, the existing HCPCS codes did not allow us to differentiate payment amounts for innovator multiple source and noninnovator multiple source forms of the drug. Therefore, effective April 1, 2004, we implemented new HCPCS codes via Program Transmittal 112 (Change Request 3144, February 27, 2004) and Program Transmittal 132 (Change Request 3154, March 30, 2004) that providers were instructed to use to bill for innovator multiple source drugs in order to receive appropriate payment in accordance with section 1833(t)(14)(A)(i)(II) of the Act. Providers were also instructed to continue to use the current HCPCS codes to bill for noninnovator multiple source drugs to receive payment in accordance with section 1833(t)(14)(A)(i)(III). In this manner, drugs, biologicals, and radiopharmaceuticals will be appropriately coded to reflect their classification and be paid accordingly. In the August 16, 2004 proposed rule, we proposed to continue this coding practice in CY 2005 with payment made in accordance with section 1833(t)(14)(A)(ii) of the Act. </P>
                    <P>We received a few public comments on our proposal. </P>
                    <P>
                        <E T="03">Comment:</E>
                         Several commenters urged that CMS delete certain newly created C codes (C9400,Thallous Chloride, brand; C9401 Strontium-89 chloride, brand; C9402 Th I131 so iodide cap, brand; C9403 Dx I131 so iodide cap, brand; C9404 Dx So iodide sol, brand; C9405 Th I131 so iodide, sol. brand) because radiopharmaceuticals are better characterized as either sole source or innovator multiple source drugs. The commenters indicated that the creation of the new codes implied that some radiopharmaceuticals are generic products and others are brand, but there was no identification of which product falls within which code. Further, there was no payment difference between some of the radiopharmaceutical brand products versus generics. The commenters believed these products did not fit the conventional brand versus generic distinctions, and should all be recognized as brand drugs until the GAO report provides additional data. Also, the commenters recommended that the current A-codes be retained at the payment levels CMS proposes for “brand” drugs and believed that deletion of these codes should result in payment for the corresponding radiopharmaceuticals based on their status as a sole source or innovator multi-source drug and would significantly lessen hospital administrative burden and confusion. Another commenter indicated that hospitals needed further clarification on which manufacturers' products can be billed under the HCPCS codes created for the brand and generic forms of a product. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         As stated in section V.A.3.a. of this final rule with comment period, section 621(a) of Pub. L. 108-173 sets forth different payment ceilings for the brand and generic versions of a drug where the CY 2005 payment rate for innovator multiple source (brand name) drugs may not exceed 68 percent of the reference AWP and the payment for generic versions may not exceed 46 percent of the reference AWP. We explained previously that we apply those ceilings only where the payment for an item based on the median hospital cost for the drug exceeds one of these ceilings. In some cases, the payment based on the median hospital cost falls below the 46 percent ceiling for generic drugs. In such cases, as the commenters indicate, the payment rate would be the same for brand and generic versions. 
                    </P>
                    <P>We will not be providing a list of brand name and generic products for hospitals to use in determining whether their product is a brand name or generic product. We believe that hospitals are in the best position to correctly determine which type of products they are using. We refer the commenter to the definitions of innovator and noninnovator multiple source drugs stated in the January 6, 2004 interim final rule with comment period (69 FR 822). Hospitals can also use the FDA's Orange Book in determining whether an item they use is a brand name product. </P>
                    <HD SOURCE="HD2">D. Payment for New Drugs, Biologicals and Radiopharmaceuticals Before HCPCS Codes Are Assigned </HD>
                    <HD SOURCE="HD3">1. Background </HD>
                    <P>Historically, hospitals have used a code for an unlisted or unclassified drug, biological, or radiopharmaceutical or used an appropriate revenue code to bill for drugs, biologicals, and radiopharmaceuticals furnished in the outpatient department that do not have an assigned HCPCS code. The codes for not otherwise classified drugs, biologicals, and radiopharmaceuticals are assigned packaged status under the OPPS. That is, separate payment is not made for the code, but charges for the code would be eligible for an outlier payment and, in future updates, the charges for the code are packaged with the separately payable service with which the code is reported for the same date of service. </P>
                    <P>Drugs and biologicals that are newly approved by the FDA and for which an HCPCS code has not yet been assigned by the National HCPCS Alpha-Numeric Workgroup could qualify for pass-through payment under the OPPS. An application must be submitted to CMS in order for a drug or biological to be assigned pass-through status, along with a temporary C-code for billing purposes, and an APC payment amount. Pass-through applications are reviewed on a flow basis, and payment for drugs and biologicals approved for pass-through status is implemented throughout the year as part of the quarterly updates of the OPPS. </P>
                    <P>
                        In the November 7, 2003 final rule with comment period (68 FR 63440), we explained how CMS generally pays under the OPPS for new drugs and biologicals that are assigned HCPCS codes, but that are not approved for pass-through payment, and for which CMS had no data upon which to base a payment rate. These codes do not receive separate payment, but are assigned packaged status. Hospitals were urged to report charges for the new codes even though separate payment is not provided. Charges reported for the new codes are used to determine hospital costs and payment rates in future updates. For CY 2004, we again 
                        <PRTPAGE P="65805"/>
                        noted that drugs that were assigned an HCPCS code effective January 1, 2004, and that were assigned packaged status, remain packaged unless pass-through status is approved for the drug. If pass-through status is approved for these drugs, pass-through payments are implemented prospectively in the next available quarterly release. 
                    </P>
                    <HD SOURCE="HD3">2. Provisions of Pub. L. 108-173 </HD>
                    <P>Section 621(a)(1) of Pub. L. 108-173 amended section 1833(t) of the Act by adding paragraph (15) to provide for payment for new drugs and biologicals until HCPCS codes are assigned under the OPPS. Under this provision, we are required to make payment for an outpatient drug or biological that is furnished as part of covered OPD services for which a HCPCS code has not been assigned in an amount equal to 95 percent of AWP. This provision applies only to payments under the OPPS, effective January 1, 2004. However, we did not implement this provision in the January 6, 2004 interim final rule with comment period because we had not determined at that time how hospitals would be able to bill Medicare and receive payment for a drug or biological that did not have an identifying HCPCS code. </P>
                    <P>As stated earlier, at its February 2004 meeting, the APC Panel heard presentations suggesting how to make payment for a drug or biological that did not have a code. The APC Panel recommended that we work swiftly to implement a methodology to enable hospitals to file claims and receive payment for drugs that are newly approved by the FDA. The APC Panel further recommended that we consider using temporary or placeholder codes that could be quickly assigned following FDA approval of a drug or biological to facilitate timely payment for new drugs and biologicals. </P>
                    <P>We explored a number of options to make operational the provisions of section 1833(t)(15) of the Act, as added by section 621(a)(1) of Pub. L. 108-173, as soon as possible. One of the approaches that we considered was to establish a set of placeholder codes in the Outpatient Code Editor (OCE) and the PPS pricing software for the hospital OPPS (PRICER) that we would instruct hospitals to use when a new drug was approved. Hospitals would be able to submit claims using the new code but would receive no payment until the next quarterly update. By that time, we would have installed an actual payment amount and descriptor for the code into the PRICER, and would mass-adjust claims submitted between the date of FDA approval and the date of installation of the quarterly release. A second option that we considered was to implement an APC, a C-code, and a payment amount as part of the first quarterly update following notice of FDA approval of a drug or biological. Hospitals would hold claims for the new drug or biological until the quarterly release was implemented and then submit all claims for the drug or biological for payment using the new C-code to receive payment on a retroactive basis. We also considered instructing hospitals to bill for a new drug or biological using a “not otherwise classified” code for which they would receive an interim payment based on charges converted to cost. Final payment would then be reconciled at cost report settlement. While each of these approaches might enable hospitals to begin billing for a newly approved drug or biological as soon as it received FDA approval, each approach had significant operational disadvantages, such as increased burden on hospitals or payment delays, or the risk of significant overpayments or underpayments that could not be resolved until cost report settlement. </P>
                    <P>We adopted an interim approach that we believe balances the need for hospitals to receive timely and accurate payment as soon as a drug or biological is approved by the FDA with minimal disruption of the OPPS claims processing modules that support the payment of claims. On May 28, 2004 (Transmittal 188, Change Request 3287), we instructed hospitals to bill for a drug or biological that is newly approved by the FDA by reporting the National Drug Code (NDC) for the product along with a new HCPCS code C9399, Unclassified drug or biological. When C9399 appears on a claim, the OCE suspends the claim for manual pricing by the fiscal intermediary. The fiscal intermediary prices the claim at 95 percent of its AWP using Red Book or an equivalent recognized compendium, and processes the claim for payment. This approach enables hospitals to bill and receive payment for a new drug or biological concurrent with its approval by the FDA. The hospital does not have to wait for the next quarterly release or for approval of a product-specific HCPCS to receive payment for a newly approved drug or biological or to resubmit claims for adjustment. Hospitals would discontinue billing C9399 and the NDC upon implementation of an HCPCS code, status indicator, and appropriate payment amount with the next quarterly update. </P>
                    <P>In the August 16, 2004 proposed rule, we proposed to formalize this methodology for CY 2005 and to expand it to include payment for new radiopharmaceuticals to which a HCPCS code is not assigned (see section V.G. of this preamble). We solicited comments on the methodology and expressed particular interest in the reaction of hospitals to using this approach to bill and receive timely payment under the OPPS for drugs, biologicals, and radiopharmaceuticals that are newly approved by the FDA, prior to assignment of a product-specific HCPCS code. </P>
                    <P>We received a number of public comments on our proposal. </P>
                    <P>
                        <E T="03">Comment:</E>
                         One commenter, a state hospital association, is concerned about the ability of hospitals to correctly code for newly approved drugs and biologicals without HCPCS codes using the NDC codes. The commenter indicates that typically only pharmacy systems within hospitals can properly handle the assignment and reporting of a drug's NDC, not the hospital billing systems. Additionally, the use of the Remarks field to report the NDC creates payment delays as it requires manual review and pricing by the fiscal intermediaries. Several commenters, including a national hospital association and several state hospital associations, recommended that CMS adopt a new revenue code subcategory for hospitals to use when reporting these newly FDA-approved drugs and biologicals on UB-92 paper claims. The hospital could use the new revenue code along with the reported NDC in the revenue-code description field. Establishing a new revenue code field, to be used with the description field, allows clearinghouses to scan the paper UB-92 and then convert the data into the appropriate HIPAA standard for auto adjudication. The FI would then no longer have to suspend these paper claims for manual pricing, because it would build logic into the system to auto-adjudicate these claims. The hospital would then continue to report C9399 (HCPCS code indicating Unclassified drug or biological) in the HCPCS field, the units in the Unit field, the date the drug was administered in the date field, and finally, the price of these drugs in the Total Charges field. These commenters believed that this alternative policy would greatly improve the current process for both hospitals and fiscal intermediaries. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We read the hospital associations' recommendation for an alternative approach to report NDCs on UB-92 paper claims with interest and will explore its feasibility with the different components within CMS that are responsible for claims processing, information technology and systems, 
                        <PRTPAGE P="65806"/>
                        and HIPAA standards. It appears that time-consuming systems changes could be required were we to adopt such an approach, which could delay implementation, but we will consider the proposal carefully. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         A maker of pharmaceuticals commends CMS for implementing the mechanism where hospitals can bill and be paid for new drugs without HCPCS codes. However, the commenter is concerned that the use of a miscellaneous code may result in significant payment delays and potentially prevent patient access to new therapies. The commenter suggests that CMS monitor claims submission, timely processing, and payments more closely so that patient access to new therapies is not impeded. Another commenter suggested that CMS should modify this mechanism if necessary to ensure patients have access to cutting-edge drugs. One commenter suggested that CMS explore with its contractors the feasibility of automating processing of these claims by including the NDC number as a claims processing field when the miscellaneous C code appears on a claim since such a process would eliminate the additional costs of manual claim review and expedite provider payment. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We share the commenters' concerns that claims processing systems not impede beneficiary access to new drug therapies. However, we believe the approach that we implemented in CY 2004 and that we proposed to adopt permanently beginning in CY 2005, which requires the use of HCPCS code C9399 to be reported with an appropriate NDC, will result in hospitals receiving payment for new drugs more quickly compared to the process that we followed previously, even though some manual handling of claims is required. We agree with the commenter who suggested that CMS closely monitor claims submission, timely processing, and payments for new drugs, and we intend to do so. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         One commenter encouraged CMS to reconsider the payment policy that requires the reporting of the NDC for new drugs as “mandatory” and consider making the NDC “optional.” For providers unable to automate the reporting of the NDC number due to software limitations, it suggested that CMS consider allowing providers the option of listing the NDC number in the detailed drug name as reported on the itemized statement of charges that can be requested along with the UB reporting the C9399 code. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         As we have indicated in previous responses to commenters' suggestions regarding ways to implement the payment requirement for new drugs and biologicals that have not been assigned a HCPCS code, we will also consider this commenter's recommendation to determine its feasibility. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         Several commenters urged CMS to reconsider the policy of preloading several new codes into CMS' computer system and assigning them to new drugs and biologicals as the Food and Drug Administration approved them, rather than requiring manual processing of claims using a single miscellaneous code. If CMS determines that the current policy is imposing too great an administrative burden on hospitals and delays in processing claims that harm hospitals' ability to provide new drugs and biologicals to Medicare beneficiaries, the commenters urged CMS to reconsider its proposal and to explore preloading placeholder codes instead. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         Preloading placeholder codes was one of the options that we considered before we implemented C9399, but we found that this approach had its disadvantages, most of which stemmed from concerns about delays related to the dissemination of new codes to providers and installing prices into the claims processing modules in a timely manner. We propose to monitor throughout CY 2005 the use of HCPCS code C9399 and NDC codes to evaluate whether this approach is an improvement over how hospitals were previously paid for new drugs to which a HCPCS code had not been assigned and to determine if changes in the process would be beneficial.
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         One commenter indicated that requiring hospitals to submit the National Drug Code on claims imposes an enormous administrative burden on hospitals because there is no field for NDCs on the claims form and, therefore, NDCs cannot be entered on the claim automatically. Rather, claims must be flagged and adjusted manually. The commenter suggested that the best solution is to close the lag time between FDA approval and HCPCS assignment of a new drug. By creating a seamless execution of approval and code assignment, CMS can ensure that the MMA mandate is fulfilled in the least burdensome manner and that providers are adequately paid for providing these new drugs. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         While the use of NDCs may impose a degree of reporting burden on hospitals, we believe that, in spite of the inconvenience of manual reporting and claims processing, this approach is the most efficient way to expedite payment to hospitals for newly approved drugs to which a HCPCS code has not been assigned. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         One commenter, an association for cancer centers, supported CMS' proposal for reporting new drugs without HCPCS codes using C9399 and any other necessary data. However, the commenter requested clarification from CMS on whether C9399 can only be used for injectible drugs or whether this code can also be used to report all newly approved FDA drugs (including oral drugs). The commenter believed that C9399 can be used for all Medicare-covered drugs, including oral anti-emetics and oral chemotherapeutics with IV equivalents, but requested that CMS clarify this issue to ensure that fiscal intermediaries correctly process this new code. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         Our instructions regarding how hospitals may report a new drug using C9399 and NDCs only indicate the method by which hospitals can bill Medicare for payment if the new drug is covered by the Medicare program. These instructions do not represent a determination that the Medicare program covers a new drug for which a hospital submits a bill using C9399. In addition to determining payment, fiscal intermediaries must determine whether a drug billed with C9399 meets all program requirements for coverage. For example, they must assess whether the drug is reasonable and necessary to treat the beneficiary's condition and whether the drug is excluded from payment because it is usually self-administered. The same rules, regulations, and policies that apply to coverage of drugs, biologicals, and radiopharmaceutical agents that already have a HCPCS code also apply to newly approved items for which a HCPCS code has not yet been assigned. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         Two commenters urged CMS to publish the approved drugs and radiopharmaceuticals that may be submitted under HCPCS code C9399, as well as the appropriate units of measure applicable for each drug or biological and the payment amount for the drug based on 95 percent of the AWP. One commenter indicated that hospitals are concerned that they will not identify all of the drugs that are eligible for this payment and are also concerned that they may inappropriately assign the HCPCS code to drugs that are not eligible for this payment. Additionally, there is an administrative burden placed both on providers and the fiscal intermediaries when CMS does not publish the payment rates for these drugs. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We understand that use of C9399 and NDCs is a departure from how hospitals have become accustomed 
                        <PRTPAGE P="65807"/>
                        to preparing Medicare claims for the OPPS services. However, the MMA mandates that hospitals be paid 95 percent of AWP for new drugs until a HCPCS code is assigned to that drug. We believe this MMA provision is intended to ensure that hospitals can receive timely payment for new drugs, biologicals, and radiopharmaceuticals without having to wait for a HCPCS code to be created and disseminated or for an OPPS payment amount to be implemented in a quarterly OPPS update. Generally, CMS learns of FDA approval of a new product at approximately the same time the public learns of the approval. Hospitals may wish to look to their advocacy associations for assistance in monitoring the FDA Web site to identify new products as they are approved, as a supplemental information source. We also intend to explore ways hospitals could systematically receive timely reports of newly approved drugs by means other than checking the FDA Web site. However, how to report a product rests with the hospital, as it does for any drug, biological, radiopharmaceutical agent, procedure, or service, with or without a HCPCS code. Therefore, we are not accepting the commenters' suggestion that we publish the approved drugs and radiopharmaceuticals that may be submitted under HCPCS code C9399, as well as the appropriate units of measure applicable for each drug or biological and the payment amount for the drug based on 95 percent of the AWP. Rather, we prefer to focus our resources on updating the OPPS on a quarterly basis with codes, APC assignments, and payment amounts for drugs, biologicals, and radiopharmaceuticals newly approved by the FDA during the prior quarter. 
                    </P>
                    <P>We have carefully considered commenters' recommendations and concerns, and we believe that our proposed methodology for using C9399 and NDC codes to bill for drugs, biologicals, and radiopharmaceutical agents newly approved by FDA to which a HCPCS code is not assigned is the most efficient and practicable approach at this time to ensure timely, appropriate Medicare payment for these new products. Therefore, we are making final for CY 2005 our proposed methodology, without modification. </P>
                    <HD SOURCE="HD2">E. Payment for Vaccines </HD>
                    <P>Outpatient hospital departments administer large numbers of immunizations for influenza (flu) and pneumococcal pneumonia (PPV), typically by participating in immunization programs. In recent years, the availability and cost of some vaccines (particularly the flu vaccine) have fluctuated considerably. As discussed in the November 1, 2002 final rule (67 FR 66718), we were advised by providers that the OPPS payment was insufficient to cover the costs of the flu vaccine and that access of Medicare beneficiaries to flu vaccines might be limited. They cited the timing of updates to the OPPS rates as a major concern. They indicated that our update methodology, which uses 2-year-old claims data to recalibrate payment rates, would never be able to take into account yearly fluctuations in the cost of the flu vaccine. We agreed with this concern and decided to pay hospitals for influenza and pneumococcal pneumonia vaccines based on a reasonable cost methodology. As a result of this change, hospitals, home health agencies (HHAs), and hospices, which were paid for these vaccines under the OPPS in CY 2002, have been receiving payment at reasonable cost for these vaccines since CY 2003. We are aware that access concerns continue to exist for these vaccines. However, we continue to believe that payment other than on a reasonable cost basis would exacerbate existing access problems. Therefore, in the August 16, 2004 proposed rule, we proposed to continue paying for influenza and pneumococcal pneumonia vaccines under the reasonable cost methodology in CY 2005. </P>
                    <P>
                        <E T="03">Comment:</E>
                         Several commenters applauded CMS' proposal to continue to pay for vaccines under the reasonable cost methodology. The commenters indicated that payment on a reasonable cost basis helps ensure that the OPPS rates are adequate to cover hospitals' costs of providing vaccines to Medicare beneficiaries, protecting their health, and reducing Medicare's costs of treating influenza and other preventable illnesses. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We appreciate the commenters' continued support of our policy to pay for influenza and pneumococcal pneumonia vaccines at reasonable cost and finalize our proposal in this final rule with comment period. We note that for CY 2005 a new CPT code for an influenza vaccine was created. The new CPT code 90656 (Influenza virus vaccine, split virus, preservative free, for use in individuals 3 years and above, for intramuscular use) will be paid at reasonable cost in CY 2005. We have assigned status indicator “L” (Not Paid under OPPS. Paid at reasonable cost) to this new CPT code. 
                    </P>
                    <HD SOURCE="HD2">F. Changes in Payment for Single Indication Orphan Drugs </HD>
                    <P>Section 1833(t)(1)(B)(i) of the Act gives the Secretary the authority to designate the hospital outpatient services to be covered. The Secretary has specified coverage for certain drugs as orphan drugs (section 1833(t)(14)(B)(ii)(III) of the Act as added by section 621(a)(1) of Pub. L. 108-173). Section 1833(t)(14)(C) of the Act as added by section 621(a)(1) of Pub. L. 108-173, gives the Secretary the authority in CYs 2004 and 2005 to specify the amount of payment for an orphan drug that has been designated as such by the Secretary. </P>
                    <P>We recognize that orphan drugs that are used solely for an orphan condition or conditions are generally expensive and, by definition, are rarely used. We believe that if the cost of these drugs were packaged into the payment for an associated procedure or visit, the payment for the procedure might be insufficient to compensate a hospital for the typically high cost of this special type of drug. Therefore, in the August 16, 2004 proposed rule, we proposed to continue making separate payments for orphan drugs based on their currently assigned APCs. </P>
                    <P>In the November 1, 2002 final rule (67 FR 66772), we identified 11 single indication orphan drugs that are used solely for orphan conditions by applying the following criteria: </P>
                    <P>• The drug is designated as an orphan drug by the FDA and approved by the FDA for treatment of only one or more orphan conditions(s). </P>
                    <P>• The current United States Pharmacopoeia Drug Information (USPDI) shows that the drug has neither an approved use nor an off-label use for other than the orphan condition(s). </P>
                    <P>Eleven single indication orphan drugs were identified as having met these criteria and payments for these drugs were made outside of the OPPS on a reasonable basis. </P>
                    <P>
                        In the November 7, 2003 final rule with comment period (68 FR 63452), we discontinued payment for orphan drugs on a reasonable cost basis and made separate payments for each single indication orphan drug under its own APC. Payments for the orphan drugs were made at 88 percent of the AWP listed for these drugs in the April 1, 2003 single drug pricer, unless we were presented with verifiable information that showed that our payment rate did not reflect the price that is widely available to the hospital market. For CY 2004, Ceredase (alglucerase) and Cerezyme (imiglucerase) were paid at 94 percent of AWP because external data 
                        <PRTPAGE P="65808"/>
                        submitted by commenters on the August 12, 2003 proposed rule caused us to believe that payment at 88 percent of AWP would be insufficient to ensure beneficiaries' access to these drugs. 
                    </P>
                    <P>In the December 31, 2003 correction of the November 7, 2003 final rule with comment period (68 FR 75442), we added HCPCS code J9017, arsenic trioxide (per unit) to our list of single indication orphan drugs. As of the time of our August 16, 2004 proposed rule, the following were the 12 orphan drugs that we have identified as meeting our criteria: J0205 Injection, alglucerase, per 10 units; J0256 Injection, alpha 1-proteinase inhibitor, 10 mg; J9300 Gemtuzumab ozogamicin, 5 mg; J1785 Injection, imiglucerase, per unit; J2355 Injection, oprelvekin, 5 mg; J3240 Injection, thyrotropin alpha, 0.9 mg; J7513 Daclizumab parenteral, 25 mg; J9015 Aldesleukin, per vial; J9017 Arsenic trioxide, per unit; J9160 Denileukin diftitox, 300 mcg; J9216 Interferon, gamma 1-b, 3 million units and Q2019 Injection, basiliximab, 20 mg. In the August 16, 2004 proposed rule, we did not propose any changes to this list of orphan drugs for CY 2005. </P>
                    <P>In the proposed rule, we noted that had we not classified these drugs as single indication orphan drugs for payment under the OPPS, they would have met the definition as a single source specified covered outpatient drug and been paid lower payments which could impede beneficiary access to these unique drugs dedicated to the treatment of rare diseases. Instead, for CY 2005, under our authority at section 1833(t)(14)(C) of the Act, we proposed to pay for all 12 single indication orphan drugs, including Ceredase and Cerezyme, at the rate of 88 percent of AWP or 106 percent of the ASP, whichever is higher. However, for drugs where 106 percent of the ASP would exceed 95 percent of AWP, payment would be capped at 95 percent of AWP, which is the upper limit allowed for sole source specific covered outpatient drugs. For example, Ceredase and Cerezyme would each be paid at 95 percent of the AWP because payment at ASP plus 6 percent for these two drugs not only exceeds 88 percent of the AWP but also exceeds 95 percent of the AWP. We proposed to pay the higher of 88 percent of AWP or 106 percent of ASP capped at 95 percent of AWP to ensure that beneficiaries will continue to have access to such important drugs. </P>
                    <P>We received the following comments to our August 16, 2004 proposed rule on single indication orphan drugs. </P>
                    <P>
                        <E T="03">Comment:</E>
                         A few commenters recommended that CMS adopt the FDA's definition of an orphan drug as under the Orphan Drug Act. The commenters indicated that CMS should expand the current list of 12 single-indication orphan drugs that receive special treatment to include several other FDA-designated orphan drugs. One commenter requested that CMS adopt a utilization threshold to identify orphan drugs that would receive the special treatment rather than using its current criteria. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         Using the statutory authority in section 1833(t)(1)(B)(i) of the Act, which gives the Secretary broad authority to designate covered OPD services under the OPPS, we have established criteria which distinguish single-indication orphan drugs from other drugs designated as orphan drugs by the FDA under the Orphan Drug Act. Our determination to provide special payment for these drugs neither affects nor deviates from FDA's classification of any drugs as orphan drugs. The special treatment given to this subset of FDA-designated orphan drugs is intended to ensure that beneficiaries have continued access to these life-saving therapies given that these drugs have a relatively low volume of patient use, lack any other non-orphan indication and are typically very costly. Although we are not expanding our criteria to identify orphan drugs that will receive special payment for CY 2005, we will consider the commenters' recommendation of a utilization threshold in future changes to the OPPS orphan drug list. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         We received comments from different drug manufacturers separately requesting that Campath (J9010, Alemtuzumab), Elitek (J2783, Rasburicase), Vidaza (C9218, Azacitidine for injectable suspension), and Botox (J0585, Botulinum toxin type A) be included in the list of single-indication orphan drugs that will receive special payment for CY 2005. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         After careful review of the requests for these four drugs to be included in the list of single-indication orphan drugs, we have determined that Campath (J9010) and Vidaza (C9218) do meet our criteria for inclusion in the list. Thus, effective for January 1, 2005, J9010 and C9218 will be paid in accordance with the payment policy for single indication orphan drugs for CY 2005. However, we have determined that Elitek (J2783) and Botox (J0585) do not meet the criteria for inclusion in the list because these drugs have an off-label use as indicated by the 2004 United States Pharmacopoeia Drug Information (USPDI). 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         Several commenters, including manufacturers of alpha-1 proteinase inhibitor (J0256) sold under the brand names Prolastin, Aralast and Zemaira, submitted comments expressing concern over the decrease in the payment rate for HCPCS J0256 from the CY 2004 level to the CY 2005 proposed rate. The majority of commenters requested that the payment rate for J0256 be frozen at the CY 2004 levels, rather than based on the AWP of Prolastin, the least expensive drug among the three name brands. As some commenters explained, Prolastin has experienced supply shortages in the past and if the payment rate for the alpha-1 therapy did not take into account the higher AWPs of Aralast or Zemaira, it would be inadequate to cover the actual acquisition costs of the drugs to hospitals. 
                    </P>
                    <P>The manufacturer of Aralast requested that CMS exclude pricing information associated with Prolastin when setting the payment rate for J0256. The commenter stated that although Prolastin is currently available and used in greater quantities than either Aralast or Zemaira , it has experienced supply shortages in the past. Therefore, according to the commenter, the payment rate for J0256 needs to be such that patients will have continued access to all three brand names. Alternatively, the commenter recommended that new HCPCS codes could be created so each brand name could be paid appropriately or CMS could freeze the payment rate for J0256 at the CY 2004 levels, as the majority of commenters recommended. </P>
                    <P>The manufacturer of Zemaira expressed concern that the proposed payment rate does not meet the actual hospital acquisition cost for this brand name, which is the newest of the three brand names to come on the market to be used in alpha-1 therapy. </P>
                    <P>We received a comment from an organization representing voluntary health organizations and individual patients that stated that the proposed payments for CY 2005 were adequate to avoid problems with access to the orphan drugs that patients with rare diseases need. In addition, the commenter requested that CMS take actions to monitor any changes in beneficiaries' access to orphan drugs as a result of payment changes, to review the claims database for changes in utilization patterns, to seek input from beneficiaries about access problems, and to inform beneficiaries about payment changes and the potential impact of such changes on their access. </P>
                    <P>
                        We also received recommendations from a patient advocacy organization requesting that CMS work with the manufacturers of the alpha-1 therapy to obtain the data necessary to raise the proposed OPPS rate of $2.46 (per 10 mg) or to establish the ASP rate which may 
                        <PRTPAGE P="65809"/>
                        enhance patient access to care. The commenter also recommended that CMS base the payment rate for J0256 on all available brands. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         After careful evaluation of the issues and concerns raised by commenters in response to our proposed rule, we recognize that our proposed payment rate for HCPCS code J0256 may create an unanticipated access problem during periods of short supply. Therefore, in order to ensure continued beneficiaries' access to this important drug, we will base the payment rate for HCPCS code J0256 on all three brands of the alpha-1 proteinase inhibitor currently available on the market. The adjusted AWP of HCPCS code J0256 will be based on the volume-weighted average of the three drugs. The adjusted AWP will be updated each quarter, as necessary, to reflect any changes in the individual AWP or relative weight of each drug in the calculation of the AWP for HCPCS code J0256. We would expect that as the volume and/or individual AWP increases or decreases for a brand, these changes will be captured in its relative weight and will be reflected in the adjusted AWP for HCPCS code J0256. 
                    </P>
                    <P>We share the commenters' concern for protecting beneficiaries' access to these therapies used for rare disease conditions. As part of our process of developing special payment rates for single indication orphan drugs in CY 2005, our analysis of CY 2003 claims data does not indicate a decrease in utilization of any orphan drugs that may signify barriers to beneficiaries' access to these drugs. </P>
                    <P>
                        <E T="03">Comment:</E>
                         Several commenters recommended that CMS eliminate the 95 percent AWP cap on single-indication orphan drugs whose ASP plus 6 percent would exceed their 88 percent AWP. According to the commenters, these drugs would not be subject to the 95 percent AWP cap when administered in the physician's office. They argued that CMS should pay for these drugs at the same rate, irrespective of the site of service. 
                    </P>
                    <P>We received a request from the drug manufacturer of Ontak to increase the payment rate for the drug from 88 percent of the May 2004 AWP to 92 percent of the current AWP. Alternatively, the commenter requested that CMS remove the 95 percent AWP cap for J9160 (Ontak). </P>
                    <P>
                        <E T="03">Response:</E>
                         We believe that access to these life-saving therapies is extremely important and after careful consideration, we will not implement the cap of 95 percent of AWP for any of the single-indication orphan drug for those drugs whose 106 percent ASP exceeds 88 percent of AWP. Effective for CY 2005, payment for all single-indication orphan drugs will be set at the higher of 106 percent of the most current ASP or 88 percent of the most current AWP. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         A few commenters recommended that CMS update the payment rates quarterly, based on the latest ASP and AWP data available. They argue that to lock in the rates for a year based on outdated information could impede patient access to these drugs. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We agree with the commenters and will base payments for single-indication orphan drugs on a quarterly comparison of ASP and AWP data. Appropriate adjustments to the payment amounts shown in Addendum A and B will be made if ASP submissions and AWP data in a later quarter indicate that adjustments to the payment rates are necessary. These changes to the Addenda will be announced in our program instructions released on a quarterly basis and posted on our Web site at 
                        <E T="03">http://www.cms.hhs.gov.</E>
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         We also received a comment from the manufacturer of Fabrazyme requesting that CMS consider making payment for Fabrazyme (C9208, agalsidase beta) as a single-indication orphan drug. The commenter believes that by statute, CMS is required to pay for the drug at 106 percent of ASP; however, the commenter stated that if CMS were to somehow reach a different conclusion, it would request to be treated as a single-indication orphan drug. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We agree with the commenter that the statute requires that payment for Fabrazyme (C9208), a drug that currently has pass-through status, be made at 106 percent of ASP for CY 2005. 
                    </P>
                    <P>In summary, we have set payment rates for single-indication orphan drugs according to the following policy, effective January 1, 2005: </P>
                    <P>• We are using the same criteria that we implemented in CY 2003 to identify single indication orphan drugs used solely for an orphan condition for special payment under the OPPS; and, </P>
                    <P>• We are setting payment under the CY 2005 OPPS for single indication orphan drugs at the higher of 88 percent of the AWP or the ASP plus 6 percent, updated quarterly to reflect the most current AWP and ASP data. </P>
                    <P>While we are not implementing the 95 percent AWP cap on single-indication orphan drugs in CY 2005, we will monitor this decision and may apply the cap in future OPPS updates. </P>
                    <HD SOURCE="HD2">G. Change in Payment Policy for Radiopharmaceuticals </HD>
                    <P>In the November 1, 2002 OPPS final rule (67 FR 66757), we determined that we would classify any product containing a therapeutic radioisotope to be in the category of benefits described under section 1861(s)(4) of the Act. We also determined that the appropriate benefit category for diagnostic radiopharmaceuticals is section 1861(s)(3) of the Act. We stated in the November 1, 2002 final rule that we will consider neither diagnostic nor therapeutic radiopharmaceuticals to be drugs as defined in 1861(t) of the Act (67 FR 66757). Therefore, beginning with the CY 2003 OPPS update, and continuing with the CY 2004 OPPS update, we have not qualified diagnostic or therapeutic radiopharmaceuticals as drugs or biologicals. </P>
                    <P>As we stated in the August 16, 2004 proposed rule, when we analyzed the many changes mandated by Pub. L. 108-173 that affect how we would pay for drugs, biologicals, and radiopharmaceuticals under the OPPS in CY 2005, we revisited the decision that we implemented in CY 2003 not to classify diagnostic and therapeutic radiopharmaceuticals as drugs or biologicals. In our analysis, we noted that although we did not consider radiopharmaceuticals for pass-through payment in CYs 2003 and 2004, we did apply to radiopharmaceuticals the same packaging threshold policy that we applied to other drugs and biologicals, and which we proposed to continue in CY 2005. In addition, for the CY 2004 OPPS update, we applied the same adjustments to median costs for radiopharmaceuticals that we applied to separately payable drugs and biologicals that did not have pass-through status (68 FR 63441). </P>
                    <P>In our review of this policy, we noted that section 1833(t)(14)(B)(i) of the Act, as amended by section 621(a) of Pub. L. 108-173, does include “radiopharmaceutical” within the meaning of the term “specified covered outpatient drugs,” although neither section 621(a)(2) nor section 621(a)(3) of Pub. L. 108-173 includes a reference to radiopharmaceuticals. </P>
                    <P>
                        In an effort to provide a consistent reading and application of the statute, we proposed to apply to radiopharmaceuticals certain provisions in section 621 of Pub. L. 108-173 which affect payment for drugs and biologicals billed by hospitals for payment under the OPPS. We believed it was reasonable to include radiopharmaceuticals in the general category of drugs in light of their 
                        <PRTPAGE P="65810"/>
                        inclusion as specified covered outpatient drugs in section 1833(t)(14)(B) of the Act, as added by section 621(a)(1) of Pub. L. 108-173. 
                    </P>
                    <P>Section 621(a)(1) of Pub. L. 108-173, which amends section 1833(t) of the Act by adding a new subparagraph (14) affecting payment for radiopharmaceuticals under the OPPS, is unambiguous. This provision clearly requires that separately paid radiopharmaceuticals be classified as “specified covered outpatient drugs.” Therefore, in CY 2005, we proposed to continue to set payment for radiopharmaceuticals in accordance with these requirements, which are discussed in detail in section V.B.3. of this preamble. </P>
                    <P>Section 1833(t)(16)(B) of the Act, as added by section 621(a)(2) of Pub. L. 108-173, requires us to reduce the threshold for the establishment of separate APCs with respect to drugs and biologicals to $50 per administration for drugs and biologicals furnished in 2005 and 2006. We proposed to apply the $50 packaging threshold methodology discussed in section V.B.2. of this final rule with comment period to radiopharmaceuticals as well as to drugs and biologicals. </P>
                    <P>Section 1833(t)(15) of the Act, added by section 621(a)(1) of Pub. L. 108-173, requires us to make payment equal to 95 percent of the AWP for an outpatient drug or biological that is covered and furnished as part of covered OPD services for which a HCPCS code has not been assigned. We proposed, beginning in CY 2005, to extend to radiopharmaceuticals the same payment methodology discussed in section V.D. of this preamble for new drugs and biologicals before HCPCS codes are assigned. That is, we proposed to pay for newly approved radiopharmaceuticals, as well as newly approved drugs and biologicals, at 95 percent of AWP prior to assignment of a HCPCS code. </P>
                    <P>Section 1833(t)(5)(E) of the Act, as added by section 621(a)(3) of Pub. L. 108-173, excludes separate drug and biological APCs from outlier payments. Beginning in CY 2005, we proposed to apply section 621(a)(3) of Pub. L. 108-173 to APCs for radiopharmaceuticals. That is, beginning in CY 2005, radiopharmaceuticals would be excluded from receiving outlier payments. </P>
                    <P>Consistent with our proposed policy to apply to radiopharmaceutical agents payment policies that apply to drugs and biologicals, we further proposed, beginning in CY 2005, to accept applications for pass-through status for certain radiopharmaceuticals. That is, we proposed on a prospective basis to consider for pass-through status those radiopharmaceuticals to which a HCPCS code is first assigned on or after January 1, 2005. As we explain in section V.A.3. of this final rule with comment period, section 1833(t)(6)(D)(i) of the Act sets the payment rate for pass-through eligible drugs and biologicals as the amount determined under section 1842(o) of the Act. In the August 16, 2004 proposed rule, we proposed to pay for drugs and biologicals with pass-through status in CY 2005 consistent with the provisions of section 1842(o) of the Act as amended by Pub. L. 108-173, at a rate that is equivalent to the payment these drugs and biologicals would receive in the physician office setting and set in accordance with the methodology described in the Medicare Physician Fee Schedule Proposed Rule for CY 2005 (69 FR 47488, 47520 through 47524). </P>
                    <P>
                        We issued an interim final rule with comment period entitled “Medicare Program: Manufacturer Submission of Manufacturer's Average Sales Price (ASP) Data for Medicare Part B Drugs and Biologicals” in the April 6, 2004 
                        <E T="04">Federal Register</E>
                        , related to the calculation and submission of manufacturer's ASP data (69 FR 17935). We need these data in order to determine payment for drugs and biologicals furnished in a physician office setting in accordance with the methodology described in the Medicare Physician Fee Schedule Proposed Rule (69 FR 47488, 47520 through 47524). However, the April 6, 2004 interim final rule with comment period excludes radiopharmaceuticals from the data reporting requirements that apply to Medicare Part B covered drugs and biologicals paid under sections 1842(o)(1)(D), 1847A, or 1881(b)(13)(A)(ii) of the Act (69 FR 17935). As a consequence, we would not have the same type of data available to determine payment for a new radiopharmaceutical approved for pass-through status after January 1, 2005 that would be available to determine payment for a new drug or biological with pass-through status in CY 2005. 
                    </P>
                    <P>
                        Therefore, in order to set payment for a new radiopharmaceutical approved for pass-through status in accordance with 1842(o) of the Act and in a manner that is consistent with how we proposed to set payment for a pass-through drug or biological, we proposed a methodology that would apply solely to new radiopharmaceuticals for which payment would be made under the OPPS and for which an application for pass-through status is submitted after January 1, 2005. That is, in order to receive pass-through payment for a new radiopharmaceutical under the OPPS, a manufacturer would be required to submit data and certification for the radiopharmaceutical in accordance with the requirements that apply to drugs and biologicals under section 303 of Pub. L. 108-173 as set forth in the interim final rule with comment period issued in the April 6, 2004 
                        <E T="04">Federal Register</E>
                         (66 FR 17935) and described on the CMS Web site at 
                        <E T="03">http://cms.hhs.gov.</E>
                         We proposed that payment would be determined in accordance with the methodology applicable to drugs and biologicals that is discussed in the CY 2005 Medicare Physician Fee Schedule proposed rule (69 FR 47488, 47520-47524). In the event the manufacturer seeking pass-through status for a radiopharmaceutical does not submit data in accordance with the requirements specified for new drugs and biologicals, we proposed to set payment for the new radiopharmaceutical as a specified covered outpatient drug, under section 1833(t)(14)(A) as added by section 621(a)(1) of Pub. L. 108-173. 
                    </P>
                    <P>We received many public comments on our proposals. </P>
                    <P>
                        <E T="03">Comment:</E>
                         Many commenters applauded CMS for proposing to treat radiopharmaceuticals as drugs and encouraged CMS to continue to pay for these products as “specified covered outpatient drugs” under the OPPS, consistent with section 621(a) of the MMA. They indicated that this policy ensures consistent treatment of drugs and radiopharmaceuticals, eliminates confusion related to the prior differences in their treatment under the OPPS, and facilitates patient access to these important therapies in clinically appropriate settings. One of the commenters also supported the proposal to exclude radiopharmaceuticals from receiving outlier payments in CY 2005. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We appreciate the commenters' support of our policy to treat radiopharmaceuticals as drugs and will finalize this policy for CY 2005. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         Several commenters opposed our proposal to require manufacturers to submit ASP data for radiopharmaceutical agents with pass-through status. One manufacturer of radiopharmaceuticals stated that there are significant practical problems and legal barriers to reporting ASP for radiopharmaceuticals. The commenter indicated that manufacturers often sell the components of a radiopharmaceutical to independent radiopharmacies. These radiopharmacies then sell unit doses to many hospitals; however, some hospitals also purchase the components 
                        <PRTPAGE P="65811"/>
                        of the radiopharmaceutical and prepare the radiopharmaceutical through in-house radiopharmacies. This commenter asserted that the end result is that there is very often no ASP for the finished radiopharmaceutical product. For example, there may only be manufacturer pricing for the components; however, the price set by the manufacturer for one component of a radiopharmaceutical does not directly translate into the acquisition cost of the “complete” radiopharmaceutical, which may result from the combination of several components. This commenter recommended that CMS be consistent and not require ASP in the OPPS, as CMS does not require ASP for radiopharmaceuticals in the Medicare Physician Fee Schedule. The commenter thus urged CMS to determine payment for pass-through radiopharmaceuticals as specified covered outpatient drugs, based on AWP or acquisition costs. Another commenter recommended that CMS set payment for all pass-through radiopharmaceuticals in CY 2005 using the AWP-based “specified covered outpatient drugs” payment methodology, regardless of whether ASP data are available for the drug and stated that this methodology is more appropriate for these products, because it will be more likely to ensure adequate payment as use of the product is adopted, and thus will provide for robust cost data for future rate-setting purposes. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We appreciate these comments and understand the concerns commenters stated regarding our proposal to require manufacturers of radiopharmaceutical agents with pass-through status to submit ASP data. We recognize the complexities of determining ASP for radiopharmaceuticals because of their unique preparation processes; therefore, we agree with the commenters' concerns about finalizing the proposed policy. Because radiopharmaceuticals are not paid on ASP in the physician office setting, manufacturers of these agents will not be required to report ASPs for payment purposes under the OPPS. Therefore, payment for radiopharmaceuticals with pass-through status will be made in accordance with their status as sole source “specified covered outpatient drugs.” That is, in the absence of both ASP data and hospital claims data, we will set payment for new radiopharmaceuticals approved for pass-through status beginning in CY 2005 at the floor for sole source “specified coveraged outpatient drugs,” which is 83 percent of the AWP. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         A few commenters urged CMS to revise the HCPCS code descriptors for radiopharmaceutical products that do not currently have “per dose” or “per study” descriptors and indicated that “per dose” or “per study” code descriptors will facilitate the collection of more accurate charge and cost data which are necessary to establish equitable payment for radiopharmaceutical agents. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We recognize the concerns expressed by these commenters. As we have stated in the November 7, 2003 OPPS final rule with comment period (68 FR 63451), we continue to believe that in changing descriptors to “per dose” or “per study”, we will lose specificity with respect to the data we will receive from hospitals. We are not convinced that there is a programmatic need to change the radiopharmaceutical code descriptors to “per dose” or that claims data based on the current code descriptors are problematic for setting payment rates for these products. However, we will continue to work with industry representatives to ensure that the current HCPCS descriptors are appropriate and review this issue in the future, if needed. Furthermore, we stress the importance of proper coding by providers so that we can obtain accurate data for future rate setting. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         A commenter strongly supported CMS requiring that hospitals report all HCPCS codes for drugs including those that are packaged and indicated that this will enable CMS to track costs and help to ensure that only correctly coded claims (those with radiopharmaceuticals) are used in setting payment rates for nuclear medicine procedures. Therefore, the commenter recommended that CMS require continued reporting of HCPCS codes for all radiopharmaceuticals (packaged and non-packaged products). 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We will continue to strongly encourage hospitals to report charges for all drugs using the correct HCPCS codes for the items used, including the drugs that have packaged status in CY 2005. We agree with the commenter that it is most useful to us when we have a robust set of claims for each item paid for under the OPPS. We would note, however, that with just a very few exceptions, hospitals do appear to be reporting charges for drugs, biologicals and radiopharmaceuticals using the existing HCPCS codes, even when such items have packaged status. At this time, we do not believe it is necessary to institute a requirement for drugs as we are doing for the device category codes. However, we will continue to monitor this through our annual analysis of claims data and will reconsider this in the future, if we determine that it is necessary. 
                    </P>
                    <HD SOURCE="HD2">H. Coding and Payment for Drug Administration </HD>
                    <P>Since implementation of the OPPS, Medicare OPPS payment for administration of cancer chemotherapy drugs and infusion of other drugs has been made using the following HCPCS codes: </P>
                    <P>• Q0081, Infusion therapy other than chemotherapy, per visit </P>
                    <P>• Q0083, Administration of chemotherapy by any route other than infusion, per visit </P>
                    <P>• Q0084, Administration of chemotherapy by infusion only, per visit </P>
                    <P>• Q0085, Administration of chemotherapy by both infusion and another route, per visit </P>
                    <P>In the CY 2004 proposed rule, we proposed to change coding and payment for these services to enable us to pay more accurately for the wide range of services and the drugs that we package into these per visit codes. (Background discussion on these codes is included in the August 12, 2003 OPPS proposed rule (68 FR 47998). Commenters on the CY 2004 proposed rule recommended that we use the CPT codes for drug administration. One commenter provided a crosswalk from the CPT codes for drug administration to the Q codes that we could use in a transition. We did not implement this in the final rule for CY 2004 OPPS but indicated that we would consider it for CY 2005 and would discuss it with the APC Panel at its February 2004 meeting. </P>
                    <P>Commenters and the APC Panel recommended that we discontinue use of code Q0085 for CY 2004 because codes Q0083 and Q0084 could be used together to report the services described by code Q0085. We did implement this change for CY 2004 and made code Q0085 nonpayable for CY 2004 OPPS. </P>
                    <P>
                        At the February 2004 APC Panel meeting, we presented a proposal from an outside organization that matched CPT codes for chemotherapy and nonchemotherapy infusions to the Q codes currently used to pay for these services under the OPPS. We asked the APC Panel for their perspective on the potential benefit of using the proposed coding approach as the basis for billing and determining the OPPS payment for administering these drugs. The APC Panel recommended that CMS continue to review the organization's proposed coding crosswalk with the goal of using it to transition from the use of Q-codes 
                        <PRTPAGE P="65812"/>
                        to that of CPT codes to bill for administration of these drugs. 
                    </P>
                    <P>In the August 16, 2004 proposed rule, for CY 2005, we proposed to use the CPT codes for drug administration but to crosswalk the CPT codes into APCs that reflect how the services would have been paid under the Q codes. Although hospitals would bill the CPT codes and include the charges for each CPT code on the claim, payment would be made on a per visit basis, using the cost data from the per visit Q codes (Q0081, Q0083 and Q0084) to set the payment rate for CY 2005. See Table 29 of the proposed rule for the proposed crosswalk of CPT codes into APCs based on the Q codes (69 FR 50521). The only change from the crosswalk that was submitted by the outside organization is that we proposed a Q code and APC crosswalk for CPT code 96549 (Unlisted chemotherapy procedure), rather than bundling that service. We believe that Q0083 is the code that would have previously been reported by hospitals to describe the unlisted service. In addition, this would place the unlisted service in our lowest resource utilization APC for chemotherapy, consistent with our policy for other unlisted services. </P>
                    <P>We proposed to establish the Q code and APC crosswalk for CPT code 96549 because there is no CPT specific charge or frequency data on which to set payments. The CY 2005 OPPS is based on CY 2003 claims data which used the Q codes. Therefore, the only cost data available to us for establishment of median costs is the data based on the Q codes for drug administration. Moreover, the only frequency data that are available for use in calculating the scalar for budget neutrality of payment weights are the frequency data for the Q codes. Therefore, the payments set for the CPT codes must use the cost data for the Q codes and must result in the same payments that would have been made had the Q codes been continued. </P>
                    <P>Under this proposed methodology, hospitals would report the services they furnish with the CPT codes and would show the charges that they assign to the CPT codes on the claim. The Medicare OCE would assign the code to an APC whose payment is based on the per visit Q code that would have been used absent coding under CPT. In most cases, the OCE would collapse multiple codes or multiple units of the same CPT code into a single unit to be paid a single APC amount. This approach is needed because the data for the Q codes is reported on a per visit basis and more than one unit of a CPT code can be provided in a visit. </P>
                    <P>For example, CPT code 96410 (Chemotherapy administration infusion technique, up to 1 hour) is for infusion of chemotherapy drugs for the first hour, and CPT code 96412 is for chemotherapy infusion up to 8 hours, each additional hour. The claims data used to set the APC payment rate for these codes is for a per visit amount (taken from CY 2003 data for Q0084 a per visit code). The frequency data on the claim are also on a per visit basis. For CY 2005, we proposed that CPT code 96410 would be paid one unit of APC 0117 (to which CPT code 96410 would be crosswalked) and no separate payment would be made for CPT code 96412, regardless of whether one unit or more than one unit is billed. CPT code 96412 would be a packaged code for CY 2005. Under the Q code data on which the payment weight for APC 0117 is based, the per visit amount would represent a payment that is appropriate for all drug administration services in a visit (that is, one unit of CPT code 96410 and as many units of CPT code 96412 as were furnished in the same visit). </P>
                    <P>Similarly, we proposed that when a hospital bills 3 units of CPT code 96400 (Chemotherapy administration, subcutaneous or intramuscular, with or without local anesthesia), the OCE would assign one unit of APC 0116 for that code. (APC 0116 is the APC to which CPT code 96400 would be crosswalked.) The payment would be based on Q0083, a per visit code, because, absent the ability to be paid based on CPT codes, the hospital would have billed one unit of Q0083 (for the 3 injections) had we not discontinued the Q codes for CY 2005. The OCE would assume that there was one and only one visit in which there were 3 injections and would pay accordingly (that is, one unit of APC 0116). </P>
                    <P>We noted that if we adopt the CPT codes for drug administration to ensure accurate payment in the future, it would be critical for hospitals to bill the charges for the packaged CPT codes for drug administration for CY 2005 (that is, the CPT codes with SI=N), even though there would be no separate payment for them in CY 2005. For CY 2007 OPPS, CY 2005 claims data would be used as the basis for setting median costs for each CPT code, based on the reported charges reduced to cost, and would determine what APC configuration ensures most appropriate payment for the CPT drug administration codes. If hospitals do not bill charges in CY 2005 for the packaged drug administration CPT codes such as CPT codes 96412, 96423, 96545, or 90781, they would jeopardize our ability to make accurate payments for services billed and paid under these codes in CY 2007 when we use the CY 2005 data to set the payment weights. </P>
                    <P>
                        <E T="03">Comment:</E>
                         Most commenters supported our proposal to code drug administration using CPT codes instead of the HCPCS codes. They indicated that it would be less burdensome for hospitals to code services using just one method for Medicare and all other payers. Some commenters opposed the use of CPT codes unless CMS pays an amount for each use of the CPT code, as CMS does under the Medicare Physician Fee Schedule. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We cannot pay an amount for each use of each CPT code because all of our drug administration cost data are on a per visit (not a per code) basis as charges for each of the following three HCPCPS codes, Q0081, Q0083, and Q0084, are reported for a visit and not a service. 
                    </P>
                    <P>We agree that billing for drug administration using the CPT codes will be less burdensome to hospitals and will also facilitate development of more accurate payment rates for drug administration services in future years. For CY 2005 OPPS, we will collapse the CPT codes billed for drug administration into a single unit of the applicable APC for payment as we do not have the CPT code specific claims data for use in establishing a CPT code specific payment. However, we anticipate that we would have the necessary claims for CY 2007 OPPS to set an appropriate APC payment rate for the services described by the CPT codes. </P>
                    <P>
                        <E T="03">Comment:</E>
                         Several commenters asked that we affirm that hospitals may report CPT codes 90780 (intravenous infusion for therapy/diagnosis administered by physician or under direct supervision of physician; up to one hour) and 90781 (each additional hour up to (8) hours), notwithstanding that the administration is not done by a physician or under the direct supervision of a physician. The commenters stated that such services are typically administered in hospitals by nurses without direct physician supervision and that if hospitals report these codes only when the full definition of the code is met, they would not be able to report the infusion services they furnish. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We do not view the language of these CPT codes' definitions as being an obstacle to or inconsistent with the use of the codes by hospitals for billing Medicare. We view our general requirements regarding physician supervision (with respect to payment for services that are incident to a physician's service in the outpatient hospital setting) as meeting the 
                        <PRTPAGE P="65813"/>
                        physician supervision aspect of the codes and thus, do not believe that use of the codes in the hospital outpatient setting would be prevented by the inclusion of the language in the code definition. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         A commenter asked that we change the status indicator for CPT code 90780 and 90781 to “X” from “T” thereby eliminating the multiple procedure reduction for these codes, which in CY 2005 will replace HCPCS code Q0081 in billing for the administration of infusion therapy. The commenter stated that there is no situation in which the time and resources involved in infusion care should be reduced in the case of an observation patient. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We disagree. The costs of space, utilities and staff attendance are duplicated when the beneficiary is receiving another service at the same time as infusion therapy, in particular when the patient is in observation. Hence it is appropriate to apply a multiple procedure reduction to infusion therapy particularly when the patient is in observation status. We believe it is necessary to understand how the OCE multiple procedure discounting logic functions. Line-items with a service indicator of “T” are subject to multiple procedure discounting unless modifiers 76, 77, 78, and/or 79 are present on the claim. The “T” line-item with the highest payment amount will not be discounted but all other “T” line items will be discounted as multiple procedures. All line-items that do not have a service indicator of “T” will be ignored in determining the discount. Therefore, if the only other services reported with infusion therapy are an emergency department or other visit code, or diagnostic tests and services assigned status indicator “S,” the infusion therapy code would not be subject to the multiple procedure discounting. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         Several commenters stated that multiple visits per day for antibiotic infusion are common and the drug administration policies should permit such visits to be paid separately. The commenters stated that multiple visits for chemotherapy are possible and that provisions should be made for billing and paying them when they occur. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We agree with the commenters on this issue. The reporting and payment for these multiple visits and services will not be an issue once payment for drug administration under the OPPS is made based on CPT code-specific data. However, until such time, hospitals will need to use modifier 59 (distinct procedure) when billing charges for services furnished during multiple visits that follow the initial visit. For CPT codes 90780 and 90781, where there are multiple visits for infusion on the same day, the hospital should report CPT code 90780 with modifier 59 and CPT code 90781, if appropriate, with modifier 59 for each separate visit for infusion. With modifier 59 appended to CPT codes 90780 and 90781, the OCE will allow up to 4 units of APC 0120 (Infusion of nonchemotherapy drugs) to be paid. Similarly, for the chemotherapy administration codes, where there is no modifier 59 reported, the OCE will collapse all codes that map to a particular APC into one unit of that APC and will pay one unit of each applicable APC. The system will assume that all services were furnished in one single encounter. Where the chemotherapy services are provided in multiple encounters, the hospital will need to show modifier 59 on the service furnished in the second encounter. The OCE will map those services into an additional unit of each applicable APC and will pay for each visit. The OCE will not, for a single date of service, pay more than 4 units of APC 120, nor more than 2 units of APCs 116 and 117 (chemotherapy by route other than infusion and infusion of chemotherapy drugs). We intend to reassess these limits based on provider feedback and our review of later claims data. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         One commenter asked that CMS ensure that the costs for CPT code 90780 (Infusion therapy one hour) are included in payment for CPT codes 67221 (Ocular photodynamic therapy) and 67225 (Eye photodynamic therapy add-on) because CPT code 90780 is bundled into both of these procedure codes. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         The procedure code definition for CPT code 67221 specifies that intravenous infusion is included, and CPT code 67225 is to be listed separately in addition to CPT code 67221, if a second eye is treated. Therefore, the National Correct Coding Initiative (NCCI) edits preclude payment for CPT code 90780 with CPT codes 67221 and 67225 because the charges for the procedure CPT codes 67221 and 67225 are presumed to include all costs of administering the drug. Correct coding would not include reporting CPT code 90780 for the same visits when photodynamic therapy was provided. We expect that hospitals will include their charges for the necessary infusion in their charges for the procedure codes when they bill CPT codes 67221 or 67225, so that our claims data reflect the costs of all resources necessary to perform the services. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         Several commenters urged CMS to adopt the new and revised AMA definitions for drug administration, which will be HCPCS G-codes in the CY 2005 Medicare Physician Fee Schedule, because the existing CPT codes do not adequately capture the costs of the range of drug administrations. They also urged CMS to educate providers on the correct use of the new CPT codes. The commenters indicated that implementing the new CPT codes for drug administration will be more difficult in hospitals than in physicians' offices because the services are typically provided in more places in hospitals than in physicians' offices. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         For CY 2005 OPPS, we are implementing the existing CPT codes for drug administration rather than the new G-codes that will be used for the Medicare Physician Fee Schedule payments. We do not intend to use the new HCPCS G-codes for the OPPS drug administration services until such time as the new CPT codes for those services are issued in CY 2006. We believe that it would be disruptive to hospitals if we required them to implement the HCPCS alphanumeric codes for drug administration in CY 2005 and then switch to the new CPT codes in CY 2006. While only a subset of the physician community administers anti-neoplastic drugs in their offices, we believe that most hospitals do so on an outpatient basis and hence most hospitals would have to change to the new HCPCS codes for CY 2005, only to change again to new CPT codes for CY 2006. However, we are told that all hospitals use the current CPT codes to bill other payers and crosswalk from the current CPT codes to the Q codes to bill Medicare. Thus, using the current CPT codes should be easier for hospitals than their current method for billing Medicare. This would not be the case if we were to require that they use the new HCPCS codes for drug administration. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         One commenter indicated that CMS should revise the OPPS to mirror the policy under the Medicare Physician Fee Schedule that pays separately for each drug administered to permit the payment of one unit of each APC for each and every drug administered. The commenter stated that since CMS acknowledged that there are additional resources used with each administration of a drug, it should apply the same policy to hospitals since all of these services are furnished by nurses, whether in a physician's office setting or a hospital setting. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We are moving to the use of CPT codes for CY 2005 OPPS. However, we will not be paying an APC amount for each unit of each CPT code. 
                        <PRTPAGE P="65814"/>
                        The APC rate is, by necessity, based on historic data for a code that was billed and reported on a per visit basis. Therefore, to pay each unit of a CPT code an APC amount would not accurately reflect the resources used and would result in an overpayment of the costs of the services provided. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         A commenter asked CMS to permit hospitals to continue billing HCPCS codes Q0081, Q0083 and Q0084 for drug administration until April 1, 2005 so that hospitals that do not currently bill the CPT codes for drug administration may have a transition period to convert to CPT code billing. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         The three cited Q-codes will be deactivated for the OPPS effective January 1, 2005 and therefore cannot be used up to April 1, 2005. As discussed in our proposed rule, we are eliminating the 90-day grace period for deleted codes effective January 1, 2005. We are adopting this policy because the Health Insurance Portability and Accountability Act (HIPAA) transaction and code set rules require usage of the medical code that is valid at the time that the service is provided. Details regarding elimination of the 90-day grace period for billing deleted codes were issued to our contractors on February 4, 2004, in Transmittal 89, Change Request 3093. Moreover, we are not aware that there are any hospitals that do not bill the CPT codes for drug administration, as hospitals have told us that all payers other than Medicare require that they use the CPT codes and will not accept the Q-codes. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         A commenter asked that CMS use the first two quarters of the CY 2005 claims to set the median costs for drug administration in CY 2006 OPPS so that the transition to the more accurate payments under the CPT codes could begin earlier than CY 2007.
                    </P>
                    <P>Response: As the CY 2005 claims data will be the basis for the CY 2007 payment weights, we regret that we are unable to transition to the new payments earlier than CY 2007 because of the time required to access the CY 2005 claims data and to process and construct our database for ratesetting and impact analyses. The second quarter of CY 2005 data will not be available to us until at least August 15, 2005, which is far too late for us to have developed and published any CY 2006 proposed rule. </P>
                    <P>After carefully reviewing all comments received, we are adopting as final our proposal to use the CPT codes for drug administration, effective January 1, 2005. We will collapse the CPT codes billed into a single unit of the applicable APC for payment. In addition, we are establishing the Q-code and APC crosswalk for CPT code 96549 and will be paying 1 unit of APC 0117 for CPT code 96410 (to which CPT code 96410 will be crosswalked). We will not make a separate payment for CPT code 96412 regardless of whether 1 unit or more units are billed. For CY 2005, CPT code 96412 will be a packaged and not paid separately. Further, when a hospital bills 3 units of CPT code 96400 (Chemotherapy administration, subcutaneous or intramuscular, with or without local anesthesia), the OCE will assign 1 unit of APC 0116 for that code and the payment will be based on HCPCS code Q0083, a per visit code. Modifier 59 may be used with codes in APCs 0116, 0117, and 0120 to signify additional encounters on the same date of service for which additional APC payments may be made. </P>
                    <P>Table 33 below contains the crosswalk of CPT codes for drug administration to drug administration APCs for CY 2005. The last two columns of this table indicate the maximum number of units of the APC that the OCE will assign without or with modifier 59, respectively. </P>
                    <BILCOD>BILLING CODE 4120-01-P</BILCOD>
                    <GPH SPAN="3" DEEP="597">
                        <PRTPAGE P="65815"/>
                        <GID>ER15NO04.051</GID>
                    </GPH>
                    <BILCOD>BILLING CODE 4120-01-C</BILCOD>
                    <HD SOURCE="HD2">I. Payment for Blood and Blood Products </HD>
                    <P>
                        Since the OPPS was first implemented in August 2000, separate payments have been made for blood and blood products in APCs rather than packaging them into payment for the procedures with which they were administered. Administrative costs for processing and storage specific to the transfused blood product are included in the blood product APC payment, which is based on hospitals' charges. Payment for the collection, processing, and storage of autologous blood, as described by CPT code 86890, is made 
                        <PRTPAGE P="65816"/>
                        through APC 0347 (Level III Transfusion Laboratory Procedures). 
                    </P>
                    <P>In CY 2000, payments for bloods were established based on external data provided by commenters due to limited Medicare claims data. From CY 2000 to CY 2002, blood and blood product payment rates were updated for inflation. For CY 2003, as described in the November 1, 2002 final rule (67 FR 66773), we applied a special dampening methodology to blood and blood products that had significant reductions in payment rates from CY 2002 to CY 2003, when median costs were first calculated from hospital claims. Using the dampening methodology, we limited the decrease in payment rates for blood and blood products to approximately 15 percent. For CY 2004, as recommended by the APC Panel, we froze payment rates for blood and blood products at CY 2003 levels. This allowed us to undertake further study of the issues raised by commenters and presenters at the August 2003 and February 2004 APC Panel meetings. </P>
                    <P>
                        In the August 16, 2004 proposed rule for CY 2005 OPPS, we proposed to continue to pay separately for blood and blood products. We also proposed to establish new APCs that would allow each blood product to be in its own separate APC, as several of the blood product APCs currently contained multiple blood products with no clinical homogeneity or whose product-specific median costs may not have been similar. Thus, we also proposed to reassign some of these HCPCS codes already contained in certain APCs to new APCs. (
                        <E T="03">See</E>
                         Table 30 of the proposed rule (69 FR 50523.) 
                    </P>
                    <P>Other than for autologous blood products, hospital reimbursement for the costs of collection, processing, and storage of blood and blood products are made through the OPPS payments for specific blood product APCs. Wastage and other administrative costs for blood are attributable to overhead and distributed across all hospital services linked to cost centers in the Medicare cost report, through the standard process of converting charges to costs using hospitals' CCRs for each cost center on the cost report. </P>
                    <P>In the August 16, 2004 proposed rule, we noted that comments to previous OPPS rules had stated that the CCRs that we used to adjust claim charges to costs for blood in past years were too low, resulting in underestimation of the true hospital costs for blood and blood products. In response, we conducted a thorough analysis of the OPPS claims to compare CCRs between hospitals with a blood-specific cost center and hospitals defaulting to the overall hospital CCR. Our past methodology for determining CCRs for blood products included a default to the overall CCR when any given provider had chosen not to report costs and charges in a blood-specific cost center on the cost report. After matching the two blood-specific cost centers to the 38X and 39X revenue codes, we observed a significant difference in CCRs utilized for conversion of blood product charges to costs for those hospitals with and without blood-specific cost centers. The median CCR for those hospitals with a blood-specific cost center was 0.66 for revenue code 38X and 0.64 for revenue code 39X, and for those defaulting to the overall hospital CCR, the result was a CCR of 0.34 for revenue code 38X and 0.33 for revenue code 39X. The median overall CCR for all hospitals in the CY 2005 analysis was 0.33. </P>
                    <P>In light of this information, we applied the methodology described in our August 16, 2004 proposed rule to calculate simulated medians for each blood and blood product based on our CY 2003 claims data. We assumed that those hospitals not reporting costs and charges in a blood-specific cost center on their annual cost report, in general, face similar costs and engage in comparable charging practices for blood as those reporting a blood-specific cost center. For those hospitals not reporting a blood-specific cost center, we simulated a blood-specific CCR, which we then applied to convert charges to costs for blood products. Overall, this methodology increased the estimated median costs of blood and blood products by 25 percent for CY 2005 relative to the median costs used to set CY 2004 APC rates. For example, the estimated median for HCPCS code P9016 (Red blood cells, leukocyte reduced), the most frequently billed blood product, increased by 32 percent relative to the CY 2004 median. </P>
                    <P>As discussed in the proposed rule, in reviewing the simulated medians calculated using the methodology described above relative to those medians used to set CY 2004 payment rates, we noticed that some low-volume blood products (&lt; 1,000 units) demonstrated significant decreases in median costs utilizing our general methodology. Overall, the simulated median costs for low-volume blood products declined by 14 percent for CY 2005. Because a small sample size can lead to great variability in point estimates, we sought to increase the number of units of low-volume blood products by combining CY 2002 and CY 2003 claims data for the low-volume products. We used the simulated CCRs to calculate costs from charges from CY 2002 and CY 2003 claims data. To ensure that we combined comparable costs, we updated the simulated costs on the CY 2002 claims to the base year of CY 2003 using the Producer Price Index (PPI) for blood and derivatives for human use (Commodity Code #063711). This is the PPI used to update blood and blood product prices in the market basket (67 FR 50039, August 1, 2002). We recognize that not all of the low-volume blood products had claims in CY 2002. </P>
                    <P>After combining the 2 years of claims data, we were able to raise the volume of blood units billed for several of these products above 1,000 units. Since the publication of the proposed rule, additional claims data from the last quarter of CY 2003 have become available to us. The data showed that a few of the blood products had utilization in CY 2003 that exceeded the 1,000 unit low-volume threshold and will not be subject to the low-volume blood product payment adjustment described below, that we are adopting for CY 2005. The low-volume blood products that we are adopting as final are listed below in Table 31 of this final rule with comment period. </P>
                    <P>The DHHS Advisory Committee on Blood Safety and Availability has recommended that CMS establish payment rates for blood and blood products based on current year acquisition costs and actual total costs of providing such blood products. At the February 2004 APC Panel meeting, the APC Panel recommended that CMS use external data to derive costs of blood and blood products in order to establish payment rates. At the September 2004 APC Panel meeting, the APC Panel recommended that CMS freeze payment rates for low-volume blood products for CY 2005 at CY 2004 levels. The Panel also recommended that CMS consider using external data for setting payment rates for blood and blood products in the future. </P>
                    <P>We received the following comments on our August 16, 2004 proposed rule regarding payment for blood and blood products. </P>
                    <P>
                        <E T="03">Comment:</E>
                         A few commenters expressed strong support for payment rates developed using hospital data rather than blood industry data. The commenters urged CMS to exercise caution in using blood industry data and to consider evaluating the data for their validity, reliability and consistency with geographic variations in costs, in addition to being publicly available and subject to audit. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We agree with the commenters that the OPPS payment rates should be based on the most 
                        <PRTPAGE P="65817"/>
                        recently available and accurate hospital claims data. However, in rare circumstances when accurate hospital claims data capturing the full costs of services may not be available, we evaluate all external data very carefully to make sure that they meet our external data criteria. As discussed above, in setting all blood and blood product payment rates for CY 2005, we have relied upon data from hospital claims submitted to CMS. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         Several commenters expressed concern about the proposed payment rates for blood and blood products. The commenters indicated that despite increases in the CY 2005 proposed payment rates for blood and blood products, the proposed payment rates still do not meet the actual costs to hospitals of acquiring these products. Some commenters stated that, in addition to hospital coding and billing problems, only a small number of hospitals were actually reporting blood costs, and that lack of reporting explains why the payment rates are still significantly below hospital acquisition costs. The commenters expressed concerns that this would create barriers to access to a safe blood supply for Medicare beneficiaries. 
                    </P>
                    <P>The commenters also expressed concerns about reductions in payment rates for low-volume blood products. They recommended that CMS either freeze payment rates at the CY 2004 OPPS levels for low-volume blood products that experienced a decrease in their proposed rates or use external data in setting payment rates for these products. </P>
                    <P>
                        <E T="03">Response:</E>
                         We appreciate the commenters' concerns and share the same concern for protecting beneficiaries' access to a safe blood supply. As with all of the OPPS services, we prefer to rely on our claims data whenever possible. Comments received for previous rules also suggested that current hospital blood costs are not captured because hospitals underreport blood on their claims because it is too costly to bill for blood. However, our thorough analysis of billing for blood from CY 2003 claims data indicated that 81 percent of all hospitals included in our ratesetting and modeling for CY 2005 billed at least one unit of blood or blood product in CY 2003. Of these hospitals however, only 47 percent reported separate costs and charges in the two cost centers specific to blood on their most recent annual cost reports. It may be that those hospitals billing for blood but not reporting costs and charges on their cost reports for either of the two blood-specific cost centers reported their blood costs and charges under other cost centers, such as operating room. As discussed in the proposed rule, we simulated blood-specific hospital CCRs to account for these reporting differences and used these simulated CCRs to develop proposed median costs for blood products for CY 2005. Our claims data clearly show that the vast majority of hospitals do bill the OPPS for blood and blood products. In addition, the distribution of costs for individual products provides no evidence of significant coding problems. 
                    </P>
                    <P>As explained in the preamble of this section, we estimate that by using our new methodology of simulating medians and implementing the proposed payment rates for blood and blood products, excluding low-volume blood products, there would be a 25 percent increase in payment for blood and blood products overall. This includes a 32 percent increase in payment from CY 2004 for leukocyte reduced red blood cells (HCPCS code P9016), the highest volume blood product in the hospital OPD, and a 25 percent increase in payment for each unit of red blood cells (HCPCS code P9021), the second highest volume blood product. </P>
                    <P>After carefully reviewing all of the public comments received timely regarding low-volume blood products, we are convinced that due to the low utilization of these products, in addition to possible hospital coding and billing problems for these low-volume products, the claims data may not have captured the complete costs of these products to hospitals as fully as possible. We believe it is imperative that Medicare beneficiaries have full access to all medically necessary blood and blood products, including products that are infrequently utilized. Therefore, for blood products that would have experienced a decrease in median cost from CY 2004 to CY 2005 based on our proposed methodology, we are establishing CY 2005 payment rates that are adjusted to a 50/50 blend of CY 2004 product-specific OPPS median costs and our proposed CY 2005 simulated medians. This adjustment methodology will allow us to undertake further study of the issues raised by commenters and by presenters at the September 2004 APC Panel meeting, without putting beneficiary access to these low-volume blood products at risk. </P>
                    <P>
                        <E T="03">Comment:</E>
                         One commenter suggested that CMS survey all hospitals across the country to investigate direct and indirect costs for blood. The commenter expressed concern that our proposed rates were insufficient to cover the costs of blood and its testing and storage. The commenter also expressed the need for continued increases in payments for blood products. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We appreciate the commenter's recommendation and will take it into consideration as needed, when we reassess the payment rates for blood and blood products. While we believe our payment rates are appropriate and adequate for the provision of blood and blood product services, we are aware of the increasing number of tests required to ensure the safety of the nation's blood supply, which could possibly add to the costs of processing blood and blood products. The APC payment rates for blood and blood products are intended to cover the costs of medically necessary testing by community blood banks or blood banks operated by hospitals. However, the APC payment rates are not meant to include costs of tests requiring a specific patient's blood, such as cross-matching in preparation for transfusion, because these tests are separately payable under the OPPS. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         Several commenters, including a hospital association, recommended that CMS issue more specific guidance to hospitals for billing of blood-related services in order to improve hospital claims data. Specifically, commenters requested that CMS address issues related to application of the Medicare blood deductible, differences between donor and nondonor states, hospital markups for blood costs, the appropriate use of HCPCS code P9011 (Split blood unit) in billing, blood processing and preparation costs and autologous blood collection. In addition, the same commenter recommended that CMS share its draft guidance for review with the Outpatient Medicare Technical Advisory Group (MTAG) or the National Uniform Billing Committee (NUBC), or both, to ensure it is correct, comprehensive, and reflective of the billing provider's perspective. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We recognize the need for comprehensive billing guidelines for hospitals and other providers to address a variety of blood-related services under the OPPS. In the near future, we intend to provide further billing guidelines to clarify our original Program Transmittal A-01-50 issued on April 12, 2001 (CR Request 1585) regarding correct billing for blood-related services. We agree with the commenters and intend to gather information from all relevant and available resources. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         One commenter, a hospital association, indicated that the revenue code 390 (Blood Storage and Processing) should not have been included in Table 18 (Proposed Packaged Services by 
                        <PRTPAGE P="65818"/>
                        Revenue Codes) of the August 16, 2004 proposed rule. The commenter expressed concern that by including revenue code 390 in this table, hospitals would not be paid for the services because of a line-item claim rejection. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We are clarifying that a HCPCS code billed with revenue codes listed in Table 18 of the proposed rule could be paid separately as long as the HCPCS code is not assigned a status indicator of “N.” When a revenue code charge is billed without a HCPCS code, the charge is reduced to cost using the appropriate CCR for the revenue code. This cost is then added to a line item charge (reduced to cost) for a separately payable HCPCS code. This allows costs associated with uncoded revenue code charges to be captured so we can make a more accurate payment for the claim. If we did not add the costs of the line item revenue code charges without HCPCS codes, the full cost data for all resources necessary to deliver a separately payable service might not be captured, possibly resulting in a lesser payment for the claim. 
                    </P>
                    <P>In summary, after carefully reviewing all public comments received timely, we are adopting as final for CY 2005 OPPS the following proposals: </P>
                    <P>• To continue to pay separately for blood and blood products, to establish new APCs that would place each blood product in its own separate APC, and to implement proposed APC reassignments for such blood and blood products. </P>
                    <P>• Effective for services furnished on or after January 1, 2005, in this final rule with comment period, we are providing that the payment rates for blood and blood products, excluding low-volume blood products whose CY 2005 simulated medians decreased from the CY 2004 medians, will be determined according to the methodology we described in the August 16, 2004 proposed rule. </P>
                    <P>• Effective for services furnished on or after January 1, 2005, in this final rule with comment period, we are providing that the CY 2005 payment rates for low-volume blood products that would have experienced a decrease in median costs from CY 2004 to CY 2005 based on our proposed methodology are adjusted to a 50/50 blend of CY 2004 product-specific median costs and our proposed CY 2005 simulated medians. </P>
                    <BILCOD>BILLING CODE 4120-01-P</BILCOD>
                    <GPH SPAN="3" DEEP="537">
                        <PRTPAGE P="65819"/>
                        <GID>ER15NO04.052</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="240">
                        <PRTPAGE P="65820"/>
                        <GID>ER15NO04.053</GID>
                    </GPH>
                    <BILCOD>BILLING CODE 4120-01-C</BILCOD>
                    <HD SOURCE="HD1">VI. Estimated Transitional Pass-Through Spending in CY 2005 for Drugs, Biologicals, and Devices </HD>
                    <HD SOURCE="HD2">A. Basis for Pro Rata Reduction </HD>
                    <P>Section 1833(t)(6)(E) of the Act limits the total projected amount of transitional pass-through payments for a given year to an “applicable percentage” of projected total Medicare and beneficiary payments under the hospital OPPS. For a year before CY 2004, the applicable percentage is 2.5 percent; for CY 2004 and subsequent years, we specify the applicable percentage up to 2.0 percent. </P>
                    <P>If we estimate before the beginning of the calendar year that the total amount of pass-through payments in that year would exceed the applicable percentage, section 1833(t)(6)(E)(iii) of the Act requires a prospective uniform reduction in the amount of each of the transitional pass-through payments made in that year to ensure that the limit is not exceeded. We make an estimate of pass-through spending to determine not only whether payments exceed the applicable percentage but also to determine the appropriate reduction to the conversion factor. </P>
                    <P>For devices, making an estimate of pass-through spending in CY 2005 entails estimating spending for two groups of items. The first group consists of those items for which we have claims data for procedures that we believe used devices that were eligible for pass-through status in CY 2003 and CY 2004 and that would continue to be eligible for pass-through payment in CY 2005. The second group consists of those items for which we have no direct claims data, that is, items that became, or would become, eligible in CY 2004 and would retain pass-through status in CY 2005, as well as items that would be newly eligible for pass-through payment beginning in CY 2005.</P>
                    <HD SOURCE="HD2">B. Estimate of Pass-Through Spending for CY 2005 </HD>
                    <P>In the August 16, 2004 proposed rule, we proposed to set the applicable percentage cap at 2.0 percent of the total OPPS projected payments for CY 2005. In this final rule with comment period, we are setting the applicable percentage cap at the same 2.0 percent. </P>
                    <P>We are using the same methodology described in the proposed rule to estimate the pass-through spending for CY 2005. To estimate CY 2005 pass-through spending for device categories in the first group described above, we used volume information from CY 2003 claims data for procedures associated with a pass-through device and manufacturer's price information from applications for pass-through status. This information was projected forward to CY 2005 levels, using inflation and utilization factors based on total growth in Medicare Part B as projected by the CMS Office of the Actuary (OACT). </P>
                    <P>To estimate CY 2005 pass-through spending for device categories included in the second group, that is, items for which we have no direct claims data, we used the following approach: For categories with no claims data in CY 2003 that would be active in CY 2005, we followed the methodology described in the November 2, 2001 final rule (66 FR 55857). That is, we used price information from manufacturers and volume estimates based on claims for procedures that would most likely use the devices in question. This information was projected forward to CY 2005 using the inflation and utilization factors supplied by the CMS OACT to estimate CY 2005 pass-through spending for this group of device categories. For categories that become eligible in CY 2005, we will use the same methodology. No new device categories for January 1, 2005, were announced after the publication of the proposed rule. Therefore, the estimate of pass-through spending does not incorporate any pass-through spending for categories made effective January 1, 2005. </P>
                    <P>With respect to CY 2005 pass-through spending for drugs and biologicals, as we explain in section V.A.3. of this final rule with comment period, the pass-through payment amount for new drugs and biologicals that we determine have pass-through status equals zero. Therefore, our estimate of total pass-through spending for drugs and biologicals with pass-through status in CY 2005 equals zero. </P>
                    <GPH SPAN="3" DEEP="177">
                        <PRTPAGE P="65821"/>
                        <GID>ER15no04.054</GID>
                    </GPH>
                    <P>In accordance with the methodology described above, we estimate that total pass-through spending for devices in CY 2005 would equal approximately $23.4 million, which represents 0.10 percent of total OPPS projected payments for CY 2005. This figure includes estimates for the current device categories continuing into CY 2005, in addition to projections for categories that first become eligible during CY 2005. This estimate is significantly lower than previous year's estimates because of the method we discuss in section V.A.3. of this preamble for determining the amount of pass-through payment for drugs and biologicals with pass-through status in CY 2005. </P>
                    <P>Therefore, we will institute no pro rata reduction for CY 2005. </P>
                    <P>In section V.G. of this final rule with comment period, we indicate that we are accepting pass-through applications for new radiopharmaceuticals that are assigned a HCPCS code on or after January 1, 2005. The pass-through amount for new radiopharmaceuticals approved for pass-through status in CY 2005 would be the difference between the OPPS payment for the radiopharmaceutical, that is, the payment amount determined for the radiopharmaceutical as a sole source specified covered drug, and the payment amount for the radiopharmaceutical under section 1842(o) of the Act. However, we have no information identifying new radiopharmaceuticals to which a HCPCS code might be assigned after January 1, 2005 for which pass-through status would be sought. We also have no data regarding payment for new radiopharmaceuticals with pass-through status under the methodology that we specify in section V.G. However, we do not believe that pass-through spending for new radiopharmaceuticals in CY 2005 will be significant enough to materially affect our estimate of total pass-through spending in CY 2005. Therefore, we are not including radiopharmaceuticals in our estimate of pass-through spending in CY 2005. </P>
                    <P>Because we estimate pass-through spending in CY 2005 will amount to 0.10 percent of total projected OPPS CY 2005 spending, we are returning 1.90 percent of the pass-through pool to adjust the conversion factor, as we discuss in section VIII. of this preamble. </P>
                    <P>We received a few public comments on our estimate of CY 2005 pass-through spending for drugs, biologicals, and devices. </P>
                    <P>
                        <E T="03">Comment:</E>
                         One commenter, a hospital organization, commended CMS for returning a portion of the pass-through pool that exceeds its estimate for pass-through payments for CY 2005, by increasing the conversion factor. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We appreciate the commenter's support. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         One commenter was concerned that CMS did not provide information on the extent to which amounts that are actually spent on pass-through payments and outlier payments compared to the amounts that are carved out of the total amount allowed OPPS payments for these projected payments. The commenter was concerned that the amounts carved out for these purposes may not actually be spent and thus would be lost to hospitals. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We are required by law to estimate the amounts that we expect to spend on pass-through payments and outliers each year before the start of the calendar year. We share the commenter's interest in making those estimates as accurately as possible to ensure that hospitals receive the amount to which they are entitled. We make our final estimate for each calendar year to the best of our ability based on all of the most recently available data when we prepare our final rule, including comments we receive concerning those issues in response to the proposed rule. With respect to the availability of data, we have established limited data sets that include the set of claims we use for, first, the proposed rule and, ultimately, the final rule estimates. For example, the claims for CY 2003 used for the final rule for CY 2005 will be available to the public in a limited data set format. We will continue to assess the means by which we provide such information to determine if there are alternate ways to ensure that our stakeholders obtain the information that is important to them on a timely basis. 
                    </P>
                    <HD SOURCE="HD1">VII. Other Policy Decisions and Policy Changes </HD>
                    <HD SOURCE="HD2">A. Statewide Average Default Cost-to-Charge Ratios </HD>
                    <P>
                        CMS uses cost-to-charge ratios (CCRs) to determine outlier payments, payments for pass-through devices, and monthly interim transitional corridor payments under the OPPS. Some hospitals do not have a valid CCR. These hospitals include, but are not limited to, hospitals that are new and have not yet submitted a cost report, hospitals that have a CCR that falls outside predetermined floor and ceiling thresholds for a valid CCR, or hospitals that have recently given up their all-inclusive rate status. When OPPS was first implemented in CY 2000, we used CY 1996 and CY 1997 cost reports to calculate default urban and rural CCRs for each State to use in determining the reasonable cost-based payments for those hospitals without a valid CCR (Program Memorandum A-00-63, CR 1310, issued on September 8, 2000). In the August 16, 2004 OPPS proposed rule, we proposed to update the default ratios for CY 2005. 
                        <PRTPAGE P="65822"/>
                    </P>
                    <P>As we proposed, in this final rule, we calculated the statewide default CCRs using the same CCRs that we use to adjust charges to costs on claims data. Table 31 lists the final CY 2005 default urban and rural CCRs by State. These CCRs are the ratio of total costs to total charges from each provider's most recently submitted cost report, for those cost centers relevant to outpatient services. We also adjusted these ratios to reflect final settled status by applying the differential between settled to submitted costs and charges from the most recent pair of settled to submitted cost reports. </P>
                    <P>The majority of submitted cost reports, 87 percent, were for CY 2002. We only used valid CCRs to calculate these default ratios. That is, we removed the CCRs for all-inclusive hospitals, CAHs, and hospitals in Guam and the U.S. Virgin Islands because these entities are not paid under the OPPS, or in the case of all-inclusive hospitals, because their CCRs are suspect. We further identified and removed any obvious error CCRs and trimmed any outliers. We limited the hospitals used in the calculation of the default CCRs to those hospitals that billed for services under the OPPS during CY 2003. </P>
                    <P>Finally, we calculated an overall average CCR, weighted by a measure of volume, for each State except Maryland. This measure of volume is the total lines on claims and is the same one that we use in our impact tables. Calculating a rate for Maryland presented a unique challenge. There are only a few providers in Maryland that are eligible to receive payment under the OPPS. However, we had no usable in-house cost report data for these Maryland hospitals, which is why we remove Maryland providers from our claims data for modeling OPPS. Therefore, we obtained data from the fiscal intermediary for Maryland, which we attempted to use in calculating the CCRs for Maryland, but which we ultimately determined could not be used to calculate representative CCRs. The cost data for three Maryland hospitals with very low volumes of services and cost data were so irregular that we lacked confidence that it would result in a valid statewide CCR. Thus, for Maryland, we used an overall weighted average CCR for all hospitals in the nation to calculate the weighted average CCRs appearing in Table 37. The overall decrease in default statewide CCRs can be attributed to the general decline in the ratio between costs and charges widely observed in the cost report data. </P>
                    <BILCOD>BILLING CODE 4120-01-P</BILCOD>
                    <GPH SPAN="3" DEEP="521">
                        <PRTPAGE P="65823"/>
                        <GID>ER15NO04.055</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="611">
                        <PRTPAGE P="65824"/>
                        <GID>ER15NO04.056</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="354">
                        <PRTPAGE P="65825"/>
                        <GID>ER15NO04.057</GID>
                    </GPH>
                    <BILCOD>BILLING CODE 4120-01-C</BILCOD>
                    <P>
                        <E T="03">Comment:</E>
                         Several commenters recommended that CMS instruct fiscal intermediaries to work with those facilities that have given up their all-inclusive rate status to quickly determine an appropriate CCR that will provide an accurate estimate of costs for each facility. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We have already instructed intermediaries to update CCRs in a timely manner. In Program Memorandum A-03-004 dated January 17, 2003, we instructed fiscal intermediaries to recalculate each provider's CCR on an ongoing basis whenever a more recent full year cost report becomes available, which includes tentatively settled cost reports. Fiscal intermediaries will calculate a hospital-specific CCR for all-inclusive rate hospitals, as with all hospitals relying on default CCRs, when their first tentatively settled cost report becomes available after no longer being considered as all-inclusive rate hospitals. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         A few commenters asserted that the decrease in CCRs between 1996 and 2002 was caused by the fact that charges were increasing faster than costs and that the increase in charges has been much lower since 2003. They requested that CMS take this fact into account in developing default CCRs. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We did not inflate charges when calculating the default CCRs, and therefore, we do not believe that there is a need to adjust for charge inflation since CY 2002. 
                    </P>
                    <HD SOURCE="HD2">B. Transitional Corridor Payments: Technical Change </HD>
                    <HD SOURCE="HD3">1. Provisions of the August 16, 2004 Proposed Rule </HD>
                    <P>When the OPPS was implemented, every provider was eligible to receive an additional payment adjustment (or transitional corridor payment) if the payments it received under the OPPS were less than the payment it would have received for the same services under the prior reasonable cost-based system (section 1833(t)(7) of the Act). Transitional corridor payments were intended to be temporary payments for most providers but permanent payments for cancer and children's hospitals to ease their transition from the prior reasonable cost-based payment system to the prospective payment system. Section 411 of Pub. L. 108-173 amended section 1833(t)(7)(D)(i) of the Act to extend such payments through December 31, 2005, for rural hospitals with 100 or fewer beds and extended such payments for services furnished during the period that begins with the provider's first cost reporting period beginning on or after January 1, 2004 and ends on December 31, 2005, for sole community hospitals located in rural areas. Accordingly, transitional corridor payments are only available to children's hospitals, cancer hospitals, rural hospitals having 100 or fewer beds, and sole community hospitals located in rural areas. </P>
                    <P>
                        At the time the OPPS was implemented, section 1833(t)(7)(F)(ii) of the Act defined the payment-to-cost ratio (PCR) used to calculate the “pre-BBA amount” 
                        <SU>2</SU>
                        <FTREF/>
                         for purposes of calculating the transitional corridor 
                        <PRTPAGE P="65826"/>
                        payments to be determined using the payments and reasonable costs of services furnished during the provider's cost reporting period ending in calendar year 1996. The BIPA, Pub. L. 106-554, enacted on December 21, 2000, revised that requirement. Section 403 of BIPA amended section 1833(t)(7)(F)(ii)(I) of the Act to allow transitional corridor payments to hospitals subject to the OPPS that did not have a 1996 cost report by authorizing use of the first available cost reporting period ending after 1996 and before 2001 in calculating a provider's PCR. 
                    </P>
                    <FTNT>
                        <P>
                            <SU>2</SU>
                             Section 1833(t)(7) of the Act defined the “pre-BBA” amount for a period as the amount equal to the product of (1) the payment-to-cost ratio for the hospital based on its 
                            <E T="03">cost reporting period ending in 1996,</E>
                             and (2) the reasonable cost of the services for the period. (Emphasis added.) In this context, BBA refers to the Balanced Budget Act of 1997, Pub. L. 105-33, enacted on August 5, 1997.
                        </P>
                    </FTNT>
                    <P>Although we discussed the BIPA amendment in the CY 2002 OPPS proposed rule published on August 24, 2001 (66 FR 44674), and implemented the amendment through Program Memorandum No. A-01-51, issued on April 13, 2001, we failed to revise the regulations at § 419.70(f)(2) to reflect the change. In the August 16, 2004 OPPS proposed rule, we proposed a technical correction to § 419.70(f)(2) to conform it to the provision of section 1833(t)(7)(F)(ii)(I) of the Act. </P>
                    <P>We did not receive any comments on this proposed technical change. Accordingly, in this final rule with comment period, we are adopting as final without modification our proposal and correcting § 419.70(f)(2) to conform it to the provision of section 1833(t)(7)(F)(ii)(I) of the Act. </P>
                    <P>However, we did receive several comments on the proposed rule related to the transitional corridor payments. </P>
                    <P>
                        <E T="03">Comment:</E>
                         A few commenters expressed appreciation for the extension of transitional corridor payments for children's hospitals, cancer hospitals, rural hospitals having 100 or fewer beds, and sole community hospitals located in rural areas, but requested that CMS consider extending payment protections to rural hospitals that are not eligible for transitional corridor payments. The commenters noted that rural hospitals that have converted to critical access hospitals are paid at cost and, therefore, have a competitive advantage over rural hospitals that are not eligible for transitional corridor payments and cannot convert to critical access hospital status. One commenter requested protection for rural hospitals that provide emergency services. 
                    </P>
                    <P>A few commenters noted that the transitional corridor payment provision for rural hospitals having 100 or fewer beds and sole community hospitals located in rural areas expires on December 31, 2005, and requested that CMS further extend this payment protection. </P>
                    <P>
                        <E T="03">Response:</E>
                         We share the concerns of rural hospitals and do not intend to limit access to health care to beneficiaries in rural areas. However, we note that the statute is very specific and does not provide transitional corridor payments for entities other than those listed in the statute, nor extend transitional corridor payments past December 31, 2005, for rural or sole community hospitals. 
                    </P>
                    <HD SOURCE="HD3">2. Comments on the Provisions of the January 6, 2004 Interim Final Rule With Comment Period </HD>
                    <P>As discussed in the January 6, 2004 interim final rule with comment period (69 FR 828), section 411(a)(1)(B) of Pub. L. 108-173 provided that hold harmless transitional corridor provisions shall apply to sole community hospitals located in rural areas. Section 411(a)(2) states that the effective date for section 411(a)(1)(B) “shall apply with respect to cost reporting periods beginning on or after January 1, 2004” for sole community hospitals located in rural areas. The Conference Agreement for Pub. L. 108-173 states, “The hold harmless provisions are extended to sole community hospitals located in a rural area starting for services furnished on or after January 1, 2004 * * *” </P>
                    <P>
                        <E T="03">Comment:</E>
                         Commenters noted that there appears to be a discrepancy between the effective date in section 411 of Pub. L. 108-173 and the Conference Agreement. The commenters noted that, in accordance with section 411, a sole community hospital with a cost reporting period beginning on a date other than January 1 will not receive transitional corridor payments and “interim” transitional corridor payments for services furnished after December 31, 2003, and before the beginning of the provider's next cost reporting period. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         Section 411(a)(2) of Pub. L. 108-173 provides the effective date with respect to the transitional corridor payments applied to sole community hospitals. Specifically, a sole community hospital with a cost reporting period beginning on or after April 1, 2004, is subject to the hold harmless provisions. We note that if a hospital qualifies as both a rural hospital having 100 or fewer beds and as a sole community hospital located in a rural area, for purposes of receiving transitional corridor payments and interim transitional corridor payments, the hospital will be treated as a rural hospital having 100 or fewer beds. In this case, transitional corridor payments would begin on January 1, 2004, and there would be no gap in transitional corridor payments. 
                    </P>
                    <HD SOURCE="HD2">C. Status Indicators and Comment Indicators Assigned in the Outpatient Code Editor (OCE) </HD>
                    <HD SOURCE="HD3">1. Payment Status Indicators </HD>
                    <P>The payment status indicators (SIs) that we assign to HCPCS codes and APCs under the OPPS play an important role in determining payment for services under the OPPS because they indicate whether a service represented by a HCPCS code is payable under the OPPS or another payment system and also whether particular OPPS policies apply to the code. As we proposed, for CY 2005, we are providing our status indicator assignments for APCs in Addendum A, for the HCPCS codes in Addendum B, and the definitions of the status indicators in Addendum D1 to this final rule with comment period. </P>
                    <P>Payment under the OPPS is based on HCPCS codes for medical and other health services. These codes are used for a wide variety of payment systems under Medicare, including, but not limited to, the Medicare fee schedule for physician services, the Medicare fee schedule for durable medical equipment and prosthetic devices, and the Medicare clinical laboratory fee schedule. For purposes of making payment under the OPPS, we must be able to signal the claims processing system through the Outpatient Code Editor (OCE) software, as to HCPCS codes that are paid under the OPPS and those codes to which particular OPPS payment policies apply. We accomplish this identification in the OPPS through the establishment of a system of status indicators with specific meanings. Addendum D1 contains the definitions of each status indicator for purposes of the OPPS for CY 2005. </P>
                    <P>We assign one and only one status indicator to each APC and to each HCPCS code. Each HCPCS code that is assigned to an APC has the same status indicator as the APC to which it is assigned. </P>
                    <P>In the August 16, 2004 OPPS proposed rule, for CY 2005, we proposed to use the following status indicators in the specified manner: </P>
                    <P>• “A” to indicate services that are paid under some payment method other than OPPS, such as under the durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS) fee schedule or the Medicare Physician Fee Schedule. Some, but not all, of these other payment systems are identified in Addendum D1 to this final rule with comment period. </P>
                    <P>
                        • “B” to indicate the services that are not payable under the OPPS when submitted on an outpatient hospital Part B bill type, but that may be payable by 
                        <PRTPAGE P="65827"/>
                        fiscal intermediaries to other provider types when submitted on an appropriate bill type. 
                    </P>
                    <P>• “C” to indicate inpatient services that are not payable under the OPPS. </P>
                    <P>• “D” to indicate a code that is discontinued, effective January 1, 2005. </P>
                    <P>• “E” to indicate items or services that are not covered by Medicare or codes that are not recognized by Medicare. </P>
                    <P>• “F” to indicate acquisition of corneal tissue, which is paid on a reasonable cost basis and certain CRNA services that are paid on a reasonable cost basis. </P>
                    <P>• “G” to indicate drugs, biologicals, and radiopharmaceutical agents that are paid under the OPPS transitional pass-through rules. </P>
                    <P>• “H” to indicate devices that are paid under the OPPS transitional pass-through rules and brachytherapy sources that are paid on a cost basis. </P>
                    <P>• “K” to indicate drugs, biologicals (including blood and blood products), and radiopharmaceutical agents that are paid in separate APCs under the OPPS, but that are not paid under the OPPS transitional pass-through rules. </P>
                    <P>• “L” to indicate flu and pneumococcal immunizations that are paid at reasonable cost but to which no coinsurance or copayment apply. </P>
                    <P>• “N” to indicate services that are paid under the OPPS, but for which payment is packaged into another service or APC group. </P>
                    <P>• “P” to indicate services that are paid under the OPPS, but only in partial hospitalization programs. </P>
                    <P>• “S” to indicate significant procedures that are paid under the OPPS, but to which the multiple procedure reduction does not apply. </P>
                    <P>• “T” to indicate significant services that are paid under the OPPS and to which the multiple procedure payment discount under the OPPS applies. </P>
                    <P>• “V” to indicate medical visits (including emergency department or clinic visits) that are paid under the OPPS. </P>
                    <P>• “X” to indicate ancillary services that are paid under the OPPS. </P>
                    <P>• “Y” to indicate nonimplantable durable medical equipment that must be billed directly to the durable medical equipment regional carrier rather than to the fiscal intermediary. </P>
                    <P>We proposed the payment status indicators identified above for each HCPCS code and each APC in Addenda A and B and requested comments on the appropriateness of the indicators we have assigned. </P>
                    <P>We received several public comments on our proposal relating to status indicators. </P>
                    <P>
                        <E T="03">Comment:</E>
                         Two commenters, representing radionuclide, radiopharmaceutical, and nuclear medicine interests, expressed concern about assignment of status indicator “N” in Transmittal 290, issued August 27, 2004, to the new revenue codes for diagnostic and therapeutic radiopharmaceuticals, revenue codes 0343 and 0344, that were effective October 1, 2004. The commenters recommended changing the status indicators for both 0343 and 0344 to “K” for nonpass-through drugs, biologicals, and radiopharmaceutical agents, and asked that CMS clarify and notify hospitals to use these revenue codes when billing and reporting costs for radiopharmaceuticals that can be paid separately. The commenters also stated that clarifying that these are nonpass-through and not packaged will assist CMS in tracking and analyzing costs for the radiopharmaceuticals and contribute to more accurate payment determinations. They recommended that CMS require hospitals to use the new revenue codes to report charges for radiopharmaceuticals. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         The assignment of status indicator “N” to revenue codes 0343 and 0344 in Transmittal 290 relates to OCE treatment of lines on a claim that report a charge with a revenue code but with no HCPCS code. The assignment of certain status indicators to revenue codes reported in the attachment to quarterly OPPS updates entitled “Summary of Data Modifications” is an OCE specification only, and should not be confused with how we use the status indicators listed in Addendum D1 that we assign to HCPCS codes and to APCs. 
                    </P>
                    <P>
                        Additional information related to how revenue codes are used can be found in Pub. 100-04, Medicare Claims Processing, Chapter 4, Section 20, Subsection 5.1.1, entitled “Packaged Revenue Codes.” As indicated in that section, certain revenue codes when reported on an OPPS bill 
                        <E T="03">without</E>
                         a HCPCS code, including revenue codes 0343 and 0344, are considered packaged services that are to be factored into the transitional outpatient payment and outlier calculations. 
                    </P>
                    <P>Although we strongly encourage hospitals to report charges and HCPCS codes for diagnostic and therapeutic radiopharmaceuticals using revenue codes 0343 and 0344, respectively, we generally try to not to impose requirements on the assignment of HCPCS codes to revenue codes for OPPS services because the way hospitals assign costs varies so widely. Nevertheless, we agree with the commenters that, to the extent hospitals report charges for radiopharmaceuticals, both packaged and separately payable, using the new revenue codes 0343 and 0344, our cost data related to radiopharmaceuticals should be more precise. </P>
                    <P>We will review our manual instructions and previous issuances related to the reporting of revenue codes and make any revisions needed to clarify and update those instructions. </P>
                    <P>
                        <E T="03">Comment:</E>
                         One commenter asked that CMS change the status indicator for code 90780 and 90781 to “X” from “T” and thereby cease the application of the multiple procedure reduction to these services, which will be billed for administration of infusion therapy in place of Q0081 for CY 2005. The commenter indicated that there is no situation in which the time and resources involved in infusion care should be reduced in the case of an observation patient. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We disagree. The costs of space, utilities and staff attendance are duplicated when the beneficiary is receiving another service at the same time as infusion therapy, in particular when the patient is in observation. Hence, a multiple procedure reduction to infusion therapy is appropriate, particularly when the patient is in observation status. However, we are noting how the multiple procedure discounting logic in the OCE functions. Line items with a service indicator of “T” are subject to multiple procedure discounting unless modifiers 76, 77, 78, or 79, or all, are present. The “T” line item with the highest payment amount will not be multiple procedure discounted, and all other “T” line items will be multiple procedure discounted. All line items that do not have a service indicator of “T” will be ignored in determining the discount. Therefore, if the only other services reported with infusion therapy are an emergency department or other visit code, or diagnostic tests and services assigned status indicator “S,” the infusion therapy code would not be subject to the multiple procedure discounting. 
                    </P>
                    <HD SOURCE="HD3">2. Comment Indicators </HD>
                    <P>In the November 1, 2002 and the November 7, 2003 final rules with comment period, which implemented changes in the OPPS for CYs 2003 and 2004, respectively, we provided code condition indicators in Addendum B. The code condition indicators and their meaning are as follows: </P>
                    <P>
                        • “DG”—Deleted code with a grace period; Payment will be made under the deleted code during the 90-day grace period. 
                        <PRTPAGE P="65828"/>
                    </P>
                    <P>• “DNG”—Deleted code with no grace period; Payment will not be made under the deleted code. </P>
                    <P>• “NF”—New code final APC assignment; Comments were accepted on a proposed APC assignment in the Proposed Rule; APC assignment is no longer open to comment. </P>
                    <P>• “NI”—New code interim APC assignment; Comments will be accepted on the interim APC assignment for the new code. </P>
                    <P>Medicare had permitted a 90-day grace period after implementation of an updated medical code set, such as the HCPCS, to give providers time to incorporate new codes in their coding and billing systems and to remove the discontinued codes. HCPCS codes are updated annually every January 1, so the grace period for billing discontinued HCPCS was implemented every January 1 through March 31. </P>
                    <P>The Health Insurance Portability and Accountability Act (HIPAA) transaction and code set rules require usage of the medical code set that is valid at the time that the service is provided. Therefore, effective January 1, 2005, CMS is eliminating the 90-day grace period for billing discontinued HCPCS codes. Details about elimination of the 90-day grace period for billing discontinued HCPCS codes were issued to our contractors on February 6, 2004, in Transmittal 89, Change Request 3093. </P>
                    <P>In order to be consistent with the HIPPA rule that results in the elimination of the 90-day grace period for billing discontinued HCPCS codes, in the August 16, 2004 OPPS proposed rule, we proposed, effective January 1, 2005, to delete code condition indicators “DNG” and “DG”. We proposed to designate codes that are discontinued effective January 1, 2005 with status indicator “D,” as described in section VII.C.1. of this preamble. </P>
                    <P>Further, we proposed to rename “code condition” indicators as “comment indicators.” In Addendum D2 to this final rule with comment period, we list the following two comment indicators that we had proposed to use to identify HCPCS codes assigned to APCs that are or are not subject to comment: </P>
                    <P>• “NF”—New code, final APC assignment; Comments were accepted on a proposed APC assignment in the Proposed Rule; APC assignment is no longer open to comment. </P>
                    <P>• “NI”—New code, interim APC assignment; Comments will be accepted on the interim APC assignment for the new code. </P>
                    <P>We did not receive any public comments on our proposal relating to comment indicators. We are implementing the comment indicators and discontinuing the use of code condition indicators as we proposed, without modification. </P>
                    <HD SOURCE="HD2">D. Observation Services </HD>
                    <P>Frequently, beneficiaries are placed in “observation status” in order to receive treatment or to be monitored before making a decision concerning their next placement (that is, admit to the hospital or discharge). This status assignment occurs most frequently after surgery or a visit to the emergency department. For a detailed discussion of the clinical and payment history of observation services, see the November 1, 2002 final rule with comment period (67 FR 66794). </P>
                    <P>Before the implementation of the OPPS in CY 2000, payment for observation care was made on a reasonable cost basis, which gave hospitals a financial incentive to keep beneficiaries in “observation status” even though clinically they were being treated as inpatients. With the initiation of the OPPS, observation services were no longer paid separately; that is, they were not assigned to a separate APC. Instead, costs for observation services were packaged into payments for the services with which the observation care was associated. </P>
                    <P>Beginning in early 2001, the APC Panel began discussing the topic of separate payment for observation services. In its deliberations, the APC Panel asserted that observation services following clinical and emergency room visits should be paid separately, and that observation following surgery should be packaged into the payment for the surgical procedure. For CY 2002, we implemented separate payment for observation services (APC 0339) under the OPPS for three medical conditions: chest pain, congestive heart failure, and asthma. A number of accompanying requirements were established, including the billing of an evaluation and management visit in conjunction with the presence of certain specified diagnosis codes on the claim, hourly billing of observation care for a minimum of 8 hours up to a maximum of 48 hours, timing of observation beginning with the clock time on the nurse's admission note and ending at the clock time on the physician's discharge orders, a medical record documenting that the beneficiary was under the care of a physician who specifically assessed patient risk to determine that the beneficiary would benefit from observation care, and provision of specific diagnostic tests to beneficiaries based on their diagnoses. In developing this policy for separately payable observation services, we balanced issues of access, medical necessity, potential for abuse, and the need to ensure appropriate payment. We selected the three medical conditions, noted previously, and the accompanying diagnosis codes and diagnostic tests to avoid significant morbidity and mortality from inappropriate discharge while, at the same time, avoiding unnecessary inpatient admissions. </P>
                    <P>Over the past 2 years, we have continued to review observation care claims data for information on utilization and costs, along with additional information provided to us by physicians and hospitals concerning our current policies regarding separately payable observation services. Our primary goal is to ensure that Medicare beneficiaries have access to medically necessary observation care. We also want to ensure that separate payment is made only for beneficiaries actually receiving clinically appropriate observation care. </P>
                    <P>In January 2003, the APC Panel established an Observation Subcommittee. Over the last year, this subcommittee has held discussions concerning observation care and reviewed data extracted from claims that reported observation services. The subcommittee presented the results of its deliberations to the full APC Panel at the February 2004 meeting. The APC Panel recommendations regarding observation care provided under the OPPS were broad in scope and included elimination of the diagnosis requirement for separate payment for observation services, elimination of the requirement for the concomitant diagnostic tests for patients receiving observation care, unpackaging of observation services beyond the typical expected recovery time from surgical and interventional procedures, and modification of the method for measuring beneficiaries' time in observation to make it more compatible with routine hospital practices and their associated electronic systems. </P>
                    <P>In response to the APC Panel recommendations, we undertook a number of studies regarding observation services, while acknowledging data limitations from the brief 2-year experience the OPPS has had with separately payable observation services. </P>
                    <P>
                        To assess the appropriateness of the APC Panel's recommendation not to pay separately for observation services following surgical or interventional procedures, we analyzed the claims for these procedures to determine the extent to which the claims reported packaged observation services codes. This analysis revealed that while 
                        <PRTPAGE P="65829"/>
                        observation services are being reported on some claims for surgical and interventional procedures, the great majority of claims for these procedures reported no observation services. The packaged status of these observation services codes may result in underreporting their frequency, but the proportion of surgical and interventional procedures reported with the packaged observation services codes was so small that any increase would not change our substantive conclusion. This confirmed our belief that, although an occasional surgical case may require a longer recovery period than expected for the procedure, as a rule, surgical outpatients do not require observation care. Given the rapidly changing nature of outpatient surgical and interventional services, it would be difficult to determine an expected typical recovery time for each procedure. We have concerns about overutilization of observation services in the post-procedural setting as partial replacement for recovery room time. However, we noted that, to the extent observation care or extended recovery services are provided to surgical or interventional patients, the cost of that care is packaged into the payment for the procedural APC which may result in higher median costs for those procedures. 
                    </P>
                    <P>We also analyzed the possibility of expanding the list of medical conditions for separately payable visit-related observation services, altering the requirements for diagnostic tests while in observation, and modifying the rules for counting time in observation care. </P>
                    <P>We looked at CY 2003 OPPS claims data for all packaged visit-related observation care for all medical conditions in order to determine whether or not there were other diagnoses that would be candidates for separately payable observation services. Our analysis confirmed that the three diagnoses that are currently eligible for separate payment for observation services are appropriate, as those diagnoses are frequently reported in our visit-related claims with packaged observation services. In fact, diagnoses related to chest pain were, by far, the diagnosis most frequently reported for observation care, either separately payable or packaged. Other diagnoses that appeared in the claims data with packaged observation services included syncope and collapse, transient cerebral ischemia, and hypovolemia. </P>
                    <P>The packaged status of those observation stays means that the data are often incomplete and the frequency of services may be underreported. Generally, information about packaged services is not as reliably reported as is that for separately paid services. However, we are not convinced that, for those other conditions (such as hypovolemia, syncope and collapse, among others), there is a well-defined set of hospital services that are distinct from the services provided during a clinic or emergency room visit. Separately payable observation care must include specific, clinically appropriate services, and we are still accumulating data and experience for the three medical conditions for which we are currently making separate payment. Therefore, we believed it was premature to expand the conditions for which we would separately pay for visit-related observation services. </P>
                    <P>Hospitals have indicated that, even in the cases where the diagnostic tests have been performed, to assure that billing requirements for separately payable observation services under APC 0339 are met, they must manually review the medical records to prepare the claims. If they do not conduct this manual review, they may not be coding appropriately for separately payable observation services. </P>
                    <P>As noted in our August 16, 2004 proposed rule, we have also received comments from the community and the APC Panel asserting that the requirements for diagnostic testing are overly prescriptive and administratively burdensome, and that hospitals may perform tests to comply with the CMS requirements, rather than based on clinical need. For example, a patient admitted directly to observation care with a diagnosis of chest pain may have had an electrocardiogram in a physician's office just prior to admission to observation and may only need one additional electrocardiogram while receiving observation care. Thus, two more electrocardiograms performed in the hospital as required under the current OPPS observation policy might not be medically necessary. </P>
                    <P>We continue to believe that the diagnostic testing criteria we established for the three medical conditions are the minimally appropriate tests for patients receiving a well-defined set of hospital observation services for those conditions. The previous example, notwithstanding, we also continue to believe that the majority of these tests would be performed in the hospital outpatient setting. We define observation care as an active treatment to determine if a patient's condition is going to require that he or she be admitted as an inpatient or if the condition resolves itself and the patient is discharged. The currently required diagnostic tests reflect that an active assessment of the patient was being undertaken, and we believe they are generally medically necessary to determine whether a beneficiary will benefit from being admitted to observation care and aid in determining the appropriate disposition of the patient following observation care. </P>
                    <P>After careful consideration, we agree that specifying which diagnostic tests must be performed as a prerequisite for payment of APC 0339 may be imposing an unreasonable reporting burden on hospitals and may, in some cases, result in unnecessary tests being performed. Therefore, in the August 16, 2004 proposed rule, we proposed, beginning in CY 2005, to remove the current requirements for specific diagnostic testing, and to rely on clinical judgment in combination with internal and external quality review processes to ensure that appropriate diagnostic testing (which we expect would include some of the currently required diagnostic tests) is provided for patients receiving high quality, medically necessary observation care. </P>
                    <P>Accordingly, we proposed that, beginning in CY 2005, the following tests would no longer be required to receive payment for APC 0339 (Observation): </P>
                    <P>• For congestive heart failure, a chest x-ray (71010, 71020, 71030), and electrocardiogram (93005) and pulse oximetry (94760, 94761, 94762) </P>
                    <P>• For asthma, a breathing capacity test (94010) or pulse oximetry (94760, 94761, 94762) </P>
                    <P>• For chest pain, two sets of cardiac enzyme tests; either two CPK (82550, 82552, 82553) or two troponins (84484, 84512) and two sequential electrocardiograms (93005) </P>
                    <P>We believe that this proposed policy change would benefit hospitals because it would reduce administrative burden, allow more flexibility in management of beneficiaries in observation care, provide payment for clinically appropriate care, and remove a requirement that may have resulted in duplicative diagnostic testing. </P>
                    <P>We received numerous public comments supporting our proposed policy. We did not receive any comments that opposed the proposed policy. Therefore, we are adopting, without modification, our proposal to no longer require specified diagnostic tests to receive payment for APC 0339, beginning in CY 2005. </P>
                    <P>
                        Hospitals and the APC Panel further suggested that we modify the method for accounting for the beneficiary's time in observation care. Currently, hospitals report the time in observation beginning with the admission of the beneficiary to 
                        <PRTPAGE P="65830"/>
                        observation and ending with the physician's order to discharge the patient from observation. There are two problems related to using the time of the physician discharge order to determine the ending time of observation care. First, providers assert that it is not possible to electronically capture the time of the physician's orders for discharge. As a result, manual medical record review is required in order to bill accurately. Second, the hospital may continue to provide specific discharge-related observation care for a short time after the discharge orders are written and, therefore, may not be allowed to account for the full length of the observation care episode. In an effort to reduce hospitals' administrative burden related to accurate billing, in the proposed rule, we proposed to modify our instructions for counting time in observation care to end at the time the outpatient is actually discharged from the hospital or admitted as an inpatient. Our expectation was that specific, medically necessary observation services were being provided to the patient up until the time of discharge. However, we did not expect reported observation time to include the time patients remain in the observation area after treatment is finished for reasons that include waiting for transportation home. 
                    </P>
                    <P>Although beneficiaries may be in observation care up to 48 hours or longer, we believed that, in general, 24 hours was adequate for the clinical staff to determine what further care the patient needs. In CY 2005, we proposed to continue to make separate payment for observation care based on claims meeting the requirement for payment of HCPCS code G0244 (Observation care provided by a facility to a patient with CHF, chest pain, or asthma, minimum 8 hours, maximum 48 hours). However, we proposed not to include claims reporting more than 48 hours of observation care in calculating the final payment rate for APC 0339. </P>
                    <P>We received several public comments on our proposal. </P>
                    <P>
                        <E T="03">Comment:</E>
                         A number of commenters urged that CMS include claims for stays greater than 48 hours in the data used to calculate the payment rate for observation because any such claims in our dataset would have withstood local fiscal intermediary scrutiny for reasonableness and medical necessity and should therefore be regarded as legitimate for pricing calculations. One commenter requested that CMS provide clarification to fiscal intermediaries regarding billing for stays that exceed 48 hours because code G0244 (Observation care provided by a facility to a patient with CHF, chest pain or asthma, minimum 8 hours, maximum 48 hours) would seem to preclude billing G0244 for stays that exceed 48 hours but that otherwise meet all the criteria for payment. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         In an effort to clarify the apparent confusion cited by commenters with regard to billing for stays that exceed 48 hours, beginning in CY 2005, we are changing the descriptor for HCPCS code G0244 to read as follows: 
                    </P>
                    <P>G0244, Observation care provided by a facility to a patient with CHF, chest pain or asthma, minimum 8 hours. </P>
                    <P>We expect that hospitals will report one unit of G0244 for each hour of observation care provided to patients for congestive heart failure, chest pain, or asthma, with a minimum 8 units billed to be eligible for separate observation payment. </P>
                    <P>We carefully considered the comments that urged us to include reporting more than 48 hours to calculate the median cost of G0244. The final payment rate for APC 0339 listed in Addendum A is based on all CY 2003 claims for G0244 taken from the National Claims History file, without regard to units of service. Prior to implementation of the OPPS, when hospital outpatient services were paid on a reasonable cost basis, Medicare did allow payment for observation services that exceeded 48 hours when medical review determined that a more extended period of observation care was reasonable and necessary. Since implementation of the OPPS, Medicare has ceased paying separately for observation care, with the exception of services reported with G0244, because payment for observation services was packaged into payment for services with which observation services were reported. We believe that, in the overwhelming majority of cases, decisions can be and are routinely made in less than 48 hours whether to release a beneficiary from the hospital following resolution of the reason for the outpatient visit or whether to admit the beneficiary as an inpatient. Therefore, we intend to revisit this issue in future updates. </P>
                    <P>For the reasons stated above, we are not adopting as final for CY 2005, our proposal to exclude claims for G0244 that reported more than 48 hours of observation from calculation of the median cost for APC 0339. </P>
                    <P>We also proposed the following requirements to receive separate payment for HCPCS code G0244 in APC 0339 for medically necessary observation services involving specific goals and a plan of care that are distinct from the goals and plan of care for an emergency department, physician office, or clinic visit: </P>
                    <P>• The beneficiary must have one of three medical conditions: congestive heart failure, chest pain, or asthma. The hospital bill must report as the admitting or principal diagnosis an appropriate ICD-9-CM code to reflect the condition. The eligible ICD-9-CM diagnosis codes for CY 2005 are shown in Table 38 below. </P>
                    <P>• The hospital must provide and report on the bill an emergency department visit (APC 0610, 0611, or 0612), clinic visit (APC 0600, 0601, or 0602), or critical care (APC 0620) on the same day or the day before the separately payable observation care (G0244) is provided. For direct admissions to observation, in lieu of an emergency department visit, clinic visit, or critical care, G0263 (Adm with CHF, CP, asthma) must be billed on the same day as G0244. </P>
                    <P>• HCPCS code G0244 must be billed for a minimum of 8 hours. </P>
                    <P>• No procedures with a ‘T' status indicator, except the code for infusion therapy of other than a chemotherapy drug (CPT code 90780) can be reported on the same day or day before observation care is provided. </P>
                    <P>• Observation time must be documented in the medical record and begins with the beneficiary's admission to an observation bed and ends when he or she is discharged from the hospital. </P>
                    <P>• The beneficiary must be in the care of a physician during the period of observation, as documented in the medical record by admission, discharge, and other appropriate progress notes that are timed, written, and signed by the physician. </P>
                    <P>• The medical record must include documentation that the physician explicitly assessed patient risk to determine that the beneficiary would benefit from observation care. </P>
                    <P>We received numerous public comments on our proposal. </P>
                    <P>
                        <E T="03">Comment:</E>
                         Most commenters applauded our proposal to eliminate the requirement that specified diagnostic tests be reported in order to receive payment for HCPCS code G0244. However, many commenters expressed disappointment that CMS did not propose to expand the conditions for which separate payment would be provided for observation care. One commenter, representing cancer centers, requested that CMS study febrile neutropenia, chemotherapy hypersensitivity reaction, hypovolemia, and electrolyte imbalance as conditions that would warrant separate payment for observation. A few commenters 
                        <PRTPAGE P="65831"/>
                        supported the APC Panel recommendation that we eliminate altogether the diagnosis coding requirement for APC 0339. One commenter stated that medical care included in hourly observation charges billed under revenue code 762 for syncope and collapse, transient cerebral ischemia, and hypovolemia is medically necessary and distinct from services rendered in the emergency department or a clinic, is similar to that furnished to patients with congestive heart failure, asthma, and chest pain, and should therefore be paid for separately. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We appreciate the support expressed by numerous commenters for the changes in requirements that we proposed for CY 2005 in order for hospitals to receive separate payment for observation services. As we indicate below, we are making final most of the changes that we proposed, with some modifications based on comments that we received. Although we are not going to implement in the CY 2005 OPPS the recommendations made by commenters and the APC Panel to expand separate payment for observation to include conditions in addition to congestive heart failure, asthma, and chest pain, we will continue to analyze our data and study the impact of such a change for reconsideration in future updates of the OPPS. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         Several commenters supported our proposal to change how we define ending time or “discharge” from observation care. However, those commenters also requested further clarification of what we mean by “discharge.” 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We carefully considered the thoughtful comments related to our proposal to modify the current policy regarding the time that should be recorded to designate when observation care ends. Based on suggestions from commenters, we are elaborating upon our proposal to define as the end of observation, the time the outpatient is either discharged from the hospital or admitted as an inpatient. Specifically, we consider the time when a patient is “discharged” from observation status to be the clock time when all clinical or medical interventions have been completed, including any necessary followup care furnished by hospital staff and physicians that may take place after a physician has ordered that the patient be released or admitted as an inpatient. However, observation care does not include time spent by the patient in the hospital subsequent to the conclusion of therapeutic, clinical, or medical interventions, such as time spent waiting for transportation to go home. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         A few commenters requested clarification of the starting time for observation. One commenter recommended that CMS make it clear that observation time begins with the patient's placement in the bed and initiation of observation care, regardless of whether the bed is in a holding area or is in an actual observation bed or unit, as long as appropriate observation care is being provided. Another commenter asked if CMS will allow providers to document observation start time on any applicable document in the medical record and not limit the start time documentation to the nurse's observation admission note. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We have stated in past issuances and rules that observation time begins at the clock time appearing on the nurse's observation admission note, which coincides with the initiation of observation care or with the time of the patient's arrival in the observation unit (66 FR 59879, November 30, 2001; Transmittal A-02-026 issued on March 28, 2002; and Transmittal A-02-129 issued on January 3, 2003.) In the August 16, 2004 proposed rule, we stated that observation time must be documented in the medical record and begins with the beneficiary's admission to an observation bed (69 FR 50534). We agree with the commenter on the need for clarification, and we will reiterate in provider education materials developed for the CY 2005 OPPS update that observation time begins at the clock time documented in the patient's medical record, which coincides with the time the patient is placed in a bed for the purpose of initiating observation care in accordance with a physician's order. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         One commenter, a hospital trade association, recommended that CMS reconsider requiring hospitals to report one of the ICD-9-CM diagnosis codes designated for payment of APC 0339 as the admitting or principal diagnosis on the hospital claim. The commenter was concerned that, if we restrict the position of the diagnosis code to the admitting or principal field, many claims that otherwise meet the criteria for separate payment of observation will not be payable because coding rules and the frequency by which Medicare beneficiaries with asthma, congestive heart failure or chest pains have other presenting signs, symptoms, and clinical conditions will result in inappropriate placement of the requisite diagnosis code. Therefore, the commenter recommended that CMS accept the required diagnosis code in any diagnosis code field. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         Our proposal to require hospitals to report one of the specified ICD-9-CM codes in the admitting or principal diagnosis field is a modification of policy that we implemented in the November 30, 2001 final rule (66 FR 59880). We disagree with the commenter that this requirement will result in many claims for APC 0339 not being paid. Rather, we believe that requiring hospitals to report the signs, symptoms, and conditions that are the reason for the patient's visit will enhance coding accuracy and ensure that we are paying appropriately for APC 0339 by limiting separate payment to those observation services furnished to monitor asthma, chest pain, or congestive heart failure. If we continued to accept the required ICD-9-CM diagnosis code as a secondary diagnosis, we would remain concerned that we may be making separate payment for observation for conditions other than asthma, congestive heart failure or chest pain because these conditions are reported in the secondary diagnosis field even though they are not the clinical reason that the patient is receiving observation services. 
                    </P>
                    <P>Because we want to give hospitals ample time to incorporate this requirement into their billing systems, we will not implement this requirement before April 1, 2005. However, we are making final in this final rule with comment period the requirement that, beginning April 1, 2005, hospitals must report a qualifying ICD-9 CM diagnosis code in Form Locator (FL) 76, Patient Reason for Visit, and/or FL 67, principal diagnosis, in order for the hospital to receive separate payment for APC 0339. If a qualifying ICD-9 diagnosis code(s) is reported in the secondary diagnosis field but is not reported in either the Patient Reason for Visit field (FL 76) or the principal diagnosis field (FL 67), separate payment for APC 0339 will not be allowed. </P>
                    <P>
                        <E T="03">Comment:</E>
                         One commenter requested that CMS modify the requirement that there be documentation that the physician has explicitly assessed the beneficiary risk to determine that he would benefit from observation care. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We expect that, prior to issuing an order to place a patient in observation status, it is standard procedure for the physician to assess the patient's condition to determine the clinically appropriate intervention that is most likely to result in maximum benefit for the patient given his or her condition at that time. To expect documentation of that assessment in the medical record of a patient for whom an order to receive observation care has been issued is not new, excessive, or 
                        <PRTPAGE P="65832"/>
                        unduly burdensome, but rather is an essential part of the patient's medical record to support the medically reasonable and necessary nature of the services ordered and furnished.
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         One commenter requested that CMS allow observation care following surgery if recovery time is longer than expected. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         As stated in the proposed rule, this situation is precisely contrary to the purpose of the observation care benefit. We again note that recovery time has been factored into the payment for the surgery. Although there is variation among patients' recovery times, that variation is part of the averaging that is inherent in a prospective payment system. Those costs are not considered as part of the payment for observation care, which serves an entirely different purpose for beneficiaries in the outpatient setting. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         One commenter recommended adding ICD-9-CM diagnosis code 427.31 (Atrial fibrillation) to the list of specified diagnosis codes that could be included on claims for separately payable observation services furnished to patients with congestive heart failure or chest pain, or both. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         While many patients may have chronic atrial fibrillation that is asymptomatic, we agree that some patients may present chest pain as a significant symptom associated with atrial fibrillation. Atrial fibrillation may also complicate acute myocardial infarction. Patients who are being evaluated and managed with observation care for chest pain in a hospital may be found to have symptomatic atrial fibrillation as the likely etiology of their chest discomfort following comprehensive assessment. However, we would generally expect that patients with chest pain and atrial fibrillation receiving observation services in the hospital would be receiving these services specifically for their chest pain and that one of the chest pain diagnoses already on our list of diagnosis codes would be present on the claim as the reason for the visit or the principal diagnosis. Similarly, with respect to atrial fibrillation and congestive heart failure, congestive heart failure is an independent predictor of atrial fibrillation. However, as with chest pain and atrial fibrillation, we would generally expect that patients with congestive heart failure and atrial fibrillation receiving observation services in the hospital to be receiving these services specifically for their congestive heart failure and that one of the congestive heart failure diagnoses already on our list of diagnosis codes would be present on the claim as the reason for the visit or the principal diagnosis. 
                    </P>
                    <P>Therefore, while we agree with the commenter's suggestion that code 427.31 could be viewed as a reasonable diagnosis code for chest pain for which separate payment for observation services might be made under the OPPS, we believe it is unnecessary and redundant to add it to the list for chest pain because any of the existing ICD-9-CM diagnosis codes listed in Table 32 for chest pain suffices for purposes of the OPPS observation payment policy. Likewise, we are not adding code 427.31 to the list of acceptable congestive heart failure diagnoses for which separate payment for observation services is made by the OPPS. </P>
                    <P>
                        <E T="03">Comment:</E>
                         One commenter recommended that diagnostic heart catheterization procedures, CPT codes 93510 through 92529, performed within 24 hours of an observation stay not disqualify separate payment for the observation even though these codes are assigned status indicator “T,” because it is not uncommon for patients admitted through the emergency department to observation for chest pain to be followed up with a diagnostic heart catheterization within 24 hours. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         This scenario was discussed during the February 2004 APC Panel meeting, although it was not advanced as a formal recommendation. While we are not adopting the commenter's recommendation at this time, we are making final in this final rule with comment period several changes in the requirements for separate payment for observation care, for implementation in CY 2005. We believe further analysis of any impact of such a change, in addition to analysis of the other changes being implemented in CY 2005, is necessary. We note that by the APC Panel may wish to consider this in future meetings. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         One commenter, representing a health system, suggested extensive billing and coding changes to further simplify claims submission for observation services. These suggestions included revision of the definition of HCPCS code G0263 and elimination of HCPCS code G0264 for direct admissions; replacing use of HCPCS code G0244 with a revenue code and CPT codes and letting the OCE determine if the criteria for payment of APC 0339 are met; clarification of billing for postanesthesia care unit (PACU) services; and use of revenue codes to distinguish between observation in a clinic and observation in an emergency department. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We welcome the commenter's suggestions and will endeavor during the next year to evaluate their feasibility and impact of any such changes. However, we recognize that extensive systems changes would be required to implement many of these suggestions, but will consider them for possible implementation in future updates of the OPPS. 
                    </P>
                    <P>After carefully considering the public comments received related to our proposed requirements to receive separate payment for observation services in CY 2005, we are adopting our proposal as final without modification. </P>
                    <BILCOD>BILLING CODE 4120-01-P</BILCOD>
                    <GPH SPAN="3" DEEP="504">
                        <PRTPAGE P="65833"/>
                        <GID>ER15NO04.058</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="439">
                        <PRTPAGE P="65834"/>
                        <GID>ER15NO04.059</GID>
                    </GPH>
                    <BILCOD>BILLING CODE 4120-01-C</BILCOD>
                    <HD SOURCE="HD2">E. Procedures That Will Be Paid Only as Inpatient Procedures </HD>
                    <P>Before implementation of the OPPS, Medicare paid reasonable costs for services provided in the outpatient department. The claims submitted were subject to medical review by the fiscal intermediaries to determine the appropriateness of providing certain services in the outpatient setting. We did not specify in regulations those services that were appropriate to provide only in the inpatient setting and that, therefore, should be payable only when provided in that setting. </P>
                    <P>Section 1833(t)(1)(B)(i) of the Act gives the Secretary broad authority to determine the services to be covered and paid for under the OPPS. In the April 7, 2000 final rule with comment period, we identified procedures that are typically provided only in an inpatient setting and, therefore, would not be paid by Medicare under the OPPS (65 FR 18455). These procedures comprise what is referred to as the “inpatient list.” The inpatient list specifies those services that are only paid when provided in an inpatient setting. These are services that require inpatient care because of the nature of the procedure, the need for at least 24 hours of postoperative recovery time or monitoring before the patient can be safely discharged, or the underlying physical condition of the patient. As we discussed in the April 7, 2000 final rule with comment period (65 FR 18455) and the November 30, 2001 final rule (66 FR 59856), we use the following criteria when reviewing procedures to determine whether or not they should be moved from the inpatient list and assigned to an APC group for payment under the OPPS: </P>
                    <P>• Most outpatient departments are equipped to provide the services to the Medicare population. </P>
                    <P>• The simplest procedure described by the code may be performed in most outpatient departments. </P>
                    <P>• The procedure is related to codes that we have already removed from the inpatient list. </P>
                    <P>In the November 1, 2002 final rule (67 FR 66792), we added the following criteria for use in reviewing procedures to determine whether they should be removed from the inpatient list and assigned to an APC group for payment under the OPPS: </P>
                    <P>
                        • We have determined that the procedure is being performed in multiple hospitals on an outpatient basis; or 
                        <PRTPAGE P="65835"/>
                    </P>
                    <P>• We have determined that the procedure can be appropriately and safely performed in an ASC and is on the list of approved ASC procedures or proposed by us for addition to the ASC list. </P>
                    <P>In the November 7, 2003 final rule with comment period, we did not implement any changes in our payment policies for the OPPS inpatient list. However, we addressed issues and concerns raised by commenters in response to the August 12, 2003 proposed rule and further clarified payment policies related to the OPPS inpatient list. </P>
                    <P>At the February 2004 meeting, the APC Panel made the recommendation to remove the following four abscess drainage CPT codes from the inpatient list: 44901, 49021, 49041, and 49061. As discussed in the proposed rule, we agreed with the APC Panel's recommendation and we proposed to remove these four abscess codes from the inpatient list and to assign them to APC 0037 for OPPS payment in CY 2005. </P>
                    <P>The APC Panel also made a recommendation to either eliminate the inpatient list from the OPPS or to evaluate the current list of procedures for any other appropriate changes. As recommended by the APC Panel, we sought to identify additional procedure codes to propose for removal from the inpatient list, consistent with the criteria listed above. To assist us in identifying procedures that were being widely performed on an outpatient basis for clinical review, we looked for services on the inpatient list that were performed on Medicare beneficiaries in all sites of service other than the hospital inpatient setting approximately 60 percent or more of the time. We relied on CY2003 Medicare Part B Extract and Summary System (BESS) data for this information. We chose 60 percent as a threshold because, in general, we believe that a procedure should be specifically considered for removal from the inpatient list if there is evidence that it is being performed less than one half of the time in the hospital inpatient setting. For procedures where data demonstrate that they are being delivered to Medicare beneficiaries in a safe and appropriate manner on an outpatient basis in a variety of different hospitals, we believe that it is reasonable to consider the removal of these procedures from the inpatient list. After further clinical evaluation of codes that met our 60-percent threshold to ensure that these procedures met our other criteria for removal from the inpatient list and were truly appropriate for consideration, we proposed to place 20 procedures that are on the inpatient list for the CY 2004 OPPS into clinical APCs for payment under the OPPS for CY 2005. We proposed to assign all of these codes the status indicator “T.” Two additional services, CPT codes 00174 and 00928, were proposed to be removed and assigned a status indicator “N” because, under the OPPS, anesthesia codes are packaged into the procedures with which they are billed. </P>
                    <P>We proposed not to accept the APC Panel's recommendation to completely eliminate the inpatient list for CY 2005. We solicited comments, especially from professional societies and hospitals, on whether any procedures on the CY 2005 proposed inpatient list were appropriate for removal and whether any other such procedures should be separately paid under the OPPS. We also asked commenters who recommend that a procedure that is currently on the inpatient list be reclassified to an APC to include evidence (preferably from peer-reviewed medical literature) that the procedure is being performed on an outpatient basis in a safe and effective manner. We requested that commenters suggest an appropriate APC assignment for the procedure and furnish supporting data to assist us in determining, based on comments, if the procedure could be payable under the OPPS in CY 2005. </P>
                    <P>We received a number of public comments on our proposal to retain the inpatient list and to delete 22 procedure codes from the inpatient list and our solicitation of additional procedures currently on the inpatient list that should be reclassified to an APC, with supporting evidence. </P>
                    <P>
                        <E T="03">Comment:</E>
                         One commenter recommended that CMS remove the following CPT codes for spinal procedures currently on the inpatient list: CPT codes 22554, 22585, 22840, 22842, 22845, 22846, 22855, 63043, 63044, 63075, and 63076. The commenter submitted several published articles related to the performance of these procedures in the hospital outpatient setting. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         After careful review of the list of procedures and the accompanying articles submitted by the commenter, we believe these procedures should remain on the inpatient list for CY 2005. All of the procedures recommended by the commenter for removal were performed more than 90 percent of the time in the hospital inpatient setting on Medicare beneficiaries according to our BESS data. There was no evidence submitted to demonstrate that the procedures were being provided safely and effectively to patients demographically similar to Medicare beneficiaries in multiple hospitals in the outpatient hospital setting. We are concerned that none of the published studies, with the exception of one, included patients in the general Medicare-eligible age range of 65 years or older. We do not believe that experience in providing these major spinal procedures to young and middle-aged adults in the outpatient setting can necessarily be generalized as safe and appropriate for typical Medicare beneficiaries. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         One commenter requested that CPT code 58260 (Vaginal hysterectomy) be removed from the inpatient list. The commenter stated that surgeons at the hospital believed that performing this procedure in an outpatient setting has been a standard of practice for a long time. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         According to our BESS data, the procedure described by CPT 58260 was performed more than 90 percent of the time in the hospital inpatient setting on Medicare beneficiaries. There was no evidence submitted by the commenter to demonstrate that this procedure was being provided safely and effectively to patients demographically similar to Medicare beneficiaries in multiple hospitals in the outpatient hospital setting. Thus, we believe this procedure should remain on the inpatient list. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         Several commenters, including a hospital association, recommended the elimination of the inpatient list, echoing the APC Panel's recommendation from February 2004. The commenters stated that, while it is appropriate to leave the decision of site of service to the physicians, hospitals are unable to receive payment for services on this list that are performed in the hospital outpatient setting. One commenter argued that the current policy penalizes beneficiaries because they must be admitted as inpatients to receive these procedures, rather than receiving these services in an outpatient setting and being allowed to return home. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         In the November 7, 2003 final rule (67 FR 66797), we specified the inpatient list to include services that are payable by Medicare only when provided in an inpatient setting. These are services that generally require inpatient care because of the nature of the procedure, the need for at least 24 hours of postoperative recovery time or monitoring before the patient can be safely discharged, or the underlying physical condition of the Medicare beneficiary. We also listed in the November 7, 2003 final rule (68 FR 63466) the criteria that we use to evaluate whether a procedure should be 
                        <PRTPAGE P="65836"/>
                        removed from the inpatient list. We do not believe that all services can be safely and effectively delivered to Medicare beneficiaries in the outpatient setting. We are concerned that elimination of the inpatient list could result in unsafe or uncomfortable care for Medicare beneficiaries. Among the potential results are long observation stays after some procedures and imposition of OPPS copayments, which could differ significantly from a patient's inpatient cost-sharing responsibilities. 
                    </P>
                    <P>We believe that it is important for hospitals to educate physicians on Medicare services provided under the OPPS to avoid inadvertently providing services in an outpatient setting that are more appropriate to an inpatient setting. </P>
                    <P>
                        <E T="03">Comment:</E>
                         A few commenters recommended that CMS consider developing an appeals process to address circumstances in which payment for a procedure provided on an outpatient basis is denied because it is on the inpatient list. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We would like to emphasize that procedures on the inpatient list that are performed on a patient whose status is that of an outpatient are not payable under Medicare. CPT codes assigned a status indicator of “C,” such as those listed in Addendum E, are not payable under the OPPS, except under conditions described in the November 1, 2002 final rule (67 FR 66799). 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         A few commenters requested that CMS clarify the criteria and the sources of data used to determine whether a procedure is appropriate for removal from the list. Other commenters expressed concern with the 60-percent threshold criterion used to evaluate codes for removal from the inpatient list. One commenter recommended that CMS revise its criteria because major teaching hospital outpatient departments often are the first places to perform services that had previously been performed only in the inpatient setting. This commenter argued that there would most likely be a time gap between when these services could be performed safely in teaching hospital outpatient departments and their dissemination to most hospitals' outpatient departments. The commenter recommended that the determining factor regarding whether a procedure should be removed from the inpatient list should be whether the procedure can be performed safely in an outpatient department and not the number of outpatient departments in which the procedure is performed. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We recognize that teaching hospitals may have more technologically advanced equipment, more experienced staff, and greater resources than nonteaching hospitals. These characteristics may lead teaching hospitals to be the first places to perform on an outpatient basis some procedures on the inpatient list. On the other hand, community, nonteaching hospitals have pioneered the movement of some procedures to the outpatient setting, in part because of their responsiveness to identified local needs or their development of specific pathways for care. We cannot expect that all hospitals will have the necessary staff experience, resources, equipment, and interest to move many procedures to the outpatient setting. For these reasons, we do not believe that procedures that have been demonstrated to be performed safely and effectively on an outpatient basis in any single hospital or small group of hospitals alone are routinely appropriate for removal from the inpatient list. 
                    </P>
                    <P>In addition, we want to clarify that the 60-percent threshold discussed in our proposed rule is not an established criterion that we use to determine whether a procedure is appropriate for removal from the inpatient list. The 60-percent threshold was used as an operational tool to identify from the entire inpatient list those procedures that we believe are currently already being performed in the outpatient setting a majority of the time based on our CY 2003 BESS data, so that these services could then undergo clinical review against the criteria for removal from the inpatient list. The BESS database aggregates all physician billing throughout the year for each service provided to Medicare beneficiaries and billed under the Medicare Physician Fee Schedule. Summary data include information regarding the site of service (hospital inpatient, hospital outpatient, physician's office, among others) and specialty of the physician performing the service. We emphasize that our review of the codes recommended by the commenters for removal from the list was not based on this threshold. Rather, our determination was based on the set of criteria described in the November 7, 2003 final rule (68 FR 63466).</P>
                    <P>We encourage hospitals and physicians to submit recommendations regarding procedures they believe meet our criteria for removal from the inpatient list at any time. We ask that evidence be submitted to demonstrate that the procedure is being performed on an outpatient basis in a safe and appropriate manner in a variety of different types of hospitals. </P>
                    <P>
                        <E T="03">Comment:</E>
                         Numerous commenters supported the proposed removal of the 22 CPT codes from the inpatient list. In addition, a few commenters expressed support for retaining the list of inpatient procedures. One commenter stated that eliminating the list could create an increase in inappropriate observation stays by assigning observation status to patients whose status should have been inpatient. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We appreciate the commenters' support. 
                    </P>
                    <P>In this final rule, we are finalizing our proposed retention of the inpatient list for the OPPS. We also are finalizing our proposal to remove 22 procedures from the CY 2004 list. Table 39 below lists the procedure codes that are being removed from the inpatient list and their APC assignments, effective January 1, 2005. </P>
                    <BILCOD>BILLING CODE 4120-01-P</BILCOD>
                    <GPH SPAN="3" DEEP="406">
                        <PRTPAGE P="65837"/>
                        <GID>ER15NO04.060</GID>
                    </GPH>
                    <BILCOD>BILLING CODE 4120-01-C</BILCOD>
                    <HD SOURCE="HD2">F. Hospital Coding for Evaluation and Management Services </HD>
                    <HD SOURCE="HD3">1. Background </HD>
                    <P>Currently, for claims processing purposes, we direct hospitals to use the CPT codes used by physicians to report clinic and emergency department visits on claims paid under the OPPS. However, as discussed in the proposed rule, we have received comments suggesting that the CPT codes are insufficient to describe the range and mix of services provided to patients in the clinic and emergency department setting because they are defined to reflect only the activities of physicians (for example, ongoing nursing care, and patient preparation for diagnostic tests). For both clinic and emergency department visits, there are currently five levels of care. To facilitate proper coding, we require each hospital to create an internal set of guidelines to determine what level of visit to report for each patient (April 7, 2000, final rule with comment period (65 FR 18434)). </P>
                    <P>We have continued our efforts to address the situation of proper coding of clinic and emergency department visits to ensure proper Medicare payments to hospitals. Commenters who responded to the August 24, 2001 OPPS proposed rule (66 FR 44672) recommended that we retain the existing evaluation and management coding system until facility-specific evaluation and management codes for emergency department and clinic visits, along with national coding guidelines, were established. Commenters also recommended that we convene a panel of experts to develop codes and guidelines that are simple to understand and to implement, and that are compliant with the HIPAA requirements. We agreed with these commenters, and in our November 1, 2002 OPPS final rule (67 FR 66792), we stated that we believed the most appropriate forum for development of new code definitions and guidelines would be an independent expert panel that could provide information and data to us. We believed that, in light of the expertise of organizations such as the AHA and the AHIMA, these organizations were particularly well equipped to do so and to provide ongoing education to providers. </P>
                    <P>
                        The AHA and the AHIMA, on their own initiative, convened an independent expert panel comprised of members of the AHA and AHIMA, as well as representatives of the American College of Emergency Physicians, the Emergency Nurses Association, and the American Organization of Nurse Executives, to develop code descriptions and guidelines for hospital emergency department and clinic visits and to provide us with the information and data. In June 2003, we received the panel's input concerning a set of national coding guidelines for emergency and clinic visits.
                        <PRTPAGE P="65838"/>
                    </P>
                    <P>As we noted in the proposed rule, we are still considering the panel's set of coding guidelines. Although we did not propose the panel's set of coding guidelines, we received several comments on the Panel's coding guidelines and are continuing to review these public comments. In the November 7, 2003 OPPS final rule with comment period (68 FR 63463), we also indicated that we would implement new evaluation and management codes only when we are also ready to implement guidelines for their use. As we have not yet proposed new evaluation and management codes, we again note that we will allow ample opportunity for public comment, systems changes, and provider education before implementing such new coding requirements. </P>
                    <HD SOURCE="HD3">2. Proposal for Evaluation and Management Guidelines </HD>
                    <P>In the November 7, 2003 OPPS final rule with comment period (68 FR 63463), we discussed our primary concerns and direction for developing the proposed coding guidelines for emergency department and clinic visits and indicated our plans to make available for public comment the proposed coding guidelines that we are considering through the CMS OPPS Web site as soon as we have completed them. </P>
                    <P>We received a number of comments on our proposal. </P>
                    <P>
                        <E T="03">Comment:</E>
                         Many commenters supported the development of evaluation and management codes and guidelines in the hospital outpatient setting and urged CMS to move forward as quickly as possible with reviewing the guidelines presented by the AHA and AHIMA Evaluation and Management Panel. Several commenters expressed concern that the current lack of uniformity impairs CMS' ability to gather consistent, meaningful data on services provided in the emergency department and hospital clinics. Commenters reminded CMS of its commitment to make the evaluation and management codes and guidelines available for public comment and to provide at least 6 to 12 months notice prior to implementation of the new evaluation and management codes and guidelines. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         As stated in the August 16, 2004 OPPS proposed rule, we intend to make available for public comment the proposed coding guidelines that we are considering through the CMS OPPS Web site as soon as we have completed them. As stated in the August 16, 2004 OPPS proposed rule, we will notify the public through our “listserve” when the proposed guidelines will become available. To subscribe to this listserve, individuals should access the following Web site: 
                        <E T="03">http://www.cms.hhs.gov/medlearn/listserv.asp</E>
                         and follow the directions to the OPPS listserve. When we post the proposed guidelines on the Web site, we will provide ample opportunity for the public to comment. 
                    </P>
                    <P>In addition, we will provide ample time to train clinicians and coders on the use of new codes and guidelines and for hospitals to modify their systems. We anticipate providing at least 6 to 12 months notice prior to implementation of the new evaluation and management codes and guidelines. We will continue working to develop and test the new codes even though we have not yet made plans for their implementation. </P>
                    <HD SOURCE="HD2">G. Brachytherapy Payment Issues Related to Pub. L. 108-173 </HD>
                    <HD SOURCE="HD3">1. Payment for Brachytherapy Sources (Section 621(b) of Pub. L. 108-173) </HD>
                    <P>Sections 621(b)(1) and (b)(2) of Pub. L. 108-173 amended the Act by adding section 1833(t)(16)(C) and section 1833(t)(2)(H), respectively, to establish separate payment for devices of brachytherapy consisting of a seed or seeds (or radioactive source) based on a hospital's charges for the service, adjusted to cost. Charges for the brachytherapy devices may not be used in determining any outlier payments under the OPPS. In addition, consistent with our practice under the OPPS to exclude items paid at cost from budget neutrality consideration, these items must be excluded from budget neutrality as well. The period of payment under this provision is for brachytherapy sources furnished from January 1, 2004 through December 31, 2006. </P>
                    <P>In the OPPS interim final rule with comment period published on January 6, 2004 (69 FR 827), we implemented sections 621(b)(1) and 621(b)(2)(C) of Pub. L. 108-173. We stated that we will pay for the brachytherapy sources listed in Table 4 of the interim final rule with comment period (69 FR 828) on a cost basis, as required by the statute. The status indicator for brachytherapy sources was changed to “H.” The definition of status indicator “H” was for pass-through payment only for devices, but the brachytherapy sources affected by new sections 1833(t)(16)(C) and 1833(t)(2)(H) of the Act are not pass-through device categories. Therefore, we also changed, for CY 2004, the definition of payment status indicator “H” to include nonpass-through brachytherapy sources paid on a cost basis. This use of status indicator “H” was a pragmatic decision that allowed us to pay for brachytherapy sources in accordance with new section 1833(t)(16)(C) of the Act, effective January 1, 2004, without having to modify our claims processing systems. We stated in the January 6, 2004 interim final rule with comment period that we would revisit the use and definition of status indicator “H” for this purpose in the OPPS update for CY 2005. Therefore, in the August 16, 2004 proposed rule, we solicited further comments on this policy. </P>
                    <P>We received several public comments on our August 16, 2004 proposal and on the January 6, 2004 interim final rule with comment period. </P>
                    <P>
                        <E T="03">Comment:</E>
                         One commenter, a hospital association, recommended that CMS establish a new status indicator for brachytherapy sources paid on a cost basis other than the status indicator “H”, which is also used for device categories paid on a transitional pass-through basis. The commenter noted that, because brachytherapy sources are subject to coinsurance and devices paid on a pass-through basis are not, a separate status indicator is needed for consistency in the classification of status indicators. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         The commenter is correct that beneficiaries are not subject to copayment for the cost of device categories with pass-through payment, while beneficiaries are subject to copayment for other separately paid brachytherapy sources. However, our systems' logic incorporates this difference in copayment for pass-through device categories versus nonpass-through brachytherapy sources, even though the status indicator for each is “H”. Therefore, we are not establishing a separate status indicator at this time. However, we will consider making a change if the need arises. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         A number of commenters on the January 6, 2004 interim final rule with comment period urged us to continue to use, for CY 2005, the C-codes and descriptors that we published in that interim final rule with comment period (69 FR 828) for both prostate and nonprostate brachytherapy that we implemented for CY 2004. Several commenters also suggested that we add the phrase “per source” to each of the brachytherapy source descriptors to reinforce that each source equals one unit of payment. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We agree and are retaining the current brachytherapy source C-codes and descriptors with which hospitals are familiar. We have been using these codes and descriptors since we unpackaged brachytherapy sources when the pass-through payment for 
                        <PRTPAGE P="65839"/>
                        these sources ended on December 31, 2002, in addition to other C-codes that we established either for pass-through payment (for example, C2632) or nonpass-through payment (for example, C2633). We also note that, in the August 16, 2004 proposed rule, we proposed adding “per source” to each of the applicable brachytherapy descriptors, similar to the APC Panel's recommendation (and the commenter's suggestion) to do so for two new high-activity source categories, discussed below. We are adopting this clarification as final policy in this final rule with comment period and adding “per source” to the brachytherapy source descriptors that are paid on a per unit basis for each source. 
                    </P>
                    <HD SOURCE="HD3">2. HCPCS Codes and APC Assignments for Brachytherapy Sources </HD>
                    <P>As we indicated in the January 6, 2004 interim final rule with comment period, we began payment for the brachytherapy source in HCPCS code C1717 (Brachytx source, HCR lr-192) based on the hospital's charge adjusted to cost beginning January 1, 2004. Prior to enactment of Pub. L. 108-173, these sources were paid as packaged services in APC 0313. As a result of the requirement under Pub. L. 108-173 to pay for C1717 separately, we adjusted the payment rate for APC 0313, Brachytherapy, to reflect the unpackaging of the brachytherapy source. We received no public comments on this methodology, and we are finalizing the payment methodology in this final rule with comment period. </P>
                    <P>Section 1833(t)(2)(H) of the Act, as added by section 621(b)(2)(C) of Pub. L. 108-173, mandated the creation of separate groups of covered OPD services that classify brachytherapy devices separately from other services or groups of services. The additional groups must be created in a manner that reflects the number, isotope, and radioactive intensity of the devices of brachytherapy furnished, including separate groups for Palladium-103 and Iodine-125 devices. </P>
                    <P>We invited the public to submit recommendations for new codes to describe brachytherapy sources in a manner that reflects the number, radioisotope, and radioactive intensity of the sources. We requested commenting parties to provide a detailed rationale to support recommended new codes. We stated that we would propose appropriate changes in codes for brachytherapy sources in the CY 2005 OPPS update. </P>
                    <P>At its meetings of February 18 through 20, 2004, the APC Panel heard from parties that recommended the addition of two new brachytherapy codes and HCPCS codes for high activity Iodine-125 and high activity Paladium-103. The APC Panel, in turn, recommended that CMS establish new HCPCS codes and new APCs, on a per source basis, for these two brachytherapy sources. </P>
                    <P>We considered this recommendation and agreed with the APC Panel. Therefore, in the August 16, 2004 proposed rule, we proposed to establish the following two new brachytherapy source codes for CY 2005: </P>
                    <P>• Cxxx1 Brachytherapy source, high activity, Iodine-125, per source. </P>
                    <P>• Cxxx2 Brachytherapy source, high activity, Paladium-103, per source. </P>
                    <P>In addition, we believe the APC Panel's recommendation to establish new HCPCS codes that would distinguish high activity Iodine-125 from high activity Paladium-103 on a per source basis should be implemented for other brachytherapy code descriptors, as well. Therefore, as stated previously, we proposed to include “per source” in the HCPCS code descriptors for all those brachytherapy source descriptors for which units of payment are not already delineated. </P>
                    <P>Further, a new linear source Paladium-103 came to our attention in CY 2003 by means of an application for a new device category for pass-through payment. While we declined to create a new category for pass-through payment, we believe that this source falls under the provisions of Pub. L. 108-173 for separate cost-based payment as a brachytherapy source. Accordingly, we proposed to add, for separate payment, the following code of linear source Paladium-103: Cxxx3 Brachytherapy linear source, Paladium-103, per 1 mm. </P>
                    <P>We received a number of public comments on our August 16, 2004 proposed rule and on the January 6, 2004 interim final rule with comment period, which deal with these issues. </P>
                    <P>
                        <E T="03">Comment:</E>
                         In response to the January 6, 2004 interim final rule with comment period, several commenters recommended adding two new brachytherapy source codes and descriptors, to reflect the ranges in radioactive intensities that are frequently required in clinical practice for Iodine-125 and Palladium-103. The recommendations are for high activity payment codes for these two isotopes. The commenters recommended the following specific descriptors: 
                    </P>
                    <P>Cxxx1 Brachytherapy source, Low Dose Rate, High Activity Iodine-125, greater than 1.01 mCi (NIST), per source. </P>
                    <P>Cxxx2 Brachytherapy source, Low Dose Rate, High Activity Palladium-103, greater than 2.2 mCi (NIST), per source. </P>
                    <P>The commenters suggested that CMS include in the two proposed APCs and HCPCS codes an appropriate measurement of minimum radioactivity in mCi, based on calibrations establish by the National Institute of Standards and Technology (NIST). </P>
                    <P>In response to the August 16, 2004 OPPS proposed rule, one commenter agreed with our proposal to create two new brachytherapy codes for high activity Iodine-125 and Palladium-103 sources, but recommended that we change the proposed descriptors. The commenter again recommended that we add the mCi (NIST) descriptions for the high activity ranges to these new high activity Iodine-125 and Palladium-103 sources we proposed. </P>
                    <P>
                        <E T="03">Response:</E>
                         During its meetings of February 18 through 20, 2004, the APC Panel recommended that CMS establish two new HCPCS codes and APCs for High Activity Iodine-125 and High Activity Palladium-103 on a per source basis, but did not recommend adoption of other specific language regarding mCi in the descriptions above. As previously mentioned, in the August 16, 2004 proposed rule, we noted the APC Panel's recommendation to establish two new HCPCS codes and APCs for these high activity sources, as noted above. 
                    </P>
                    <P>We agree that, with the establishment of these new codes, which are the first to specify high activity, we should provide an appropriate quantitative measurement of minimum source activity to specifically differentiate the high activity sources from other sources with differences in radioactive intensity for the two isotopes. </P>
                    <P>Accordingly, we are accepting the commenter's suggestion to utilize the calibrations established by the NIST to specify the high activity ranges. </P>
                    <P>The final code descriptors are: </P>
                    <P>C2634 Brachytherapy source, High Activity Iodine-125, greater than 1.01 mCi (NIST), per source. </P>
                    <P>C2635 Brachytherapy source, High Activity Palladium-103, greater than 2.2 mCi (NIST), per source. </P>
                    <P>
                        <E T="03">Comment:</E>
                         One commenter objected to our proposal to create the two high activity brachytherapy codes based on radioactive intensity and claimed that there is uncertainty regarding availability of radioactive substance and that providers will need to distinguish between low and high activity without a definition of high activity. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We have now defined high activity level in our code descriptors for C2634 and C2635, using calibrations 
                        <PRTPAGE P="65840"/>
                        established by the NIST. We will implement these codes with the definitions described herein. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         One commenter on the January 6, 2004 interim final rule with comment period suggested that we include “low dose rate” into the descriptors for each of the existing APCS for which the low dose rate may be applicable, to clarify that those descriptors refer to “low dose rate” brachytherapy. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We do not believe that changes in the descriptors of all APCs and HCPCS codes are warranted without evidence that there are alternative low and high dose rate sources requiring a high or low dose rate indicator in the C-code descriptor to distinguish among the sources. In this manner, if there are both low and high dose rate forms, they may be paid on a cost basis for brachytherapy sources described by the same C-code until a new code is indicated for a high dose rate source. If we receive evidence that high dose rate sources are used in clinical practice, we will determine at that time whether to establish new codes and APCs and whether the existing codes need to be modified in some way. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         One commenter on the January 6, 2004 interim final rule with comment period recommended that we establish a new source category for Brachytherapy linear source, Palladium-103, per 10 millimeter length. The commenter claimed that this linear source is provided in 10-millimeter lengths from 10 to 60 millimeters, and not on a “per seed” basis. Although the commenter indicated there were dosimetry studies comparing the Palladium-103 linear source to the per seed form, the commenter recommended against using the same Palladium-103 code for both sources, claiming it would cause confusion in billing and cost reporting. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We agree that a separate code for Palladium-103 linear source should be established for payment under Pub. L. 108-173. In our proposed rule, we indicated that we were aware of a new linear source Palladium-103, which came to our attention by means of an application for a new device category for pass-through payment. We stated that, while we decided not to create a new category for pass-through payment, we believed that the new linear source falls under the provisions of Pub. L. 108-173 for separate cost-based payment as a brachytherapy source. Therefore, we proposed to add the following code for linear source Palladium-103: Cxxx3 Brachytherapy linear source, Palladium-103, per 1 mm. We believe that the 1 millimeter increments of payment affords greater flexibility for describing other linear source Palladium-103 sources that may enter the market and be sold in other than 10 mm increments. 
                    </P>
                    <P>We received several public comments in support of our proposed addition and descriptor of Brachytherapy linear source, Palladium-103, per 1 mm. Therefore, in this final rule with comment period, we are establishing the new code and descriptor for this new brachytherapy source, to be paid at cost: </P>
                    <P>C2636 Brachytherapy linear source, Palladium-103, per 1 mm. </P>
                    <P>
                        <E T="03">Comment:</E>
                         One commenter on the January 6, 2004 interim final rule with comment period stated that CMS should pay for codes C1715 (Brachytherapy needle) and C1728 (Catheter, brachytherapy seed administration) on a cost basis as well as brachytherapy sources, asserting that these are brachytherapy devices. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         Brachytherapy needles and catheters for administration of sources are not brachytherapy devices under section 621(b) of Pub. L. 108-173. Section 1833(t)(16)(C) of the Act specifies that, to qualify for payment at charges reduced to cost, a device of brachytherapy must consist of “a seed or seeds (or radioactive sources).” The special payment provision does not include needles or catheters in the definition of devices of brachytherapy. Therefore, in this final rule with comment period, we are not establishing new payment categories for these devices that were formerly paid as transitional pass-through devices. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         One commenter, a developer of a brachytherapy radiation system, recommended that CMS create a C-code and APC for miscellaneous brachytherapy sources for payment of new brachytherapy sources at cost in accordance with Pub. L. 108-173. This commenter contended that such a miscellaneous source code would allow CMS to pay hospitals for new brachytherapy sources in the interval between FDA approval of the source and the development of specific coding for new sources. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         Section 621(b) of Pub. L. 108-173 requires us to establish new codes and separate payment for specific seed or seeds or other radioactive sources of brachytherapy. We do not believe that the statute contemplates a separate payment for an over-inclusive (“catch-all”) category such as a miscellaneous brachytherapy source code. Such a category would inappropriately include all new brachytherapy sources until separate payment is established. Moreover, we note that hospitals and brachytherapy source manufacturers might be able to use a miscellaneous category to bill Medicare for brachytherapy systems that do not meet our standard of a separately payable radioactive source of brachytherapy. In addition, new brachytherapy sources may be added more frequently than annually, when we are able to add new codes and payment instructions to our electronic claims processing systems. Therefore, in this final rule with comment period, we are not creating a new code of miscellaneous brachytherapy sources. 
                    </P>
                    <P>Table 40 provides a complete listing of the HCPCS codes, long descriptors, APC assignments and status indicators that we will use for brachytherapy sources paid under the OPPS in CY 2005. </P>
                    <GPOTABLE COLS="5" OPTS="L2,i1" CDEF="xs50,r60,6,r50,xs50">
                        <TTITLE>Table 40.—Separately Payable Brachytherapy Sources </TTITLE>
                        <BOXHD>
                            <CHED H="1">HCPCS </CHED>
                            <CHED H="1">Long descriptor </CHED>
                            <CHED H="1">APC </CHED>
                            <CHED H="1">APC title </CHED>
                            <CHED H="1">New status indicator </CHED>
                        </BOXHD>
                        <ROW>
                            <ENT I="01">C1716 </ENT>
                            <ENT>Brachytherapy source, Gold 198, per source </ENT>
                            <ENT>1716 </ENT>
                            <ENT>Brachytx source, Gold 198 </ENT>
                            <ENT>H </ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">C1717 </ENT>
                            <ENT>Brachytherapy source, High Dose Rate Iridium 192, per source </ENT>
                            <ENT>1717 </ENT>
                            <ENT>Brachytx source, HDR Ir-192 </ENT>
                            <ENT>H </ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">C1718 </ENT>
                            <ENT>Brachytherapy source, Iodine 125, per source </ENT>
                            <ENT>1718 </ENT>
                            <ENT>Brachytx source, Iodine 125 </ENT>
                            <ENT>H </ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">C1719 </ENT>
                            <ENT>Brachytherapy source, Non-High Dose Rate Iridium 192, per source </ENT>
                            <ENT>1719 </ENT>
                            <ENT>Brachytx source, Non-HDR Ir-192 </ENT>
                            <ENT>H </ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">C1720 </ENT>
                            <ENT>Brachytherapy source, Palladium 103, per source </ENT>
                            <ENT>1720 </ENT>
                            <ENT>Brachytx source, Palladium 103 </ENT>
                            <ENT>H </ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">C2616 </ENT>
                            <ENT>Brachytherapy source, Yttrium-90, per source </ENT>
                            <ENT>2616 </ENT>
                            <ENT>Brachytx source, Yttrium-90 </ENT>
                            <ENT>H </ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">C2632* </ENT>
                            <ENT>Brachytherapy solution, Iodine125, per mCi </ENT>
                            <ENT>2632 </ENT>
                            <ENT>Brachytx sol, I-125, per mCi </ENT>
                            <ENT>H </ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">C2633 </ENT>
                            <ENT>Brachytherapy source, Cesium-131, per source </ENT>
                            <ENT>2633 </ENT>
                            <ENT>Brachytx source, Cesium-131 </ENT>
                            <ENT>H </ENT>
                        </ROW>
                        <ROW>
                            <PRTPAGE P="65841"/>
                            <ENT I="01">C2634** </ENT>
                            <ENT>Brachytherapy source, High Activity, Iodine-125, greater than 1.01 mCi (NIST), per source </ENT>
                            <ENT>2634 </ENT>
                            <ENT>Brachytx source, HA, I-125 </ENT>
                            <ENT>H </ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">C2635** </ENT>
                            <ENT>Brachytherapy source, High Activity, Palladium-103, greater than 2.2 mCi (NIST), per source </ENT>
                            <ENT>2635 </ENT>
                            <ENT>Brachytx source, HA, P-103 </ENT>
                            <ENT>H </ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">C2636** </ENT>
                            <ENT>Brachytherapy linear source, Palladium-103, per 1MM </ENT>
                            <ENT>2636 </ENT>
                            <ENT>Brachytx linear source, P-103 </ENT>
                            <ENT>H </ENT>
                        </ROW>
                        <TNOTE>* Currently paid as a pass-through device category, scheduled to expire from pass-through payment as of January 1, 2005. </TNOTE>
                        <TNOTE>** Newly created brachytherapy payment codes beginning January 1, 2005. </TNOTE>
                    </GPOTABLE>
                    <P>
                        <E T="03">Comment:</E>
                         A few commenters requested that CMS discuss in the OPPS final rule the process for adding other new brachytherapy devices for qualification under the separate cost-based payment methodology under Pub. L. 108-173. The commenters urged CMS to add new brachytherapy devices for separate cost-based payment on a quarterly basis, rather than annually. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         In the OPPS interim final rule published on January 6, 2004 that implemented the brachytherapy provisions of Pub. L. 108-173 for CY 2004, we invited the public to submit recommendations for new codes to describe brachytherapy sources in a manner reflecting the number, radioisotope, and radioactivity intensity of the sources (69 FR 828). We requested that commenters provide a detailed rationale to support recommended new codes. The public may send such recommendations to the Division of Outpatient Care, Mailstop C4-05-17, Centers for Medicare and Medicaid Services, 7500 Security Blvd., 21244. We will endeavor to add new brachytherapy source codes and descriptors to our systems for payment on a quarterly rather than an annual basis. 
                    </P>
                    <HD SOURCE="HD2">H. Payment for APC 0375, Ancillary Outpatient Services When Patient Expires </HD>
                    <P>In CY 2003, we implemented a new modifier -CA, Procedure payable only in the inpatient setting when performed emergently on an outpatient who dies before admission. The purpose of this modifier is to allow payment, under certain conditions, for outpatient services on a claim that have the same date of service as a HCPCS code with status indicator “C” that is billed with modifier -CA. When a procedure with status indicator “C” (inpatient services not payable under the OPPS) was billed with modifier -CA, we made payment of a fixed amount, under New Technology APC 0977. </P>
                    <P>In the November 7, 2003 final rule with comment period, we implemented APC 0375 to pay for services furnished in CY 2004 on the same date billed for a procedure code with modifier -CA (68 FR 63467). We were concerned that our policy of paying a fixed amount under a new technology APC for otherwise payable outpatient services furnished on the same date of service that a procedure with status indicator “C” is performed emergently on an outpatient would not result in appropriate payment for these services. That is, continuing to make payment under a new technology APC would not allow us to establish a relative payment weight for the services, subject to recalibration based on actual hospital costs. </P>
                    <P>We implemented a payment rate of $1,150 for APC 0375, which is the payment amount for the restructured New Technology—Level XIII, APC 1513, that replaced APC 0977, in CY 2004. We also stated that for the CY 2005 update of the OPPS, we would calculate a median cost and relative payment weight for APC 0375 using charge data from CY 2003 claims for line items with a HCPC code and status indicator “V,” “S,” “T,” “X,” “N,” “K,” “G,” and “H,” in addition to charges for revenue codes without a HCPCS code, that have the same date of service reported for a procedure billed with modifier -CA. We would then determine whether to set payment for APC 0375 based on our claims data or continue a fixed payment rate for these special services. </P>
                    <P>In accordance with this methodology, for CY 2005 we reviewed the services on the 18 claims that reported modifier -CA in CY 2003. We calculated a median cost for the aggregated payable services on the 18 claims reporting modifier -CA in the amount of $2,804.18. The mix of outpatient services that were reported appeared reasonable for a patient with an emergent condition requiring immediate medical intervention, and revealed a wide range of costs, which would also be expected. As we indicated in the August 16, 2004 proposed rule, we proposed to set the payment rate for APC 0375 in accordance with the same methodology we have followed to set payment rates for the other procedural APCS in CY 2005, based on the relative payment weight calculated for APC 0375. </P>
                    <P>
                        <E T="03">Comment:</E>
                         A few commenters were concerned whether the proposed rate of $2,757.68 for CY 2005 appropriately reflects the costs incurred by hospitals in cases where the -CA modifier is reported and requested that CMS review the rate and adjust it accordingly for CY 2006. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We appreciate the commenters' concerns. Services with a -CA modifier appended are paid under APC 0375. As we explained in our August 16, 2004 proposed rule, the proposed rate of $2,757.68 for CY 2005 was calculated using actual claims billed in CY 2003. The final payment rate for CY 2005, using the updated data file, is calculated as $3,214.22. As we stated previously, review of the claims data revealed a reasonable mix of outpatient services that a hospital could be expected to furnish during an encounter with a patient with an emergent condition requiring immediate medical intervention, as well as cases with a wide range of costs. We will continue to monitor the appropriateness of this payment rate as we develop future rules. 
                    </P>
                    <HD SOURCE="HD1">VIII. Conversion Factor Update for CY 2005 </HD>
                    <P>Section 1833(t)(3)(C)(ii) of the Act requires us to update the conversion factor used to determine payment rates under the OPPS on an annual basis. Section 1833(t)(3)(C)(iv) of the Act provides that, for CY 2005, the update is equal to the hospital inpatient market basket percentage increase applicable to hospital discharges under section 1886(b)(3)(B)(iii) of the Act. </P>
                    <P>
                        The forecast of the hospital market basket increase for FY 2005 published in the IPPS final rule on August 11, 2004 is 3.3 percent (69 FR 49272), the same as the forecast published in the IPPS proposed rule on May 18, 2004 (69 FR 28374) and referenced in the CY 2005 OPPS August 16, 2004 proposed rule. To set the OPPS conversion factor 
                        <PRTPAGE P="65842"/>
                        for CY 2005, we increased the CY 2004 conversion factor of $54.561, as specified in the November 7, 2003 final rule with comment period (68 FR 63459), by 3.3 percent. 
                    </P>
                    <P>In accordance with section 1833(t)(9)(B) of the Act, we further adjusted the conversion factor for CY 2004 to ensure that the revisions we are making to our updates by means of the wage index are made on a budget-neutral basis. For the OPPS proposed rule, we calculated a budget neutrality factor of 1.001 for wage index changes by comparing total payments from our simulation model using the FY 2005 IPPS wage index values to those payments using the FY 2004 IPPS wage index values. For this final rule with comment period, we calculated a budget neutrality factor of 0.9986 for wage index changes by comparing total payments from our simulation model using the revised final FY 2005 IPPS wage index values to those payments using the current (FY 2004) IPPS wage index values. In addition, for CY 2005, allowed pass-through payments have decreased to 0.10 percent of total OPPS payments, down from 1.3 percent in CY 2004. The conversion factor is also adjusted by the difference in estimated pass-through payments of 1.20 percent. </P>
                    <P>The market basket increase update factor of 3.3 percent for CY 2005, the required wage index budget neutrality adjustment of approximately 0.9986, and the 1.20 percent adjustment to the pass-through estimate result in a conversion factor for CY 2005 of $56.983. </P>
                    <P>We did not receive any public comments on the proposed conversion factor update for CY 2005. </P>
                    <HD SOURCE="HD1">IX. Wage Index Changes for CY 2005 </HD>
                    <P>Section 1833(t)(2)(D) of the Act requires the Secretary to determine a wage adjustment factor to adjust, for geographic wage differences, the portion of the OPPS payment rate and the copayment standardized amount attributable to labor and labor-related cost. This adjustment must be made in a budget neutral manner. As we have done in prior years, we proposed to adopt the IPPS wage indices and extend these wage indices to TEFRA hospitals that participate in the OPPS but not the IPPS. </P>
                    <P>As discussed in the proposed rule and finalized in section III.B. of this preamble, we standardize 60 percent of estimated costs (labor-related costs) for geographic area wage variation using the IPPS wage indices that are calculated prior to adjustments for reclassification to remove the effects of differences in area wage levels in determining the OPPS payment rate and the copayment standardized amount. </P>
                    <P>
                        As published in the original OPPS April 7, 2000 final rule (65 FR 18545), OPPS has consistently adopted the final IPPS wage indices as the wage indices for adjusting the OPPS standard payment amounts for labor market differences. As initially explained in the September 8, 1998 OPPS proposed rule, we believed and continue to believe that using the IPPS wage index as a source of an adjustment factor for OPPS is reasonable and logical, given the inseparable, subordinate status of the hospital outpatient within the hospital overall. We also continue to believe that individual hospitals do not distinguish in hiring practices between their inpatient and outpatient departments and that hospitals face one labor market for both inpatient and outpatient services. Further, because hospital staff frequently provide services in both the inpatient and outpatient departments, labor costs associated with the hospital outpatient services are generally reflected in the hospital wage and salary data that are the basis of the IPPS wage index. In accordance with section 1886(d)(3)(E) of the Act, the IPPS wage index is updated annually. In the August 16, 2004 proposed rule, we proposed to use the corrected proposed FY 2005 hospital IPPS wage index for urban areas published in the 
                        <E T="04">Federal Register</E>
                         on June 25, 2004 (69 FR 35919) and the proposed FY 2005 hospital IPPS wage index for rural areas published in the 
                        <E T="04">Federal Register</E>
                         on May 18, 2004 (69 FR 28580) to determine the wage adjustments for the OPPS payment rate and the copayment standardized amount for CY 2005. 
                    </P>
                    <P>
                        We customarily publish the wage index tables in the final rule for the OPPS update. We are not including the tables in this final rule with comment period as CMS is in the process of reviewing the wage indices for IPPS. This review may impact the wage index values. We emphasize that our methodology for calculating the wage index for the OPPS has not changed. As noted above, our policy has consistently been to adopt the IPPS wage index for purposes of payment under the OPPS. We will publish finalized tables in a later 
                        <E T="04">Federal Register</E>
                         document. 
                    </P>
                    <P>We note that the FY 2005 IPPS wage indices reflect a number of changes as a result of the new OMB standards for defining geographic statistical areas, the implementation of an occupational mix adjustment as part of the wage index, and new wage adjustments provided for under Pub. L. 108-173. The following is a brief summary of the changes in the FY 2005 IPPS wage indices and any adjustments that we are applying to the OPPS for CY 2005. (We refer the reader to the August 11, 2004 IPPS final rule (69 FR 49026-49070) and the October 7, 2004 IPPS correction notice (69 FR 60242) for a fuller discussion of the changes to the wage indices.) </P>
                    <P>
                        A. The use of the new Core Based Statistical Areas (CBSAs) issued by the Office of Management and Budget (OMB) as revised standards for designating geographical statistical areas based on the 2000 Census data, to define labor market areas for hospitals for purposes of the IPPS wage index. The OMB revised standards were published in the 
                        <E T="04">Federal Register</E>
                         on December 27, 2000 (65 FR 82235), and OMB announced the new CBSAs on June 6, 2003, through an OMB bulletin. In the FY 2005 hospital IPPS final rule, CMS adopted the new OMB definitions for wage index purposes. We treated, as urban, hospitals located in MSAs and treated, as rural, hospitals that are located in Micropolitan Areas or Outside CBSAs. To help alleviate the decreased payments for previously urban hospitals that became rural under the new MSA definitions, we allowed these hospitals to maintain their assignment to the MSA where they previously had been located for the 3-year period from FY 2005 through FY 2007. To be consistent, we are applying the same criterion to TEFRA hospitals paid under the OPPS but not under the IPPS and to maintain that MSA designation for determining a wage index for the next 3 years. This policy will impact four TEFRA providers for purposes of OPPS payment. In addition to this “hold harmless” provision, the IPPS final rule implemented a one-year transition for hospitals that experienced a decrease in their FY 2005 wage index compared to their FY 2004 wage index due solely to the changes in labor market definitions. These hospitals received 50 percent of their wage indices based on the new MSA configurations and 50 percent based on the FY 2004 labor market areas. For purposes of the OPPS, we also are applying this 50-percent transition blend to TEFRA hospitals. 
                    </P>
                    <P>
                        B. The incorporation of a blend of an occupational mix adjusted wage index into the unadjusted wage index to reflect the effect of hospitals' employment choices of occupational categories to provide specific patient care. Specifically, OPPS will adopt the 10-percent blend of an average hourly wage, adjusted for occupational mix, and 90 percent of an average hourly wage, unadjusted for occupational mix, as finalized in the IPPS final rule. As discussed in the IPPS final rule, this 
                        <PRTPAGE P="65843"/>
                        blend is appropriate because this was the first time that the occupational mix survey was administered and optimum data could not be collected in the limited timeframe available. In addition, CMS had no baseline data to use in developing a desk review program that could ensure the accuracy of the occupational mix survey data. Moving slowly to implement the occupational mix adjustment is also appropriate because of changing trends in the hiring nurses due changes in State law governing staffing levels and physician shortages. Finally, the blend minimizes the impact of the occupational mix adjustment on hospitals' wage index values without nullifying the value and intent of the adjustment. 
                    </P>
                    <P>C. The reclassifications of hospitals to geographic areas for purposes of the wage index. For purposes of the OPPS wage index, we are adopting all of the IPPS reclassifications in effect for FY 2005, including reclassifications that the Medicare Geographic Classification Review Board (MGCRB) approved under the one-time appeal process for hospitals under section 508 of Pub. L. 108-173. </P>
                    <P>D. The implementation of an adjustment to the wage index to reflect the “out-migration” of hospital employees who reside in one county but commute to work in a different county with a higher wage index, in accordance with section 505 of Pub. L. 108-173 (August 11, 2004 IPPS final rule (69 FR 49061 through 49067), as revised and corrected on October 7, 2004 (69 FR 60242)). Hospitals paid under the IPPS located in the qualifying section 505 “out-migration” counties received a wage index increase. We are applying the same criterion to TEFRA hospitals paid under the OPPS but not paid under the IPPS. Therefore, TEFRA hospitals located in a qualifying section 505 county will also receive an increase to their wage index under OPPS. </P>
                    <P>We will use final revised IPPS indices to adjust the payment rates and coinsurance amounts that we are publishing in this OPPS final rule with comment period for CY 2005. </P>
                    <P>In general, geographic labor market area reclassifications must be done in a budget neutral manner. Accordingly, in calculating the OPPS budget neutrality estimates for CY 2005, we have included the wage index changes that result from MGCRB reclassifications, implementation of section 505 of Pub. L. 108-173, and other refinements made in the IPPS final rule, such as the 50-percent transition blend for hospitals with FY 2005 wage indices that decreased solely as a result of the new MSA definitions. However, we did not take into account the reclassifications that resulted from implementation of the one-time appeal process under section 508 of Pub. L. 108-173. Section 508 set aside $900 million to implement the section 508 reclassifications. We considered the increased Medicare payments that the section 508 reclassifications would create in both the IPPS and OPPS when we determined the impact of the one-time appeal process. Because the increased OPPS payments already counted against the $900 million limit, we did not consider these reclassifications when we calculated the OPPS budget neutrality adjustment. </P>
                    <P>We received a number of public comments on the application of the FY 2005 IPPS wage indices under the OPPS. </P>
                    <P>
                        <E T="03">Comment:</E>
                         In general, commenters approved of CMS' adoption of the FY 2005 final rule wage indices for IPPS. Several commenters requested clarification that CMS would adopt the temporary, 1-year relief for hospitals with wage areas changing due to the revised labor market definitions provided in the FY 2005 IPPS final rule. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We are adopting the IPPS temporary, 1-year relief provision of a 50/50 blend of old and new wage indices in this OPPS final rule with comment period. Hospitals billing Medicare under IPPS in FY 2005 will receive the same wage index for OPPS. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         One commenter requested clarification that CMS would adopt the technical correction to the IPPS wage index to include counties incorrectly excluded from the out-migration adjustment under section 505 of Pub. L. 108-173. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         In this OPPS final rule with comment period, we are adopting all technical corrections to the FY 2005 IPPS final rule wage indices, including the referenced correction to the out-migration counties. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         Several commenters requested clarification that CMS would adopt the wage index provisions for “Special Circumstances of Hospitals in All-Urban States.” 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We are adopting all of the changes to the IPPS wage indices discussed in the FY 2005 IPPS final rule and any subsequent corrections to that final rule, including calculation of a wage index floor for hospitals in all-urban States. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         One commenter noted that the wage index listed in the impact file that we made available on the CMS Web site for the August 16, 2004 proposed rule listed a different wage index from the wage index adopted in the FY 2005 IPPS final rule and requested clarification that the hospital would receive the IPPS final rule wage index. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We note that the proposed wage indices have to be assembled before the IPPS wage indices are finalized in order to model impact tables for the OPPS proposed rule. The final wage indices used for payment in CY 2005 for OPPS will reflect the wage indices in the FY 2005 IPPS final rule and any subsequent corrections to that final rule. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         Several commenters, specifically individual hospitals adversely impacted by the final FY 2005 IPPS wage index, requested that CMS address several issues beyond the scope of the OPPS proposed rule, such as exempting hospitals from the new wage indices and employing former wage indices, calculating new wage indices or recalculating the current wage indices with additional provider or providers removed, calculating new “in-migration” adjustments, and, where permanent wage indices changes are not possible, providing a transition period beyond the 1-year 50/50 blend discussed above or extending “hold harmless” provisions. One commenter also requested that adversely impacted hospitals be able to bill under the provider numbers of affiliated institutions. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         As noted earlier in this section of the preamble, we believe, and other commenters concurred, that hospitals face the same labor costs for their inpatient and outpatient departments and that separate wage indices are not appropriate for different integrated components of the same institution. It is for this reason that we have always adopted the same wage index for both the IPPS and the OPPS payment systems. Moreover, our policy has consistently been to use the IPPS wage indices and, to the extent these wage indices are used, the IPPS process provides an opportunity for hospitals to comment specifically on the construction of the IPPS wage indices. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         Several commenters requested that CMS reduce the labor-related share from the current 60 percent to some smaller percentage, frequently 52 percent or less, for outpatient payment purposes for hospitals in areas with a Medicare wage index of 1.0 or lower to maintain consistency with the inpatient hospital policy. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         Section 403 of Pub. L. 108-173 mandated that the IPPS make a change to the labor-related share of the wage index, reducing the percentage from 71 to 62 for hospitals in areas with a wage index of 1.0 or lower. However, as discussed in the IPPS final rule (69 
                        <PRTPAGE P="65844"/>
                        FR 49069, August 11, 2004), prior to this mandate, we had determined that the labor-related share was increasing for inpatient services, not declining. Unlike IPPS, OPPS has no mandate to reduce the labor-related share, and we believe the current 60 percent labor-related share remains appropriate for OPPS payment purposes. We recognize that the IPPS final rule discusses CMS' current analyses of the labor-related share, and we will carefully consider any research findings in light of their appropriateness for OPPS. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         Several commenters expressed concern that CMS proposed to adopt the IPPS proposed wage index rather than the IPPS final wage index. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         As we have stated previously in this section of the preamble, we note that we are adopting the final IPPS wage indices and any subsequent corrections for the OPPS. 
                    </P>
                    <HD SOURCE="HD1">X. Determination of Payment Rates and Outlier Payments for CY 2005 </HD>
                    <HD SOURCE="HD2">A. Calculation of the National Unadjusted Medicare Payment </HD>
                    <P>The basic methodology for determining prospective payment rates for OPD services under the OPPS is set forth in existing regulations at §§ 419.31 and 419.32. The payment rate for services and procedures for which payment is made under the OPPS is the product of the conversion factor calculated in accordance with section VIII. of this final rule with comment period, and the relative weight determined under section III. of this final rule with comment period. Therefore, the national unadjusted payment rate for APCs contained in Addendum A to this final rule with comment period and for payable HCPCS codes in Addendum B to this final rule with comment period (Addendum B is provided as a convenience for readers) was calculated by multiplying the CY 2005 scaled weight for the APC by the CY 2005 conversion factor. </P>
                    <P>To determine the payment that will be made in a calendar year under the OPPS to a specific hospital for an APC for a service other than a drug, in a circumstance in which the multiple procedure discount does not apply, we take the following steps: </P>
                    <P>
                        <E T="03">Step 1.</E>
                         Calculate 60 percent (the labor-related portion) of the national unadjusted payment rate. Since initial implementation of the OPPS, we have used 60 percent to represent our estimate of that portion of costs attributable, on average, to labor. (See the April 7, 2000 final rule with comment period (65 FR 18496 through 18497), for a detailed discussion of how we derived this percentage.) 
                    </P>
                    <P>
                        <E T="03">Step 2.</E>
                         Determine the wage index area in which the hospital is located and identify the wage index level that applies to the specific hospital. The wage index values assigned to each area reflect the new geographic statistical areas as a result of revised OMB standards (urban and rural) to which hospitals would be assigned for FY 2005 under the IPPS, reclassifications through the Medicare Classification Geographic Review Board, LUGAR, and section 401 of Pub. L. 108-173, and the reclassifications of hospitals under the one-time appeals process under section 508 of Pub. L. 108-173. Assess whether the previous MSA-based wage index is higher than the CBSA-based wage index, and, if higher, apply a 50/50 blend. The wage index values include the occupational mix adjustment described in section IX. of this final rule with comment period that was developed for the IPPS. 
                    </P>
                    <P>
                        <E T="03">Step 3.</E>
                         Adjust the wage index of hospitals located in certain qualifying counties that have a relatively high percentage of hospital employees who reside in the county but who work in a different county with a higher wage index, in accordance with section 505 of Pub. L. 108-173. This step is to be followed only if the hospital has chosen not to accept reclassification under step 2 above. 
                    </P>
                    <P>
                        <E T="03">Step 4.</E>
                         Multiply the applicable wage index determined under Steps 2 and 3 by the amount determined under Step 1 that represents the labor-related portion of the national unadjusted payment rate. 
                    </P>
                    <P>
                        <E T="03">Step 5.</E>
                         Calculate 40 percent (the nonlabor-related portion) of the national unadjusted payment rate and add that amount to the resulting product of Step 4. The result is the wage index adjusted payment rate for the relevant wage index area. 
                    </P>
                    <HD SOURCE="HD2">B. Hospital Outpatient Outlier Payments </HD>
                    <P>For OPPS services furnished between August 1, 2000, and April 1, 2002, we calculated outlier payments in the aggregate for all OPPS services that appear on a bill in accordance with section 1833(t)(5)(D) of the Act. In the November 30, 2001 final rule (66 FR 59856 through 59888), we specified that, beginning with CY 2002, we calculate outlier payments based on each individual OPPS service. We revised the aggregate method that we had used to calculate outlier payments and began to determine outlier payments on a service-by-service basis. </P>
                    <P>As explained in the April 7, 2000 final rule with comment period (65 FR 18498), we set a projected target for outlier payments at 2.0 percent of total payments. For purposes of simulating payments to calculate outlier thresholds, we set the projected target for outlier payments at 2.0 percent for CYs 2001, 2002, 2003, and 2004. For reasons discussed in the November 7, 2003 final rule with comment period (68 FR 63469), for CY 2004, we established a separate outlier threshold for CMHCs. For CY 2004, the outlier threshold is met when costs of furnishing a service or procedure by a hospital exceed 2.6 times the APC payment amount or when the cost of furnishing services by a CMHC exceeds 3.65 times the APC payment amount. The current outlier payment is calculated to equal 50 percent of the amount of costs in excess of the threshold. </P>
                    <P>As we proposed, for CY 2005, we are continuing to set the projected target for outlier payments at 2.0 percent of total OPPS payments (a portion of that 2.0 percent, 0.6 percent, will be allocated to CMHCs for partial hospitalization program (PHP) services). </P>
                    <P>Outlier payments are intended to ensure beneficiary access to services by having the Medicare program share in the financial loss incurred by a provider associated with individual, extraordinarily expensive cases. They are not intended to pay hospitals additional amounts for specific services on a routine basis. In its March 2004 Report, MedPAC found that 50 percent of OPPS outlier payments in CY 2004 were for 21 fairly common services that had relatively low APC payment rates, such as plain film x-rays and pathology services. We remain concerned by the MedPAC findings which indicate that a significant portion of outlier payments are being made for high volume, lower cost services rather than for unusually high cost services, contrary to the intent of an outlier policy. (A full discussion of the 2004 MedPAC recommendations related to the OPPS and the CMS response to those recommendations can be found in section XII. of this preamble.) </P>
                    <P>
                        In light of the MedPAC findings, in the August 16, 2004 proposed rule, we proposed to change the standard we have used to qualify a service for outlier payments since the OPPS was originally implemented. That is, in addition to the outlier threshold we have applied since the beginning of the OPPS, which requires that a hospital's cost for a service exceed the APC payment rate for that service by a specified multiple of the APC payment rate, we proposed to add a fixed dollar threshold that would have to be met in order for a service to qualify for an outlier payment. Section 1833(t)(5)(A) of the Act gives the 
                        <PRTPAGE P="65845"/>
                        Secretary the authority to impose a fixed dollar threshold in addition to an APC multiplier threshold. By imposing a dollar threshold, we expect to redirect outlier payments from lower cost, relatively simple procedures to more complex, expensive procedures for which the costs associated with individual cases could be exceptionally high and for which hospitals would be at greater risk financially. 
                    </P>
                    <P>In the proposed rule, we proposed to require that, in order to qualify for an outlier payment, the cost of a service must exceed 1.5 times the APC payment rate and the cost must also exceed the sum of the APC rate plus a $625 fixed dollar threshold. Based upon our review of the data, a proposed threshold of $625 best met our 2.0 percent projected target. When the cost of a hospital outpatient service exceeds these thresholds, we proposed to pay 50 percent of the amount by which the cost of furnishing the service exceeds 1.5 times the APC payment rate (the APC multiple) as an outlier payment. </P>
                    <P>However, in this final rule, we are increasing the proposed APC multiplier of 1.5 to 1.75 and the fixed-dollar threshold from $625 to $1,175. This revision to the proposed rule estimates results from the inclusion of a charge inflation factor of 18.76 percent to account for charge inflation between the CY 2003 claims data that we used to model the outlier thresholds and their application in CY 2005. As we note below, many hospital associations expressed concern that the proposed $625 threshold for outlier payments was too high and suggested that OPPS consider the decision in the IPPS final rule to lower the charge inflation assumption from 31.1 percent to 18.76 percent. These same commenters suggested that we provide the details of the assumptions used to set outlier thresholds and asked that we ensure that the charges used to set outlier thresholds were not inappropriately inflated. </P>
                    <P>Previously, OPPS has not used a charge inflation factor to adjust charges on the claims used to model the payment system to reflect current dollars. We have historically set the projected target for outlier payments at 2 percent of the estimated spending under the proposed payment system, but have modeled that projected target without inflating charges on the claims, which usually lag behind the proposed system by 2 years. This year, we used CY 2003 claims to model the CY 2005 payment system. When we modeled the thresholds discussed in the August 16, 2004 proposed rule, we did not include a charge inflation factor. By not adjusting for charge inflation between CY 2003 and CY 2005, the estimated service costs will be lower than those that will be billed under OPPS next year. Underestimated service costs also led us to underestimate our outlier thresholds. As reflected in the comments, we should have included a charge inflation factor similar to that used in the IPPS outlier calculation when we developed the proposed outlier payments. In this final rule with comment period, we have done so as explained below, which results in an APC multiplier of 1.75 and a fixed-dollar threshold of $1,175. </P>
                    <P>To calculate the 1.75 multiple and $1,175 fixed-dollar thresholds, we first estimated the 2-percent projected target for outlier payments by estimating 2 percent of total spending in CY 2005 using the CY 2005 APC payment rates in this final rule with comment period and services in the CY 2003 claims. We then inflated the charges on these claims by 18.76 percent, which is the estimated increase in charges between CY 2003 and CY 2005 used in the outlier policy for the IPPS final rule. We believe the use of this estimate is appropriate for OPPS because, with the exception of the routine service cost centers, hospitals use the same cost centers to capture costs and charges across inpatient and outpatient services. As also noted in the IPPS final rule, we believe that this inflation factor is more appropriate than an adjustment to costs because charges increase at a faster rate than costs. We then used the same CCRs that we used to adjust charges to costs in our ratesetting process to estimate a cost for each service from the inflated charges on the CY 2003 claims. Although these CCRs are based largely on CY 2002 cost report data, we did not adjust them for probable increases in charges relative to costs between CY 2002 and CY 2005. Finally, we estimated a multiple threshold and fixed-dollar threshold that would produce outlier payments that met our 2-percent projected target amount. </P>
                    <P>The large increase in the fixed-dollar threshold is largely a function of the additive impact of increasing all estimated outlier payments by 18.76 percent and restricting increased estimates of outlier payments to a fixed, projected target of 2 percent, as well as the addition of a fixed-dollar threshold to determine outlier eligibility instead of using only a multiple threshold to determine outlier payment. As charges are inflated, each estimated outlier payment is higher by some proportional amount, but the total dollar increase varies with the magnitude of the difference in the cost of the service and APC payment rate. The addition of the fixed-dollar threshold policy ensures that outlier payments are made for high-cost services, thereby increasing the dollar amount of outlier payments and the total dollar impact of 18.76 percent that must be contained within the projected outlier target. Further, the actual based on outlier payment for a service is not affected by the fixed-dollar threshold but, rather, is the difference between the hospital's cost and the product of the multiple threshold and the APC payment rate. Changing the fixed-dollar threshold does not impact the amount of outlier payment. Adding the inflation adjustment to charges also increases the number of services eligible for an outlier payment under the proposed 1.5 multiple and $625 fixed-dollar thresholds. The combined impact of more services and higher payments greatly increases estimated outlier payments. Therefore, in order to reduce the number of services eligible for higher payments and the payments themselves to stay within our projected target of 2 percent of total OPPS payments, we had to raise both the fixed-dollar and multiple thresholds. </P>
                    <P>We are setting the dollar threshold at a level that will, for all intents and purposes, exclude outliers for a number of lower cost services. For example, under the CY 2004 methodology, a service mapped to an APC with a payment rate of $20 would only have to exceed $52 (2.6 × APC payment amount) in order to qualify for an outlier payment. Our final policy for CY 2005 with the additional fixed dollar threshold will require that the service in this example exceed $1,195 in order to qualify for an outlier payment. That is, the cost of the service will have to exceed both 1.75 times the APC payment rate, or $35, and $1,195 ($20 + $1,175). </P>
                    <P>
                        The dollar threshold will also enable us to lower the APC multiplier portion of the total outlier threshold from 2.6 to 1.75. We have chosen a multiple of 1.75 because this continues to recognize some variability relative to APC payment implicit in the current statute, but limits its impact in determining outlier payments. Under the changes to the outlier methodology, it will also be easier for the higher cost cases of a complex, expensive procedure or service to qualify for outlier payments because the $1,175 threshold is a small portion of the total payment rate for high cost services. For example, under the CY 2004 methodology, a service mapped to an APC with a payment rate of $20,000 would have to exceed $52,000 in order to qualify for an outlier 
                        <PRTPAGE P="65846"/>
                        payment but, as proposed for CY 2005, will have to exceed only $35,000. That is, the cost of the service will have to exceed both 1.75 times the APC payment rate, or $35,000, and $21,175 ($20,000 + $1,175). Further, outlier payments for unusually expensive cases would be higher because the APC multiplier for outlier payment would decrease from 2.6 to 1.75 times the APC payment rate. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         Many commenters, including MedPAC, favored our proposed outlier policy that redirects outlier payments to expensive procedures for which hospitals' financial risk is potentially greater. (Under the proposed rule, outlier payments would be made when the cost of a separately payable service exceeds both 1.5 times the APC payment and a fixed dollar amount.) Several commenters agreed with this revision in policy, but requested that CMS monitor the impact of the new policy on hospitals with a relatively high volume of low cost cases and find some way to ensure that providers of less-intensive services be afforded outlier “protection.” 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         As noted above, outlier payments are intended to ensure beneficiary access to services by having the Medicare program share in the financial loss incurred by a provider associated with individual, extraordinarily expensive cases. They are not intended to pay hospitals additional amounts for specific services on a routine basis, and we demonstrated in Table 39 of the proposed rule that this policy moderately redistributes outlier dollars to providers of high-cost, complex services, such as teaching hospitals. We will continue to model the distribution of outlier payments among hospitals. However, the purpose of the new policy is to limit financial risk attributable to patients whose costs are extraordinarily high. Therefore, our goal is to redirect outlier payments to those services that better meet our goal of providing outlier payments to those costly services with high financial risk. The intent is not to continue to provide a significant portion of outlier payments to high volume, low cost services. 
                    </P>
                    <P>Using the final rule data and updated charge inflation estimates, we have modeled a fixed-dollar threshold of $1,175 for CY 2005. </P>
                    <P>
                        <E T="03">Comment:</E>
                         Several commenters requested data that support the presumption that the revised outlier methodology will definitely result in payment of 2 percent of total OPPS payments. The commenters also urged CMS to release data on actual outlier payments made in CY 2004 and in prior years, and to continue to report this data in the future. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         The outlier thresholds and payment percentages are determined each year based on our best estimate of the thresholds and payment percentages needed to achieve the projected target of outlier payment. As discussed above, in order to estimate the outlier multiple and fixed-dollar thresholds, we first estimated 2 percent of the total spending using the APC payment rates in this final rule with comment period and the services in the CY 2003 claims. Using this estimate, we inflated the charges on the CY 2003 claims to reflect CY 2005 dollars using the 1.1876 inflation adjustment used in the IPPS final rule. We then applied the overall CCR for each hospital based on their most recently submitted cost report, whether tentatively settled or final, and if tentatively settled, adjusted by a submitted-to-settled ratio taken from the previous year's cost report. These are the same CCRs that we use in our ratesetting process. We then estimated outlier payments for various combinations of multiple and fixed-dollar thresholds until we reached the targeted outlier expenditures. 
                    </P>
                    <P>Interested parties may calculate the amount of outlier spending from previous years. Such information is available in the claims data, not the limited data set, available from CMS for this final rule with comment period. </P>
                    <P>
                        <E T="03">Comment:</E>
                         Several commenters were concerned that the proposed fixed-dollar threshold of $625 was too high. Specifically, the commenters were concerned that CMS had overstated its charge inflation estimates in calculating the fixed dollar threshold, as had been done in the FY 2005 IPPS proposed rule. The commenters requested that CMS review its estimates and make comparable adjustments to these in the FY 2005 IPPS final rule. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         As noted previously, the OPPS had not used a charge inflation factor. In this final rule with comment period, we realized that we should have adopted a charge inflation estimate. We used the charge inflation estimate used in the IPPS final rule of 18.76 percent to update charges on the CY 2003 claims that we used to model the fixed-dollar threshold in order to reflect CY 2005 dollars. Comparable to IPPS, we did not update the CCRs that we employed to estimate costs from these inflated charges. The CCRs are based on hospitals' most recently submitted cost report, frequently CY 2002, adjusted by the most recent settled-to-submitted ratio, and were not updated for changes in relative costs and charges since the cost report year. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         One commenter supported the proposed change, but urged CMS to adopt MedPAC's recommendation to fully eliminate outpatient outlier payments and to increase the base APC rates by a commensurate amount. The commenter asserted that the separate payment of services under OPPS eliminates the need for an outlier policy. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We believe that an outlier policy is necessary and appropriate under the OPPS. Outlier payments dampen the financial risk of and improve beneficiary access to expensive, complex outpatient services. The range of services provided in the outpatient setting continues to expand, continually including more services previously performed in the inpatient setting. Many of these procedures are high-cost, extensive, and as complex as inpatient procedures. The device-dependent APCs provide a good example. We agree that separate payment for many individual services under OPPS reduces the need for an extensive outlier policy, but do not believe it eliminates the need entirely. We believe that the lower outlier payment percentage under the OPPS of 50 percent relative to 80 percent under the IPPS and the smaller OPPS projected outlier target of 2 percent relative to the IPPS projected target of between 5 and 6 percent reflect the more limited outlier liability associated with the outpatient payment system. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         One commenter disagreed with our proposed policy and noted that it will substantially restrict outlier payments for a lot of outpatient services and recommended that CMS remove the fixed-dollar threshold and apply outlier payments only when the cost of a service exceeds 1.5 times the APC payment. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We disagree with the commenter as removing the fixed-dollar threshold and relying only on a multiple of 1.5 or 1.75 would result in outlier payments well in excess of the proposed 2-percent projected target. To meet the projected target, we would have to raise the multiple threshold to 2.95 if we eliminated the fixed dollar threshold. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         Several commenters requested that CMS release limited data set data files in a more timely manner. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We have always attempted to, and will continue to, provide data necessary for evaluation of the OPPS in a timely manner. For example, this year, several data files were available through CMS' Web site before the publication of the proposed rule. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         Several commenters recommended that CMS consider reinstating outlier payments at the claim 
                        <PRTPAGE P="65847"/>
                        level, rather than at the individual service level, resulting in easier administration of outliers and payments that are more equitable for high cost patients. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We believe that calculating outliers on a service-by-service basis is the most appropriate way to calculate outliers for outpatient services. Outliers on a claim or bill basis requires both the aggregation of costs and the aggregation of OPPS payments thereby introducing some degree of offset among services; that is, the aggregation of low cost services and high cost services on a bill may result in the claim or bill not meeting the outlier criterion. While the implementation of service-based outliers is somewhat more complex because it involves allocating the costs of packaged services across multiple payable codes, we believe that under this approach, outlier payments are more appropriately directed to those specific services for which a hospital incurs significantly increased costs. We also believe that the introduction of the fixed dollar threshold improves payment for expensive patients by targeting outlier payments to the more high-cost, complex services. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         One commenter requested that CMS demonstrate the accuracy of its assumption that providers are receiving inappropriate outlier payments and suggest that the distribution of packaged costs on a claim could be affecting the outlier determination and payment. The commenter specifically requested that CMS exempt all drug administration APCs from the new fixed-dollar threshold methodology. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We agree that the allocation of packaged costs could modestly under or overestimate the cost of a single procedure for purposes of determining outlier payments. However, this observation cannot explain the huge concentration of services in low-cost, simple procedures receiving outlier payments observed by MedPAC in its March 2004 report referenced above. This concentration is clearly a function of the multiple threshold policy. 
                    </P>
                    <P>In accordance with section 1833(t)(5) of the Act, we have set a uniform fixed-dollar outlier threshold that applies to all OPPS services in a given calendar year. We cannot exempt specific services from the outlier methodology because the statute does not provide for different thresholds for different types of OPPS services. Further, the magnitude of the multiple and fixed dollar thresholds is determined prospectively before the beginning of each year based on all OPPS services qualifying for outlier payments in that year. </P>
                    <P>
                        <E T="03">Comment:</E>
                         One commenter was concerned that CMS does not provide information to determine how the amounts that are actually spent on pass-through and outlier payments compare to the amount that is carved out of the total amount allowed OPPS payment for these projected payments. The commenter was concerned that the amounts carved out for these purposes may not actually be spent and thus, would be lost to hospitals. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We are required by law to estimate the amounts that we expect to spend on pass-through and outlier payments each year before the start of the calendar year. We share the commenter's interest in assuring that those estimates are made as accurately as possible to ensure that hospitals receive the amount to which they are entitled by law. We make our final estimate for each calendar year to the best of our ability based on all of the best data available at the time we prepare our final rule, including comments we receive in response to our proposed rule. With respect to the availability of data for modeling our outlier estimates, we have established limited data sets which include the set of claims we used first for the proposed rule estimates and, ultimately, for those for our final rule with comment period. For example, the CY 2003 claims used in ratesetting and modeling for this final rule with comment period for CY 2005 OPPS will be available to the public in a limited data set format. However, estimates of total outlier payments made in previous years are not available in the limited data set, in no small part because outlier payments on these claims would underestimate total outlier payments. Interested parties can estimate total outlier expenditures from a full year of OPPS claims data. We will continue to assess the means by which we provide data. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         One commenter who did not support the proposed outlier policy suggested that the payment for outliers in low-cost services could be an indication that the APC payment rate is too low for these services. The commenter also wondered if the concentration of outlier payments in low-cost services was the result of high packaged costs appearing with these separately payable services, and indicated that one example might include packaged observation services. Ultimately, this commenter suggested that a better understanding of why outlier payments are directed to common services is necessary before a change in policy can be supported. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         As MedPAC discussed in its March 2004 report, the main reason to include outlier policies with prospective payment systems is to limit providers' financial risk attributable to patients whose costs are extraordinarily high relative to the median cost of providing the service. We believe that such risk is more substantial in high cost procedures. When the financial risk of providing a service becomes too high, providers may choose not to provide the service, an outcome that can harm beneficiary access. 
                    </P>
                    <P>The CY 2004 outlier policy does not distinguish between high cost services and low cost services. In fact, MedPAC found that 50 percent of OPPS outlier payments in CY 2004 were for services in low-paying APCs. These observations suggested the need to modify the outlier policy to provide better protection against financial risk. The fixed-dollar threshold limits financial risk to providers who provide high-cost services. </P>
                    <P>Although it is possible that extensive packaged costs have created the current concentration of outliers in low cost services, it is unlikely in most circumstances. Separately payable services consistently billed with extensive packaged costs would ultimately increase payment rates as packaged costs were incorporated in the cost of the payable service. Although packaged observation services can be extensive, the review of OPPS claims data indicates that there are too many outlier payments to be associated with the limited number of claims with packaged observation services. We believe the current policy creates an easy threshold for low-cost services to qualify for outlier payments and does little to protect hospitals against the financial risk associated with complex and high-cost services. </P>
                    <HD SOURCE="HD2">C. Payment for Partial Hospitalization </HD>
                    <HD SOURCE="HD3">1. Background </HD>
                    <P>
                        Partial hospitalization is an intensive outpatient program of psychiatric services provided to patients as an alternative to inpatient psychiatric care for beneficiaries who have an acute mental illness. A partial hospitalization program (PHP) may be provided by a hospital to its outpatients or by a Medicare-certified CMHC. Section 1833(t)(1)(B)(i) of the Act provides the Secretary with the authority to designate the hospital outpatient services to be covered under the OPPS. Section 419.21(c) of the Medicare regulations that implement this provision specifies that payments under the OPPS will be made for partial hospitalization services 
                        <PRTPAGE P="65848"/>
                        furnished by CMHCs. Section 1883(t)(2)(C) of the Act requires that we establish relative payment weights based on median (or mean, at the election of the Secretary) hospital costs determined by 1996 claims data and data from the most recent available cost reports. Payment to providers under the OPPS for PHPs represents the provider's overhead costs associated with the program. Because a day of care is the unit that defines the structure and scheduling of partial hospitalization services, we established a per diem payment methodology for the PHP APC, effective for services furnished on or after August 1, 2000. For a detailed discussion, see the April 7, 2000 OPPS final rule (65 FR 18452). 
                    </P>
                    <HD SOURCE="HD3">2. PHP APC Update for CY 2005 </HD>
                    <P>As proposed, for calculation of the CY 2005 per diem payment in this final rule, we used the same methodology that was used to compute the CY 2004 per diem payment. For CY 2004, the per diem amount was based on three quarters of hospital and CMHC PHP claims data (for services furnished from April 1, 2002, through December 31, 2002). We used data from all hospital bills reporting condition code 41, which identifies the claim as partial hospitalization, and all bills from CMHCs because CMHCs are Medicare providers only for the purpose of providing partial hospitalization services. We used CCRs from the most recently available hospital and CMHC cost reports to convert each provider's line item charges as reported on bills, to estimate the provider's cost for a day of PHP services. Per diem costs are then computed by summing the line item costs on each bill and dividing by the number of days on the bill. </P>
                    <P>Unlike hospitals, CMHCs do not file cost reports electronically and the cost report information is not included in the Healthcare Cost Report Information System (HCRIS). The CMHC cost reports are held by the Medicare fiscal intermediaries. In a Program Memorandum issued on January 17, 2003 (Transmittal A-03-004), we directed fiscal intermediaries to recalculate hospital and CMHC CCRs using the most recently settled cost reports by April 30, 2003. Following the initial update of CCRs, fiscal intermediaries were further instructed to continue to update a provider's CCR and enter revised CCRs into the outpatient provider specific file. Therefore, for CMHCs, we use CCRs from the outpatient provider specific file. For CY 2005, we analyzed 12 months of data for hospital and CMHC PHP claims for services furnished between January 1, 2003, and December 31, 2003. Updated CCRs reduced the median cost per day for CMHCs. The revised medians are $310 for CMHCs and $215 for hospitals. Combining these files results in a median per diem PHP cost of $289. As with all APCs in the OPPS, the median cost for each APC is scaled to be relative to a mid-level office visit and the conversion factor is applied. The resulting APC amount for PHP is $281.33 for CY 2005, of which $56.33 is the beneficiary's coinsurance. </P>
                    <P>
                        <E T="03">Comment:</E>
                         One commenter summed payments for three Group Therapy Sessions (APC 0325) and one Extended Individual Therapy Session (APC 0323) and requested that amount as the minimum for a day of PHP. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We do not believe this is an appropriate comparison. It is important to note that the APC services cited by the commenter (APC 0325 and APC 0323) are not PHP services, but rather single outpatient therapeutic sessions. As stated earlier, we used data from PHP programs (both hospitals and CMHCs) to determine the median cost of a day of PHP. PHP is a program of services where savings can be realized by hospitals and CMHCs over delivering individual psychotherapy services. In addition, a minimal day of PHP treatment does encompass three services. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         One commenter requested that the same provisions given to rural hospital outpatient departments also be given to rural CMHCs. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We believe the commenter may be referring to the statutory hold harmless provisions. Section 1833(t)(7)(D) of the Act authorizes such payments, on a permanent basis, for children's hospitals and cancer hospitals and, through CY 2005, for rural hospitals having 100 or fewer beds and sole community hospitals in rural areas. Section 1866(t)(7)(D) of the Act does not authorize hold harmless payments to CMHC providers. 
                    </P>
                    <HD SOURCE="HD3">3. Separate Threshold for Outlier Payments to CMHCs </HD>
                    <P>In the November 7, 2003 final rule with comment period (68 FR 63469), we indicated that, given the difference in PHP charges between hospitals and CMHCs, we did not believe it was appropriate to make outlier payments to CMHCs using the outlier percentage target amount and threshold established for hospitals. There was a significant difference in the amount of outlier payments made to hospitals and CMHCs for PHP. Further analysis indicated the use of outlier payments was contrary to the intent of the outlier policy as discussed previously in section X.B. above. Therefore, for CY 2004, we established a separate outlier threshold for CMHCs. We designated a portion of the estimated 2.0 percent outlier target amount specifically for CMHCs, consistent with the percentage of projected payments to CMHCs under the OPPS in CY 2004, excluding outlier payments. </P>
                    <P>As stated in the November 7, 2003 final rule with comment period, CMHCs were projected to receive 0.5 percent of the estimated total OPPS payments in CY 2004. The CY 2004 outlier threshold is met when the cost of furnishing services by a CMHC exceeds 3.65 times the APC payment amount. The current outlier payment percentage is 50 percent of the amount of costs in excess of the threshold. </P>
                    <P>CMS and the Office of the Inspector General are continuing to monitor the excessive outlier payments to CMHCs. However, we do not yet have CY 2004 claims data that will show the effect of the separate outlier threshold for CMHCs that was effective January 1, 2004. Therefore, for CY 2005, as discussed in section X.B. of this preamble, we are continuing to set the target for hospital outpatient outlier payments at 2.0 percent of total OPPS payments. We are also allocating a portion of that 2.0 percent, 0.6 percent, to CMHCs for PHP services. We are adopting as final 0.6 percent for CMHCs because the percentage of CMHC's payment to total OPPS payment rose slightly in the CY 2003 claims data. In the absence of CY 2004 claims data, we developed simulations for CY 2005. As discussed in section X.B. of this final rule, we are establishing a dollar threshold in addition to an APC multiplier threshold for hospital OPPS outlier payments. However, because PHP is the only APC for which CMHCs may receive payment under the OPPS, we would not expect to redirect outlier payments by imposing a dollar threshold. Therefore, we are not establishing a dollar threshold for CMHC outliers. In this final rule, we are setting the outlier threshold for CMHCs for CY 2005 at 3.5 percent times the APC payment amount and the CY 2005 outlier payment percentage applicable to costs in excess of the threshold at 50 percent. </P>
                    <P>
                        <E T="03">Comment:</E>
                         One commenter expressed concern about a separate outlier threshold for partial hospitalization services because many partial hospitalization programs are hospital based. The commenter recommended that CMS use the same threshold for all hospital services. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We agree that the same outlier policy should apply to all 
                        <PRTPAGE P="65849"/>
                        hospital services. Under OPPS, we establish two sets of outlier thresholds, one for hospitals and one for CMHCs. The higher multiple threshold of 3.5 is reserved for services provided by CMHCs only. Hospitals billing for partial hospitalization will be subject to the outlier thresholds and payment percentages identified for all hospital services. 
                    </P>
                    <HD SOURCE="HD1">XI. Beneficiary Copayments for CY 2005 </HD>
                    <HD SOURCE="HD2">A. Background </HD>
                    <P>Section 1833(t)(3)(B) of the Act requires the Secretary to set rules for determining copayment amounts to be paid by beneficiaries for covered OPD services. Section 1833(t)(8)(C)(ii) of the Act specifies that the Secretary must reduce the national unadjusted copayment amount for a covered OPD service (or group of such services) furnished in a year in a manner so that the effective copayment rate (determined on a national unadjusted basis) for that service in the year does not exceed specified percentages. For all services paid under the OPPS in CY 2005, the specified percentage is 45 percent of the APC payment rate. The statute provides a further reduction in CY 2006 so that the national unadjusted coinsurance for an APC cannot exceed 40 percent in CY 2006 and in calendar years thereafter. Section 1833(t)(3)(B)(ii) of the Act provides that, for a covered OPD service (or group of such services) furnished in a year, the national unadjusted coinsurance amount cannot be less than 20 percent of the OPD fee schedule amount. </P>
                    <P>
                        <E T="03">Comment:</E>
                         One commenter expressed concern that the law does not further reduce the maximum coinsurance rate for CY 2007. The commenter believed that this may cause coinsurance rates to stagnate at 40 percent for a few years. The commenter indicated that its organization will continue to advocate for a legislative change that would accelerate the copayment buy-down. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We understand the concerns of this organization. In CY 2004, we determined that 63 percent of APCs had a national unadjusted coinsurance rate of 20 percent. Therefore, we will continue to apply our current methodology for calculating national unadjusted coinsurance rates, as explained in earlier 
                        <E T="04">Federal Register</E>
                         notices, which ensures that the copayments of the remaining 37 percent of APCs will continue to decrease relative to increases in payment rates. 
                    </P>
                    <HD SOURCE="HD2">B. Copayment for CY 2005 </HD>
                    <P>For CY 2005, we determined copayment amounts for new and revised APCs using the same methodology that we implemented for CY 2004 (see the November 7, 2003 OPPS final rule with comment period, 68 FR 63458). The unadjusted copayment amounts for services payable under the OPPS effective January 1, 2005 are shown in Addendum A and Addendum B of this final rule with comment period. </P>
                    <HD SOURCE="HD1">XII. Addendum Files Available to the Public Via Internet </HD>
                    <P>
                        The data referenced for Addendum C to this final rule with comment period are available on the following CMS Web site via Internet only: 
                        <E T="03">http://www.cms.hhs.gov/providers/hopps/.</E>
                         We are not republishing the data represented in this Addendum to this final rule with comment period because of its volume. For additional assistance, contact Chris Smith Ritter at (410) 786-0378. Addendum C—Healthcare Common Procedure Coding System (HCPCS) Codes by Ambulatory Payment Classification (APC). 
                    </P>
                    <P>This file contains the HCPCS codes sorted by the APCs into which they are assigned for payment under the OPPS. The file also includes the APC status indicators, relative weights, and OPPS payment amounts. </P>
                    <HD SOURCE="HD1">XIII. Collection of Information Requirements </HD>
                    <P>This document does not impose information collection and recordkeeping requirements. Consequently, it need not be reviewed by the Office of Management and Budget under the authority of the Paperwork Reduction Act of 1995. </P>
                    <HD SOURCE="HD1">XIV. Regulatory Impact Analysis </HD>
                    <HD SOURCE="HD2">A. OPPS: General </HD>
                    <P>We have examined the impacts of this final rule with comment period as required by Executive Order 12866 (September 1993, Regulatory Planning and Review), the Regulatory Flexibility Act (RFA) (September 19, 1980, Pub. L. 96-354), section 1102(b) of the Social Security Act, the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4), and Executive Order 13132. </P>
                    <HD SOURCE="HD3">1. Executive Order 12866 </HD>
                    <P>Executive Order 12866 (as amended by Executive Order 13258, which merely reassigns responsibility of duties) directs agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). A regulatory impact analysis (RIA) must be prepared for major rules with economically significant effects ($100 million or more in any 1 year). </P>
                    <P>We estimate the effects of the provisions that will be implemented by this final rule with comment period will result in expenditures exceeding $100 million in any 1 year. We estimate the total increase (from changes in this final rule with comment period as well as enrollment, utilization, and case-mix changes) in expenditures under the OPPS for CY 2005 compared to CY 2004 to be approximately $1.5 billion. Therefore, this final rule with comment period is an economically significant rule under Executive Order 12866, and a major rule under 5 U.S.C. 804(2). </P>
                    <HD SOURCE="HD3">2. Regulatory Flexibility Act (RFA) </HD>
                    <P>The RFA requires agencies to determine whether a rule would have a significant economic impact on a substantial number of small entities. For purposes of the RFA, small entities include small businesses, nonprofit organizations, and government agencies. Most hospitals and most other providers and suppliers are small entities, either by nonprofit status or by having revenues of $6 million to $29 million in any 1 year (65 FR 69432). </P>
                    <P>
                        For purposes of the RFA, we have determined that approximately 37 percent of hospitals would be considered small entities according to the Small Business Administration (SBA) size standards. We do not have data available to calculate the percentages of entities in the pharmaceutical preparation manufacturing, biological products, or medical instrument industries that would be considered to be small entities according to the SBA size standards. For the pharmaceutical preparation manufacturing industry (NAICS 325412), the size standard is 750 or fewer employees and $67.6 billion in annual sales (1997 business census). For biological products (except diagnostic) (NAICS 325414), with $5.7 billion in annual sales, and medical instruments (NAICS 339112), with $18.5 billion in annual sales, the standard is 50 or fewer employees (see the standards Web site at 
                        <E T="03">http://www.sba.gov/regulations/siccodes/</E>
                        ). Individuals and States are not included in the definition of a small entity. 
                    </P>
                    <HD SOURCE="HD3">3. Small Rural Hospitals </HD>
                    <P>
                        In addition, section 1102(b) of the Act requires us to prepare a regulatory impact analysis if a rule may have a 
                        <PRTPAGE P="65850"/>
                        significant impact on the operations of a substantial number of small rural hospitals. This analysis must conform to the provisions of section 603 of the RFA. With the exception of hospitals located in certain New England counties, for purposes of section 1102(b) of the Act, we previously defined a small rural hospital as a hospital with fewer than 100 beds that is located outside of a Metropolitan Statistical Area (MSA) (or New England County Metropolitan Area (NECMA)). However, under the new labor market definitions that we are adopting in this final rule with comment period (consistent with the FY 2005 IPPS final rule), we no longer employ NECMAs to define urban areas in New England. Therefore, we now define a small rural hospital as a hospital with fewer than 100 beds that is located outside of an MSA. Section 601(g) of the Social Security Amendments of 1983 (Pub. L. 98-21) designated hospitals in certain New England counties as belonging to the adjacent NECMA. Thus, for purposes of the OPPS, we classify these hospitals as urban hospitals. We believe that the changes in this final rule with comment period will affect both a substantial number of rural hospitals as well as other classes of hospitals and that the effects on some may be significant. Therefore, we conclude that this final rule with comment period will have a significant impact on a substantial number of small entities. 
                    </P>
                    <HD SOURCE="HD3">4. Unfunded Mandates </HD>
                    <P>Section 202 of the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4) also requires that agencies assess anticipated costs and benefits before issuing any rule that may result in an expenditure in any 1 year by State, local, or tribal governments, in the aggregate, or by the private sector, of $110 million. This final rule with comment period does not mandate any requirements for State, local, or tribal governments. This final rule with comment period also does not impose unfunded mandates on the private sector of more than $110 million dollars. </P>
                    <HD SOURCE="HD3">5. Federalism </HD>
                    <P>Executive Order 13132 establishes certain requirements that an agency must meet when it publishes any rule (proposed or final rule) that imposes substantial direct costs on State and local governments, preempts State law, or otherwise has Federalism implications. </P>
                    <P>We have examined this final rule with comment period in accordance with Executive Order 13132, Federalism, and have determined that it would not have an impact on the rights, roles, and responsibilities of State, local or tribal governments. The impact analysis (see Table 41) shows that payments to governmental hospitals (including State, local, and tribal governmental hospitals) will increase by 3.7 percent under this final rule with comment period. </P>
                    <P>
                        <E T="03">Comment:</E>
                         One commenter expressed concern that CMS had removed the eye and ear specialty hospital category from our regulatory impact analysis and requested that we reinstate this line-item. They further requested information on why specific analyses were retained for cancer and children's hospitals. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We removed the specific regulatory impact analysis of eye and ear hospitals because, unlike cancer and children's hospitals, they are not specifically protected by statute. Section 1833(t)(7)(D) of the Act holds harmless cancer hospitals, children's hospitals, small rural hospitals with less than 100 beds, and sole community hospitals in rural areas. These hospitals cannot receive less payment in CY 2005 than they did in the CY 2004. However, because hold harmless provisions for cancer and children's hospitals are permanent, we will not specifically identify these hospital classes in future impact analyses. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         One commenter expressed concern about the observed impact on teaching hospitals, specifically the observed increase of 2.9 percent under the proposed system, which is less than the overall increase modeled for all hospitals of 4.6 percent in the proposed rule. This commenter requested that CMS conduct analyses assessing the need for an adjustment for specific classes of hospitals, which is within CMS' regulatory authority. The commenter further suggested that these analyses assess whether teaching hospitals rely more on pass-through, outlier, transitional corridor, and device-dependent APC payments, and suggested that an adjustment is necessary if this is the outcome. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We agree that it is important to monitor ongoing trends for specific classes of hospitals, and we are especially concerned when hospitals experience a negative increase. In this specific instance, major teaching hospitals are experiencing a positive increase in payments. We also agree that major teaching hospitals may be more dependent on costs estimated outside of the primary impact tables provided in the regulation. However, we are not convinced that a reliance on pass-through, outlier, or transitional corridor payments is a reason to propose an adjustment. This is especially true in light of the outlier policy as proposed, which redirects money to complex and costly procedures that are more likely to be performed at academic medical institutions. 
                    </P>
                    <HD SOURCE="HD2">B. Impact of Changes in This Final Rule With Comment Period </HD>
                    <P>We are adopting as final the proposed changes to the OPPS that are required by the statute. We are required under section 1833(t)(3)(C)(ii) of the Act to update annually the conversion factor used to determine the APC payment rates. We are also required under section 1833(t)(9)(A) of the Act to revise, not less often than annually, the wage index and other adjustments. In addition, we must review the clinical integrity of payment groups and weights at least annually. Accordingly, in this final rule with comment period, we are updating the conversion factor and the wage index adjustment for hospital outpatient services furnished beginning January 1, 2005, as we discuss in sections VIII. and IX., respectively, of this final rule with comment period. We also have revised the relative APC payment weights using claims data from January 1, 2003, through December 31, 2003. Finally, we are removing 6 device categories and 13 drugs and biological agents from pass-through payment status. In particular, see section V.A.2 with regard to the expiration of pass-through status for devices and see section IV.A.2 with regard to the expiration of pass-through status for drugs and biological agents. </P>
                    <P>Under this final rule with comment period, the update change to the conversion factor as provided by statute as well as the additional money for the OPPS payments in CY 2005 as authorized by Pub. L. 108-173, including money for drugs and increases in the wage indices, will increase total OPPS payments by 4.0 percent in CY 2005. The changes to the wage index and to the APC weights (which incorporate the cessation of pass-through payments for several drugs and devices) would not increase OPPS payments because the OPPS is budget neutral. However, the wage index and APC weight changes would change the distribution of payments within the budget neutral system as shown in Table 41 and described in more detail in this section. </P>
                    <HD SOURCE="HD2">C. Alternatives Considered </HD>
                    <P>
                        Alternatives to the changes we are making and the reasons that we have chosen the options we have are discussed throughout this final rule with comment period. Some of the 
                        <PRTPAGE P="65851"/>
                        major issues discussed in this final rule with comment period and the options considered are discussed below. 
                    </P>
                    <HD SOURCE="HD3">1. Payment for Device-Dependent APCs </HD>
                    <P>We package payment for an implantable device into the APC payment for the procedure performed to insert the device. Because almost all devices lost pass-through status at the end of CY 2002, we discontinued use of separate codes to report devices in CY 2003. We have found that claims that we use to set payment rates for device-dependent APCs frequently have packaged costs that are much lower than the cost of the device. This is attributed, in part, to variations in hospital billing practices. In response, we reestablished device codes for reporting on a voluntary basis in CY 2004. </P>
                    <P>The APC Panel recommended that we use CY 2004 device-dependent APC rates updated for inflation as the CY 2005 payments. We considered this option but did not adopt it because it would not recognize changes in relative cost for these APCs and would not advance us towards our goal of using unadjusted claims data as the basis for payment weights for all OPPS services. </P>
                    <P>In addition to consideration of the APC Panel's recommendation, we considered using CY 2002 claims to calculate a ratio between the median calculated using all single bills and the median calculated using only claims with HCPCS codes for devices on them, and applying that ratio to the median calculated using CY 2003 claims data. We rejected this option because it assumes that the relationship between the costs of the claims with and without codes for devices is a valid relationship not only for CY 2002 but CY 2003 as well. It also assumes no changes in billing behavior. We have no reason to believe either of these assumptions is true and, therefore, we did not choose this option. We also considered using external data provided by manufacturers and other stakeholders as the estimated device cost. We did not choose this alternative because we believe that, in a relative weight system, there should be a single stable and objective source of data for setting relative weights for all items and services for which payment is made in the system. </P>
                    <P>We do not believe that any of the above options would help us progress toward reliance on our data. Rather than adopt any of those approaches, we developed an option to adjust the payment for only those device-dependent APCs that have the most dramatic decreases for CY 2005. We believe that the better payment approach for determining median costs for device-dependent APCs in CY 2005 is to base these medians on the greater of: (1) Median costs calculated using CY 2003 claims data; or (2) 95 percent of the APC payment median used in CY 2004 for these services. We believe that this adjustment methodology provides an appropriate transition to eventual use of all single bill claims data without adjustment. </P>
                    <P>We are also requiring hospitals to report C-codes for device categories used in conjunction with procedures billed and paid for under the OPPS. We have decided to implement edits, starting April 1, to enforce the reporting of C-codes to bill for most of the device-dependent procedures for which we adjusted the medians for CY 2005, as well as for a few APCs that require devices that are coming off pass-through payment in CY 2005 (a continuation of current billing practice). We believe that adoption of our proposal will mitigate barriers to beneficiary access to care while encouraging hospitals to bill correctly for the services they furnish. For a more detailed discussion of this issue, see section III.C. of this final rule with comment period. </P>
                    <HD SOURCE="HD3">2. Hospital Outpatient Outlier Payments </HD>
                    <P>In its March 2004 Report, MedPAC made a recommendation to the Congress to eliminate the outlier provision under the OPPS. MedPAC made its recommendation after studying outlier payments on claims for services furnished during CY 2002 and concluding that in 2002, 50 percent of outlier payments were paid for 21 fairly common services that had relatively low APC payment rates, while high cost services accounted for only a small share of outlier payments. However, outlier payments are required under the statute. Therefore, we cannot discontinue outlier payments absent a legislative change by the Congress. </P>
                    <P>In light of the MedPAC findings, we are adopting a fixed-dollar threshold in addition to the threshold based on a multiple of the APC amount that we have applied since the beginning of the OPPS. A fixed-dollar threshold will redirect OPPS outlier payments toward the complex and expensive services that can create high financial risk for a hospital. In its comments on the proposed rule, MedPAC recognized that elimination of the outlier policy for OPPS requires a legislative change and approved of the proposed policy to adopt a fixed-dollar threshold. For a more detailed discussion of this issue, see section X. of this final rule with comment period. </P>
                    <HD SOURCE="HD2">D. Limitations of Our Analysis </HD>
                    <P>The distributional impacts presented here are the projected effects of the policy changes, as well as the statutory changes that would be effective for CY 2005, on various hospital groups. We estimate the effects of individual policy changes by estimating payments per service while holding all other payment policies constant. We use the best data available but do not attempt to predict behavioral responses to our policy changes. We also do not make adjustments for future changes in variables such as service volume, service mix, or number of encounters. </P>
                    <HD SOURCE="HD2">E. Estimated Impacts of This Final Rule With Comment Period on Hospitals </HD>
                    <P>
                        The estimated increase in the total payments made under OPPS is limited by the increase to the conversion factor set under the methodology in the statute. The distributional impacts presented do not include assumptions about changes in volume and service-mix. However, total payments actually made under the system also may be influenced by changes in volume and service-mix, which CMS cannot forecast. The enactment of Pub. L. 108-173 on December 8, 2003, provided for the payment of additional dollars in 2004 and 2005 to providers of OPPS services outside of the budget neutrality requirements for both specified covered outpatient drugs (see section V.A.3.a. of this final rule with comment period) and the wage indexes for specific hospitals through reclassification reform in section 508 of Pub. L. 108-173 (see section IX. of this final rule with comment period). Table 41 shows the estimated redistribution of hospital payments among providers as a result of a new APC structure and wage indices, which are budget neutral; the estimated distribution of increased payments in CY 2005 resulting from the combined impact of APC recalibration and wage effects, and market basket update to the conversion factor; and estimated payments considering all payments for CY 2005 relative to all payments for CY 2004. In some cases, specific hospitals may receive more total payment in CY 2005 than in CY 2004, while, in other cases, they may receive less total payment than they received in CY 2004. However, our impact analysis suggests that no class of hospitals would receive less total payments in CY 2005 than in CY 2004. Because updates to the conversion factor, including the market basket and any reintroduction of pass-through dollars, are applied uniformly, observed redistributions of payments in the impact table largely depends on the 
                        <PRTPAGE P="65852"/>
                        mix of services furnished by a hospital (for example, how the APCs for the hospital's most frequently furnished services would change) and the impact of the wage index changes on the hospital. However, the extent to which this final rule redistributes money during implementation will also depend on changes in volume, practice patterns, and case-mix of services billed between CY 2003 and CY 2005. 
                    </P>
                    <P>Overall, the final OPPS rates for CY 2005 will have a positive effect for all hospitals paid under OPPS. Adopted changes will result in a 4.0 percent increase in Medicare payments to all hospitals, exclusive of outlier and transitional pass-through payments. As described in the preamble, budget neutrality adjustments are made to the conversion factor and the relative weights to ensure that the revisions in the wage indices, APC groups, and relative weights do not affect aggregate payments. The impact of the wage and APC recalibration changes are fairly moderate across most classes of hospitals. </P>
                    <P>To illustrate the impact of the CY 2005 changes adopted in this final rule with comment period, our analysis begins with a baseline simulation model that uses the final CY 2004 weights, the FY 2004 final post-reclassification IPPS wage indices, as subsequently corrected, without changes in wage indices resulting from section 508 reclassifications, and the final CY 2004 conversion factor. Columns 2 and 3 in Table 41 reflect the independent effects of the changes in the APC reclassification and recalibration changes and the wage indices, respectively. These effects are budget neutral, which is apparent in the overall zero impact in payment for all hospitals in the top row. Column 2 shows the independent effect of changes resulting from the reclassification of HCPCS codes among APC groups and the recalibration of APC weights based on a complete year of CY 2003 hospital OPPS claims data. We modeled the independent effect of APC recalibration by varying only the weights, the final CY 2004 weights versus the final CY 2005 weights, in our baseline model, and calculating the percent difference in payments. Column 3 shows the impact of updating the wage indices used to calculate payment by applying the final FY 2005 IPPS wage indices, as subsequently corrected. In addition to new wage data, the new IPPS wage indices use the CBSA system as the basis for geographic adjustment for wages, rather than the MSA designations used previously. The FY 2005 IPPS wage indices also include the new adjustment for occupational mix, the reclassifications of hospitals to geographic areas by the MGCRB, the increased payment authorized by section 505 of Pub. L. 108-173 for out-migration, hold-harmless provisions for hospitals redesignated from urban to rural by the new labor market definitions, and the one-year transition, 50/50 blend for hospitals that experienced a decrease in their FY 2005 wage index compared to their FY 2004 wage index due solely to the changes in labor market definitions. The OPPS wage indices used in Column 3 do not include wage increases due to reclassification of hospitals through section 508 of Pub. L. 108-173. We modeled the independent effect of introducing the new wage indices by varying only the wage index between years, using CY 2004 weights, and a CY 2004 conversion factor that included a budget neutrality adjustment for changes in wage effects between 2004 and 2005. </P>
                    <P>Column 4 demonstrates the combined “budget neutral” impact of APC recalibration and wage index updates on various classes of hospitals, as well as the impact of updating the conversion factor with the market basket. We modeled the independent effect of budget neutrality adjustments and the market basket update by using the weights and wage indices for each year, and using a CY 2004 conversion factor that included a budget neutrality adjustment for differences in wages and the market basket increase. Finally, column 5 depicts the full impact of final CY 2005 policy on each hospital group by including the effect of all the changes for CY 2005 and comparing them to the full effect of all payments in CY 2004, including those authorized by Pub. L. 108-173. Column 5 shows not only the combined budget neutral effects of APC and wage updates, and the market basket update, but it also shows the effects of additional monies added to the OPPS as a result of Pub. L. 108-173 and pass-through money returned to the conversion factor from CY 2004. We modeled the independent effect of all changes using the final weights for CY 2004 and CY 2005 with additional money for drugs authorized by section 621 of Pub. L. 108-173, final wage indices including wage index increases for hospitals eligible for reclassification under section 508 of Pub. L. 108-173, and the CY 2005 conversion factor of $56.983. </P>
                    <HD SOURCE="HD2">Column 1: Total Number of Hospitals </HD>
                    <P>Column 1 in Table 41 shows the total number of hospital providers (4,296) for which we were able to use CY 2003 hospital outpatient claims to model CY 2004 and CY 2005 payments by classes of hospitals. We excluded all hospitals for which we could not accurately estimate CY 2004 or CY 2005 payment and entities that are not paid under the OPPS. The latter include critical access hospitals, all-inclusive hospitals, and hospitals located in Guam, the U.S. Virgin Islands, and the State of Maryland. This process is discussed in greater detail in section III.B of this final rule with comment period. In prior years, we displayed non-TEFRA hospitals paid under PPS separately from TEFRA hospitals in our impact and outlier tables. The distinction between TEFRA and non-TEFRA holds little value for OPPS as all hospitals are treated equally under the OPPS payment system. For this reason, we did not include TEFRA hospitals as a distinct hospital category in Table 41. The impact on this specific class of hospitals is captured in the rows addressing disproportionate share (DSH) as we only calculate a DSH variable for hospitals participating in the IPPS. Finally, of the hospitals displayed in Table 41 and Table 42, it is important to note that section 1833(t)(7)(D) of the Act holds harmless cancer hospitals, children's hospitals, small rural hospitals with less than 100 beds, and sole community hospitals in rural areas. The hold harmless provisions for cancer and children's hospitals are permanent; these hospitals cannot receive less payment in CY 2005 than they did in the CY 2004. For this reason, we will not specifically identify these classes of hospitals in future impact analyses. </P>
                    <HD SOURCE="HD2">Column 2: APC Recalibration </HD>
                    <P>The APC reclassification and recalibration changes tend to favor rural hospitals especially those characterized as small, although the overall redistribution impact is modest. Rural hospitals show a 0.6 percent increase, which is somewhat less than that observed in the proposed rule of 0.9. Specifically, rural hospitals with 50 to 100 beds show a 0.8 percent increase and rural hospitals with 101 to 149 beds show a 0.7 percent increase attributable to the APC recalibration. Mid-volume hospitals performing between 11,000 and 20,999 services experience an increase of 1.0 percent. Rural hospitals also show overall increases by region, with the East North Central and East South Central regions benefiting by at least 0.9 percent and the South Atlantic and West North Central regions benefiting by 0.7 percent. </P>
                    <P>
                        Urban hospitals show, on an average, a 0.2 percent decrease, which is comparable to that observed in the 
                        <PRTPAGE P="65853"/>
                        proposed rule. This decrease is spread among all urban hospitals. Large urban hospitals experience a decline of 0.1 percent and “other” urban hospitals experience a decline of 0.2 percent. Urban hospitals with greater than 200 beds show decreases, and the largest urban hospitals with bed size greater than 500 report a decrease of 0.9 percent. The smallest urban hospitals report a positive percent increases. Urban hospitals providing the lowest volume of services and those providing the highest also demonstrate negative impacts from APC recalibration. Decreases for urban hospitals are also concentrated in some regions, specifically, the South Atlantic, West South Central, Mountain, and Pacific experience decreases of at least 0.1 percent. West South Central loses the most, 0.9 percent. 
                    </P>
                    <P>The largest observed impacts among other hospital classes resulting from APC recalibration include declines of 1 percent for major teaching hospitals and 2.3 percent for hospitals without a valid DSH variable, most of which are TEFRA hospitals. Hospitals treating more low-income patients (high DSH percentage) also demonstrate declines of 0.8 percent. However, hospitals treating fewer low-income patients experience positive impacts from APC recalibration. Government hospitals demonstrate a decline of 0.8 percent. The specialty hospitals, cancer and children's hospitals, also would experience declines of 2.4 and 1.5 percent due to APC recalibration, respectively, if they were not held harmless under section 1833(t)(7)(D) of the Act. </P>
                    <P>In general, APC changes effect the distribution of hospital payments by increasing payments to small rural hospitals while decreasing payments made to large urban hospitals, including major teaching hospitals and those serving a high percentage of low-income patients. </P>
                    <HD SOURCE="HD2">Column 3: Wage Effect </HD>
                    <P>Changes introduced by the new IPPS wage indices had a modest impact, but the distributions have changed since the proposed rule with the changes and additional provisions included in the final IPPS wage indices. Decreases in OPPS payment due to the new wage indices are generally located in rural hospitals, although specific classes of other hospitals also experience declines. Overall, urban hospitals experience no change in payments as a result of the new wage indices. However, large urban hospitals experience an increase of 0.1 percent. We estimate that rural hospitals will experience a decrease in payments of 0.2 percent. This pattern of urban gain and rural loss is evident in all of the urban and rural comparisons. Low-volume urban hospitals with fewer than 5,000 services and urban hospitals in the West South Central region show the largest percentage increase of 0.5. </P>
                    <P>Rural hospitals show modest decreases for most bed sizes but show the largest losses for hospitals with more than 200 beds. The new wage indices result in a 0.5 percent decrease for the largest rural hospitals. Similarly, high volume rural hospitals demonstrate an anticipated decline of 0.4 percent. Hospitals located in the New England and Middle Atlantic regions show a negative impact due to wage index changes regardless of urban or rural designation. However, rural hospitals in New England and the Middle Atlantic experience the largest decreases among regions of 0.7 and 0.6 percent, respectively. Rural hospitals in the South Atlantic, East North Central, East South Central, and Mountain regions also experience decreased payments. Rural sole community hospitals show the same impact as other rural hospitals; they experience a decline of 0.2 percent. </P>
                    <P>Looking across other categories of hospitals, major teaching hospitals are estimated to lose 0.3 percent. Almost all hospitals serving low-income patients lose 0.1 percent. Hospitals for which DSH is not available, mostly TEFRA hospitals, lose 0.3 percent. </P>
                    <HD SOURCE="HD2">Column 4: Budget Neutrality and Market Basket Update </HD>
                    <P>In general, the market basket update alleviates any negative impacts on payments created by the budget neutrality adjustments made in columns 2 and 3. As column 4 demonstrates, with the addition of the market basket update, we do not expect any class of hospital providers to experience an overall negative impact as a result of the proposed changes to OPPS for CY 2005. Further, the redistributions created by APC recalibration tend to offset those created by the new wage indices. For example, rural hospitals gain 0.6 percent from the APC changes but lose 0.2 percent as a result of changes to the wage indices, leading to an overall adjustment of 3.7 percent with the addition of the market basket. Urban hospitals show a decrease of 0.2 percent resulting from APC recalibration and no change as a result of the new wage index, leading to an update in column 4 of 3.2 percent. </P>
                    <P>For several classes of hospitals, positive or neutral wage effects do not offset the larger impacts of APC recalibration leading to lower update amounts. For example, low volume urban hospitals experience a negative APC recalibration effect of 1.1, but a positive wage effect of 0.5. The result is an overall update of 2.6, which is less than the market basket. A few hospital providers may experience much lower and much higher update amounts than the market basket because the combined impact of the budget neutrality adjustments for the APC recalibration and the new wage index are reinforcing. Urban hospitals with more than 500 beds show a gain of 2.2 percent because the impact of APC recalibration was −0.9 percent and the new wage indices added −0.1 percent. Major teaching hospitals experience a decline in payment due to APC recalibration of −1.0 and a decline due to wage indices of −0.3 resulting in an overall, budget neutral update of 2.0. Hospitals for which we have no DSH variable, mostly TEFRA hospitals, will experience a decrease in payments due to both APC recalibration and the new wage indices, leading to a budget neutral increase of 0.7 percent. Hospitals serving a high number of low-income patients experience an overall update of 2.4 percent. Finally, cancer hospitals show an update of only 0.2 percent, and children's hospitals, of only 2.0 percent, but statutory provisions ensure that each of these hospitals is “held harmless” relative to last year's payments. </P>
                    <P>A few hospitals may also gain from the combined positive effect of the APC recalibration and the wage effect. Overall, mid-volume urban hospitals and urban hospitals with a small number of beds, rural hospitals in the East South and North Central, West North and South Central, and nonteaching hospitals experience positive impacts from both APC recalibration and the new wage indices. </P>
                    <HD SOURCE="HD2">Column 5: All Changes for CY 2005 </HD>
                    <P>
                        Column 5 compares all changes for CY 2005 to a final simulated payment for CY 2004 and includes all additional dollars resulting from provisions in Pub. L. 108-173 in both years and the difference in pass-through estimates. Overall, we estimate that hospitals will gain 4.0 percent under this final rule with comment period relative to total spending with Pub. L. 108-173 dollars for drugs and wage indices in CY 2004. Hospitals do receive a 4.5-percent increase in dollars (3.3 percent for the market basket and 1.2 percent for pass-through dollars returned to the conversion factor), which is reflected in the conversion factor. However, hospitals received more additional money from provisions in Pub. L. 108-173 for spending on drugs and wage 
                        <PRTPAGE P="65854"/>
                        indices in CY 2004 than in CY 2005. This is largely a result of the decline in the statutory minimum payment for sole source specified covered outpatient drugs from 88 percent to 83 percent of AWP. The observed 4.0 percent reflects this difference in spending. 
                    </P>
                    <P>Some hospitals experience large increases in addition to those already garnered under budget neutrality. In rural areas, hospitals providing between 11,000 and 20,999 services are projected to experience an increase of 5.1 percent. Rural hospitals in the East South Central, West North Central, and West South Central are all projected to experience an increase of at least 5 percent. Very small urban hospitals, less than 99 beds, will experience an increase of 4.9 percent. On the other hand, a handful of types of hospitals will experience much smaller updates. Large urban hospitals will receive an update of 3.9 percent. Urban hospitals in the Middle Atlantic and Mountain regions will experience updates less than or equal to 3.5 percent. Rural hospitals in New England and the Middle Atlantic also have updates less than or equal to 3.5 percent. </P>
                    <P>Major teaching hospitals are projected to experience a smaller increase in payments, 2.6 percent, than the 4.0 percent aggregate for all hospitals due to negative impacts from both the APC recalibration, the new wage indices, and most probably the decline in spending for drugs under Pub. L. 108-73. Hospitals serving a disproportionate share of low-income patients also experience a lower increase, 3.4 percent. Hospitals for which there is no DSH information, mostly TEFRA hospitals, are estimated to receive an update of 0.3 percent. This low-observed increase appears to be largely due to APC recalibration issues and declines in the payment for drugs. The impact of final payment on the specialty hospitals, cancer and children's hospitals, is not shown. If these hospitals were paid under OPPS, the cancer hospitals would experience a negative impact. However, these hospitals are held harmless and, therefore, will not experience any decline in payment. As noted above, we do not intend to specifically identify these hospitals in our future impact analyses. </P>
                    <HD SOURCE="HD2">F. Projected Distribution of Outlier Payments </HD>
                    <P>As stated in section X.B. of this preamble, we have a projected target of 2 percent of the estimated CY 2005 expenditures to outlier payments. For CY 2005, we are adopting a fixed-dollar threshold. As discussed in section X.B. of the preamble, we are changing our current policy, which sets the outlier threshold using only a multiple of the APC payment rate, to a policy that includes both a multiple of the APC payment rate and a new fixed dollar threshold. This policy will better target outlier payments to higher cost, complex cases that create greater financial risk for hospitals. </P>
                    <P>For CY 2005, we are specifically proposing to require that, in order to qualify for an outlier payment, the cost of a service must exceed 1.75 times the APC payment rate and the cost must also exceed the sum of the APC rate plus a $1,175 fixed-dollar threshold. The outlier payment under this policy remains at 50 percent of the cost minus the multiple of the APC payment rate. </P>
                    <P>Table 42 below compares the percentage of outlier payments relative to total projected payments for the simulated CY 2004 and CY 2005 outlier policies. As discussed in section X.B. of this preamble, we included a charge inflation factor in our modeling for this final rule with comment period that was not included in our modeling for the proposed rule. This resulted in increased thresholds for both the simulated CY 2004 and final CY 2005 outlier policies. To provide an accurate comparison for the new policy, we estimated the CY 2004, multiple-only policy, using the CY 2003 claims with inflated charges to pay total outlier payments that are 2 percent of total estimated spending. This resulted in a multiple threshold of 2.95. </P>
                    <P>Overall, Table 42 demonstrates that the outlier policy accomplishes the goal of redistributing outlier payments to hospitals performing more expensive procedures and incurring greater financial risk. Notwithstanding the inclusion of a charge inflation factor, the observed distributions for both policies differ very little from those provided in the proposed rule. First, based on the mix of services for the hospitals that would be paid under the OPPS in CY 2005, fewer hospitals would receive outlier payments. This is appropriate as more outlier money is targeted to specific services. We estimate that approximately 85 percent of all hospitals will receive outlier payments under the new policy, whereas 95 percent of all hospitals were estimated to get outlier payments under the CY 2004 policy. </P>
                    <P>We estimate that the redistribution of outlier payments is modest, rarely shifting total payments by more than 1 percent. In light of this, many hospitals receiving outlier payments under the previous policy will continue to receive outlier payments but for a different set of services. Nonetheless, this final outlier policy appears to accomplish the goal of redirecting payments to high-cost, expensive services. The adopted outlier policy tends to benefit large urban hospitals, teaching hospitals, proprietary hospitals, and hospitals serving a moderate share of low-income patients. The distribution observed here may offset the less than average increases in payment observed for these same classes of hospitals in the overall impact Table 41. Selected hospitals are predicted to lose outlier payments. Rural hospitals, specifically those that show a small number of beds and provide a low volume of services, are eligible for fewer outlier payments when compared to other types of hospital categories, but, in general, these hospitals experience greater OPPS payment increases. Government hospitals experience a decrease in outlier payments of 0.3 percent, and TEFRA hospitals are projected to lose 1.2 percent in outlier payments. </P>
                    <HD SOURCE="HD2">G. Estimated Impacts of This Final Rule With Comment Period on Beneficiaries </HD>
                    <P>For services for which the beneficiary pays a coinsurance of 20 percent of the payment rate, the beneficiary share of payment will increase for services for which OPPS payments will rise and will decrease for services for which OPPS payments will fall. For example, for a mid-level office visit (APC 0601), the minimum unadjusted copayment in CY 2004 was $10.71. In this final rule with comment period, the minimum unadjusted copayment for APC 601 is $11.22 because the OPPS payment for the service will increase under this final rule with comment period. In another example, for a Level III Pathology Procedure (APC 0344), the minimum unadjusted copayment in CY 2004 was $17.16. In this final rule with comment period, the minimum unadjusted copayment for APC 0344 is $15.66 because the minimum unadjusted copayment is limited to 45 percent of the APC payment rate for CY 2005, as discussed in section XI. of this final rule with comment period. </P>
                    <P>However, in all cases, the statute limits beneficiary liability for co-payment for a service to the inpatient hospital deductible for the applicable year. This amount is $912 for CY 2005. </P>
                    <BILCOD>BILLING CODE 4102-01-P</BILCOD>
                    <GPH SPAN="3" DEEP="533">
                        <PRTPAGE P="65855"/>
                        <GID>ER15NO04.061</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="614">
                        <PRTPAGE P="65856"/>
                        <GID>ER15NO04.062</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="607">
                        <PRTPAGE P="65857"/>
                        <GID>ER15NO04.063</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="409">
                        <PRTPAGE P="65858"/>
                        <GID>ER15NO04.064</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="601">
                        <PRTPAGE P="65859"/>
                        <GID>ER15NO04.065</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="600">
                        <PRTPAGE P="65860"/>
                        <GID>ER15NO04.066</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="606">
                        <PRTPAGE P="65861"/>
                        <GID>ER15NO04.067</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="522">
                        <PRTPAGE P="65862"/>
                        <GID>ER15NO04.068</GID>
                    </GPH>
                    <BILCOD>BILLING CODE 4120-01-C</BILCOD>
                    <HD SOURCE="HD2">Conclusion </HD>
                    <P>The changes in this final rule with comment period affect all classes of hospitals. Some hospitals experience significant gains and others less significant gains, but all hospitals will experience positive updates in OPPS payments in CY 2005. Table 41 demonstrates the estimated distributional impact of the OPPS budget neutrality requirements and an additional 4.0 percent increase in payments for CY 2005, exclusive of outlier and transitional pass-through payments, across various classes of hospitals. Table 42 demonstrates the distributional impact of outlier payments under the new policy of a multiple and fixed-dollar threshold. These two tables and the accompanying discussion, in combination with the rest of this final rule with comment period, constitute a regulatory impact analysis. </P>
                    <P>In accordance with the provisions of Executive Order 12866, this final rule with comment period was reviewed by the Office of Management and Budget. </P>
                    <HD SOURCE="HD1">XV. Regulation Text </HD>
                    <LSTSUB>
                        <HD SOURCE="HED">List of Subjects in 42 CFR Part 419 </HD>
                        <P>Hospitals, Medicare, Reporting and recordkeeping requirements.</P>
                    </LSTSUB>
                    <REGTEXT TITLE="42" PART="419">
                        <AMDPAR>For the reasons set forth in the preamble, the Centers for Medicare &amp; Medicaid Services amends 42 CFR Chapter IV, Part 419, as set forth below: </AMDPAR>
                        <PART>
                            <PRTPAGE P="65863"/>
                            <HD SOURCE="HED">PART 419—PROSPECTIVE PAYMENT SYSTEM FOR HOSPITAL OUTPATIENT DEPARTMENT SERVICES </HD>
                        </PART>
                        <AMDPAR>1. The authority citation for Part 419 continues to read as follows: </AMDPAR>
                        <AUTH>
                            <HD SOURCE="HED">Authority:</HD>
                            <P>Secs. 1102, 1833(t), and 1871 of the Social Security Act (42 U.S.C. 1302, 1395l(t), and 1395hh). </P>
                        </AUTH>
                    </REGTEXT>
                    <REGTEXT TITLE="42" PART="419">
                          
                        <AMDPAR>2. Section 419.21 is amended by adding a new paragraph (e) to read as follows: </AMDPAR>
                        <SECTION>
                            <SECTNO>§ 419.21 </SECTNO>
                            <SUBJECT>Hospital outpatient services subject to the outpatient prospective payment system. </SUBJECT>
                            <STARS/>
                            <P>(e) Effective January 1, 2005, an initial preventive physical examination, as defined in § 410.16 of this chapter, if the examination is performed no later than 6 months after the individual's initial Part B coverage date that begins on or after January 1, 2005. </P>
                        </SECTION>
                    </REGTEXT>
                    <REGTEXT TITLE="42" PART="419">
                        <AMDPAR>3. Section 419.22 is amended by adding a new paragraph (s) to read as follows: </AMDPAR>
                        <SECTION>
                            <SECTNO>§ 419.22 </SECTNO>
                            <SUBJECT>Hospital outpatient services excluded from payment under the hospital outpatient prospective payment system. </SUBJECT>
                            <STARS/>
                            <P>(s) Effective December 8, 2003, screening mammography services and effective January 1, 2005, diagnostic mammography services. </P>
                        </SECTION>
                    </REGTEXT>
                    <REGTEXT TITLE="42" PART="419">
                        <AMDPAR>4. Section 419.64 is amended by revising paragraph (d) to read as follows: </AMDPAR>
                        <SECTION>
                            <SECTNO>§ 419.64 </SECTNO>
                            <SUBJECT>Transitional pass-through payments: Drugs and biologicals. </SUBJECT>
                            <STARS/>
                            <P>
                                (d) 
                                <E T="03">Amount of pass-through payment.</E>
                                 Subject to any reduction determined under § 419.62(b), the pass-through payment for a drug or biological equals the amount determined under section 1842(o) of the Social Security Act, minus the portion of the APC payment amount that CMS determines is associated with the drug or biological. 
                            </P>
                        </SECTION>
                    </REGTEXT>
                    <REGTEXT TITLE="42" PART="419">
                        <AMDPAR>5. Section 419.70 is amended by revising the section heading and paragraphs (f)(2)(i) and (f)(2)(ii) to read as follows: </AMDPAR>
                        <SECTION>
                            <SECTNO>§ 419.70 </SECTNO>
                            <SUBJECT>Transitional adjustment to limit decline in payments. </SUBJECT>
                            <STARS/>
                            <P>
                                (f) 
                                <E T="03">Pre-BBA amount defined.</E>
                                 * * * 
                            </P>
                            <P>
                                (2) 
                                <E T="03">Base payment-to-cost ratio defined.</E>
                                 * * * 
                            </P>
                            <P>(i) The provider's payment under this part for covered outpatient services furnished during one of the following periods, including any payment for these services through cost-sharing described in paragraph (e) of this section: </P>
                            <P>(A) The cost reporting period ending in 1996; or </P>
                            <P>(B) If the provider does not have a cost reporting period ending in 1996, the first cost reporting period ending on or after January 1, 1997, and before January 1, 2001; and </P>
                            <P>(ii) The reasonable costs of these services for the same cost reporting period. </P>
                            <STARS/>
                              
                            <EXTRACT>
                                <FP>(Catalog of Federal Domestic Assistance Program No. 93.773, Medicare—Hospital Insurance; and Program No. 93.774, Medicare—Supplementary Medical Insurance Program) </FP>
                            </EXTRACT>
                        </SECTION>
                    </REGTEXT>
                    <SIG>
                        <DATED>Dated: October 28, 2004. </DATED>
                        <NAME>Mark B. McClellan, </NAME>
                        <TITLE>Administrator, Centers for Medicare &amp; Medicaid Services. </TITLE>
                        <DATED>Dated: October 28, 2004. </DATED>
                        <NAME>Tommy G. Thompson, </NAME>
                        <TITLE>Secretary.</TITLE>
                    </SIG>
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                    </GPH>
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                    </GPH>
                    <GPH SPAN="3" DEEP="640">
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                    </GPH>
                    <GPH SPAN="3" DEEP="640">
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                    <GPH SPAN="3" DEEP="640">
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                    <GPH SPAN="3" DEEP="640">
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                        <GID>ER15NO04.110</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="640">
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                        <GID>ER15NO04.111</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="640">
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                        <GID>ER15NO04.112</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="640">
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                    </GPH>
                    <GPH SPAN="3" DEEP="640">
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                        <GID>ER15NO04.114</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="640">
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                        <GID>ER15NO04.115</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="640">
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                    </GPH>
                    <GPH SPAN="3" DEEP="640">
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                        <GID>ER15NO04.119</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="640">
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                    </GPH>
                    <GPH SPAN="3" DEEP="640">
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                        <GID>ER15NO04.121</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="640">
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                    </GPH>
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                    </GPH>
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                    </GPH>
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                    </GPH>
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                    </GPH>
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                    </GPH>
                    <GPH SPAN="3" DEEP="640">
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                    </GPH>
                    <GPH SPAN="3" DEEP="640">
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                    </GPH>
                    <GPH SPAN="3" DEEP="640">
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                    </GPH>
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                    </GPH>
                    <GPH SPAN="3" DEEP="640">
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                    </GPH>
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                    </GPH>
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                    </GPH>
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                        <GID>ER15NO04.201</GID>
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                        <GID>ER15NO04.202</GID>
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                    </GPH>
                </SUPLINF>
                <FRDOC>[FR Doc. 04-24759  Filed 11-2-04; 4:45 am]</FRDOC>
                <BILCOD>BILLING CODE 4120-01-P</BILCOD>
            </RULE>
        </RULES>
    </NEWPART>
    <VOL>69</VOL>
    <NO>219</NO>
    <DATE>Monday, November 15, 2004</DATE>
    <UNITNAME>Rules and Regulations</UNITNAME>
    <NEWPART>
        <PTITLE>
            <PRTPAGE P="66235"/>
            <PARTNO>Part III</PARTNO>
            <BOOK>Book 3 of 4 Books</BOOK>
            <PGS>Pages 66235-66916</PGS>
            <AGENCY TYPE="P">Department of Health and Human Services</AGENCY>
            <SUBAGY>Centers for Medicare &amp; Medicaid Services</SUBAGY>
            <HRULE/>
            <CFR>42 CFR Parts 403, 405, 410, et al.</CFR>
            <TITLE>Medicare Program; Revisions to Payment Policies Under the Physician Fee Schedule for Calendar Year 2005; Final Rule</TITLE>
        </PTITLE>
        <RULES>
            <RULE>
                <PREAMB>
                    <PRTPAGE P="66236"/>
                    <AGENCY TYPE="S">DEPARTMENT OF HEALTH AND HUMAN SERVICES</AGENCY>
                    <SUBAGY>Centers for Medicare &amp; Medicaid Services</SUBAGY>
                    <CFR>42 CFR Parts 403, 405, 410, 411, 414, 418, 424, 484, and 486</CFR>
                    <DEPDOC>[CMS-1429-FC] </DEPDOC>
                    <RIN>RIN 0938-AM90 </RIN>
                    <SUBJECT>Medicare Program; Revisions to Payment Policies Under the Physician Fee Schedule for Calendar Year 2005 </SUBJECT>
                    <AGY>
                        <HD SOURCE="HED">AGENCY:</HD>
                        <P>Centers for Medicare &amp; Medicaid Services (CMS), HHS. </P>
                    </AGY>
                    <ACT>
                        <HD SOURCE="HED">ACTION:</HD>
                        <P>Final rule with comment period. </P>
                    </ACT>
                    <SUM>
                        <HD SOURCE="HED">SUMMARY:</HD>
                        <P>This final rule refines the resource-based practice expense relative value units (RVUs) and makes other changes to Medicare Part B payment policy. These policy changes concern: supplemental survey data for practice expense; updated geographic practice cost indices for physician work and practice expense; updated malpractice RVUs; revised requirements for supervision of therapy assistants; revised payment rules for low osmolar contrast media; changes to payment policies for physicians and practitioners managing dialysis patients; clarification of care plan oversight requirements; revised requirements for supervision of diagnostic psychological testing services; clarifications to the policies affecting therapy services; revised requirements for assignment of Medicare claims; addition to the list of telehealth services; and, several coding issues. We are making these changes to ensure that our payment systems are updated to reflect changes in medical practice and the relative value of services. </P>
                        <P>This final rule also addresses the following provisions of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (Pub. L. 108-17) (MMA): coverage of an initial preventive physical examination; coverage of cardiovascular (CV) screening blood tests; coverage of diabetes screening tests; incentive payment improvements for physicians in shortage areas; payment for covered outpatient drugs and biologicals; payment for renal dialysis services; coverage of routine costs associated with certain clinical trials of category A devices as defined by the Food and Drug Administration; hospice consultation service; indexing the Part B deductible to inflation; extension of coverage of intravenous immune globulin (IVIG) for the treatment in the home of primary immune deficiency diseases; revisions to reassignment provisions; and, payment for diagnostic mammograms, physicians' services associated with drug administration services and coverage of religious nonmedical health care institution items and services to the beneficiary's home. </P>
                        <P>In addition, this rule updates the codes subject to the physician self-referral prohibition, discusses payment for set-up of portable x-ray equipment, discusses the third five-year refinement of work RVUs, and solicits comments on potentially misvalued work RVUs. </P>
                        <P>We are also finalizing the calendar year (CY) 2004 interim RVUs and are issuing interim RVUs for new and revised procedure codes for CY 2005. </P>
                        <P>As required by the statute, we are announcing that the physician fee schedule update for CY 2005 is 1.5 percent, the initial estimate for the sustainable growth rate for CY 2005 is 4.3, and the conversion factor for CY 2005 is $37.8975. </P>
                    </SUM>
                    <EFFDATE>
                        <HD SOURCE="HED">DATES:</HD>
                        <P>
                            <E T="03">Effective Date:</E>
                             These regulations are effective on January 1, 2005. 
                        </P>
                        <P>
                            <E T="03">Applicability Date:</E>
                             Section 623 of the MMA, that is, the case-mix portion of the revised composite payment methodology and the budget neutrality adjustment required by the MMA, is applicable on April 1, 2005. 
                        </P>
                        <P>
                            <E T="03">Comment Date:</E>
                             To be assured consideration, comments must be received at one of the addresses provided below, no later than 5 p.m. on January 3, 2005. 
                        </P>
                    </EFFDATE>
                    <ADD>
                        <HD SOURCE="HED">ADDRESSES:</HD>
                        <P>In commenting, please refer to file code CMS-1429-FC. Because of staff and resource limitations, we cannot accept comments by facsimile (FAX) transmission. </P>
                        <P>You may submit comments in one of three ways (no duplicates, please): </P>
                        <P>
                            1. 
                            <E T="03">Electronically.</E>
                             You may submit electronic comments on specific issues in this regulation to 
                            <E T="03">http://www.cms.hhs.gov/regulations/ecomments.</E>
                             (Attachments should be in Microsoft Word, WordPerfect, or Excel; however, we prefer Microsoft Word.) 
                        </P>
                        <P>
                            2. 
                            <E T="03">By mail.</E>
                             You may mail written comments (one original and two copies) to the following address ONLY: Centers for Medicare &amp; Medicaid Services, Department of Health and Human Services,  Attention: CMS-1429-FC, P.O. Box 8012,  Baltimore, MD 21244-8012. 
                        </P>
                        <P>Please allow sufficient time for mailed comments to be received before the close of the comment period. </P>
                        <P>
                            3. 
                            <E T="03">By hand or courier.</E>
                             If you prefer, you may deliver (by hand or courier) your written comments (one original and two copies) before the close of the comment period to one of the following addresses. If you intend to deliver your comments to the Baltimore address, please call telephone number 800-743-3951 in advance to schedule your arrival with one of our staff members. Room 445-G, Hubert H. Humphrey Building, 200 Independence Avenue, SW., Washington, DC 20201; or 7500 Security Boulevard, Baltimore, MD 21244-1850. 
                        </P>
                        <P>(Because access to the interior of the HHH Building is not readily available to persons without Federal Government identification, commenters are encouraged to leave their comments in the CMS drop slots located in the main lobby of the building. A stamp-in clock is available for persons wishing to retain a proof of filing by stamping in and retaining an extra copy of the comments being filed.) </P>
                        <P>Comments mailed to the addresses indicated as appropriate for hand or courier delivery may be delayed and received after the comment period. </P>
                        <P>
                            <E T="03">Submission of comments on paperwork requirements.</E>
                             You may submit comments on this document's paperwork requirements by mailing your comments to the addresses provided at the end of the “Collection of Information Requirements” section in this document. 
                        </P>
                        <P>
                            For information on viewing public comments, see the beginning of the 
                            <E T="02">SUPPLEMENTARY INFORMATION</E>
                             section. 
                        </P>
                    </ADD>
                    <FURINF>
                        <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                        <P SOURCE="NPAR">Pam West (410) 786-2302 (for issues related to Practice Expense, Respiratory Therapy Coding, and Therapy Supervision). </P>
                        <P>Rick Ensor (410) 786-5617 (for issues related to Geographic Practice Cost Index (GPCI) and malpractice RVUs). </P>
                        <P>Craig Dobyski (410) 786-4584 (for issues related to list of telehealth services or payments for physicians and practitioners managing dialysis patients). </P>
                        <P>Bill Larson or Tiffany Sanders (410) 786-7176 (for issues related to coverage of an initial preventive physical examination). </P>
                        <P>Cathleen Scally (410) 786-5714 (for issues related to payment of an initial preventive physical examination). </P>
                        <P>Joyce Eng (410) 786-7176 (for issues related to coverage of cardiovascular screening tests). </P>
                        <P>Betty Shaw (410) 786-7176 (for issues related to coverage of diabetes screening tests). </P>
                        <P>Anita Greenberg (410) 786-0548 (for issues related to payment of cardiovascular and diabetes screening tests). </P>
                        <P>
                            David Worgo (410) 786-5919, (for issues related to incentive payment 
                            <PRTPAGE P="66237"/>
                            improvements for physicians practicing in shortage areas). 
                        </P>
                        <P>Angela Mason or Jennifer Fan (410) 786-0548 (for issues related to payment for covered outpatient drugs and biologicals). </P>
                        <P>David Walczak (410) 786-4475 (for issues related to reassignment provisions). </P>
                        <P>Henry Richter (410) 786-4562 (for issues related to payments for ESRD facilities). </P>
                        <P>Steve Berkowitz (410) 786-7176 (for issues related to coverage of routine costs associated with certain clinical trials of category A devices). </P>
                        <P>Terri Deutsch (410) 786-9462 (for issues related to hospice consultation services). </P>
                        <P>Karen Daily (410) 786-7176 (for issues related to clinical conditions for payment of covered items of durable medical equipment). </P>
                        <P>Dorothy Shannon (410) 786-3396 (for issues related to outpatient therapy services performed “incident to” physicians' services). </P>
                        <P>Roberta Epps (410) 786-5919 (for issues related to low osmolar contrast media or supervision of diagnostic psychological testing services). </P>
                        <P>Gail Addis (410) 786-4522 (for issues related to care plan oversight). </P>
                        <P>Jean-Marie Moore (410) 786-3508 (for issues related to religious nonmedical health care institution services). </P>
                        <P>Diane Milstead (410) 786-3355 or Gaysha Brooks (410) 786-9649 (for all other issues). </P>
                    </FURINF>
                </PREAMB>
                <SUPLINF>
                    <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                    <P SOURCE="NPAR">
                        <E T="03">Submitting Comments:</E>
                         We welcome comments from the public on the following issues: interim RVUs for selected procedure codes identified in Addendum C; zip code areas for Health Professional Shortage Areas (HPSAs); the coverage of religious nonmedical health care institution items and services to the beneficiary's home; the physician self referral designated health services listed in tables 20 and 21; the third five-year refinement of work RVUs for services furnished beginning January 1, 2007; and, potentially misvalued work RVUs for all services in the CY 2005 physician fee schedule. You can assist us by referencing the file code CMS-1429-FC and the specific “issue identifier” that precedes the section on which you choose to comment. 
                    </P>
                    <P>
                        <E T="03">Inspection of Public Comments:</E>
                         Comments received timely will be available for public inspection as they are processed, generally beginning approximately 3 weeks after publication of a document, at the headquarters of the Centers for Medicare &amp; Medicaid Services, 7500 Security Boulevard, Baltimore, Maryland 21244, Monday through Friday of each week from 8:30 a.m. to 4 p.m. To schedule an appointment to view public comments, call 800-743-3951. 
                    </P>
                    <P>
                        <E T="03">Copies:</E>
                         To order copies of the 
                        <E T="04">Federal Register</E>
                         containing this document, send your request to: New Orders, Superintendent of Documents, P.O. Box 371954, Pittsburgh, PA 15250-7954. Specify the date of the issue requested and enclose a check or money order payable to the Superintendent of Documents, or enclose your Visa or Master Card number and expiration date. Credit card orders can also be placed by calling the order desk at (202) 512-1800 (or toll-free at 1-888-293-6498) or by faxing to (202) 512-2250. The cost for each copy is $10. As an alternative, you can view and photocopy the 
                        <E T="04">Federal Register</E>
                         document at most libraries designated as Federal Depository Libraries and at many other public and academic libraries throughout the country that receive the 
                        <E T="04">Federal Register</E>
                        . 
                    </P>
                    <P>
                        This 
                        <E T="04">Federal Register</E>
                         document is also available from the 
                        <E T="04">Federal Register</E>
                         online database through 
                        <E T="03">GPO Access,</E>
                         a service of the U.S. Government Printing Office. The web site address is: 
                        <E T="03">http://www.access.gpo.gov/nara/index.html.</E>
                    </P>
                    <P>Information on the physician fee schedule can be found on the CMS homepage. You can access this data by using the following directions: </P>
                    <P>
                        1. Go to the CMS homepage (
                        <E T="03">http://www.cms.hhs.gov</E>
                        ). 
                    </P>
                    <P>2. Place your cursor over the word “Professionals” in the blue area near the top of the page. Select “physicians” from the drop-down menu. </P>
                    <P>3. Under “Policies/Regulations” select “Physician Fee Schedule.” </P>
                    <P>To assist readers in referencing sections contained in this preamble, we are providing the following table of contents. Some of the issues discussed in this preamble affect the payment policies but do not require changes to the regulations in the Code of Federal Regulations. Information on the regulation's impact appears throughout the preamble and is not exclusively in section VII. </P>
                    <EXTRACT>
                        <HD SOURCE="HD1">Table of Contents </HD>
                        <FP SOURCE="FP-2">I. Background </FP>
                        <FP SOURCE="FP1-2">A. Legislative History </FP>
                        <FP SOURCE="FP1-2">B. Published Changes to the Fee Schedule </FP>
                        <FP SOURCE="FP1-2">C. Components of the Fee Schedule Payment Amounts </FP>
                        <FP SOURCE="FP1-2">D. Development of the Relative Value System </FP>
                        <FP SOURCE="FP-2">II. Provisions of the Proposed Regulation Related to the Physician Fee Schedule </FP>
                        <FP SOURCE="FP1-2">A. Resource-Based Practice Expense Relative Value Units </FP>
                        <FP SOURCE="FP1-2">1. Resource-Based Practice Expense Legislation </FP>
                        <FP SOURCE="FP1-2">2. Current Methodology </FP>
                        <FP SOURCE="FP1-2">3. Practice Expense Proposals for Calendar Year 2005 </FP>
                        <FP SOURCE="FP1-2">B. Geographic Practice Cost Indices (GPCIs) </FP>
                        <FP SOURCE="FP1-2">C. Malpractice RVUs </FP>
                        <FP SOURCE="FP1-2">D. Coding Issues </FP>
                        <FP SOURCE="FP-2">III. Provisions Related to the Medicare Modernization Act of 2003 </FP>
                        <FP SOURCE="FP1-2">A. Section 611—Preventive Physical Examination </FP>
                        <FP SOURCE="FP1-2">B. Section 613—Diabetes Screening </FP>
                        <FP SOURCE="FP1-2">C. Section 612—Cardiovascular Screening </FP>
                        <FP SOURCE="FP1-2">D. Section 413—Incentive Payment for Physician Scarcity </FP>
                        <FP SOURCE="FP1-2">E. Section 303—Payment for Covered Outpatient Drugs and Biologicals </FP>
                        <FP SOURCE="FP1-2">F. Section 952—Revision to Reassignment Provisions </FP>
                        <FP SOURCE="FP1-2">G. Section 642—Extension of Coverage of IVIG for the Treatment in the Home of Primary Immune Deficiency Diseases </FP>
                        <FP SOURCE="FP1-2">H. Section 623—Payment for Renal Dialysis Services </FP>
                        <FP SOURCE="FP1-2">I. Section 731—Coverage of Routine Costs for Category A Clinical Trials </FP>
                        <FP SOURCE="FP1-2">J. Section 629—Part B Deductible </FP>
                        <FP SOURCE="FP1-2">K. Section 512—Hospice Consultation Service </FP>
                        <FP SOURCE="FP1-2">L. Section 302—Clinical Conditions for Coverage of Durable Medical Equipment (DME) </FP>
                        <FP SOURCE="FP1-2">M. Section 614—Payment for Certain Mammography Services </FP>
                        <FP SOURCE="FP1-2">N. Section 305—Payment for Inhalation Drugs </FP>
                        <FP SOURCE="FP1-2">O. Section 706 Coverage of Religious Nonmedical Health Care Institution Services Furnished in the Home </FP>
                        <FP SOURCE="FP-2">IV. Other Issues </FP>
                        <FP SOURCE="FP1-2">A. Provisions Related to Therapy Services </FP>
                        <FP SOURCE="FP1-2">1. Outpatient Therapy Services Performed “Incident to” Physicians’ Services </FP>
                        <FP SOURCE="FP1-2">2. Qualification Standards and Supervision Requirements in Therapy Private Practice Settings </FP>
                        <FP SOURCE="FP1-2">3. Other Technical Revisions </FP>
                        <FP SOURCE="FP1-2">B. Low Osmolar Contrast Media </FP>
                        <FP SOURCE="FP1-2">C. Payments for Physicians and Practitioners Managing Patients on Dialysis </FP>
                        <FP SOURCE="FP1-2">D. Technical Revision—§ 411.404 </FP>
                        <FP SOURCE="FP1-2">E. Diagnostic Psychological Tests </FP>
                        <FP SOURCE="FP1-2">F. Care Plan Oversight </FP>
                        <FP SOURCE="FP1-2">G. Assignment of Medicare Claims-Payment to the Supplier </FP>
                        <FP SOURCE="FP1-2">H. Additional Issues Raised by Commenters </FP>
                        <FP SOURCE="FP-2">V. Refinement of Relative Value Units for Calendar Year 2004 and Response to Public Comments on Interim Relative Value Units for 2003 </FP>
                        <FP SOURCE="FP-2">VI. Five-Year Refinement of Relative Value Units VII. Update to the Codes for Physician Self-Referral Prohibition </FP>
                        <FP SOURCE="FP-2">VIII. Physician Fee Schedule Update for Calendar Year 2005 </FP>
                        <FP SOURCE="FP-2">IX. Allowed Expenditures for Physicians' Services and the Sustainable Growth Rate </FP>
                        <FP SOURCE="FP-2">X. Anesthesia and Physician Fee Schedule Conversion Factors for CY 2005 </FP>
                        <FP SOURCE="FP-2">XI. Telehealth Originating Site Facility Fee Payment Amount Update </FP>
                        <FP SOURCE="FP-2">XII. Provisions of the Final Rule </FP>
                        <FP SOURCE="FP-2">XIII. Waiver of Proposed Rulemaking </FP>
                        <FP SOURCE="FP-2">
                            XIV. Collection of Information Requirements 
                            <PRTPAGE P="66238"/>
                        </FP>
                        <FP SOURCE="FP-2">XV. Response to Comments </FP>
                        <FP SOURCE="FP-2">XVI. Regulatory Impact Analysis </FP>
                        <FP SOURCE="FP-2">Addendum A—Explanation and Use of Addendum B. </FP>
                        <FP SOURCE="FP-2">Addendum B—2005 Relative Value Units and Related Information Used in Determining Medicare Payments for 2005. </FP>
                        <FP SOURCE="FP-2">Addendum C—Codes With Interim RVUs </FP>
                        <FP SOURCE="FP-2">Addendum D—2005 Geographic Practice Cost Indices by Medicare Carrier and Locality </FP>
                        <FP SOURCE="FP-2">Addendum E—2006 Geographic Practice Cost Indices by Medicare Carrier and Locality </FP>
                        <FP SOURCE="FP-2">Addendum F—Comparison of 2004 GAFs to 2005 GAFs </FP>
                        <FP SOURCE="FP-2">Addendum G—Comparison of 2004 GAFs to 2006 GAFs </FP>
                        <FP SOURCE="FP-2">Addendum H—Specialty Care PSA Zip Codes </FP>
                        <FP SOURCE="FP-2">Addendum I—2005 Primary Care HSPA Zip Codes </FP>
                        <FP SOURCE="FP-2">Addendum J—Primary Care PSA Zip Codes </FP>
                        <FP SOURCE="FP-2">Addendum K—Mental Health HPSA Zip Codes </FP>
                        <FP SOURCE="FP-2">Addendum L—Updated List of CPT/HCPCS Codes Used To Describe Certain Designated Health Services Under the Physician Self-Referral Provision </FP>
                    </EXTRACT>
                    <P>In addition, because of the many organizations and terms to which we refer by acronym in this final rule, we are listing these acronyms and their corresponding terms in alphabetical order below: </P>
                    <EXTRACT>
                        <FP SOURCE="FP-2">AAA Abdominal aortic aneurysm </FP>
                        <FP SOURCE="FP-2">AAFP American Academy of Family Physicians </FP>
                        <FP SOURCE="FP-2">AAKP American Association of Kidney Patients </FP>
                        <FP SOURCE="FP-2">AANA American Association of Nurse Anesthetists </FP>
                        <FP SOURCE="FP-2">ABI Ankle brachial index </FP>
                        <FP SOURCE="FP-2">ABN Advanced beneficiary notice </FP>
                        <FP SOURCE="FP-2">ACC American College of Cardiology </FP>
                        <FP SOURCE="FP-2">ACLA American Clinical Laboratory Association </FP>
                        <FP SOURCE="FP-2">ACP American College of Physicians </FP>
                        <FP SOURCE="FP-2">ACPM American College of Preventative Medicine </FP>
                        <FP SOURCE="FP-2">ACR American College of Radiology </FP>
                        <FP SOURCE="FP-2">ADLs Activities of daily living </FP>
                        <FP SOURCE="FP-2">AFROC Association of Freestanding Radiation Oncology Centers </FP>
                        <FP SOURCE="FP-2">AGS American Geriatric Society </FP>
                        <FP SOURCE="FP-2">AHA American Heart Association </FP>
                        <FP SOURCE="FP-2">AMA American Medical Association </FP>
                        <FP SOURCE="FP-2">AOA American Osteopathic Association </FP>
                        <FP SOURCE="FP-2">APA Administrative Procedures Act </FP>
                        <FP SOURCE="FP-2">APTA American Physical Therapy Association </FP>
                        <FP SOURCE="FP-2">ASA American Society of Anesthesiologists </FP>
                        <FP SOURCE="FP-2">ASCP American Society for Clinical Pathology </FP>
                        <FP SOURCE="FP-2">ASN American Society of Nephrology </FP>
                        <FP SOURCE="FP-2">ASP Average sales price </FP>
                        <FP SOURCE="FP-2">ASTRO American Society for Therapeutic Radiation Oncology </FP>
                        <FP SOURCE="FP-2">ATA American Telemedicine Association </FP>
                        <FP SOURCE="FP-2">AWP Average wholesale price </FP>
                        <FP SOURCE="FP-2">BBA Balanced Budget Act of 1997</FP>
                        <FP SOURCE="FP-2">BBRA Balanced Budget Refinement Act of 1999</FP>
                        <FP SOURCE="FP-2">BIPA Benefits Improvement and Protection Act of 2000</FP>
                        <FP SOURCE="FP-2">BLS Bureau of Labor Statistics</FP>
                        <FP SOURCE="FP-2">BMI Body mass index</FP>
                        <FP SOURCE="FP-2">BSA Body surface area</FP>
                        <FP SOURCE="FP-2">CAH Critical access hospital</FP>
                        <FP SOURCE="FP-2">CAP College of American Pathologists</FP>
                        <FP SOURCE="FP-2">CAPD Continuous ambulatory peritoneal dialysis</FP>
                        <FP SOURCE="FP-2">CCPD Continuous cycling peritoneal dialysis</FP>
                        <FP SOURCE="FP-2">CDC Centers for Disease Control and Prevention</FP>
                        <FP SOURCE="FP-2">CF Conversion factor</FP>
                        <FP SOURCE="FP-2">CFR Code of Federal Regulations</FP>
                        <FP SOURCE="FP-2">CLIA Clinical Laboratory Improvement Amendment</FP>
                        <FP SOURCE="FP-2">CMA California Medical Association</FP>
                        <FP SOURCE="FP-2">CMS Centers for Medicare &amp; Medicaid Services</FP>
                        <FP SOURCE="FP-2">CNMs Certified nurse midwives</FP>
                        <FP SOURCE="FP-2">CNS Clinical nurse specialist</FP>
                        <FP SOURCE="FP-2">COPD Chronic obstructive pulmonary disease</FP>
                        <FP SOURCE="FP-2">CORF Comprehensive outpatient rehabilitation facilities</FP>
                        <FP SOURCE="FP-2">CPEP Clinical Practice Expert Panel</FP>
                        <FP SOURCE="FP-2">CPI Consumer Price Index</FP>
                        <FP SOURCE="FP-2">CPO Care Plan Oversight</FP>
                        <FP SOURCE="FP-2">CPT [Physicians'] Current Procedural Terminology [4th Edition, 2002, copyrighted by the American Medical Association]</FP>
                        <FP SOURCE="FP-2">CRNAs Certified Registered Nurse Anesthetists</FP>
                        <FP SOURCE="FP-2">CT Computed tomography</FP>
                        <FP SOURCE="FP-2">CV Cardiovascular</FP>
                        <FP SOURCE="FP-2">CY Calendar year</FP>
                        <FP SOURCE="FP-2">DEXA Dual energy x-ray absorptiometry</FP>
                        <FP SOURCE="FP-2">DHS Designated health services</FP>
                        <FP SOURCE="FP-2">DME Durable medical equipment</FP>
                        <FP SOURCE="FP-2">DMEPOS Durable medical equipment, prosthetics, orthotics, and supplies</FP>
                        <FP SOURCE="FP-2">DMERC Durable medical equipment regional carrier</FP>
                        <FP SOURCE="FP-2">DOI Departments of Insurance</FP>
                        <FP SOURCE="FP-2">DRE Digital rectal exam</FP>
                        <FP SOURCE="FP-2">DRG Diagnosis-related groups</FP>
                        <FP SOURCE="FP-2">DVT Deep venous thrombosis</FP>
                        <FP SOURCE="FP-2">EKG Electrocardiogram</FP>
                        <FP SOURCE="FP-2">E/M Evaluation and management</FP>
                        <FP SOURCE="FP-2">EPO Erythropoeitin</FP>
                        <FP SOURCE="FP-2">ESRD End-stage renal disease</FP>
                        <FP SOURCE="FP-2">FAX Facsimile</FP>
                        <FP SOURCE="FP-2">FMR Fair market rental</FP>
                        <FP SOURCE="FP-2">FQHC  Federally qualified healthcare center</FP>
                        <FP SOURCE="FP-2">FR Federal Register</FP>
                        <FP SOURCE="FP-2">FY Fiscal year</FP>
                        <FP SOURCE="FP-2">GAF Geographic adjustment factor</FP>
                        <FP SOURCE="FP-2">GPCI Geographic practice cost index</FP>
                        <FP SOURCE="FP-2">GTT Glucose tolerance test</FP>
                        <FP SOURCE="FP-2">HBO Hyperbaric oxygen</FP>
                        <FP SOURCE="FP-2">HCPAC Health Care Professional Advisory Committee</FP>
                        <FP SOURCE="FP-2">HCPCS Healthcare Common Procedure Coding System</FP>
                        <FP SOURCE="FP-2">HHA Home health agency</FP>
                        <FP SOURCE="FP-2">HHS [Department of] Health and Human Services</FP>
                        <FP SOURCE="FP-2">HIPAA Health Insurance Portability and Accountability Act of 1996</FP>
                        <FP SOURCE="FP-2">HOCM High osmolar contrast media</FP>
                        <FP SOURCE="FP-2">HPSA Health professional shortage area</FP>
                        <FP SOURCE="FP-2">HRSA Health Resources and Services Administration</FP>
                        <FP SOURCE="FP-2">HsCRP high sensitivity C-reactive protein</FP>
                        <FP SOURCE="FP-2">HUD Housing and Urban Development</FP>
                        <FP SOURCE="FP-2">IDTFs Independent diagnostic testing facilities</FP>
                        <FP SOURCE="FP-2">IMRT Intensity modulated radiation therapy</FP>
                        <FP SOURCE="FP-2">IOM Internet Only Manual</FP>
                        <FP SOURCE="FP-2">IPD Intermittent peritoneal dialysis</FP>
                        <FP SOURCE="FP-2">IPPE Initial preventive physical examination</FP>
                        <FP SOURCE="FP-2">IPPS Inpatient prospective payment system</FP>
                        <FP SOURCE="FP-2">ISO Insurance Services Office</FP>
                        <FP SOURCE="FP-2">IVIG Intravenous immune globulin</FP>
                        <FP SOURCE="FP-2">JUAs Joint underwriting associations</FP>
                        <FP SOURCE="FP-2">KCP Kidney Care Partners</FP>
                        <FP SOURCE="FP-2">KECC Kidney Epidemiology and Cost Center</FP>
                        <FP SOURCE="FP-2">LCD Local coverage determination</FP>
                        <FP SOURCE="FP-2">LMRP Local medical review policies</FP>
                        <FP SOURCE="FP-2">LOCM Low osmolar contrast media</FP>
                        <FP SOURCE="FP-2">LUPA Low utilization payment adjustment</FP>
                        <FP SOURCE="FP-2">MCM Medicare Carrier Manual</FP>
                        <FP SOURCE="FP-2">MCP Monthly capitation payment</FP>
                        <FP SOURCE="FP-2">MedPAC Medicare Payment Advisory Commission</FP>
                        <FP SOURCE="FP-2">MEI Medicare Economic Index</FP>
                        <FP SOURCE="FP-2">MGMA Medical Group Management Association</FP>
                        <FP SOURCE="FP-2">MMA Medicare Prescription Drug, Improvement, and Modernization Act of 2003</FP>
                        <FP SOURCE="FP-2">MPFS Medicare physician fee schedule</FP>
                        <FP SOURCE="FP-2">MSA Metropolitan statistical area</FP>
                        <FP SOURCE="FP-2">NAMCS National Ambulatory Medical Care Survey</FP>
                        <FP SOURCE="FP-2">NCD National coverage determination</FP>
                        <FP SOURCE="FP-2">NCIPC National Center for Injury Prevention and Control</FP>
                        <FP SOURCE="FP-2">NDC National drug code</FP>
                        <FP SOURCE="FP-2">NIH National Institutes of Health</FP>
                        <FP SOURCE="FP-2">NP Nurse practitioner</FP>
                        <FP SOURCE="FP-2">NPP Nonphysician practitioners</FP>
                        <FP SOURCE="FP-2">OASIS Outcome and Assessment Information Set</FP>
                        <FP SOURCE="FP-2">OBRA Omnibus Budget Reconciliation Act</FP>
                        <FP SOURCE="FP-2">OIG Office of Inspector General</FP>
                        <FP SOURCE="FP-2">OMB Office of Management and Budget</FP>
                        <FP SOURCE="FP-2">OPPS Outpatient prospective payment system</FP>
                        <FP SOURCE="FP-2">OT Occupational therapy</FP>
                        <FP SOURCE="FP-2">OTA Occupational therapist assistant</FP>
                        <FP SOURCE="FP-2">OTPP Occupational therapists in private practice</FP>
                        <FP SOURCE="FP-2">PA Physician assistant</FP>
                        <FP SOURCE="FP-2">PAD Peripheral arterial disease</FP>
                        <FP SOURCE="FP-2">PC Professional component</FP>
                        <FP SOURCE="FP-2">PCF Patient compensation fund</FP>
                        <FP SOURCE="FP-2">PD Peritoneal dialysis</FP>
                        <FP SOURCE="FP-2">PEAC Practice Expense Advisory Committee</FP>
                        <FP SOURCE="FP-2">PET Positron emission tomography</FP>
                        <FP SOURCE="FP-2">PFS Physician Fee Schedule</FP>
                        <FP SOURCE="FP-2">PHSA Public Health Services Act</FP>
                        <FP SOURCE="FP-2">PIAA Physician Insurers Association of America</FP>
                        <FP SOURCE="FP-2">PIN Provider identification number</FP>
                        <FP SOURCE="FP-2">PLI Professional liability insurance</FP>
                        <FP SOURCE="FP-2">POS Prosthetics, orthotics and supplies</FP>
                        <FP SOURCE="FP-2">PPI Producer price index</FP>
                        <FP SOURCE="FP-2">PPS Prospective payment system</FP>
                        <FP SOURCE="FP-2">PRA Paperwork Reduction Act</FP>
                        <FP SOURCE="FP-2">PSA Physician scarcity area</FP>
                        <FP SOURCE="FP-2">PT Physical therapy</FP>
                        <FP SOURCE="FP-2">PTA Physical therapist assistant</FP>
                        <FP SOURCE="FP-2">PTPP Physical therapists in private practice</FP>
                        <FP SOURCE="FP-2">PVD Peripheral vascular disease</FP>
                        <FP SOURCE="FP-2">
                            RFA Regulatory Flexibility Act
                            <PRTPAGE P="66239"/>
                        </FP>
                        <FP SOURCE="FP-2">RHC Rural health clinic</FP>
                        <FP SOURCE="FP-2">RHHI Regional home health intermediary</FP>
                        <FP SOURCE="FP-2">RIA Regulatory impact analysis</FP>
                        <FP SOURCE="FP-2">RN Registered nurse</FP>
                        <FP SOURCE="FP-2">RNHCI Religious nonmedical health care institution</FP>
                        <FP SOURCE="FP-2">RPA Renal Physicians Association</FP>
                        <FP SOURCE="FP-2">RT Respiratory therapy</FP>
                        <FP SOURCE="FP-2">RTs Respiratory therapists</FP>
                        <FP SOURCE="FP-2">RUC [AMA's Specialty Society] Relative [Value] Update Committee</FP>
                        <FP SOURCE="FP-2">RUCA Rural-Urban commuting area</FP>
                        <FP SOURCE="FP-2">RVU Relative value unit</FP>
                        <FP SOURCE="FP-2">SAF Standard analytic file</FP>
                        <FP SOURCE="FP-2">SCHIP State Child Health Insurance Program</FP>
                        <FP SOURCE="FP-2">SGR Sustainable growth rate</FP>
                        <FP SOURCE="FP-2">SHIPs State Health Insurance Assistance Programs</FP>
                        <FP SOURCE="FP-2">SIR Society for Interventional Radiology</FP>
                        <FP SOURCE="FP-2">SLP Speech language pathology</FP>
                        <FP SOURCE="FP-2">SMR Standardized mortality ratio</FP>
                        <FP SOURCE="FP-2">SMS [AMA's] Socioeconomic Monitoring System</FP>
                        <FP SOURCE="FP-2">SNF Skilled nursing facility</FP>
                        <FP SOURCE="FP-2">TC Technical component</FP>
                        <FP SOURCE="FP-2">UAF Update adjustment factor</FP>
                        <FP SOURCE="FP-2">URR Urea reduction ratios</FP>
                        <FP SOURCE="FP-2">USPSTF U.S. Preventive Services Task Force</FP>
                    </EXTRACT>
                    <HD SOURCE="HD1">I. Background</HD>
                    <HD SOURCE="HD2">A. Legislative History</HD>
                    <P>Medicare has paid for physicians' services under section 1848 of the Social Security Act (the Act), “Payment for Physicians' Services” since January 1, 1992. The Act requires that payments under the fee schedule be based on national uniform relative value units (RVUs) reflecting the resources used in furnishing a service. Section 1848(c) of the Act requires that national RVUs be established for physician work, practice expense, and malpractice expense. Section 1848(c)(2)(B)(ii)(II) of the Act provides that adjustments in RVUs may not cause total physician fee schedule payments to differ by more than $20 million from what they would have been had the adjustments not been made. If adjustments to RVUs cause expenditures to change by more than $20 million, we must make adjustments to ensure that they do not increase or decrease by more than $20 million.</P>
                    <HD SOURCE="HD2">B. Published Changes to the Fee Schedule</HD>
                    <P>The July 2000 and August 2003 proposed rules ((65 FR 44177) and (68 FR 49030), respectively), include a summary of the final physician fee schedule rules published through February 2003.</P>
                    <P>In the November 7, 2003 final rule, we refined the resource-based practice expense RVUs and made other changes to Medicare Part B payment policy. The specific policy changes concerned: the Medicare Economic Index; practice expense for professional component services; definition of diabetes for diabetes self-management training; supplemental survey data for practice expense; geographic practice cost indices; and several coding issues. In addition, this rule updated the codes subject to the physician self-referral prohibition. We also made revisions to the sustainable growth rate and the anesthesia conversion factor. Additionally, we finalized the CY 2003 interim RVUs and issued interim RVUs for new and revised procedure codes for CY 2004.</P>
                    <P>As required by the statute, we announced that the physician fee schedule update for CY 2004 was −4.5 percent; that the initial estimate of the sustainable growth rate for CY 2004 was 7.4 percent; and that the conversion factor for CY 2004 was $35.1339.</P>
                    <P>Subsequent to the November 7, 2003 final rule, the Congress enacted the  Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (Pub. L. 108-17) (MMA). On January 7, 2004, an interim final rule was published to implement provisions of the MMA applicable in 2004 to Medicare payment for covered drugs and physician fee schedule services. These provisions included—</P>
                    <P>• Revising the current payment methodology for Medicare Part B covered drugs and biologicals that are not paid on a cost or prospective payment basis;</P>
                    <P>• Making changes to Medicare payment for furnishing or administering drugs and biologicals;</P>
                    <P>• Revising the geographic practice cost indices;</P>
                    <P>• Changing the physician fee schedule conversion factor. (Note: The 2004 physician fee schedule conversion factor is $37.3374); and</P>
                    <P>• Extending the “opt-out” provisions of section 1802(b)(5)(3) of the Act to dentists, podiatrists, and optometrists.</P>
                    <P>The information contained in the January 7, 2004 interim final rule concerning payment under the physician fee schedule superceded information contained in the November 7, 2003 final rule to the extent that the two are inconsistent.</P>
                    <HD SOURCE="HD2">C. Components of the Fee Schedule Payment Amounts</HD>
                    <P>Under the formula set forth in section 1848(b)(1) of the Act, the payment amount for each service paid under the physician fee schedule is the product of three factors: (1) A nationally uniform relative value unit (RVU) for the service; (2) a geographic adjustment factor (GAF) for each physician fee schedule area; and (3) a nationally uniform conversion factor (CF) for the service. The CF converts the relative values into payment amounts.</P>
                    <P>For each physician fee schedule service, there are three relative values: (1) An RVU for physician work; (2) an RVU for practice expense; and (3) an RVU for malpractice expense. For each of these components of the fee schedule, there is a geographic practice cost index (GPCI) for each fee schedule area. The GPCIs reflect the relative costs of practice expenses, malpractice insurance, and physician work in an area compared to the national average for each component.</P>
                    <P>The general formula for calculating the Medicare fee schedule amount for a given service in a given fee schedule area can be expressed as:</P>
                    <FP SOURCE="FP-2">Payment = [(RVU work × GPCI work) + (RVU practice expense × GPCI practice expense) + (RVU malpractice x GPCI malpractice)] × CF</FP>
                    <P>The CF for calendar year (CY) 2005 appears in section X. The RVUs for CY 2005 are in Addendum B. The GPCIs for CY 2005 can be found in Addendum D.</P>
                    <P>Section 1848(e) of the Act requires us to develop GAFs for all physician fee schedule areas. The total GAF for a fee schedule area is equal to a weighted average of the individual GPCIs for each of the three components of the service. In accordance with the statute, however, the GAF for the physician's work reflects one-quarter of the relative cost of physician's work compared to the national average.</P>
                    <HD SOURCE="HD2">D. Development of the Relative Value System</HD>
                    <HD SOURCE="HD3">1. Work Relative Value Units</HD>
                    <P>Approximately 7,500 codes represent services included in the physician fee schedule. The work RVUs established for the implementation of the fee schedule in January 1992 were developed with extensive input from the physician community. A research team at the Harvard School of Public Health developed the original work RVUs for most codes in a cooperative agreement with us. In constructing the vignettes for the original RVUs, Harvard worked with expert panels of physicians and obtained input from physicians from numerous specialties.</P>
                    <P>
                        The RVUs for radiology services were based on the American College of Radiology (ACR) relative value scale, which we integrated into the overall physician fee schedule. The RVUs for anesthesia services were based on RVUs from a uniform relative value guide. We established a separate CF for anesthesia services, and we continue to recognize 
                        <PRTPAGE P="66240"/>
                        time as a factor in determining payment for these services. As a result, there is a separate payment system for anesthesia services.
                    </P>
                    <HD SOURCE="HD3">2. Practice Expense and Malpractice Expense Relative Value Units</HD>
                    <P>Section 1848(c)(2)(C) of the Act requires that the practice expense and malpractice expense RVUs equal the product of the base allowed charges and the practice expense and malpractice percentages for the service. Base allowed charges are defined as the national average allowed charges for the service furnished during 1991, as estimated using the most recent data available. For most services, we used 1989 charge data aged to reflect the 1991 payment rules, because those were the most recent data available for the 1992 fee schedule.</P>
                    <P>Section 121 of the Social Security Act Amendments of 1994 (Pub. L. 103-432), enacted on October 31, 1994, required us to develop a methodology for a resource-based system for determining practice expense RVUs for each physician's service. As amended by the Balanced Budget Act of 1997 (BBA) (Pub. L. 105-33), enacted on August 5, 1997, section 1848(c) required the new payment methodology to be phased in over 4 years, effective for services furnished in 1999, with resource-based practice expense RVUs becoming fully effective in 2002. The BBA also required us to implement resource-based malpractice RVUs for services furnished beginning in 2000.</P>
                    <HD SOURCE="HD1">II. Provisions of the Proposed Rule Related to the Physician Fee Schedule</HD>
                    <P>In response to the publication of the August 5, 2004 proposed rule (69 FR 47488), we received approximately 9,302 comments. We received comments from individual physicians, health care workers, professional associations and societies, and beneficiaries. The majority of the comments addressed the proposals related to “incident to” therapy services, GPCI, diagnostic psychological testing, and drug issues including average sales price (ASP).</P>
                    <P>The proposed rule discussed policies that affected the number of RVUs on which payment for certain services would be based. The proposed rule also discussed policies related to implementation of the MMA. RVU changes implemented through this final rule are subject to the $20 million limitation on annual adjustments contained in section 1848(c)(2)(B)(ii)(II) of the Act.</P>
                    <P>After reviewing the comments and determining the policies we would implement, we have estimated the costs and savings of these policies and discuss in detail the effects of these changes in the Regulatory Impact Analysis in section XIV.</P>
                    <P>For the convenience of the reader, the headings for the policy issues correspond to the headings used in the August 5, 2004 proposed rule. More detailed background information for each issue can be found in the August 5, 2004 proposed rule.</P>
                    <HD SOURCE="HD2">A. Resource-Based Practice Expense Relative Value Units</HD>
                    <HD SOURCE="HD3">1. Resource-Based Practice Expense Legislation</HD>
                    <P>Section 121 of the Social Security Act Amendments of 1994 (Pub. L. 103-432), enacted on October 31, 1994, amended section 1848(c)(2)(C)(ii) of the Social Security Act (the Act) and required us to develop a methodology for a resource-based system for determining practice expense RVUs for each physician's service beginning in 1998. Until that time, physicians' practice expenses were established based on historical allowed charges.</P>
                    <P>In developing the methodology, we were to consider the staff, equipment, and supplies used in providing medical and surgical services in various settings. The legislation specifically required that, in implementing the new system of practice expense RVUs, we apply the same budget-neutrality provisions that we apply to other adjustments under the physician fee schedule.</P>
                    <P>Section 4505(a) of the Balanced Budget Act of 1997 (BBA) (Pub. L. 105-33), enacted on August 5, 1997, amended section 1848(c)(2)(C)(ii) of the Act and delayed the effective date of the resource-based practice expense RVU system until January 1, 1999. In addition, section 4505(b) of the BBA provided for a 4-year transition period from charge-based practice expense RVUs to resource-based RVUs.</P>
                    <P>Further legislation affecting resource-based practice expense RVUs was included in the Medicare, Medicaid and State Child Health Insurance Program (SCHIP) Balanced Budget Refinement Act of 1999 (BBRA) (Pub. L. 106-113) enacted on November 29, 1999. Section 212 of the BBRA amended section 1848(c)(2)(C)(ii) of the Act by directing us to establish a process under which we accept and use, to the maximum extent practicable and consistent with sound data practices, data collected or developed by entities and organizations. These data would supplement the data we normally collect in determining the practice expense component of the physician fee schedule for payments in CY 2001 and CY 2002. (The 1999 and 2003 final rules (64 FR 59380 and 68 FR 63196, respectively, extended the period during which we would accept supplemental data.)</P>
                    <HD SOURCE="HD3">2. Current Methodology for Computing the Practice Expense Relative Value Unit System</HD>
                    <P>In the November 2, 1998 final rule (63 FR 58910), effective with services furnished on or after January 1, 1999, we established at 42 CFR 414.22(b)(5) a new methodology for computing resource-based practice expense RVUs that used the two significant sources of actual practice expense data we have available—the Clinical Practice Expert Panel (CPEP) data and the American Medical Association's (AMA) Socioeconomic Monitoring System (SMS) data. The CPEP data were collected from panels of physicians, practice administrators, and nonphysicians (for example registered nurses) nominated by physician specialty societies and other groups. The CPEP panels identified the direct inputs required for each physicians service in both the office setting and out-of-office setting. The AMA's SMS data provided aggregate specialty-specific information on hours worked and practice expenses. The methodology was based on an assumption that current aggregate specialty practice costs are a reasonable way to establish initial estimates of relative resource costs for physicians' services across specialties. The methodology allocated these aggregate specialty practice costs to specific procedures and, thus, can be seen as a “top-down” approach.</P>
                    <P>Also in the November 2, 1998 final rule, in response to comments, we discussed the establishment of the Practice Expense Advisory Committee (PEAC) of the AMA's Specialty Society Relative Value Update Committee (RUC), which would review code'specific CPEP data during the refinement period. This committee would include representatives from all major specialty societies and would make recommendations to us on suggested changes to the CPEP data.</P>
                    <P>
                        As directed by the BBRA, we also established a process (
                        <E T="03">see</E>
                         65 FR 65380) under which we would accept and use, to the maximum extent practicable and consistent with sound data practices, data collected by entities and organizations to supplement the data we normally collect in determining the practice expense component of the physician fee schedule.
                        <PRTPAGE P="66241"/>
                    </P>
                    <HD SOURCE="HD2">a. Major Steps</HD>
                    <P>A brief discussion of the major steps involved in the determination of the practice expense RVUs follows. (Please see the November 1, 2001 final rule (66 FR 55249) for a more detailed explanation of the top-down methodology.) </P>
                    <P>
                        • 
                        <E T="03">Step 1—</E>
                        Determine the specialty specific practice expense per hour of physician direct patient care. We used the AMA's SMS survey of actual aggregate cost data by specialty to determine the practice expenses per hour for each specialty. We calculated the practice expenses per hour for the specialty by dividing the aggregate practice expenses for the specialty by the total number of hours spent in patient care activities. 
                    </P>
                    <P>
                        • 
                        <E T="03">Step 2—</E>
                        Create a specialty-specific practice expense pool of practice expense costs for treating Medicare patients. To calculate the total number of hours spent treating Medicare patients for each specialty, we used the physician time assigned to each procedure code and the Medicare utilization data. The primary sources for the physician time data were surveys submitted to the AMA's RUC and surveys done by Harvard for the establishment of the work RVUs. We then multiplied the physician time assigned per procedure code by the number of times that code was billed by each specialty, and summed the products for each code, by specialty, to get the total physician hours spent treating Medicare patients for that specialty. We then calculated the specialty-specific practice expense pools by multiplying the specialty practice expenses per hour (from step 1) by the total Medicare physician hours for the specialty. 
                    </P>
                    <P>
                        • 
                        <E T="03">Step 3—</E>
                        Allocate the specialty-specific practice expense pool to the specific services (procedure codes) performed by each specialty. For each specialty, we divided the practice expense pool into two groups based on whether direct or indirect costs were involved and used a different allocation basis for each group. 
                    </P>
                    <P>(i) Direct costs—For direct costs (which include clinical labor, medical supplies, and medical equipment), we used the procedure-specific CPEP data on the staff time, supplies, and equipment as the allocation basis. For the separate practice expense pool for services without physician work RVUs, we have used, on an interim basis, 1998 practice expense RVUs to allocate the direct cost pools. </P>
                    <P>(ii) Indirect costs—To allocate the cost pools for indirect costs, including administrative labor, office expenses, and all other expenses, we used the total direct costs, or the 1998 practice expense RVUs, in combination with the physician fee schedule work RVUs. We converted the work RVUs to dollars using the Medicare CF (expressed in 1995 dollars for consistency with the SMS survey years). </P>
                    <P>
                        • 
                        <E T="03">Step 4—</E>
                        The direct and indirect costs are then added together to attain the practice expense for each procedure, by specialty. For procedures performed by more than one specialty, the final practice expense allocation was a weighted average of practice expense allocations for the specialties that perform the procedure, based on the frequency with which each specialty performs the procedure on Medicare patients. 
                    </P>
                    <HD SOURCE="HD2">b. Other Methodological Issues </HD>
                    <HD SOURCE="HD3">i. Nonphysician Work Pool </HD>
                    <P>As an interim measure, until we could further analyze the effect of the top-down methodology on the Medicare payment for services with physician work RVUs equal to zero (including the technical components of radiology services and other diagnostic tests), we created a separate practice expense pool. We first used the average clinical staff time from the CPEP data and the “all physicians” practice expense per hour to create the pool. In the December 2002 final rule, we changed this policy and now use the total clinical staff time and the weighted average specialty-specific practice expense per hour for specialties with services in this pool. In the next step, we used the adjusted 1998 practice expense RVUs to allocate this pool to each service. Also, for all radiology services that are assigned physician work RVUs, we used the adjusted 1998 practice expense RVUs for radiology services as an interim measure to allocate the direct practice expense cost pool for radiology. </P>
                    <P>A specialty society may request that its services be removed from the nonphysician work pool. We have removed services from the nonphysician work pool if the requesting specialty predominates utilization of the service. </P>
                    <HD SOURCE="HD3">ii. Crosswalks for Specialties Without Practice Expense Survey Data </HD>
                    <P>Since many specialties identified in our claims data did not correspond exactly to the specialties included in the SMS survey data, it was necessary to crosswalk these specialties to the most appropriate SMS specialty. </P>
                    <HD SOURCE="HD3">iii. Physical Therapy Services </HD>
                    <P>Because we believe that most physical therapy services furnished in physicians' offices are performed by physical therapists, we crosswalked all utilization for therapy services in the CPT 97000 series to the physical and occupational therapy practice expense pool. </P>
                    <HD SOURCE="HD3">3. Practice Expense Proposals for Calendar Year 2005</HD>
                    <HD SOURCE="HD2">a. Supplemental Practice Expense Surveys</HD>
                    <HD SOURCE="HD3">i. Survey Criteria and Submission Dates </HD>
                    <P>As required by the BBRA, we established criteria to evaluate survey data collected by organizations to supplement the SMS survey data used in the calculation of the practice expense component of the physician fee schedule. The deadline for submission of supplemental data to be considered in CY 2006 is March 1, 2005.</P>
                    <HD SOURCE="HD3">ii. Survey by the College of American Pathologists (CAP) </HD>
                    <P>
                        In the August 5, 2004 rule, we proposed to incorporate the CAP survey data into the practice expense methodology and to implement a change to the practice expense methodology to calculate the technical component RVUs for pathology services as the difference between the global and professional component RVUs. (This technical change was proposed in the June 28, 2002 
                        <E T="04">Federal Register</E>
                         (67 FR 43849), but, at the specialty's request, we delayed implementation of this change for pathology services to permit evaluation of the combined effects of the use of the new survey data along with this technical change to the methodology.) We proposed to use the following practice expense per hour figures for specialty 69—Independent Laboratory. 
                    </P>
                    <GPH SPAN="3" DEEP="121">
                        <PRTPAGE P="66242"/>
                        <GID>ER15NO04.487</GID>
                    </GPH>
                    <P>
                        <E T="03">Comment:</E>
                         Specialty organizations representing clinical laboratories and pathologists expressed support for the use of the CAP supplemental survey data and urged us to finalize this proposal. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We will incorporate the CAP survey data into the practice expense methodology and implement the proposed change to the practice expense methodology to calculate the technical component RVUs for pathology services as the difference between the global and professional component RVUs. 
                    </P>
                    <HD SOURCE="HD3">iii. Submission of Supplemental Surveys </HD>
                    <P>We received surveys from the American College of Cardiology (ACC), the American College of Radiology (ACR), and the American Society for Therapeutic Radiation Oncology (ASTRO). Our contractor, The Lewin Group, evaluated the data and recommended that we accept the data from the ACC and the ACR, but indicated that the survey from ASTRO did not meet the precision criteria established for supplemental surveys and, thus, did not recommend using the ASTRO survey results at this time. We agreed with these recommendations. However, as explained in the August 5, 2004 proposed rule, the ACR and the ACC requested that we not use the data until we have a stable and global solution that is workable for all specialties that are currently paid using the nonphysician work pool. We agreed with these requests and proposed delaying use of these supplemental surveys until issues related to the nonphysician work pool can be addressed. </P>
                    <P>
                        <E T="03">Comment:</E>
                         The ACR expressed appreciation for our acceptance of the supplemental data and for our proposal to delay implementation until next year, as they had requested, to allow further time to examine the issue of the nonphysician work pool. The Society for Interventional Radiology (SIR) also expressed support for the use of the ACR data and the delay in implementation. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We look forward to working with these and other specialties as we seek a permanent solution to practice expense issues associated with the nonphysician work pool. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         ASTRO stated that they appreciate the opportunity to submit data and, that they understand we will not be using the data in 2005. ASTRO further commented that, due to the specific practice patterns and practice environment of radiation oncology, new data, regardless of the response rate, may not meet the criteria. ASTRO further stated that they will continue to work with CMS and with the Lewin Group as this issue is analyzed. The Association of Freestanding Radiation Oncology Centers (AFROC) expressed concern that freestanding centers that have higher costs than hospital-based centers were underrepresented by the ASTRO survey. They also expressed concern about the reference in the Lewin Group report to crosswalking radiation oncology costs from another specialty. In addition, AFROC argued that we should not average costs associated with freestanding centers with those that are hospital-based, because the costs would be understated. They urged us to ensure that any assumption regarding representativeness of any survey data is justified. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We will take these comments into consideration as we continue to work with these groups concerning the supplemental survey data. We currently have no plans to propose a practice expense crosswalk for radiation oncology. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         The ACC expressed appreciation that we are not eliminating the nonphysician workpool until methodologic issues are addressed. While they support the delay in implementing their supplemental survey data, they believe that the contractor's suggestion that the ACC survey data could be blended with the existing SMS survey data is invalid for two reasons: (1) The suggestion that similar changes to physician practice (for example, increased use of technology) may have occurred throughout all physician services is an unfounded speculation because few other specialties are as technologically driven as cardiology; and (2) other supplemental data has not been blended and all specialties must be treated consistently. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We will take these comments into consideration as part of the evaluation and discussion of the cardiology survey data in next year's proposed rule. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         The American Urological Association requested that, as we explore alternate sources of data and consider how to incorporate new practice expense data into the methodology, we find a way to incorporate recently collected specialty supplemental data into the new efforts. They also requested that we clarify whether we would apply the budget neutrality exemption to any increases in drug administration PE RVUs that result from the use of urology survey data that will be submitted under the supplemental survey process. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We anticipate that we would incorporate all accepted supplemental survey data into any comprehensive changes to the nonphysician work pool. 
                    </P>
                    <P>
                        As we explained in the January 7, 2004 
                        <E T="04">Federal Register</E>
                         (69 FR 1093 through 1094), section 303(a)(1) of the MMA modifies section 1848(c)(2)(B) of the Act to provide an exemption from the budget neutrality requirements in 2006 for further increases in the practice expense RVUs for drug administration that may result from using survey data from specialties meeting certain criteria. The survey must include expenses for the administration of drugs and biologicals and be submitted by a specialty that receives more than 40 percent of its 2002 Medicare revenues from drugs. Urology received more than 40 percent of its 2002 Medicare revenues from drugs. Therefore, if we were to receive a practice expense survey of urologists by March 1, 2005 
                        <PRTPAGE P="66243"/>
                        that included expenses for the administration of drugs and biologicals and the survey met the criteria we have established (and those of section 1848(c)(2)(I)(ii) of the Act), we would exempt the change in the practice expense RVUs for drug administration services from the budget neutrality requirements of section 1848(c)(2)(B) of the Act. 
                    </P>
                    <HD SOURCE="HD2">b. Practice Expense Advisory Committee (PEAC) </HD>
                    <HD SOURCE="HD3">Recommendations on CPEP Inputs for 2005 </HD>
                    <P>• CPEP Refinement Process.</P>
                    <P>In the August 5, 2004 proposed rule, we included the PEAC recommendations from meetings held in March and August 2003 and January and March 2004, which accounted for over 2,200 codes from many specialties. We also stated that future practice expense issues, including the refinement of the remaining codes not addressed by the PEAC, would be handled by the RUC. </P>
                    <P>
                        <E T="03">Comment:</E>
                         We received comments from the AMA that future practice expense issues, including the refinement of the remaining codes not addressed by the PEAC, would be handled by the RUC with the help of a new ad hoc committee, now termed the Practice Expense Review Committee (PERC), comprised of former PEAC members. The RUC also noted that their Practice Expense Subcommittee remains committed to reviewing improvements to the practice expense methodology. 
                    </P>
                    <P>The AMA and the RUC, as well as the specialty society representing neurological surgeons, noted their appreciation of our continued efforts to improve the direct practice expense data and to establish a reasonable methodology for determining practice expense relative values. </P>
                    <P>
                        <E T="03">Response:</E>
                         We look forward to our continuing work with the AMA, the RUC and all the specialty societies on the refinement of the remaining codes and with ongoing practice expense issues. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         The National Association for the Support of Long Term Care expressed concern about the dissolution of the PEAC and requested that we require the RUC to expand its membership to include a broad array of providers who are reimbursed under the physician fee schedule. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         Because the RUC is an independent committee, we are not in a position to set the requirements for RUC membership. However, we are confident that the RUC and the Health Care Professional Advisory Committee, which also sends practice expense recommendations directly to us, together represent two broad ranges of practitioners, both physician and nonphysician. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         A specialty society suggested that there should be a process for fixing minor errors that are identified outside of the refinement process. The commenter also suggested that there should be a system to address individual exceptions to PEAC standard packages. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         If we have made errors, major or minor, in any part of our calculation of practice expense RVUs in this final rule, inform us as soon as possible so that we are able to correct them in the physician fee schedule correction notice. Any other revisions would have to be made in the next physician fee schedule rule. If a specialty society believes that a RUC decision is not appropriate, the society can always request that the decision be revisited or can discuss the issue with us at any time. For the concern with the standard packages adopted by the PEAC, it is our understanding that all presenters at the RUC have the opportunity to demonstrate that something other than the standard would be more appropriate. 
                    </P>
                    <P>• PEAC Recommendations. </P>
                    <P>We proposed to adopt nearly all of the PEAC recommendations. However, we disagreed with the PEAC recommendation for clinical labor time for CPT code 99183, Physician attendance and supervision of hyperbaric oxygen therapy, per session, and proposed a total clinical labor time of 112 minutes for this service. </P>
                    <P>
                        <E T="03">Comment:</E>
                         Specialty societies representing interventional radiology and neurological surgeons, as well as the AMA, expressed appreciation for our acceptance of well over 2,000 PEAC refinements in this rule. However, the specialty society representing orthopaedic surgeons commented that some of our proposals appeared to be circumventing the PEAC process, in that we changed the PEAC recommendation for hyperbaric oxygen (HBO) therapy and proposed in-office inputs for two services rather than referring these to the RUC.
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We appreciate the hard work and perseverance on the part of the PEAC and the specialty societies that produced the recommended refinements for so many services. In addition, we do not believe that we circumvented the PEAC process in any way. We have the greatest respect for the PEAC and RUC recommendations that we received. However, we do have the final responsibility for all payments made under the physician fee schedule, and this can lead to disagreement with a specific recommendation. The RUC itself has always demonstrated its understanding and respect for our responsibility in this regard. With regard to the two services that we priced in the office, we stated explicitly in the proposed rule that we were requesting that the RUC review the practice expense inputs. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         The specialty society representing family physicians disagreed with our proposed changes to the PEAC recommendations for the clinical labor time for CPT code 99183, 
                        <E T="03">Physician attendance and supervision of hyperbaric oxygen therapy, per session.</E>
                         The commenter contended that a physician providing this service would probably have multiple hyperbaric oxygen chambers; therefore, staff would not be in constant attendance. However, the specialty society representing podiatrists supported this change in clinical staff time. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         Based on our concern that the PEAC recommendation of 20 minutes of clinical staff time during the intra-service period undervalued the clinical staff time, we proposed increasing this time to 90 minutes in the proposed rule. This was, of course, subject to comment. We believe there is some merit to the claim that the clinical staff may be monitoring more than one chamber at a time. Therefore, we are adjusting the time for the intra-service period from the proposed 90 minutes to 60 minutes in recognition of this point. We will continue our examination of this issue and entertain ongoing dialog with all interested organizations and individuals familiar with this service to assure the accuracy of the intra-service time. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         The Cardiac Event Monitoring Provider Group Coalition expressed concern about the PEAC recommendations that would substantially reduce the clinical staff time associated with cardiac monitoring services. Of particular concern to the Coalition was the 70 percent reduction in time for CPT code 93271, the code for cardiac event monitoring, receipt of transmissions, and analysis. Although all these services are currently priced in the nonphysician work pool and this decrease in the staff times has no immediate impact, the commenter was concerned that, when the nonphysician work pool is eliminated, these services will be undervalued. The commenter also believed that the PEAC recommendations may not have reflected all the supplies and equipment utilized in these services and included a complete list of necessary supplies 
                        <PRTPAGE P="66244"/>
                        and equipment. The American College of Cardiology (ACC) presented these services at the PEAC meeting and commented they had been unable to collect sufficient data so that the PEAC could make an appropriate recommendation. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         It is clear from the Coalition and ACC comments that more information is needed in order to ensure that the appropriate practice expense inputs are assigned to these services in the event that they are removed from the nonphysician work pool. We would be glad to work with the Coalition and the specialty society so that they can make a new presentation to the RUC this coming year. 
                    </P>
                    <P>• Adjustments To Conform With PEAC Standards </P>
                    <P>We also reviewed those codes that are currently unrefined or that were refined early in the PEAC process to apply some of the major PEAC-agreed standards. For the unrefined 10-day global services, we proposed to substitute for the original CPEP times the PEAC-agreed standard post-service office visit clinical staff times used for all 90-day and refined 10-day global services. We also proposed to eliminate the discharge day management clinical staff time from all but the 10 and 90-day global codes, substituting one post-service phone call if not already in the earlier data. Lastly, we proposed to delete any extra clinical staff time for post-visit phone calls for 10 and 90-day global service because that time is already included in the time allotted for the visits. </P>
                    <P>
                        <E T="03">Comment:</E>
                         A specialty society representing family physicians supported the elimination of the discharge day management time assigned in the facility setting for all 0-day global services, as well as all the other adjustments we made to apply PEAC standards. However, several specialty societies representing gastroenterology and orthopaedics, as well as the American College of Physicians, did not agree with the deletion of the discharge day management time. These groups requested restoration of the six minutes allocated to the discharge day management for 0-day global services and argued that most 0-day services require as much staff time as do many 10-day global services performed in the outpatient setting. One of these commenters did not believe a rationale was provided for this change. Another commenter, although recommending that any future refinements take into account all of the PEAC standards, expressed concern regarding all of the above changes, suggesting that this could lead to additional anomalies and recommending that the revisions should be reviewed by the RUC. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         The PEAC recommended that the discharge day management time apply only to 10-day and 90-day global services and we were complying with this recommendation. We also believe that this PEAC recommendation is reasonable; it is hard to imagine what tasks a physician's clinical staff back in the office is performing for a patient during the period that the patient is undergoing a same-day procedure in the hospital outpatient department. However, the point made about 10-day global procedures is pertinent. We would suggest that the RUC reconsider whether the discharge day management clinical staff time should apply only to services that are typically performed in the inpatient setting. We also believe that it was appropriate to apply the PEAC standards to codes that were not refined or that were refined before the standards were developed. The application of these standards is not only fair, but can also help to avoid the possible rank order anomalies cited by the commenter. 
                    </P>
                    <HD SOURCE="HD1">Methacholine Chloride </HD>
                    <P>The PEAC recommendations for CPT codes 91011 and 91052 included a supply input for methacholine chloride as the injected stimulant for these two services. In discussions with representatives from the gastroenterology specialty society subsequent to receipt of the PEAC recommendations, we learned this is incorrect. For the esophageal motility study, CPT code 91011, we proposed to include edrophonium as the drug typically used in this procedure. For the gastric analysis study, CPT code 91052, we were unable to identify the single drug that is most typically used with this procedure. We requested that commenters provide us with information on the drug that is most typically used for CPT code 91052, including drug dosage and price, so that it could be included in the practice expense database. </P>
                    <P>
                        <E T="03">Comment:</E>
                         Several specialty societies representing allergists, pulmonologists and chest physicians, as well as the AMA, requested that the additional cost of methacholine be reflected in the RVUS for the bronchial challenge test, CPT code 95070. As an alternative, the specialty society representing allergists suggested that a HCPCS code could be created so that methacholine could be billed separately. 
                    </P>
                    <P>In response to our request for information about the supply inputs for CPT codes 91011 and 91052, the American Gastroenterological Association (AGA) indicated that edrophonium may be an appropriate supply proxy for CPT code 91011, but, in practice, other agents are more commonly used. However, they provided no additional information regarding these other agents. AGA also stated that the most commonly used drug for CPT code 91052 is pentagastrin, but betazole or histamine may also be used. Again, they did not provide further specific information. </P>
                    <P>
                        <E T="03">Response:</E>
                         Because CPT code 95070 is valued in the nonphysician work pool, the PEAC's addition of methacholine to this procedure could not be captured by the practice expense RVUs. However, a J-code was established, J7674, 
                        <E T="03">Methacholine chloride administered as inhalation solution through nebulizer, per 1mg,</E>
                         so that this drug can be billed separately. Accordingly, we have deleted methacholine from the practice expense database. 
                    </P>
                    <P>For CPT code 91011, we have retained the drug edrophonium, and our proposed price of $4.67 per ml, as a supply in the practice expense database. However, we were not able to include a price for pentagastrin in the supply practice expense database for CPT code 91052. We will be happy to work with the specialty societies involved with both of these procedures to obtain accurate drug pricing for the 2006 fee schedule. </P>
                    <P>• Nursing Facility and Home Visits. </P>
                    <P>We proposed to adopt the direct practice expense input recommendations from the March 2003 PEAC meeting for CPT codes 99348 and 99350, two E/M codes for home visits, as well as the March 2004 PEAC recommendations for E/M codes for nursing home services (CPT codes 99301 through 99316). </P>
                    <P>
                        <E T="03">Comment:</E>
                         A specialty group representing family physicians supported the acceptance of the PEAC recommendations for nursing facility visits, even though this resulted in a decrease for these services. The commenter stated that the decrease occurred because the original CPEP data was flawed and the clinical staff times were too high. The commenter also stated that the payments in the facility setting will increase for these services and that setting has the higher volume of visits. Other commenters representing long term care physicians, geriatricians and podiatrists expressed disappointment in these PEAC recommendations and stated that, while the PEAC did consider the views of long term care physicians, the PEAC failed to accept these views even though they were supported by data. These commenters believe the PEAC did not 
                        <PRTPAGE P="66245"/>
                        recommend an appropriate increase based on a false assumption that the nursing home provides the staff. Another commenter contended that the new values do not adequately account for work performed by the physician's clinical staff. The commenter stated that the pre- and post-times for these codes are less than for the comparable office visit codes, even though it is clear that more clinical staff time is required for the nursing facility resident. One commenter suggested that these concerns would need to be addressed within the framework of the 5-year review. The specialty society representing homecare physicians also commented that, rather than challenging a flawed system, they will use the 5-year review process to have work and practice expense re-valuated for the home visit codes. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         While sympathetic to the concerns expressed by the long-term care physicians regarding the overall decrease in clinical staff time in the nursing facility E/M procedures, we believe the PEAC recommendations for these services to be reasonable. We also agree with commenters regarding the upcoming 5-year review process as a means to address the physician work component of these codes. To the extent that there is overlap between the physician time and the clinical labor practice expenses involved in a particular procedure, the 5-year review process can be utilized to address these issues. We encourage the home care physicians and the long-term care physicians to consider using the 5-year review process for these codes. 
                    </P>
                    <P>• Suggested Corrections to the CPEP Data. </P>
                    <P>
                        <E T="03">Comment:</E>
                         The RUC and American Podiatric Medical Association identified a number of PEAC refinements from the August 2003 meeting that were not reflected in the practice expense database and asked that these be implemented. The RUC also asked us to correct the equipment times for all of the 90-day global services to correspond with the PEAC-refined clinical staff times for these codes. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We have made the recommended corrections to our practice expense database. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         The specialty society representing hematology noted the supply items missing from the practice expense database for CPT codes 36514 through 36516 that had been included in the CMS-accepted PEAC refinements. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We regret the error. These items are incorporated into the practice expense database. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         The specialty society representing pediatrics as well as the RUC commented that the PEAC recommendations also included a recommendation for a change in the global period for CPT code 54150, 
                        <E T="03">Circumcision, using clamp or other device; newborn,</E>
                         from a 10-day global to an “xxx” designation, which would mean the global period does not apply. This issue was not discussed in the proposed rule and the commenters requested that this change be reflected in the final rule. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         As stated by the commenters, this request was included in the PEAC recommendations but was inadvertently omitted from the proposed rule. We agree that the 10-day global period currently assigned to this procedure may not be appropriate because the physician performing the procedure most likely does not see the infant for a post-procedure visit. However, we believe that a 0-day global period rather than “xxx” should be assigned to this procedure. We generally use the “xxx” designation for diagnostic tests and no surgical procedure currently is designated as an “xxx” global service. We believe this will accomplish the same end because most any other service performed at the same time as the circumcision could be billed with the appropriate modifier. We are adjusting the practice expense database to delete any staff time, supplies and equipment associated with the post-procedure office visit. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         Specialty societies representing dermatology stated that there was an error in the nonfacility practice expense RVUS for the Mohs micrographic surgery service, CPT code 17307, due to the omission of clinical staff time from the practice expense database. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We have corrected the practice expense database to reflect the appropriate clinical staff time. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         We received comments from the American College of Radiology (ACR) and Society of Nuclear Medicine noting that some of the codes used by their specialty were omitted from the listing of PEAC-refined codes that appeared in Addendum C in our proposed rule. They submitted a complete list of the codes that had gone through PEAC refinement, beginning at the first PEAC meeting in April 1999, and asked that we include these codes on the Addendum. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We appreciate the specialty societies bringing to our attention that some of their codes were omitted from Addendum C and we have reviewed the codes on their submitted list. Addendum C was meant to list only those codes that were refined in this year's rule, and thus, only listed those refined by the PEAC from March and August 2003 and January and March 2004. However, it does appear that there is some confusion regarding what codes were refined during this period, particularly from the March 2004 meeting. We will work with all medical societies and the RUC to clarify the status of all the codes in question. 
                    </P>
                    <P>• Other Issues. </P>
                    <P>
                        <E T="03">Comment:</E>
                         The RUC requested that we publish practice expense RVUs for all Medicare noncovered services for which the RUC has recommended direct inputs. We also received a request from the American Academy of Pediatrics to publish work and practice expense RVUs for the noncovered nasal or oral immunization services (CPT codes 90473 and 90474) and the visual acuity test (CPT code 99173). 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         In the past, we have published the practice expense RVUs for only a small number of noncovered codes which are listed in our national payment files that can be accessed via our physician web page under “Medicare Payment Systems” as part of the public use files at 
                        <E T="03">www.cms.hhs.gov/physicians/.</E>
                         Because we have not yet established a consistent policy regarding the publication of RVUs for noncovered services, we will need to examine this issue further to carefully weigh the pros and cons of publishing these RVUs for noncovered services. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         The American Speech-Language Hearing Association (ASHA) and the American Academy of Audiology (AAA), expressed concern about the reduction of practice expense RVUs for CPT code 92547, 
                        <E T="03">Use of vertical electrodes (List separately in addition to code for primary procedure),</E>
                         which resulted after the PEAC refinement. The commenters asked for our assistance to clarify a CPT instruction regarding this procedure because they believe it prevents the multiple billings of CPT 92547 in a given patient encounter. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         While we are sympathetic to the concerns expressed by ASHA and AAA, we also want to note that CPT code descriptors and accompanying coding instructions are proprietary to CPT. We would encourage these organizations to discuss this issue directly with the CPT editorial committee. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         A specialty society representing vascular surgery expressed concern about the wide variations in practice expense RVUs that are sometimes derived under the current methodology. The commenter suggested that some outliers require additional focus to determine whether these are errors in the direct inputs or if they 
                        <PRTPAGE P="66246"/>
                        reflect problems inherent in the methodology. According to the commenter, it would appear that some of the extreme variation is due to the high costs of certain disposable supplies in the office setting as well as high scaling factors. A few examples of outlier codes were provided. The commenter suggested that we consider an alternative methodology for payment of high-priced single-use items in the nonfacility setting. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We agree with the commenter that the issue raised is one worth study and analysis. Unfortunately, this is not a task that can be accomplished in time for discussion in this final rule. We will be very willing to work with the specialty society and with the Practice Expense Subcommittee of the RUC, as well as any other interested parties, to work further on this issue that will only be magnified as more complex procedures are moved into the office setting. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         A provider of radiology services questioned the reductions in practice expense for CPT code 77370, 
                        <E T="03">Special medical radiation physics consultation.</E>
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         The practice expense RVUs for CPT code 77370 decreased by 0.02 RVUs between last year's final rule and this year's proposed rule. This small decrease is due to the normal fluctuations resulting from updating our practice expense data. 
                    </P>
                    <HD SOURCE="HD2">c. Repricing of Clinical Practice Expense Inputs—Equipment </HD>
                    <P>We use the practice expense inputs (the clinical staff, supplies, and equipment assigned to each procedure) to allocate the specialty-specific practice expense cost pools to the procedures performed by each specialty. The costs of the original equipment inputs assigned by the CPEP panels were determined in 1997 by our contractor, Abt Associates, based primarily on list prices from equipment suppliers. Subsequent to the CPEP panels, equipment has also been added to the CPEP data, with the costs of the inputs provided by the relevant specialty society. We only include equipment with costs equal to or exceeding $500 in our practice expense database because the cost per use for equipment costing less than $500 would be negligible. We also consider the useful life of the equipment in establishing an equipment cost per minute of use. </P>
                    <P>We contracted with a consultant to assist in obtaining the current price for each equipment item in our CPEP database. The consultant was able to determine the current prices for most of the equipment inputs and clarified the specific composition of each of the various packaged and standardized rooms or ophthalmology “lanes” currently identified in the equipment practice expense database (for example, mammography room or exam lane). We proposed to delete the current “room” designation for the radiopharmaceutical receiving area and, in its place, list separately the equipment necessary for each procedure as individual line items. </P>
                    <P>Also, we proposed to replace all surgical packs and trays in the practice expense database with the appropriate standardized packs that were recommended by the PEAC, either the basic instrument pack or the medium pack. </P>
                    <P>The useful life for each equipment item was also updated as necessary, primarily based on the AHA's “Estimated Useful Lives of Depreciable Hospital Assets” (1998 edition). We noted in the August 5, 2004 proposed rule that AHA would be publishing updated guidelines this summer and that we would reflect any updates in our final rule. </P>
                    <P>In addition, we proposed the following database revisions: </P>
                    <HD SOURCE="HD2">Assignment of Equipment Categories </HD>
                    <P>We proposed that equipment be assigned to one of the following six categories: documentation, laboratory, scopes, radiology, furniture, rooms-lanes, and other equipment. These categories would also be used to establish a new numbering system for equipment that would more clearly identify them for practice expense purposes. </P>
                    <HD SOURCE="HD2">Consolidation and Standardization of Item Descriptions </HD>
                    <P>We proposed combining items that appeared to be duplicative. For example, for two cervical endoscopy procedures, our contractor identified that the price of the LEEP system includes a smoke evacuation system but that system is also listed separately. We proposed to merge these two line items and reflect both prices in the price of the LEEP system. </P>
                    <P>These changes were reflected in Addendum D of the proposed rule. </P>
                    <P>Additionally, there were specific equipment items for which a source was not identified or for which pricing information was not found that were included in Table 2 of the August 5 proposed rule. Items that we proposed to delete from the database were also identified in this table. We requested that commenters, particularly the relevant specialty groups, provide us with the needed pricing information, including appropriate documentation. Also, we stated that if we were not able to obtain any verified pricing information for an item, we might eliminate it from the database. </P>
                    <P>
                        <E T="03">Comment:</E>
                         The Society of Nuclear Medicine agreed with the deletion of the current room designation for radiopharmaceutical area and designation of categories for equipment. However, the society recommended that the category designation of “radiology” be changed to “imaging equipment” and “other equipment” be changed to “non-imaging equipment” to be inclusive of these modalities. The American College of Radiology also concurred with the elimination of the current room designation for radiopharmaceutical area. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We agree that the term “imaging equipment” rather than the term “radiology” more accurately reflects current practice and have changed the practice expense database accordingly. However, it would be inappropriate to change the “other equipment” category to “non-imaging equipment” because there are items in other categories that would not be encompassed in the proposed title change. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         The Society of Nuclear Medicine supplied information on the equipment item E51076 with the requested documentation. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We have revised the practice expense database to reflect the information provided. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         The American Society for Therapeutic Radiology and Oncology (ASTRO) submitted information and the requested documentation for fifteen items, often supplying two or more pricing sources. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We greatly appreciate the information and have revised the practice expense database to reflect the information provided. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         Commenters representing manufacturers and providers expressed concern about the reduction in payment (9 percent) for external counterpulsation (ECP), G0166. The commenters questioned the proposed change made to the life of the ECP equipment, from seven to five years, used for this service. Commenters did not believe this was supported by the AHA information (which indicated that similar diagnostic cardiovascular equipment has an equipment life of five years) and requested that this timeframe be applied to the ECP equipment for this service. The American College of Cardiology also questioned the change to the ECP equipment life. The commenters also questioned the allocation for maintenance and indirect costs applied under the practice expense methodology 
                        <PRTPAGE P="66247"/>
                        as well as the time allocated for this service. As a final point, some of the commenters requested that we adjust the work RVUs assigned to this G-code to that of an echocardiogram (CPT code 93307) and include it in the nonphysician work pool. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         Based upon review of the information provided we have revised the equipment life to five years. The methodology used for the allocation for maintenance and indirect costs is consistent with our methodology. For the request to adjust the work RVUs for this service, we refer the commenters to section VI of this final rule where we are soliciting comments on services where the physician work may be misvalued. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         The College of American Pathologists provided information on items listed in table 2: the DNA image analyzer (ACIS), and image analyzer (CAS system) code E13652. They noted that the CAS system is no longer marketed and that the ACIS system would be used in its place. Thus, they provided documentation on the price for the ACIS system. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We appreciate the information and have made the necessary changes to the database. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         The American College of Cardiology (ACC) agreed with the pricing for the ambulatory blood pressure monitor, provided prices for the ECG signal averaging system (E55035), but provided no documentation for these prices. They stated that the echocardiography digital acquisition ultrasound referenced in table 2 was no longer in the marketplace and that a digital workstation was now typically used. They requested that an appropriate equipment code be available for this item and provided a price range for this item (although without the supporting documentation). ACC also recommended that the pacemaker programmer (E55013) be removed from the equipment list because it is provided at no cost to the physician. Removal of this item from the PE database was also supported by a manufacturer that commented on the rule. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We have removed the pacemaker programmer from the practice expense database. We will temporarily retain other items and prices for the 2005 physician fee schedule and request that ACC forward the documentation as soon as possible. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         The American College of Radiology (ACR) provided partial information for the CAD processor unit and software. ACR also submitted information regarding the computer workstation for MRA and the mammography reporting software, but with insufficient documentation. For the various equipment items ACR listed for the mammography room, updated information was provided for a few of the items. ACR noted that they would submit documentation for all outstanding pieces of equipment when it is available. ACR did not agree with the room price for MRI and CT that was referenced in Addendum D and requested an extension so that they can work with us to accurately price these items. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We will maintain current pricing for all equipment items and the mammography room on an interim basis, until sufficient documentation is provided. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         The American Ophthalmology Association (AOA) and American Optometric Association both supplied pricing information along with the requested documentation for the computer, VDT, and software (E71013) listed in table 2. AOA also provided pricing information for the ophthalmology drill listed in this table, indicating a cost of $57. They expressed their appreciation for the recategorization and standardization of descriptions for equipment and supplies. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We appreciate the documentation forwarded by these two organizations and have incorporated into the practice expense database the pricing information provided for the computer, VDT, and software. Because the ophthalmology drill is less than $500 (the standard established for equipment), we are removing it from the equipment list for the practice expense database. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         The American Gastroenterological Association (AGA) expressed concern about the reduction in RVUs for CPT code 91065, a breath hydrogen test. They believe that the newer equipment listed in the practice expense database does not reflect the analyzer that is typically used, which is more expensive, and noted that the costs for the reagents have also increased. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We are sympathetic to the concerns of the AGA regarding the typical equipment used for CPT code 91065 and would like to work with them to ascertain updated pricing information about the equipment most physicians utilize for this service. However, the majority of the decrease (76 percent) in practice expense RVUs for this procedure is due to the PEAC refinement for the clinical labor time that was reduced by nearly 50 percent. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         The American Academy of Sleep Medicine indicated that most typical CPAP/BiPAP remote unit is a bilevel positive airway pressure unit and provided documentation for the price of this item. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         This price is reflected in the practice expense database. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         The Society for Vascular Surgery (SVS), Society for Vascular Ultrasound and Society of Diagnostic Medical Sonography all expressed appreciation for the refinement to the inputs that apply to vascular ultrasound services. However, the commenters requested that we incorporate the requested refinements for the other ancillary equipment present in a vascular ultrasound room into other similar procedures. SVS specifically listed the following CPT codes: 93875-9 and 93990. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         In addition to the three new CPT codes for cerebrovascular arterial studies CPT 93890, 93892 and 93893, we have added the vascular ultrasound room to the codes indicated in the SVS comment noted above. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         The American Psychiatric Association provided documentation for the cost of the ECT machine and the American Psychological Association provided information on the neurobehavioral status exam and testing, as well as the biofeedback equipment listed in table 2, along with the requested documentation. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We appreciate this information. The practice expense database was revised to reflect this cost information. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         The American Society of Clinical Oncology requested that the biohazard hood be substituted for the ventilator and hood blower as a practice expense input for the chemotherapy codes. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We revised the database to reflect this change. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         American Academy of Neurology supplied information and the necessary documentation on several equipment items listed in table 2 associated with neurology services. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We have made the revisions to the prices for the ambulatory EEG recorder (E54008), ambulatory review station (E54009), and portable digital EEG monitor based on the documentation provided. Based on the documentation provided, we note that the price for the ambulatory review station was substantially reduced ($44,950 to $7,950). 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         The American Clinical Neurophysiology Society (ACNS) stated that the payment for CPT code 95819, an EEG service, was substantially reduced. The Society believes it is due to a price reduction for the EEG equipment (E54006) used in this service that was listed in Addendum D of the 
                        <PRTPAGE P="66248"/>
                        proposed rule. The commenter indicated that the proposed price does not include the review station and software which is needed for this service and provided documentation for appropriately pricing this item. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         Based on the documentation provided, we have changed, on an interim basis for the 2005 fee schedule, the price for this item and note that this equipment price is associated only with CPT code 95819. We would be happy to work with ACNS in order to resolve any issues surrounding the RVUs for CPT code 95819. Reviewing the direct inputs for this code, we note that the largest contributor to the reduction of practice expense RVUs is the PEAC's refinement of this code's supply items. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         The National Association for Medical Direction of Respiratory Care and the American College of Chest Physicians were in agreement with the proposed prices for equipment except for the pulse oximeter (including printer), E55003. The commenters referenced a price that is $83 more than that listed in the table, but provided no documentation. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We appreciate the comments from these organizations regarding the repricing of the equipment items in the practice expense database. We have retained our price of $1,207 for the pulse oximeter and note that it is an average from two different available sources. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         We received a comment from a consumer regarding the price of the electromagnetic therapy machine for HCPCS code G0329 with concerns about the low payment for this modality. While no documentation was submitted, the commenter noted that the cost for this equipment ranged from $25,000 to $35,000. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We appreciate the commenter's remarks about the price of the electromagnetic therapy equipment, Diapulse. We have retained our price of $25,000 in the practice expense database because we do not have documentation that any higher-priced equipment is typically used. Similar to other modalities used in rehabilitation, including those used in wound care, we note that this procedure reflects comparable practice expense values. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         Several specialty organizations questioned our substitution of the two standardized packs for previously PEAC-approved packs and trays, as discussed in our proposed rule. One specialty society suggested we consult with the AMA before proceeding on this point. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We uniformly applied the PEAC-approved values for the packs and trays to all packs and trays, regardless of whether the codes had previously been refined by the PEAC. To the extent that a specialty society feels that it was disadvantaged by this policy, we would encourage them to bring the specific codes that should be excluded from this policy to the newly formed PERC (formerly PEAC) at the next RUC meeting in February 2005. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         Several specialty organizations indicated that they were in the process of obtaining pricing information on equipment items and would provide it as soon as possible. One commenter also asked that we retain the items proposed for deletion as they are necessary in providing their services, but provided no documentation. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         In the proposed rule, we noted that we might eliminate those items from the database for which documented pricing information was not received. Due to the number of outstanding equipment prices, and the number of societies that are underway in their search for this data, we have decided to extend the submission deadline. We would encourage specialty societies to submit price information soon to help ensure that it can be used to establish practice expense RVUs in next year's proposed rule. 
                    </P>
                    <BILCOD>BILLING CODE 4120-01-P</BILCOD>
                    <GPH SPAN="3" DEEP="591">
                        <PRTPAGE P="66249"/>
                        <GID>ER15NO04.488</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="588">
                        <PRTPAGE P="66250"/>
                        <GID>ER15NO04.489</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="587">
                        <PRTPAGE P="66251"/>
                        <GID>ER15NO04.490</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="587">
                        <PRTPAGE P="66252"/>
                        <GID>ER15NO04.491</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="586">
                        <PRTPAGE P="66253"/>
                        <GID>ER15NO04.492</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="586">
                        <PRTPAGE P="66254"/>
                        <GID>ER15NO04.493</GID>
                    </GPH>
                    <BILCOD>BILLING CODE 4120-01-C</BILCOD>
                    <HD SOURCE="HD2">d. Miscellaneous Practice Expense Issues </HD>
                    <P>• Pricing for Seldinger Needle. </P>
                    <P>We proposed to average two prices of this supply item to reflect a cost of $5.175. We requested that, if commenters disagreed with this change in price, the comment should provide documentation to support the recommended price, as well as the specific type of needle that is most commonly used. </P>
                    <P>
                        <E T="03">Comment:</E>
                         Commenters were in agreement with the proposed pricing of the seldinger needle. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We will use the proposed price of $5.175 for this supply item in the practice expense database. 
                        <PRTPAGE P="66255"/>
                    </P>
                    <P>• Hysteroscopic Endometrial Ablation. </P>
                    <P>
                        We proposed to assign, on an interim basis, the following direct practice expense inputs in the nonfacility setting for CPT code 58563, 
                        <E T="03">Hysteroscopy, surgical; with endometrial ablation.</E>
                         (
                        <E T="04">Note:</E>
                         In the August 5, 2004 proposed rule this code was erroneously identified as 56853, which does not exist.) We also stated we would request that the RUC review these inputs as part of the practice expense refinement process. 
                    </P>
                    <P>
                        + 
                        <E T="03">Clinical Staff:</E>
                         RN/LPN/MTA—72 minutes (18 pre-service and 54 service) 
                    </P>
                    <P>
                        + 
                        <E T="03">Supplies:</E>
                         PEAC multispecialty visit supply package, pelvic exam package, irrigation tubing, sterile impervious gown, surgical cap, shoe cover, surgical mask with face shield, 3x3 sterile gauze (20), cotton tip applicator, cotton balls (4), irrigation 0.9 percent sodium chloride 500-1000 ml (3), maxi-pad, mini-pad, 3-pack betadine swab (4), Monsel's solution (10 ml), lidocaine jelly (1000 ml), disposable speculum, spinal needle, 18-24 g needle, 20 ml syringe, bupivicaine 0.25 percent (10 ml), 1 percent xylocaine (20 ml), cidex (10 ml), Polaroid film-type 667 (2), endosheath, and hysteroscopic ablation device kit. 
                    </P>
                    <P>
                        + 
                        <E T="03">Equipment:</E>
                         power table, fiberoptic exam light, endoscopic-rigid hysteroscope, endoscopy video system, and hysteroscopic ablation system. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         Commenters, including many individual practitioners, were supportive of this proposed change. The specialty society also stated that they plan to present the inputs for this service at the RUC meeting in February 2005 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         With the exception of the post incision care kit that we deleted because this procedure does not require an incision, we will finalize these inputs as proposed. 
                    </P>
                    <P>• Photopheresis. </P>
                    <P>We proposed to assign, on an interim basis, the following nonfacility practice expense inputs for the photopheresis service, CPT code 36522: </P>
                    <P>
                        + 
                        <E T="03">Clinical Staff:</E>
                         RN—223 minutes (treatment is for approximately 4 hours) 
                    </P>
                    <P>
                        + 
                        <E T="03">Supplies:</E>
                         multispecialty visit supply package, photopheresis procedural kit, blood filter (filter iv set), IV blood administration set, 0.9 percent irrigation sodium chloride 500-1000 ml (2), heparin 1,000 units-ml (10), povidone solution-betadine, methoxsalen (UVADEX) sterile solution-10 ml vial, 1 percent-2 percent lidocaine-xylocaine, paper surgical tape (12), 2x3 underpad (chux), nonsterile drapesheet 40 inches x 60 inches, nonsterile Kling bandage, bandage strip, 3x3 sterile gauze, 4x4 sterile gauze, alcohol swab pad (3), impervious staff gown, 19-25 g butterfly needle, 14-24g angiocatheter, 18-27 g needle, 20 ml syringe, 10-12 ml syringe, 1 ml syringe, 22-26 g syringe needle-3 ml. 
                    </P>
                    <P>
                        + 
                        <E T="03">Equipment:</E>
                         plasma pheresis machine with ultraviolet light source, medical recliner. 
                    </P>
                    <P>We also stated we would request that the RUC review these inputs. </P>
                    <P>
                        <E T="03">Comment:</E>
                         One commenter supplied information on practice expense inputs for this code and indicated that an oncology nurse should be used, instead of an RN, to perform the procedure. A specialty society also stated that they would be providing information on this service at the September RUC meeting. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We appreciate the information submitted by the commenters. This code was discussed at the September RUC meeting and recommended practice expense inputs for this service were provided to us. We do not agree with the RUC recommended clinical staff procedure (intra) time of 90 minutes. We believe that this time, which is half of the proposed intra time, does not accurately reflect the total time involved in performing this procedure. Our understanding is that the filtration rate and the procedures performed by the nurse for photopheresis are similar to those that are reflected in the selective apheresis services, CPT code 36516, with a PEAC-approved intra time of 240 minutes. Based on this, and the absence of specialty representation at the RUC familiar with the process, we are assigning 180 minutes for the intra time, as proposed. We are also assigning the RN/LPN staff type to this procedure, because we believe it is similar to other apheresis procedures. We will continue our examination of this issue and entertain ongoing dialog with all interested organizations and individuals, including the AMA and the RUC, the industry, and those physicians and individuals familiar with the photopheresis procedure in order to assure the accuracy of the intra time. 
                    </P>
                    <P>• Pricing of New Supply Items. </P>
                    <P>As part of last year's rulemaking process, we reviewed and updated the prices for supply items in our practice expense database. During subsequent meetings of both the PEAC and the RUC, supply items were added that were not included in the supply pricing update. The August 5, 2004 proposed rule included Table 3 Proposed Practice Expense Supply Item Additions for 2005, which listed supply items added as a result of PEAC or RUC recommendations subsequent to last year's update of the supply items and the proposed associated prices that we will use in the practice expense calculation. </P>
                    <P>
                        We also identified certain supply items for which we were unable to verify the pricing information (
                        <E T="03">see</E>
                         Table 4, Supply Items Needing Specialty Input for Pricing, in the August 5, 2004 proposed rule). We requested that commenters provide pricing information on these items along with documentation to support the recommended price. In addition, we also requested information on the specific contents of the listed kits, so that we do not duplicate any supply items. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         Several commenters representing providers of these services stated that table 3 incorrectly associated “gold markers” with the brachtherapy intracavity codes. They were all in agreement that these markers are typically used in external beam treatments and payment is associated with unlisted procedure codes and should be paid for at cost. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We have deleted the gold markers from CPT codes 77761-77763 and removed this supply from the practice expense database. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         The American Urology Association noted that we should exclude the vasotomy kit from CPT codes 55200 and 55250. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We have deleted the vasotomy kit from CPT codes 55200 and 55250. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         The American College of Chest Physicians agreed with pricing of items used in their practices in table 3 and stated that the bronchogram tray does not need to be included in the practice expense database, as the procedure is seldom performed and, when it is, the procedure is performed in a facility. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We have deleted the bronchogram tray from the practice expense database and corrected the direct inputs for CPT code 31708 accordingly. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         We received comments from the American College of Cardiology (ACC) that included price quotes and names of sources for supply items listed on table 3. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         Unfortunately, ACC did not include the requested sufficient documentation, such as invoices or catalog web page links. We have asked ACC to forward this pricing documentation to us as soon as possible because it will be required for supplies to remain valued in the practice expense database. In the interim, for the 2005 fee schedule, we will maintain the prices currently in the practice expense database for the following supplies: 
                        <PRTPAGE P="66256"/>
                        blood pressure recording form at $0.31, pressure bag (infuser) 500cc or 1000cc at $8.925, sterile, non-vented, tubing at $1.99. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         Noting that a $15 supply item, needle-wire for localization of lesions in the breast (used preoperatively in CPT codes 19290 and 19291) was no longer used, a manufacturer requested that we replace this supply with an anchor-guide device valued at $245. The commenters also stated that this device is used in over 70 offices and imaging centers. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We appreciate the comments from the manufacturer. However, during last year's rulemaking process we repriced all of our supplies, and the needle-wire price of $15 was an average of prices from two different sources ($17 and $13). This price was proposed and accepted by the medical specialty societies that we depend on to verify typical items in our practice expense database. We have retained the $15 needle-wire for localization because we believe it is typically used for this procedure. 
                    </P>
                    <P>The following table lists the items on which we requested input, the comments received, and the action taken.</P>
                    <BILCOD>BILLING CODE 4120-01-P</BILCOD>
                    <GPH SPAN="3" DEEP="625">
                        <PRTPAGE P="66257"/>
                        <GID>ER15NO04.494</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="624">
                        <PRTPAGE P="66258"/>
                        <GID>ER15NO04.495</GID>
                    </GPH>
                    <BILCOD>BILLING CODE 4120-01-C</BILCOD>
                    <P>• Addition of Supply Item to CPT 88365, Tissue In Situ Hybridization. </P>
                    <P>
                        We proposed to add, on an interim basis, a DNA probe to the CPEP database for CPT 88365, tissue in situ hybridization, with the understanding that the inclusion of the item would be subject to forthcoming RUC review. 
                        <PRTPAGE P="66259"/>
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         Commenters were supportive of this proposal. The College of American Pathologists also encouraged us to include updated information on practice expense inputs from the September RUC meeting, while another commenter suggested that we run the information by the specialty society. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         The direct practice expense inputs for this code and two other codes in the same family were discussed at the September RUC after a presentation made by the specialty society. We have reviewed and accepted the RUC recommendations, and these practice expense inputs will be included in the practice expense database. 
                    </P>
                    <P>• Ophthalmology Equipment. </P>
                    <P>In cases where both the screening and exam lanes are included in the equipment list for the same ophthalmology service, we proposed to include only one lane because the patient could only be in one lane at a time. We proposed defaulting to the exam lane and, thus, we proposed deleting the screening lane from the practice expense inputs for these procedures. For the services where a lane change was made, time values were assigned to the exam lane in accordance with our established standard procedure. </P>
                    <P>
                        <E T="03">Comment:</E>
                         The American Academy of Ophthalmology requested that we specifically identify the codes for which we deleted the screening lane, so that they can ensure that the correct lane was deleted. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         This information can be obtained by comparing the direct inputs in the practice expense database files for the 2004 and 2005 fee schedules that are posted on our Web site (
                        <E T="03">http://www.cms.hhs.gov/physicians/pfs</E>
                        ). However, we would be happy to work with the specialty organization to verify the accuracy of the information. 
                    </P>
                    <P>• Parathyroid Imaging, CPT code 78070. </P>
                    <P>
                        Based on comments received from the RUC and the specialty society representing nuclear medicine, we proposed to crosswalk the charge-based RVUs from CPT 78306, 
                        <E T="03">Bone and/or joint imaging; whole body,</E>
                         to CPT 78070, 
                        <E T="03">Parathyroid imaging.</E>
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         Several specialty societies expressed appreciation for this proposed change. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We will finalize our proposal and crosswalk the charge-based RVUs from CPT code 78306 to CPT code 78070. 
                    </P>
                    <P>• Additional PE concerns. </P>
                    <P>
                        <E T="03">Comment:</E>
                         We received information from the American Academy of Ophthalmology that two biometry devices (a-scan ultrasonic biometry unit and an optical coherence biometer) were listed as equipment for the ophthalmic biometry service, CPT code 92136. Only the optical coherence biometer should be included for this code. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         As requested by the specialty society, we have deleted the a-scan biometry unit from the equipment list for CPT code 92136. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         We received comments from manufacturers, specialty societies representing renal physicians and vascular surgeons, and individual providers questioning the decrease in nonfacility practice expense RVUS for CPT code 36870, 
                        <E T="03">Percutaneous thrombectomy, arteriovenous fistula, autogenous or nonautogenous graft (includes mechanical thrombus extraction and intra-graft thrombolysis</E>
                        . Some commenters believe this reduction occurred because the supplies listed in the database for this service reflect only one method of providing this service. While commenters acknowledged that the database includes the supplies used in approximately 50 percent of the instances this procedure is performed, the commenters claimed that other supplies may be used in the remaining occasions. Commenters requested that we add these other specific supplies to the database. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         Because there are a variety of supplies and equipment that can be used in performing a service, under the practice expense methodology, the supplies and equipment that are used in determining payment are those that are most typical for the procedure. Although there may be alternative supplies used, the inputs in the database reflect what is typically used (which is acknowledged by the commenters) and thus we are not adding the requested supplies to the practice expense database. However, we did note that the list of equipment did not reflect the cost of the angiography room that is used during the procedure, and this has been added to our database for this code. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         Societies representing dermatologic specialties expressed concern about the reduction in practice expense RVUs for a photodynamic therapy service, CPT code 96567. The commenters believe that this reduction is due to the application of the dermatology scaling factor based on updated practice expense utilization and requested that this be reconsidered. These commenters also expressed appreciation that there is now a separate HCPCS code to bill for levulan that is needed for this procedure, but stated that there are two medical supplies that need to be included in the practice expense database: bacitracin, and a topical anesthetic cream. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         The practice expense RVUs for photodynamic therapy decreased only slightly in this year's proposed rule due to the proposed repricing of equipment. The decrease referred to by the commenter occurred after the first year that the code was established. At that time we obtained the utilization data that demonstrated that dermatologists performed the service and we then applied the same scaling factors to the code that we do for all dermatology services. Therefore, the scaling factor we now apply is correct. We will add the requested amount of bacitracin to the supply list for the code. Unfortunately, the topical anesthetic requested is not in our database and the commenters did not include pricing information so we are not able to include the item in our practice expense calculation. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         A society representing interventional pain physicians expressed concern that the practice expense RVUs for CPT code 95990, 
                        <E T="03">Refilling and maintenance of implantable pump or reservoir for drug delivery, spinal (intrathecal, epidural) or brain (intraventricular)</E>
                        , are understated when compared to the RVUs for CPT code 95991, the same service administered by a physician. According to the commenter, CPT code 95991 includes a total of 47 minutes of nonphysician labor and 37 minutes of physician labor or total professional time of 84 minutes. This is the total time spent with the patient before, during and after the refill. The commenter requested that the number of minutes of direct labor for CPT code 95990 should be a minimum of 84 minutes, since the nonphysician practitioner would be performing all the services associated with CPT code 95991 that are performed by both the physician and clinical staff. In addition, the commenter stated that CPT code 95990 should also be assigned physician work RVUs because there is physician oversight of the service even when performed by clinical staff. Two other commenters stated that both CPT codes 95990 and 95991 should be valued the same as the chemotherapy implanted pump refill service, CPT code 96530. The commenters state that this was the code originally used to report the above services, that CPT codes 95990 and 95991 originally were assigned higher RVUs than CPT code 96530 and that the MMA adjustments that increased the payment for CPT code 96530 should be applied to CPT codes 95990 and 95991. 
                        <PRTPAGE P="66260"/>
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         The commenter is correct that the clinical staff times for CPT codes 95990 and 95991 are the same (50 minutes of clinical staff time), although the clinical staff is performing the procedure in one case and assisting the physician in the other. However, the assumption underlying these times is that, in the cases where it is necessary for the physician to personally perform the procedure, the nurse is assisting for the entire time. If this assumption is not correct, then the clinical staff time for CPT code 95991 is overstated. Because CPT codes 95990 and 95991 are not considered drug administration codes under section 303 of the MMA, we will not apply the adjustments made for CPT code 96530 to these services. Therefore, we will not be revising the staff time for either code at this time, but would suggest that the RUC look further at this issue. We would also suggest that the society bring CPT code 95990 to the 5-year review, if they wish to make the case that work RVUs should be assigned. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         The society representing interventional pain physicians questioned the “professional component only” designation we assigned to the codes for the analysis of an implanted intrathecal pump, CPT codes 62367 and 62368, and the subsequent low RVUs for these services. The commenter stated that if the payment is left as proposed, more physicians would stop offering intrathecal pumps to patients. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         This was an inadvertent error on our part that we have corrected for the final rule. These services are physicians' services that do not have separate professional and technical components. We thank the commenter for pointing out this error. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         The Joint Council of Allergy, Asthma and Immunology expressed concern about the reduction in the proposed rule in practice expense RVUs for a number of allergy codes, in particular the venom therapy CPT codes, 95145 through 95149. The commenter stated that Medicare reimbursement for these services does not cover the physician's supply expense, due to the expensive venom antigens that are part of the service, and believes this is a result of the scaling factor being used. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We are sympathetic to the commenter's concern about the high cost of the venom antigens and the specialty's low scaling factor. We would be happy to work with JCAAI further to see if a remedy can be identified regarding this subset of the allergy codes. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         Two commenters stated that the practice expense RVUs for HCPCS code G0329, Electromagnetic Therapy for ulcers, were too low and supplied information on the supplies, equipment and clinical staff time for this service. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         Based on the information provided by the commenters, we added diapulse asetips and chux to the supplies in the practice expense database for this service. We also increased the equipment time to 30 minutes. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         We received comments from the North American Spine Society (NASS) stating that the specific needle used for CPT codes 22520 and 22522, which was originally recommended by NASS, is the most expensive needle and may not be the most typical. The specialty noted that available needles range from $26 to $1,295, which represent the needle (termed vertebroplasty kit) in the practice expense database. NASS indicated that the specialties involved in performing these procedures are conducting a survey to determine the most commonly used needles and their costs. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We appreciate the comments from NASS and look forward to receiving the survey results. In the interim, we have averaged the needle costs for the range indicated above by the specialty and have entered this figure, $660.50, as a placeholder for the 2005 fee schedule. Because of the large disparity between the lowest and highest needle costs, it is not reasonable to consider $660.50 as a true average cost for this supply item. We will continue to work with the specialty organizations in order to ensure that the 2006 fee schedule practice expense database reflects the value for the most typical needle used in these procedures. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         We received comments from two medical societies with concerns about a decrease in practice expense RVUs for CPT code 95819, which is part of the EEG sleep study series of codes. These two organizations noted their willingness to bring this code to the February 2005 RUC meeting in order to rectify the direct practice expense inputs for this procedure. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We have reviewed the family of EEG sleep-study codes and believe that a rank order anomaly exists relating primarily to the 2004 PEAC recommendation to delete the 25 reusable electrodes from CPT code 95819. We support and encourage these organizations to bring the entire EEG family of codes to the February 2005 RUC to ensure that this rank order anomaly can be resolved and the correct direct inputs can be identified for these procedures. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         The Coalition for Advancement of Prosthetic Urology expressed concern about the continuing decline in practice expense RVUs for prosthetic urology procedures. They believe that this is due in part to the number of post service visits assigned to these services. They stated that information from a survey they conducted shows there are typically four to five post service visits rather than three as reflected in the database. The commenter also provided a copy of the survey information. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         The number of post service visits for these services was established based on recommendations from the RUC or by using the Harvard data. If they believe that the information regarding the number of post service visits for specific procedures is incorrect, the Coalition must request that the codes be examined as part of the 5-year refinement of work RVUs. An explanation of this process and the information that must be provided is found in section VI. of this rule. 
                    </P>
                    <HD SOURCE="HD2">B. Geographic Practice Cost Indices (GPCIs) </HD>
                    <P>We are required by section 1848(e)(1)(A) of the Act to develop separate GPCIs to measure resource cost differences among localities compared to the national average for each of the three fee schedule components. While requiring that the practice expense and malpractice GPCIs reflect the full relative cost differences, section 1848(e)(1)(A)(iii) of the Act requires that the physician work GPCIs reflect only one-quarter of the relative cost differences compared to the national average. </P>
                    <P>
                        Section 1848(e)(1)(C) of the Act requires us to review and, if necessary, to adjust the GPCIs at least every 3 years. This section of the Act also requires us to phase-in the adjustment over 2 years and to implement only one-half of any adjustment if more than 1 year has elapsed since the last GPCI revision. The GPCIs were first implemented in 1992. The first review and revision was implemented in 1995, the second review was implemented in 1998, and the third review was implemented in 2001. We reviewed and revised the malpractice GPCIs as part of the November 7, 2003 (68 FR 63196) physician fee schedule final rule. We were unable to revise the work and practice expense GPCIs at the time of the publication of the November 2003 final rule because the U.S. Census data, upon which the work and practice expense GPCIs are based, were not yet available. 
                        <PRTPAGE P="66261"/>
                    </P>
                    <P>In addition, section 412 of the MMA amended section 1848(e)(1) of the Act and established a floor of 1.0 for the work GPCI for any locality where the GPCI would otherwise fall below 1.0. This 1.0 work GPCI floor is used for purposes of payment for services furnished on or after January 1, 2004 and before January 1, 2007. Section 602 of the MMA further amended section 1848(e)(1) of the Act for purposes of payment for services furnished in Alaska under the physician fee schedule on or after January 1, 2004 and before January 1, 2006, and sets the work, practice expense, and malpractice expense GPCIs at 1.67 if any GPCI would otherwise be less than 1.67. </P>
                    <P>In the August 5, 2004 proposed rule, we proposed to revise the work and practice expense GPCIs for 2005 through 2007 based on updated U.S. Census data and Department of Housing and Urban Development (HUD) fair market rental (FMR) data. The same data sources and methodology used for the development of the 2001 through 2003 GPCIs were used for the proposed 2005 through 2007 work and practice expense GPCIs. </P>
                    <P>The relative respective weights for the 2004 work, practice expense and malpractice GPCIs, as well as the proposed 2005 through 2007 GPCI revisions, were derived using the same weights that were used in the Medicare Economic Index (MEI) revision discussed in the November 2003 physician fee schedule final rule (68 FR 63245). </P>
                    <HD SOURCE="HD3">1. Work Geographic Practice Cost Indices </HD>
                    <P>As explained in the August 5, 2004 proposed rule, we used data from the 2000 decennial U.S. Census, by county, of seven professional occupations (architecture and engineering; computer, mathematical, and natural sciences; social scientists, social workers, lawyers; education, library, training; registered nurses; pharmacists; writers, artists, editors) in the development of the proposed work GPCIs. Physicians' wages are not included because Medicare payments are determinant of the physicians' earnings. Including physician wages in the physician work GPCI would, in effect, make the index dependent upon Medicare payments. Based on analysis performed by Health Economics Research, we believe that, in the majority of instances, the earnings of physicians will vary among areas to the same degree that the earnings of other professionals vary. </P>
                    <P>The U.S. Census Bureau has very specific criteria that tabulations must meet in order to be released to the public. To maximize the accuracy and availability of the data collection, the nonphysician professional wage data were aggregated by county and a median wage by county was calculated for each occupational category. These median wages were then weighted by the total RVUs associated with a given county to ultimately arrive at locality-specific work GPCIs. This geographic aggregation of Census data is the same methodology that was used in previous updates to the GPCIs. </P>
                    <P>The proposed work GPCIs reflected one-fourth of the relative cost differences, as required by statute, with the exception of those areas where MMA requires that the GPCI be set at no lower than 1.00 and that the Alaska GPCIs be set at 1.67. </P>
                    <HD SOURCE="HD3">2. Practice Expense GPCIs </HD>
                    <P>As in the past, we proposed that the practice expense GPCI would be comprised of several factors that represent the major expenses incurred in operating a physician practice. The impact of each individual factor on the calculation of the practice expense GPCI is based on the relative weight for that factor consistent with the calculation of the MEI. The specific factors included: </P>
                    <P>
                        • 
                        <E T="03">Employee Wage Indices</E>
                        —The employee wage index is based on special tabulations of 2000 Census data and is designed to capture the median wage by county of the professional labor force. The employee wage index uses the median wages of four labor categories that are most commonly present in a physician's private practice (administrative support, registered nurses, licensed practical nurses, and health technicians). Median wages for these occupations were aggregated by county in the same manner as the data for the work GPCI. 
                    </P>
                    <P>
                        • 
                        <E T="03">Office Rent Indices</E>
                        —The HUD FMR data for the residential rents were again used as the proxy for physician office rents as they are in the current practice expense GPCIs. The proposed 2005 through 2007 practice expense GPCIs reflect the final fiscal year 2004 HUD FMR data. We believe that the FMR data remain the best available source for constructing the office rent index. The FMR data are available for all areas, are updated annually, and retain consistency from area-to-area and from year-to-year. A reduction in an area's rent index does not necessarily mean that rents have gone down in that area since the last GPCI update. Since the GPCIs measure area costs compared to the national average, a decrease in an area's rent index means that that area's rental costs are lower relative to the national average rental costs. Addendum X illustrates the changes in the rental index based upon the new FMR data. 
                    </P>
                    <P>
                        • 
                        <E T="03">Medical Equipment, Supplies, and other Miscellaneous Expenses</E>
                        —The GPCIs assume that items such as medical equipment and supplies have a national market and that input prices do not vary among geographic areas. We were again unable to find any data sources that demonstrated price differences by geographic areas. As mentioned in previous updates, some price differences may exist, but these differences are more likely to be based on volume discounts rather than on geographic areas. The medical equipment, supplies, and miscellaneous expense portion of the practice expense geographic index will continue to be 1.000 for all areas in the proposed GPCIs, except for Alaska which will have an overall practice expense GPCI set at 1.67 for 2005 and 2006. 
                    </P>
                    <HD SOURCE="HD3">3. Fee Schedule Payments </HD>
                    <P>All three of the indices for a specific fee schedule locality are based on the indices for the individual counties within the respective fee schedule localities. As in the past, fee schedule RVUs are again used to weight the county indices (to reflect volumes of services within counties) when mapping to fee schedule areas and in constructing the national average indices. </P>
                    <P>Fee schedule payments are the product of the RVUs, the GPCIs, and the conversion factor. Updating the GPCIs changes the relative position of fee schedule areas compared to the national average. Because the changes represented by the GPCIs could result in total payments either greater than or less than what would have been paid if the GPCIs were not updated, it is necessary to apply scaling factors to the proposed GPCIs to ensure budget neutrality (prior to applying the provisions of MMA that change the work GPCIs to a minimum of 1.0 and increase the Alaska GPCIs to 1.67 because these provisions are exempted from budget neutrality). We determined that the proposed work and practice expense GPCIs would have resulted in slightly higher total national payments. Because the law requires that each individual component of the fee schedule—work, practice expense, and malpractice expense—be separately adjusted by its respective GPCI, we proposed to scale each of the GPCIs separately. To ensure budget neutrality prior to applying the MMA provisions, we have made the following adjustments: </P>
                    <P>
                        • Decreased the proposed work GPCI by 0.9965; 
                        <PRTPAGE P="66262"/>
                    </P>
                    <P>• Decreased the proposed practice expense GPCI by 0.9930; and </P>
                    <P>• Increased the malpractice GPCIs that were published in the November 7, 2003 final rule by 1.0021. </P>
                    <P>Because all geographic payment areas will receive the same percentage adjustments, the adjustments do not change the new relative positions among areas indicated by the proposed GPCIs. After the appropriate scaling factors are applied, the MMA provision setting a 1.0 floor has been applied to all work GPCIs falling below 1.0. Additionally, the GPCIs for Alaska have been set to 1.67 in accordance with MMA. </P>
                    <P>
                        <E T="03">Comment:</E>
                         A specialty society representing family physicians recommended that we work with the Congress to eliminate the GPCIs or set them all at 1.00. The society stated that they understand the statutory requirement to apply the GPCIs, but that all geographic adjustment factors should be eliminated from the physician fee schedule, except for those designed to achieve a specific policy good, such as adjustment to encourage physicians to practice in underserved areas. The commenter contended that elimination of the GPCIs would have a positive effect on the availability of medical care to rural beneficiaries. Other commenters suggested that we should no longer apply the work GPCI to the work RVUs. 
                    </P>
                    <P>We also received numerous comments on the subject of the source of the data we use in the development of the GPCIs. Commenters suggested that we find data sources other than Census Bureau data. They believe the census data become obsolete very quickly and want us to use data that reflect up-to-date prices for inputs. This would, they argue, make the GPCI values more realistic. </P>
                    <P>A medical specialty group commented that the index is flawed because— </P>
                    <P>• It is based on the tenuous assumption that the relative differences in the prices of the input proxies accurately reflect relative changes in prices of corresponding physician practice cost components; and, </P>
                    <P>• It applies uniform weights to practice cost components, despite evidence of geographic variation in component shares. </P>
                    <P>Several commenters had specific concerns about the proxies used for the work and practice expense GPCIs, for example— </P>
                    <P>• Using data for four employee classes to measure relative compensation differences for all physicians' office staff which does not reflect the changes in medical practice that have occurred since the index was developed; </P>
                    <P>• Using residential real estate prices to reflect relative differences in physicians' office costs; and </P>
                    <P>• Using nationally uniform prices for supplies, equipment, and other expenses. </P>
                    <P>Another particular concern among commenters is the use of HUD apartment rental data as the source of costs for physicians' rents. Instead, they argue, we should find, or carry out, a national study of retail and business rents. </P>
                    <P>Another commenter asserts that these indices have not been verified by peer-reviewed published research since they were instituted and that we should replace the indices with data from nationwide studies that validate and update actual cost of practice data. </P>
                    <P>
                        <E T="03">Response:</E>
                         As noted by a commenter, we are required by the Congress to adjust for geographic differences in the operational cost of physicians' practices by applying geographic price indices to each component of the Physician Fee Schedule. However, we also believe it appropriate in our resource based payment system to account for real differences in physicians' costs in different geographical areas. We share the concern about access to care for our rural beneficiaries and, in this rule, we are finalizing our proposals on payment adjustments to physicians in underserved areas through the HPSA Incentive Payment Program. For the commenters who object to the GPCI adjustment to the work RVUs, we would note that for 2005 and 2006 the floor for the work GPCI will be 1.00. 
                    </P>
                    <P>With reference to the issue of the GPCI data source, we are always open to suggestions about possible data sources; however, we believe the most reliable source of national, comparable data at the county level is the Census Bureau. Other data sources that we have examined either fail to produce the data at the county level, cannot be compared nationally, or offer no means of comparability over time. </P>
                    <P>We believe that the proxies, while not perfect, are the best tools available for the development of the GPCIs. For example, if we were to eliminate all proxies, we would have to collect actual physicians' office data from a sufficiently large sample in each locality to calculate the GPCIs. This would place a substantial burden on the office staff and would be prohibitively expensive. Also, the benefits from that approach would be uncertain. </P>
                    <P>The question of applying uniform weights to practice components is an area where more research could lead to better information about the variation attributable to case mix and the availability of other health resources, input prices, and practice styles. However, it is important to note that much of the variation associated with case and specialty mix is accounted for by the varying RVUs for different services. However, we are open to exploring this issue. </P>
                    <P>On the issue of which employee categories are included in the employee wage index component of the practice expense GPCI calculation, we included those that have been determined in the past to be most commonly present in a physician's private practice. We are considering the suggestion that we include a broader group of employment categories in the future. </P>
                    <P>While we recognize that apartment rents are not a perfect proxy for physician office rents, there are no existing national studies that present reliable retail and business rentals data. We would welcome any nationally consistent data that could be used for this purpose. </P>
                    <P>We noted in the proposed rule that we were unable to find any data sources that demonstrate price differences by geographic areas for medical equipment and supplies. Once again, however, we welcome any nationally consistent data for this purpose. </P>
                    <P>We appreciate the concern expressed by the commenter who suggested our GPCI methodology has not been subjected to peer-review validation since its inception, but we are not aware of any currently available data that could replace our methodology. Furthermore, we believe the process of updating the GPCIs periodically through notice and comment rulemaking affords an opportunity for a thorough review of the GPCI calculation methodology. </P>
                    <P>
                        <E T="03">Comment:</E>
                         A member of a medical society suggested that we make the floor of 1.00 permanent for the work GPCI and incrementally increase both the practice expense GPCI and the professional liability insurance GPCI to 1.00 over the next ten years. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We have no authority to extend the floor of the work GPCI, or to create a 1.00 floor for the practice expense and professional liability insurance GPCIs. Section 1848(c)(1)(A) of the Act requires that the index reflect resource costs relative to the national average, indicating that, aside from the MMA provision establishing a floor on the work GPCI through 2006, localities with costs below the national average have GPCIs below 1.00. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         A specialty organization representing the long term care industry suggested that we phase in the new 
                        <PRTPAGE P="66263"/>
                        GPCI values over a three-year period to minimize the impact of the changes. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We are required by section 1848(e)(1)(C) of the Act to review and adjust the GPCIs every 3 years. This section of the Act also requires us to phase in the adjustment over 2 years and implement only one-half of any adjustment if more than 1 year has elapsed since the last GPCI revision. We believe this phase-in appropriately balances any negative impacts of the changes with the positive impacts on those localities where the GPCIs increase. 
                    </P>
                    <HD SOURCE="HD3">4. Payment Localities </HD>
                    <P>As discussed in the August 5, 2004 proposed rule, we have considered, and are continuing to examine, alternatives to the composition of the current 89 Medicare physician payment localities to which the GPCIs are applied. </P>
                    <P>While we have considered alternatives, we have been unable to establish a policy and criteria that would satisfactorily apply to all situations. Any policy that we would propose would have to apply to all States and payment localities. If, for example, we were to establish a policy that when adjacent county geographic indices exceeded a threshold amount the lower county could be moved to the higher county or that a separate locality could be created, redistributions would be caused within a State. </P>
                    <P>Because there will be both winners and losers in any locality reconfiguration, the State medical associations should be the impetus behind these changes. The support of State medical associations has been the basis for previous changes to statewide areas, and continues to be equally important in our consideration of other future locality changes. </P>
                    <P>
                        <E T="03">Comment:</E>
                         We received numerous comments from physicians and individuals, including members of the Congress, living in and around Santa Cruz County, California. Their comments uniformly expressed the opinion that Santa Cruz be taken out of the “Rest of California” payment locality and placed in a separate payment locality. 
                    </P>
                    <P>Additionally, the California Medical Association (CMA) submitted a “placeholder” proposal to move any county with a county-specific geographic adjustment factor (GAF) that is 5 percent greater than its locality GAF to its own individual county payment locality. Under their proposal, any reductions in payments to maintain budget neutrality in light of the higher payments to physicians in the counties that are moved into the new independent county localities would be divided equally among all payment localities within the State of California. Additionally, for 2005 and 2006, the GAFs in localities from which the high-cost counties are removed would not be reduced as a result of removing the counties. </P>
                    <P>
                        <E T="03">Response:</E>
                         We greatly appreciate the efforts of the CMA and many others toward addressing this difficult issue. We also recognize the concerns expressed by the residents of Santa Cruz County about the impact of the current payment disparities upon physicians in their community. Our consistent position has been that we will be responsive to requests for locality changes when there is a demonstrated consensus within the State medical association for the change. Due to the re-distributive impacts of these types of changes, we believe this approach helps ensure the appropriateness of any such change. 
                    </P>
                    <P>We are required, however, to publish the final 2005 GPCIs and GAFs in this rule, and we have applied the current definitions for all California localities. </P>
                    <P>On October 21, 2004, the CMA Board of Trustees voted without objection to support the placeholder proposal submitted in the CMA's comment with the amendment to limit the time period to the years 2005 through 2006. However, we have determined that we do not have the authority under section 1848(e) of the Act to reduce the GPCIs of some localities in a State to offset higher payments to other localities. Nonetheless, we are eager to work with CMA and its Congressional Representatives to resolve this difficult problem as quickly and fairly as possible. </P>
                    <P>
                        <E T="03">Comment:</E>
                         We received comments from physicians, individuals and the Texas Medical Association regarding locality payments. These commenters request that we regard all counties in a metropolitan statistical area (MSA) as being in a single payment locality. This would, they argue, equalize payments in those areas where growth has expanded city boundaries across county lines. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         As noted above, we will be responsive to requests for locality changes when there is a demonstrated consensus within the State medical association for the change.
                    </P>
                    <HD SOURCE="HD2">Result of Evaluation of Comments </HD>
                    <P>We will finalize the GPCIs as proposed. </P>
                    <HD SOURCE="HD2">C. Malpractice Relative Value Units (RVUs) </HD>
                    <HD SOURCE="HD3">1. Proposed Methodology for the Revision of Resource-based Malpractice RVUs </HD>
                    <P>The methodology used in calculating the proposed resource-based malpractice RVUs is the same methodology that was used in the initial development of resource-based RVUs, the only difference being the use of more current data. The proposed resource-based malpractice expense RVUs are based upon: </P>
                    <P>• Actual 2001 and 2002 malpractice premium data; </P>
                    <P>• Projected 2003 premium data; and </P>
                    <P>• 2003 Medicare payment data on allowed services and charges. </P>
                    <P>As in the initial development of resource-based malpractice expense RVUs in the November 2, 1999 final rule, we proposed to revise resource-based malpractice expense RVUs using specialty-specific malpractice premium data because they represent the actual malpractice expense to the physician. In addition, malpractice premium data are widely available. We proposed using actual 2001 and 2002 malpractice premium data and projected 2003 malpractice premium data for three reasons: </P>
                    <P>• These are the most current national claims-made premium data available. </P>
                    <P>• These data capture the highly publicized and most recent trends in the specialty-specific costs of professional liability insurance. </P>
                    <P>• These are the same malpractice premium data that were used in the development of revised malpractice GPCIs in the November 7, 2003 final rule. </P>
                    <P>We were unable to obtain a nationally representative sample of 2003 malpractice premium data for the following two reasons: </P>
                    <P>• The premium data that we collected from the private insurance companies had to “match” the market share data that were provided by the respective State Departments of Insurance (DOI). Because none of the State DOI had 2003 market share information at the time of this data collection, 2003 premium data were not usable; and </P>
                    <P>• The majority of private insurers were not amenable to releasing premium data to us. In the majority of instances, the private insurance companies would release their premium data only to the State Department of Insurance. </P>
                    <P>
                        Discussions with the industry led us to conclude that the primary determinants of malpractice liability costs remain physician specialty, level 
                        <PRTPAGE P="66264"/>
                        of surgical involvement, and the physician's malpractice history. Malpractice premium data were collected for the top 20 Medicare physician specialties measured by total payments. Premiums were for a $1 million/$3 million mature claims-made policy (a policy covering claims made, rather than services provided during the policy term). We attempted to collect premium data from all 50 States, Washington, DC, and Puerto Rico. Data were collected from commercial and physician-owned insurers and from joint underwriting associations (JUAs). A JUA is a State government-administered risk pooling insurance arrangement in areas where commercial insurers have left the market. Adjustments were made to reflect mandatory patient compensation funds (PCFs) (funds to pay for any claim beyond the statutory amount, thereby limiting an individual physician's liability in cases of a large suit) surcharges in States where PCF participation is mandatory. The premium data collected represent at least 50 percent of physician malpractice premiums paid in each State. 
                    </P>
                    <P>For 2001, we collected premium data from 48 States (for purposes of this discussion, State counts include Washington, DC and Puerto Rico). We were unable to obtain premium data from Kentucky, New Hampshire, New Mexico, and Washington, DC. To calculate a proxy for the malpractice premium data for these four areas in 2001, we began with the most current malpractice premium data collected for these areas, 1996 through 1998 (the last premium data collection that was undertaken). We calculated an average premium price (using 1996 through 1998 data) for all States except Kentucky, New Hampshire, New Mexico, and Washington, DC. Similarly, we calculated an average premium price for the 1999 through 2001 period for all States except Kentucky, New Hampshire, New Mexico, and Washington, DC. We calculated the percentage change in these premium prices as the percent difference between the 1999 to 2001 calculated average premium price and the 1996 to 1998 calculated average premium price. We then applied this percentage change to the weighted average 1996 to 1998 malpractice premium price for these four areas to arrive at a comparable 1999 to 2001 average premium price. </P>
                    <P>For 2002, we were able to obtain malpractice premium data from 33 States. Many State Departments of Insurance had not yet obtained premium data from the primary insurers within their States at the time of this data collection. For those States for which we were unable to obtain malpractice premium data, we calculated a national average rate of growth for 2002 and applied this national rate of growth to the weighted average premium for 2001 to obtain an average premium for 2002 for each county for which we were unable to obtain malpractice premium data for 2002. </P>
                    <P>We projected premium values for 2003 based on the average of historical year-to-year changes for each locality (when locality level data were available) or by State (when only statewide premium data projections were available). First, we calculated the percentage changes in the premiums from the 1999 through 2000, 2000 through 2001, and 2001 through 2002 periods for each payment locality. Next, we calculated the geometric mean of these three percentages and applied the mean to the 2002 premium to obtain the forecasted 2003 malpractice premium. We used the geometric mean to calculate the forecasted 2003 premium data because the geometric mean is commonly used to derive the mean of a series of values that represent rates of change. Because the geometric mean is based on the logarithmic scale, it is less impacted by outlying data. Alternative methods, such as linear extrapolation tended to yield more extreme values that were the result of outlying data. </P>
                    <P>Malpractice insurers generally use five-digit codes developed by the Insurance Services Office (ISO), an advisory body serving property and casualty insurers, to classify physician specialties into different risk classes for premium rating purposes. ISO codes classify physicians not only by specialty, but in many cases also by whether or not the specialty performs surgical procedures. A given specialty could thus have two ISO codes, one for use in rating a member of that specialty who performs surgical procedures and another for rating a member who does not perform surgery. We use our own system of specialty classification for payment and data purposes. It was therefore necessary to map Medicare specialties to ISO codes and insurer risk classes. Different insurers, while using ISO codes, have their own risk class categories. To ensure consistency, we used the risk classes of St. Paul Companies, one of the oldest and largest malpractice insurers. Although St. Paul Companies have recently terminated writing professional liability insurance policies at the time of this data collection they were still the largest and most nationally representative writer of professional liability insurance policies in the nation. The crosswalks for Medicare specialties to ISO codes and to the St. Paul risk classes used are reflected in Table 4. </P>
                    <P>Some physician specialties, nonphysician practitioners, and other entities (for example, independent diagnostic testing facilities) paid under the physician fee schedule could not be assigned an ISO code. We crosswalked these specialties to similar physician specialties and assigned an ISO code and a risk class. These crosswalks are reflected in Table 5. </P>
                    <P>In the development of the proposed resource-based malpractice RVU methodology, we considered two malpractice premium-based alternatives for resource-based malpractice RVUs: the dominant specialty approach and the specialty-weighted approach. </P>
                    <HD SOURCE="HD2">Dominant Specialty Approach </HD>
                    <P>The dominant specialty approach bases the malpractice RVUs upon the risk factor of only the dominant specialty performing a given service as long as the dominant specialty accounted for at least 51 percent of the total utilization for a given service. When 51 percent of the total utilization does not comprise the dominant specialty, this approach uses a modified specialty-weighted approach. In this modified specialty-weighted approach, two or more specialties are collectively defined as the dominant specialty. Starting with the specialty with the largest percentage of allowed services, the modified specialty-weighted approach successively adds the next highest specialty in terms of percentage of allowed services until a 50 percent threshold is achieved. The next step is to sum the risk factors of those specialties (weighted by utilization) in order to achieve at least 50 percent of the total utilization of a given service and then to use the factors in the calculation of the final malpractice RVU. </P>
                    <P>The dominant specialty approach produces modest increases for some specialties and modest decreases for other specialties. The largest increase for any given specialty, over the specialty-weighted approach, is less than 1.5 percent of total RVUs, while the largest decrease for any given specialty is less than 0.5 percent of total RVUs. The dominant specialty approach also fails to account for as much as 49 percent of the utilization associated with a given procedure. </P>
                    <HD SOURCE="HD2">Specialty-Weighted Approach </HD>
                    <P>
                        The approach that we adopted in the November 1999 final rule and proposed 
                        <PRTPAGE P="66265"/>
                        to use for 2005 bases the final malpractice RVUs upon a weighted average of the risk factors of all specialties performing a given service. The specialty-weighted approach ensures that all specialties performing a given service are accounted for in the calculation of the final malpractice RVU. Under the proposed methodology, we— 
                    </P>
                    <P>
                        • 
                        <E T="03">Compute a national average premium for each specialty.</E>
                         Insurance rating area malpractice premiums for each specialty are mapped to the county level. The specialty premium for each county is then multiplied by the total county RVUs (as defined by Medicare claims data), which were divided by the malpractice GPCI applicable to each county to standardize the relative values for geographic variations. If the malpractice RVUs were not normalized for geographic variation, the locality cost differences (as reflected by the GPCIs) would be counted twice. The product of the malpractice premiums and standardized RVUs is then summed across specialties for each county. This calculation is then divided by the total RVUs for all counties, for each specialty, to yield a national average premium for each specialty. As stated previously, we used an average of the 3 most current years, 2001 to projected 2003 malpractice premiums, in our calculation of the proposed malpractice RVUs. See Table 6 for a display of the average premiums for the top 20 Medicare specialties; 
                    </P>
                    <P>
                        • 
                        <E T="03">Calculate a risk factor for each specialty.</E>
                         Differences among specialties in malpractice premiums are a direct reflection of the malpractice risk associated with the services performed by a given specialty. The relative differences in national average premiums between various specialties can be expressed as a specialty risk factor. These risk factors are an index calculated by dividing the national average premium for each specialty by the national average premium for the specialty with the lowest average premium, nephrology. The risk factors used in the development of the resource-based malpractice RVUs are displayed in Table 7; 
                    </P>
                    <P>
                        • 
                        <E T="03">Calculate malpractice RVUs for each code.</E>
                         Resource-based malpractice RVUs were calculated for each procedure. In order to calculate malpractice RVUs for each code, we identified the percentage of services performed by each specialty for each respective procedure code. This percentage was then multiplied by each respective specialty's risk factor as calculated in Step 2. The products for all specialties for the procedure were then summed, yielding a specialty-weighted malpractice RVU reflecting the weighted malpractice costs across all specialties for that procedure. This number was then multiplied by the procedure's work RVUs to account for differences in risk-of-service. Since we were unable to find an acceptable source of data to be used in determining risk-of-service, work RVUs were used. We welcome any suggestions at any time for alternative data sources to be used in determining risk-of-service. 
                    </P>
                    <P>Certain specialties may have more than one ISO rating class and risk factor. The surgical risk factor for a specialty was used for surgical services and the nonsurgical risk factor for evaluation and management services. Also, for obstetrics/gynecology, the lower gynecology risk factor was used for all codes except those obviously surgical services, in which case the higher, surgical risk factor was used. </P>
                    <P>Certain codes have no physician work RVUs. The overwhelming majority of these codes are the technical components (TCs) of diagnostic tests, such as x-rays and cardiac catheterization, which have a distinctly separate technical component (the taking of an x-ray by a technician) and professional component (the interpretation of the x-ray by a physician). Examples of other codes with no work RVUs are audiology tests and injections. Nonphysicians, in this example, audiologists and nurses, respectively, usually furnish these services. In many cases, the nonphysician or entity furnishing the TC is distinct and separate from the physician ordering and interpreting the test. We believe it is appropriate for the malpractice RVUs assigned to TCs to be based on the malpractice costs of the nonphysician or entity, not the professional liability of the physician. </P>
                    <P>Our proposed methodology, however, would result in zero malpractice RVUs for codes with no physician work, since we proposed the use of physician work RVUs to adjust for risk-of-service. We believe that zero malpractice RVUs would be inappropriate because nonphysician health practitioners and entities such as independent diagnostic testing facilities (IDTFs) also have malpractice liability and carry malpractice insurance. Therefore, we proposed to retain the current charge-based malpractice RVUs for all services with zero work RVUs. We also solicited comments and suggestions for constructing resource-based malpractice RVUs for codes with no physician work. </P>
                    <P>
                        • 
                        <E T="03">Rescale for budget neutrality.</E>
                         The law requires that changes to fee schedule RVUs be budget neutral. The current resource-based malpractice RVUs and the proposed resource-based malpractice RVUs were constructed using entirely different malpractice premium data. Thus, the last step in this process is to adjust for budget neutrality by rescaling the proposed malpractice RVUs so that the total proposed resource-based malpractice RVUs equal the total current resource-based malpractice RVUs. The proposed resource-based malpractice RVUs for each procedure were then multiplied by the frequency count for that procedure to determine the total resource-based malpractice RVUs for each procedure. The total resource-based malpractice RVUs for each procedure were summed for all procedures to determine the total fee schedule proposed resource-based malpractice RVUs. The total fee schedule 
                        <E T="03">proposed</E>
                         resource-based malpractice RVUs were compared to the total 
                        <E T="03">current</E>
                         resource-based malpractice RVUs. The total current and proposed malpractice RVUs were equal and, therefore, budget neutral. Thus, no adjustments were needed to ensure that expenditures remained constant for the malpractice RVU portion of the physician fee schedule payment. 
                    </P>
                    <P>The proposed resource-based malpractice RVUs were shown in Addendum B of the August 5, 2004 proposed rule. The values did not reflect any final budget-neutrality adjustment, which we stated would be made in the final rule based upon the more current Medicare claims data. The malpractice RVUs identified in this final rule did not require the application of a scaling factor to retain budget neutrality. </P>
                    <P>Because of the differences in the sizes of the three fee schedule components, the implementation of the updated resource-based malpractice RVUs has a smaller payment effect than the previous implementation of resource-based practice expense RVUs. On average, work represents about 52.5 percent of the total payment for a procedure, practice expense about 43.6 percent of the total payment, and malpractice expense about 3.9 percent of the total payment. Thus, a 20 percent change in practice expense or work RVUs would yield a change in payment of about 8 to 11 percent. In contrast, a corresponding 20 percent change in malpractice values would yield a change in payment of only about 0.6 percent. </P>
                    <BILCOD>BILLING CODE 4120-01-P</BILCOD>
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                        <GID>ER15NO04.496</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="614">
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                        <GID>ER15NO04.497</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="360">
                        <PRTPAGE P="66268"/>
                        <GID>ER15NO04.498</GID>
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                        <GID>ER15NO04.499</GID>
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                        <GID>ER15NO04.500</GID>
                    </GPH>
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                        <PRTPAGE P="66271"/>
                        <GID>ER15NO04.501</GID>
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                    <GPH SPAN="3" DEEP="645">
                        <PRTPAGE P="66272"/>
                        <GID>ER15NO04.502</GID>
                    </GPH>
                    <BILCOD>BILLING CODE 4120-01-C</BILCOD>
                    <PRTPAGE P="66273"/>
                    <HD SOURCE="HD2">Comments and Responses</HD>
                    <P>We received public comments on several malpractice issues. The comments and our responses are stated below. </P>
                    <P>
                        <E T="03">Comment:</E>
                         Several comments were received that requested revisions to the data sources utilized in the development of resource-based malpractice RVUs. Specifically, commenters requested that we remove utilization for assistant-at-surgery claims from the calculation of resource-based malpractice RVUs because the utilization of assistant-at-surgery services artificially lowers the average risk associated with surgical services. Additionally, we also received comments that raised questions related to the ISO crosswalks and resulting risk factors that we used. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We agree that assistants at surgery should not be reflected in the malpractice RVUs because they are not primarily responsible for performing the surgical procedures, and we are removing the assistant-at-surgery utilization, and associated risk factors, from the data that are used to calculate the resource-based malpractice RVUs. The inclusion of the lower assistant-at-surgery risk factors into the overall determination of some complex surgical services artificially lowers the average risk factor and resulting resource-based malpractice RVUs of these services. 
                    </P>
                    <P>Regarding the ISO Classifications and resulting risk factors that were applied to specialties, the majority of comments received did not offer substantive reasons or alternative methodologies for the proposed ISO crosswalks. We derived the ISO crosswalks, and resulting risk factors, based upon the review by both our contractor and CMS medical officers. Due to the lack of substantive alternatives in the comments received, we will retain the crosswalks that were proposed in the August 4, 2004 proposed rule (see Table 7) with the exception of orthopedic surgery and dermatology. </P>
                    <P>
                        <E T="03">Comment:</E>
                         Several commenters believed that the August 2004 proposed rule that established risk factors of 7.46 for orthopedic surgery with spinal and 8.06 for orthopedic surgery without spinal were counterintuitive and needed revision. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We agree with these comments and have revised the orthopedic surgery with spinal risk factor to reflect the risk factor identified in the rating manuals (8.89). In the proposed rule, the risk factors for orthopedic surgery with spinal and without spinal were taken from two separate sources (premium data and rating manuals, respectively) thus causing the anomalous result. See Table 7 for the revised orthopedic surgery risk factors. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         Two commenters, including the American College of Dermatology believe that the use of the higher risk class of major surgery is inappropriate for dermatological services as the typical dermatological practice does not encompass major surgery but instead focuses on minor surgery in the office setting. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We agree with these comments and will use the minor surgery and no-surgery risk classifications for dermatological services. See Table 7 for the revised dermatology risk factors. The impact of removing the assistant at surgery claims and revising the risk factor associated with orthopedic surgery with spinal is a 0.9 percent increase for neurosurgery and a 0.4 percent increase for orthopedic surgery over the malpractice RVUs shown in proposed rule. The effect of replacing the major surgery risk factor with the minor surgery risk factor for dermatology is a 0.9 percent decrease in total payments relative to the proposed rule. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         One commenter states that the resource-based malpractice RVU methodology underestimates the cost of PLI for physicians who perform obstetric and gynecologic services. According to the commenter, eighty percent of OB/GYNs perform both obstetric and gynecologic services yet the risk factor for most services these physicians provide to Medicare beneficiaries is based on the much lower premiums paid by physicians who offer only gynecologic services. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         Although obstetricians and gynecologists' malpractice premiums can be appreciably different, most Medicare OB/GYN services are gynecological. Therefore, all Medicare OB/GYN procedures will be assigned a gynecology risk factor except in those instances where the service provided is clearly obstetrical in nature. CPT codes in the range of 59000-59899 are clearly obstetrical services and use the obstetrics risk factor (11.30). 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         One commenter felt that it was inappropriate to assign 0.00 malpractice RVUs to services that have physician work and have historically had a small amount of malpractice RVUs associated with them. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We agree with this comment and will adjust these services in the final rule. All payable fee schedule services have some amount of PLI associated with their performance. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         One commenter requested that we consider the implementation of the resource-based malpractice expense RVUs interim until the agency has worked with the medical community to ensure that the data and methodology utilized to calculate the malpractice RVUs are appropriate. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We are continuing to work with the medical community to ensure that the methodology and data used to calculate the malpractice RVUs appropriately reflect the actual resource costs associated with professional liability insurance for physicians. Section 1848(c)(2)(B)(i) of the Act states that the Secretary is required to review the relative values not less often than every 5 years. If substantive information becomes available subsequent to the publication of the final malpractice RVUs, the statute allows us flexibility to review that information for possible inclusion in future malpractice RVU updates. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         Several commenters requested that we use a methodology that would only account for the dominant specialty in the calculation of the service-specific resource-based malpractice RVUs. Commenters stated that a dominant specialty approach would be consistent with the “typical” service approach that we use throughout the resource-based physician payment system. Commenters also feel that a dominant specialty approach would more appropriately reflect the actual premium resource costs associated with the performance of individual services. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We continue to believe that accounting for all specialties that perform a given service is the more appropriate and equitable methodology in establishing resource-based malpractice RVUs. Basing payment upon all specialties that perform a given service ensures that the actual professional liability insurance resource costs of all specialties are included in the calculation of the final malpractice RVUs. Using only the dominant specialty does not capture the true resource costs associated with a given service and under a relative value based system, results in the redistribution of RVUs based upon only partial data. 
                    </P>
                    <P>
                        The dominant specialty approach is particularly vulnerable for calculating resource-based malpractice RVUs in services that are multi-disciplinary in nature. An example that illustrates the potentially distorting effect of the dominant specialty approach on multi-disciplinary services is the specialty utilization associated with a level III established office visit. Although over 35 different specialties perform a significant number of these services, a dominant specialty approach would base the malpractice RVUs on 
                        <PRTPAGE P="66274"/>
                        approximately 2 specialties. High risk specialties such as neurosurgery, thoracic surgery, general surgery, and obstetrics and gynecology, which account for a small percentage of the total utilization but a large amount of total dollars, would no longer factor into the calculation of the malpractice RVU for this service. These four specialties alone account for nearly $300 million of the total dollars associated with a level III established office visit. The effect of removing these four high-cost, high-risk specialties from the calculation of the malpractice RVUs for this service would be an overall decrease in the malpractice RVUs, because the calculation would be based upon lower-cost, lower-risk specialties. 
                    </P>
                    <P>We disagree that a dominant specialty approach is consistent with the typical service approach used in the RUC survey process. Irrespective of the specialty performing a given service, we require that the typical service be the measurement tool for the calculation of final payments. The typical service approach utilized in the RUC survey process has never referred to the typical specialty performing a service, but instead to the typical type of service furnished. This typical service would encompass such things as the condition of the patient, the extent of the work, the staff needed to accomplish the service, and the respective resource inputs associated with the typical service. </P>
                    <P>We will continue to work with the RUC PLI Workgroup to identify alternatives to the dominant specialty approach. One alternative that we are currently exploring with the RUC PLI Workgroup is removing aberrant data from low utilization services. </P>
                    <P>
                        <E T="03">Comment:</E>
                         One commenter suggested that we determine the exponential rate of growth in the PLI premium data from 2001 through 2003 to predict the 2004 premium data. This commenter believes that we should use only this predicted 2004 premium data in the calculation of resource-based malpractice RVUs. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We disagree with the commenter's recommendation that predicted 2004 professional liability insurance premium data be utilized in the calculation of resource-based malpractice RVUs. The data sources that are currently used in the calculation of the 2005 resource-based malpractice RVUs consist of actual 2001 and 2002 premium data (when available) and projected 2003 premium data. Professional liability insurance has proven to be the most volatile data source that is used in the calculation of resource-based physician fee schedule RVUs. For this reason, we believe that it is inappropriate to use only one year of projected premium data. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         Various specialty organizations request that we work with the RUC's Professional Liability Insurance (PLI) Workgroup to ensure that the medical community has input into the refinement of the malpractice RVUs. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         Over the course of the past year, we have been working with the RUC PLI Workgroup to solicit input on the methodology and data sources utilized to calculate resource-based malpractice RVUs. We continue to actively participate in the PLI Workgroup to keep both the workgroup and the various specialty organizations aware of our progress in the development and refinement of resource-based malpractice RVUs. We have forwarded all requested contractor reports, which outline both our methodology and data sources, to the RUC for review and comment. We agree with these comments and plan to continue our cooperative relationship with the RUC PLI Workgroup and various specialty organizations to ensure that the necessary specialty organizations are involved with both the premium collection efforts and the development and refinement of resource-based malpractice RVUs. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         Tail coverage is designed to cover any claims that may be made against a new employee for services furnished on behalf of his or her old employer during the time that he or she is employed by the new employer. Several commenters suggested that we incorporate the cost of tail coverage in the determination of PLI annual premium data. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         Although we agree with the commenters that it might be desirable to use tail coverage premium data in addition to the annual premium data that are currently used in the revisions to resource-based malpractice RVUs, we have been unable to identify a nationally representative source of tail coverage premium data. We are continuing to work with the RUC PLI Workgroup, the AMA, and the various specialty organizations to identify a nationally representative source of tail coverage premium data for future rulemaking. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         One commenter recommended that professional liability insurance data for all specialties should be used rather than the data from the top 20 Medicare specialties. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         Although it might be desirable to obtain premium data from every conceivable specialty in the practice of medicine, it is not possible to obtain this scope of data under the time constraints associated with collecting the most current premium data. In order to conduct surveys that collect the maximum amount of premium data from all geographic areas without being too intrusive to the State Departments of Insurance and private insurance companies, we chose to limit the scope of the data collection to the top 20 Medicare specialties. Further, utilizing PLI data from the top 20 Medicare specialties encompasses 80 percent of fee schedule services. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         Several commenters requested that we use data from the Physician Insurers Association of America (PIAA) in the development of resource-based malpractice RVUs. This commenter further requested that we provide concise requirements for those data collection efforts. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We did explore the use of data from PIAA in the development of resource-based malpractice RVUs. Unfortunately, the PIAA does not include actual physician claims-made premium data by insurer and specialty classification. The information that was available from PIAA ranged from insured demographics information to medical malpractice claims trends. 
                    </P>
                    <P>Regarding our criteria for premium data collection efforts, we have shared the criteria for those premium data collection efforts with the RUC PLI Workgroup. </P>
                    <P>
                        <E T="03">Comment:</E>
                         Several commenters recommended that the malpractice RVUs should remain stable. Commenters suggested that any budget neutrality adjustments, positive or negative, that might occur due to the 5-year review of malpractice RVUs should be made to the conversion factor and not to the malpractice RVUs. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We acknowledge the comments that suggest that any adjustments for budget neutrality not be performed on the RVUs, but we note that any budget neutrality adjustments to the RVUs do not change the relative relationship among the values for the services but instead uniformly change all relative values. Regarding malpractice RVUs specifically, malpractice RVUs are by nature not “stable.” When the malpractice RVUs are reviewed and updated, the malpractice RVUs associated with all services could potentially change. Additionally, for 2005, we are mandated by statute to apply at least a 1.5 percent increase to the conversion factor. Thus, if the budget neutrality associated with updated malpractice RVUs were negative, it would not be possible to ensure budget neutrality and comply with the statutory 1.5 percent update. 
                        <PRTPAGE P="66275"/>
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         One commenter recommended that the exceptions to the surgical risk factor be modified to include coding changes since the initiation of the resource-based malpractice RVUs in 2000. The previous update to the malpractice RVUs made service-specific exceptions, whereby certain codes were assigned the higher surgical risk factor in the calculation of their final malpractice RVU. The commenter specifically requested that due to CPT coding modifications, the following codes should also receive this same coding modification and receive the greater of their actual average risk factor or the risk factor for cardiac catheterization: 92973-92974, 93501-93533, 93580-93581, 93600-93613, and 93650-93652. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         In order to retain the exceptions that were identified in the previous malpractice RVU update for this new series of services, we will assign the greater of the actual average risk factors or the risk factor for cardiac catheterization services. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         Several commenters agreed with our use of the work RVUs as the best available data source for adjusting the malpractice RVUs for risk of service. These commenters noted, as we did, that the work RVUs are not a perfect proxy for risk of service, but are the best available source at this time. Commenters requested that we continue our use of work RVUs as the adjuster to malpractice RVUs for risk of service, but also requested that we be responsive to potential anomalies that may be identified. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We agree with these comments and look forward to continuing our work with the various organizations to identify all potential anomalies in the malpractice RVUs. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         One commenter expressed concern that, although malpractice premiums have increased for all specialty practices, some specialty practices will experience a decline in payments as a result of the 5-Year Review of malpractice RVUs. This commenter suggested that additional dollars need to be added to the system to account for rising PLI costs. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         The impact of the malpractice RVU revisions on an individual specialty organization is not a direct reflection of the increases or decreases in their malpractice premiums but instead reflects increases or decreases in a specific state's premiums as compared to the national average. In some instances, specialty organizations might have experienced slight increases in their respective malpractice premiums since the last malpractice RVU update, but these increases have occurred at a slower rate than the national average increase for all specialty organizations. The result is a negative impact on these specialties. Specialty organizations that have increased at a rate higher than the national average will experience positive impacts. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         One commenter believes that additional dollars should be added to the Medicare physician fee schedule to account for escalating professional liability insurance premiums. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         The Medicare Economic Index (MEI) is the device by which additional dollars are added to the physician fee schedule. For 2005, the cost category associated with professional liability insurance has increased by 23.9 percent. However, for 2004 and 2005, section 601 of the MMA established an update of 1.5 percent. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         The American College of Radiology (ACR) commented that there is an imbalance between the distribution of malpractice RVUs to the professional component and technical component of a service. The ACR requested that we work with ACR staff to identify alternative methodologies for the more appropriate valuation of technical component services. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         Physician work RVUs are used to adjust for risk of service. Because technical component services do not have physician work RVUs, they are still valued using charge-based RVUs instead of the resource-based malpractice RVU methodology. We look forward to working with the ACR and other interested specialty organizations to examine alternative methodologies that would allow technical component services to also reflect resource-based malpractice RVUs. 
                    </P>
                    <HD SOURCE="HD2">Final Decision </HD>
                    <P>We are implementing the revised 2005 malpractice RVUs as proposed with the modifications noted in the discussions above. Additionally, we are continuing to work with the AMA's RUC to— </P>
                    <P>• Consider the appropriateness of a dominant specialty approach; </P>
                    <P>• Identify the most current nationally representative professional liability insurance premium data; </P>
                    <P>• Review the current ISO crosswalks; and </P>
                    <P>• Review aberrant data patterns in low-utilization services for possible inclusion in a future rulemaking cycle. </P>
                    <HD SOURCE="HD2">D. Coding Issues </HD>
                    <HD SOURCE="HD3">
                        1. Change in Global Period for CPT Code 77427, 
                        <E T="03">Radiation Treatment Management, Five Treatments</E>
                    </HD>
                    <P>This code was included in the November 2, 1999 physician fee schedule final rule (64 FR 59380) and was effective for services beginning January 1, 2000. In that rule, and subsequent rules, we have applied a global indicator of “xxx” to this code, meaning that the global concept does not apply. It was brought to our attention that this global indicator is incorrect and that the code should be assigned a 90-day global period because the RUC valuation of this service reflected a global period of 90 days which we had accepted. Therefore, we proposed to correct the global indicator for this service to reflect a global period of 90 days (090). </P>
                    <P>
                        <E T="03">Comment:</E>
                         Specialty organizations representing radiation oncology and radiology as well as individual physicians and providers, and the AMA, all expressed concern about this proposal to change the global period for CPT code 77427. The commenters stated that this code is universally recognized as a recurring service that can be provided multiple times during a course of radiation. This code is usually submitted once for each group of five treatments (or fractions) and represents substantial services furnished during that group (typically 1 week) of five treatments. Commenters believe this proposed change would—
                    </P>
                    <P>• Contradict the current CPT definitions; </P>
                    <P>• Not reflect the process of care for radiation; </P>
                    <P>• Countervene the essence of the RUC valuations; and </P>
                    <P>• Negate the guidelines that we previously issued. </P>
                    <P>Because a change in the global period could have a significant impact on the process of care for radiation oncology, commenters urged us to withdraw this proposal or to delay implementation until there is further discussion with the specialty organizations and the RUC, and clarification of billing matters related to this proposed change are provided. </P>
                    <P>
                        <E T="03">Response:</E>
                         Based on the concerns raised by the commenters, we are not changing the global period for this service as proposed. 
                    </P>
                    <HD SOURCE="HD2">Result of Evaluation of Comments </HD>
                    <P>
                        We are retaining the global period of “xxx” for CPT code 77427. 
                        <PRTPAGE P="66276"/>
                    </P>
                    <HD SOURCE="HD3">2. Requests for Adding Services to the List of Medicare Telehealth Services </HD>
                    <P>As discussed in the proposed rule (69 FR 47510), section 1834(m) of the Act defines telehealth services as professional consultations, office and other outpatient visits, and office psychiatry services defined as of July 1, 2000 by CPT codes 99241 through 99275, 99201 through 99215, 90804 through 90809, and 90862. In addition, the statute requires us to establish a process for adding services to, or deleting services from, the list of telehealth services on an annual basis. In the CY 2003 final rule, we established a process for adding to or deleting services from the list of Medicare telehealth services (67 FR 79988). This process provides the public an opportunity on an ongoing basis to submit requests for adding a service. We assign any request to add a service to the list of Medicare telehealth services to one of the following categories: </P>
                    <P>
                        • 
                        <E T="03">Category 1:</E>
                         Services that are similar to office and other outpatient visits, consultation, and office psychiatry services. In reviewing these requests, we look for similarities between the proposed and existing telehealth services in terms of the roles of, and interactions among, the beneficiary, the physician (or other practitioner) at the distant site and, if necessary, the telepresenter. We also look for similarities in the telecommunications system used to deliver the proposed service, for example, the use of interactive audio and video equipment. 
                    </P>
                    <P>
                        • 
                        <E T="03">Category 2:</E>
                         Services that are not similar to the current list of telehealth services. Our review of these requests includes an assessment of whether the use of a telecommunications system to deliver the service produces similar diagnostic findings or therapeutic interventions as compared with the face-to-face “hands on” delivery of the same service. Requestors should submit evidence showing that the use of a telecommunications system does not affect the diagnosis or treatment plan as compared to a face-to-face delivery of the requested service. 
                    </P>
                    <P>
                        Requests for adding services to the list of Medicare telehealth services must be submitted and received no later than December 31st of each calendar year to be considered for the next proposed rule. For example, requests submitted in CY 2003 are considered for the CY 2005 proposed rule. For more information on submitting a request for addition to the list of Medicare telehealth services, visit our Web site at 
                        <E T="03">http://www.cms.hhs.gov/physicians/telehealth</E>
                        . 
                    </P>
                    <P>We received the following public requests for addition in CY 2003:</P>
                    <P>• Inpatient hospital care (as represented by CPT codes 99221 through 99223 and 99231 through 99233). </P>
                    <P>• Emergency department visits (as defined by CPT codes 99281 through 99285). </P>
                    <P>• Hospital observation services (as represented by CPT codes 99217, 99218 through 99220). </P>
                    <P>• Inpatient psychotherapy (as defined by CPT codes 90816 through 90822). </P>
                    <P>• Monthly management of patients with end-stage renal disease (ESRD), (as represented by HCPCS codes G0308 through G0319). </P>
                    <P>• Speech and audiologist services (as defined by CPT code range 92541 through 92596). </P>
                    <P>• Case management (as identified by CPT codes 99361 and 99362) </P>
                    <P>• Care plan oversight services (as represented by CPT codes 99374 and 99375). </P>
                    <P>After reviewing the public requests for addition, we proposed to add ESRD-related services as described by G0308, G0309, G0311, G0312, G0314, G0315, G0317, and G0318 to the list of Medicare telehealth services. However, we specified that the required clinical examination of the vascular access site must be furnished face-to-face “hands on” (without the use of an interactive telecommunications system) by a physician, certified nurse specialist (CNS), nurse practitioner (NP), or physician's assistant (PA). An interactive telecommunications system may be used for providing additional visits required under the 2 to 3 visit Monthly Capitation Payment (MCP) code and the 4 or more visit MCP code. </P>
                    <P>Moreover, we proposed to add the term “ESRD-related visits” to the definition of Medicare telehealth services at § 410.78 and § 414.65 as appropriate. </P>
                    <P>We did not propose to add any additional services to the list of Medicare telehealth services for CY 2005. </P>
                    <P>
                        For further information on the addition to the list of telehealth services, see the 
                        <E T="04">Federal Register</E>
                         dated August 5, 2004 (69 FR 47510). 
                    </P>
                    <HD SOURCE="HD2">Inpatient Hospital Care, Hospital Observation Services, Inpatient Psychotherapy, and Emergency Department Services </HD>
                    <P>
                        <E T="03">Comment:</E>
                         We received conflicting comments on our proposal not to add inpatient hospital care, hospital observation services, inpatient psychotherapy, and emergency department services to the list of approved telehealth services. For example, one professional society supported our proposal not to add inpatient hospital care, hospital observation services, inpatient psychotherapy, and emergency department services to the list. That commenter believes conclusive efficacy data is necessary before adding the aforementioned services. Likewise, an association representing emergency department management agreed that emergency department visits should not be added to the list of Medicare telehealth services. That commenter believes that hospitals in rural areas have physicians with sufficient experience to handle the complexities of emergent care. 
                    </P>
                    <P>An association representing family physicians agreed with our proposal not to add inpatient hospital care and hospital observation services. However, they disagreed with our proposal not to add emergency department visits to the list of Medicare telehealth services. The commenter stated that emergency department visits should not be assigned to category 2 based on the acuity of the patient. The commenter believes that the range of potential acuity is the same in the emergency room as it is in the office setting and noted that office and other outpatient visits are currently on the list of Medicare telehealth services. A professional society encouraged us to reexamine the request to add inpatient hospital care, observation services, and inpatient psychotherapy to the list of Medicare telehealth services in the future. </P>
                    <P>
                        <E T="03">Response:</E>
                         We agree that the acuity for some patients may be the same in the emergency department as in a physician's office. However, we also believe that more acutely ill patients are more likely to be seen in the emergency department. Although telehealth is an acceptable alternative to face-to-face “hands on” patient care in certain settings, the potential for misdiagnosis and/or mismanagement, with more serious consequences, exists in high acuity environments like the emergency department when telehealth is used as a replacement for an onsite physician or practitioner. The practice of emergency medicine often requires frequent patient reassessments, rapid physician interventions, and sometimes the continuous physician interaction with ancillary staff and consultants. We do not have evidence suggesting the use of telehealth could be a reasonable surrogate service for this type of care. In the absence of sufficient evidence that illustrates that the use of a telecommunications system produces 
                        <PRTPAGE P="66277"/>
                        similar diagnoses or therapeutic interventions as would the face-to-face delivery of inpatient hospital care, emergency department visits, hospital observation services, and inpatient psychotherapy, we do not plan to add these services to the list of approved telehealth services. As discussed in the proposed rule, we believe that the current list of Medicare telehealth services is appropriate for hospital inpatients, emergency room cases, and patients designated as observation status. If guidance or advice is needed in these settings, a consultation may be requested from an appropriate source. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         A telehealth association and a telehealth network requested that we clarify what consultation codes could be used for hospital inpatients, emergency room cases, and patients designated as observation status. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         The appropriate consultation code depends on the admission status of the beneficiary. When the beneficiary is an inpatient of a hospital, the physician or practitioner at the distant site bills an initial or follow-up inpatient consultation as described by CPT codes 99251 through 99263. For the hospital observation setting and emergency department, the appropriate office or other outpatient consultation code is CPT codes 99241 through 99245. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         Some commenters believe that hospital inpatient care, inpatient psychotherapy, observation services, and emergency department visits should all be assigned to category 1 because they are clinically the same as a consultation. Moreover, the commenters expressed their opinion that a telecommunications system would not substitute for an in-person practitioner for the requested hospital services. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We agree that the key components of a consultation are similar to inpatient hospital care, observation services, and emergency department visits. However, a consultation service is distinguished from the requested hospital services because it is provided by a physician or practitioner whose opinion or advice regarding evaluation and management of a specific problem is requested by another physician or appropriate source. The ongoing management of the patient's condition remains the responsibility of the practitioner who requested the consultation. As discussed in our response to another comment, a consultation may be provided as a Medicare telehealth service for hospital inpatients, emergency room cases, and patients designated in observation status. 
                    </P>
                    <P>In furnishing a consultation as a telehealth service, the physician at the distant site provides additional expertise, to ensure optimal patient outcomes. For consultation services, a practitioner is available to manage the patient at the originating site. However, adding the requested hospital services would permit a telecommunications system to be used as a substitute for an onsite practitioner because the physician or practitioner at the distant site assumes responsibility for the ongoing management of the patient's condition. </P>
                    <HD SOURCE="HD2">End Stage Renal Disease—Monthly Management of Patients on Dialysis </HD>
                    <P>
                        <E T="03">Comment:</E>
                         Many commenters, including a telehealth association, a nephrology nurses association, a renal physicians association, a health system, a community hospital, a telemedicine law group, and others applauded our proposal to add the ESRD-related services with 2 or 3 visits per month and ESRD-related services with 4 or more visits per month to the list of Medicare telehealth services. For example, two commenters believe that adding these services will help provide dialysis patients living in rural areas sufficient access to nephrology specialists and will save both patients and practitioners a significant amount of travel time. Additionally, many commenters expressed strong support for not permitting the visit that includes a clinical examination of the vascular access site to be added to the list of Medicare telehealth services and agreed that this exam should be furnished in person. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We agree with the comments. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         With regard to furnishing ESRD-related visits under the MCP, a nephrology association suggested that we permit the use of e-mail and telephone conferencing for one year. The commenter believes this grace period would enable physicians and originating sites to acquire the necessary technology and execute their implementation plans. Additionally, an association of kidney patients questioned whether telehealth services would be available to ESRD patients in non-rural areas. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         Services added to the list of Medicare telehealth services are subject to the requirements and conditions of payment in the law and regulations. Under the Medicare telehealth provision, the use of an interactive audio and video telecommunications system that permits real-time interaction between the patient, physician or practitioner at the distant site, and telepresenter (if necessary) is a substitution for the face-to-face requirements under Medicare. Electronic mail systems and telephone calls are specifically excluded from the definition of an interactive telecommunications system. Moreover, we do not have the legislative authority to expand the geographic areas where telehealth services may be furnished. Telehealth services may only be furnished in non-Metropolitan Statistical Area counties or rural health professional shortage areas. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         An association representing kidney patients questioned whether we plan to evaluate the provision of telehealth services to ESRD patients to determine best practices. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We believe that most physicians and practitioners will use telehealth services for providing additional visits required under the MCP as appropriate to manage their patients on dialysis. However, we would welcome specific data on best practice methods for furnishing ESRD-related services as telehealth services. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         Some commenters indicated a belief that the ESRD-related services were assigned to category 2 for review. For example, one telehealth group believed that a discrepancy exists between the rationale we used to add ESRD-related services to the list of telehealth services and our decision not to add inpatient hospital care, observation services, inpatient psychotherapy, and emergency department visits. The commenter stated that ESRD-related services were added in the absence of randomized clinical trials or comparison studies and mentioned that the same level of evidence was submitted for ESRD-related services as for other requests (for example, inpatient hospital services). The commenter requested clarification on the method used to assign services to category 1 or category 2. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         As discussed in the proposed rule, the MCP represents a range of services provided during the month, including various physician and practitioner services, such as the establishment of a dialyzing cycle, outpatient evaluation and management of the dialysis visit(s), telephone calls, and patient management as well as clinically appropriate physician or practitioner visit(s) during the month. At least one of the visits must include a clinical examination of the vascular access site furnished face-to-face, “hands-on” by a physician, CNS, NP, or PA. 
                    </P>
                    <P>
                        We considered the outpatient evaluation and management of the dialysis visits to be similar to an office 
                        <PRTPAGE P="66278"/>
                        visit and other outpatient visits currently on the list of Medicare telehealth services. However, we believe that the clinical examination of the vascular access site is not similar to the existing telehealth services, and, therefore, it meets the criteria for a category 2 request. We did not propose to add a comprehensive visit including a clinical examination of the vascular access site, to the list of Medicare telehealth services because the requestor did not provide comparative analyses illustrating that the use of a telecommunications system is an adequate substitute for a face-to-face clinical examination of the vascular access site. However, as discussed in the proposed rule, we do believe that the subsequent visits to monitor the patient's condition met our criteria for approving a category 1 request. For category 1 services, we look for similarities between the proposed and existing telehealth services in terms of the roles of, and interactions among, the beneficiary, the physician or practitioner at the distant site, and, if necessary, the telepresenter. 
                    </P>
                    <P>Therefore, we proposed that the MCP physician, that is, the physician or practitioner responsible for the evaluation and management of the patient's ESRD, and other practitioners within the same group practice or employed by the same employer or entity, may furnish additional ESRD-related visits as telehealth services using an interactive audio and video telecommunications system. However, for purposes of billing the MCP, at least one visit must include a clinical examination of the vascular access site, and must be furnished face-to-face, “hands on” by a physician, CNS, NP, or PA each month. </P>
                    <P>
                        <E T="03">Comment:</E>
                         One commenter requested that we allow a physician or surgeon located at the originating site (who is not the MCP physician) to furnish ESRD-related visits involving the clinical examination of the vascular access site. The commenter stated that having a physician or surgeon skilled in vascular access management available to work in coordination with the MCP physician is necessary for geographically remote areas such as Alaska and in severe weather conditions. The commenter believes that this type of arrangement is well suited for telehealth. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         The MCP physician may use another physician to provide some of the visits during the month however, the non-MCP physician must have a relationship with the billing physician such as a partner, employees of the same group practice or an employee of the MCP physician, for example, the physician at the originating site is either a W-2 employee or 1099 independent contractor. 
                    </P>
                    <HD SOURCE="HD2">Case Management and Care Plan Oversight (Team Conferences and Physician Supervision) </HD>
                    <P>A telehealth association and a network of clinics requested clarification on— </P>
                    <P>• The scope of authority relating to the addition of services that do not require a face-to-face encounter with the patient; and </P>
                    <P>• Whether our policy for care plan oversight is similar to the interpretation of an x-ray and other services that do not require a face-to-face encounter. </P>
                    <P>Additionally, a neurological society urged us to reconsider our decision not to add medical team conferences to the list of telehealth services. The commenter argued that adding medical team conferences as a telehealth service would improve the quality of the care plan and save time for all physicians involved in the patient's care. </P>
                    <P>
                        <E T="03">Response:</E>
                         We add services to the list of Medicare telehealth services that traditionally require a face-to-face physician or practitioner encounter. The use of an interactive audio and video telecommunications system, permitting real time interaction between the beneficiary, physician or practitioner at the distant site, and telepresenter (if necessary) is a substitute for face-to-face requirements under Medicare. Services not requiring a face-to-face encounter with the patient that may be furnished through the use of a telecommunications system are already covered under Medicare. As discussed in chapter 15, section 30 of the Medicare Benefit Policy Manual, payment may be made for physicians' services delivered via a telecommunications system for services that do not require a face-to-face patient encounter. The interpretation of an x-ray, electrocardiogram, electroencephalogram and tissue samples are listed as examples of these services. The Medicare Benefit Policy Manual may be found on our Web site at 
                        <E T="03">http://www.cms.hhs.gov/manuals/</E>
                         by selecting the internet-only manuals link. 
                    </P>
                    <P>Medical team conferences and monthly physician supervision do not require a face-to-face encounter with the patient, and, thus, a telecommunications system may be used to accomplish them. However, Medicare payment for CPT codes 99361, 99362, and 99374 are bundled; no separate payment is made under the Medicare program for these services, and CPT code 99375 (physician supervision; 30 minutes or more) is invalid for Medicare payment purposes. We pay for monthly physician supervision as described by HCPCS codes G0181 and G0182. </P>
                    <HD SOURCE="HD2">Process for Adding Services to the List of Medicare Telehealth Services </HD>
                    <P>
                        <E T="03">Comment:</E>
                         We received conflicting comments on our process for adding services to the list of Medicare telehealth services. For example, a surgeons' association supported the evidence-based approach for adding category 2 services. However, a school of medicine and a telemedicine and electronic health group believe that we should consider changing our categorical system for adding a service to the list of Medicare telehealth services, specifically, in relation to the requested hospital services for hospital inpatients, emergency room cases, and patients designated as observation status. 
                    </P>
                    <P>One of the commenters believes that the decision to use a telehealth system should be up to the physician or practitioner at the distant site. The commenter argues that, if the physician or practitioner at the distant site is not comfortable in making a clinical judgment, the patient may be asked to travel to the physician's office for further examination. </P>
                    <P>Moreover, the commenter contends that the nature of telehealth services is not well suited for clinical trials and that the evidence that we require under category 2 may never be obtained because of the lack of reimbursement. As an alternative, the commenters recommended a method of review that considers—</P>
                    <P>• Clinical utilization of the requested telehealth service; </P>
                    <P>• The opinions of physicians and practitioners furnishing the telehealth service; and </P>
                    <P>• The opportunity for the physicians and practitioners to prove the service is being delivered appropriately via telecommunications system. </P>
                    <P>
                        <E T="03">Response:</E>
                         We believe that the current method for reviewing requests for addition already considers the criteria mentioned by the commenter. The process for adding services to the list of Medicare telehealth services provides the public an ongoing opportunity to propose services that they believe are appropriate for Medicare payment. Requestors may submit data showing that patients who receive the requested service via telecommunications system are satisfied with the service delivered and that the use of a telecommunications system does not change the diagnosis or therapeutic 
                        <PRTPAGE P="66279"/>
                        interventions for the requested service. Additionally, we believe that having different categories of review allows us to add requested services that are most like the current telehealth services (for example, office visits, consultation, and office psychiatry) without subjecting these requests to a comparative analysis. 
                    </P>
                    <P>Since establishing the process to add services to the list of Medicare telehealth services, we have added the psychiatric diagnostic interview examination and have proposed specific ESRD-related services for the CY 2005 rule. </P>
                    <P>
                        <E T="03">Comment:</E>
                         One commenter recommended that we replace the term face-to-face with “in-person”. The commenter believes that the term “in-person” is a better description of an encounter where the practitioner is in the same physical location as the beneficiary. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         The commenter's suggestion to use the term “in-person” to describe an encounter where the physician or practitioner and the beneficiary are physically in the same room has been noted. We will consider the commenter's suggestion as we discuss Medicare telehealth payment policy in the future. 
                    </P>
                    <HD SOURCE="HD2">Report to Congress </HD>
                    <P>
                        <E T="03">Comment:</E>
                         An audiology society and a language and hearing association strongly believe that most audiology services and speech therapy can be furnished remotely as telehealth services. To that end, many commenting groups and associations requested that we complete the report to Congress (as required by section 223(d) of the BIPA) and urged us to recommend adding speech language pathologists and audiologists as medical professionals that may provide and receive payment for Medicare telehealth services. 
                    </P>
                    <P>Moreover, in light of the proposed addition of ESRD-related services to the list of telehealth services, many of these same commenters along with a nephrology society requested that we recommend adding dialysis facilities to the list of originating sites. One commenter requested that we add the patient's home to the definition of an originating site. </P>
                    <P>
                        <E T="03">Response:</E>
                         The report to Congress on additional sites and settings, practitioners, and geographic areas that may be appropriate for Medicare telehealth payment is under development. We are considering the suggestions raised by the commenters as we formulate our recommendations to the Congress. 
                    </P>
                    <HD SOURCE="HD2">Result of Evaluation of Comments </HD>
                    <P>We are adding ESRD-related services as described by G0308, G0309, G0311, G0312, G0314, G0315, G0317, and G0318 to the list of Medicare telehealth services. However, we will require that the complete assessment must include a face-to-face clinical examination of the vascular access site furnished “hands on” (without the use of an interactive telecommunications system) by a physician, clinical nurse specialist, nurse practitioner, or physician's assistant. An interactive telecommunications system may be used for providing additional visits required under the 2 to 3 visit MCP code and the 4 or more visit MCP code. Additionally, we are adding the term “ESRD-related visits” to the definition of Medicare telehealth services at § 410.78 and § 414.65, as appropriate. </P>
                    <HD SOURCE="HD3">3. National Pricing of G0238 and G0239 Respiratory Therapy Service Codes. </HD>
                    <P>In the 2001 final rule, we created the following three G codes for respiratory therapy services: </P>
                    <P>• G0237 Therapeutic procedures to increase strength or endurance of respiratory muscles, face-to-face, one-on-one, each 15 minutes (includes monitoring). </P>
                    <P>• G0238 Therapeutic procedures to improve respiratory function, other than ones described by G0237, one-on-one, face-to-face, per 15 minutes (includes monitoring). </P>
                    <P>• G0239 Therapeutic procedures to improve respiratory function or increase strength or endurance of respiratory muscles, two or more individuals (includes monitoring). </P>
                    <P>We assigned RVUs to one of the codes (G0237), and indicated that the other two codes (G0238 and G0239) would be carrier-priced. Since the services represented by these codes are frequently being performed in comprehensive outpatient rehabilitation facilities (CORFs), paid under the physician fee schedule through fiscal intermediaries, there has been some uncertainty surrounding the payment for the carrier-priced services. We believe assigning RVUs to G0238 and G0239 will provide needed clarity. Since these services are typically performed by respiratory therapists, we did not assign physician work to G0237, and we did not propose work RVUs for either G0238 or G0239. </P>
                    <P>Therefore, we proposed to value nationally the practice expense for these services using the nonphysician work pool. We proposed to crosswalk practice expense RVUs for G0238 to those for G0237 based on our belief that the practice expense for the activities involved is substantially the same for both services. </P>
                    <P>For G0239, we believe a typical group session to be 30 minutes in length and to consist of 3 patients. Therefore, for the practice expense RVUs for G0239, we proposed using the practice expense RVUs of G0237 reduced by one-third to account for the fact that the service is being provided to more than one patient simultaneously and each patient in a group can be billed for the services of G0329. </P>
                    <P>We also proposed a malpractice RVU of 0.02, the malpractice RVU assigned to G0237, for these two G-codes. </P>
                    <P>
                        <E T="03">Comment:</E>
                         Commenters supported the national pricing for these 2 G-codes, G0238 and G0239. However, these organizations disagree with our RVU assignment. Specifically, most commenters disagreed with the lack of physician work RVUs and also believed that the malpractice RVU is inadequate to reflect the costs associated with the delivery of the services. These organizations contend that pulmonary rehabilitation services “include a physician-directed individualized plan of care using multidisciplinary qualified health professionals to enhance the effective management of pulmonary diseases and resultant functional deficits.” They believe that beneficiaries may receive pulmonary rehabilitation services at physician offices, outpatient departments of acute care hospitals, CORFs and rehabilitation clinics. The commenters noted that physicians and qualified nurse practitioners (NPs) and PAs order, supervise, and approve the plans of care for patients receiving respiratory therapy services, irrespective of the delivery setting. 
                    </P>
                    <P>Because respiratory rehabilitation is often furnished in a physician office, these organizations believe the malpractice RVU assigned is inadequate to account for the physician involvement and requested that a more appropriate risk factor be used. </P>
                    <P>
                        <E T="03">Response:</E>
                         Because we believe that respiratory therapists (RTs) typically deliver these services, it would be inappropriate to assign a physician work RVU to these services. The malpractice RVU of 0.02 is similar to RVUs of therapeutic procedures delivered by physical and occupational therapists for similar services, including procedures performed one-on-one and in groups. We believe that the 0.02 malpractice RVU fairly represents the risk value inherent in the provision of these procedures. However, because the commenters expressed concerns about work and malpractice RVUs, we are assigning these RVUs on an interim 
                        <PRTPAGE P="66280"/>
                        basis, and we are requesting that the RUC or HCPAC consider this series of three G-codes at an upcoming meeting. 
                    </P>
                    <P>Because RTs cannot directly bill Medicare for their services, these G-codes can only be billed as incident to services in physician offices and outpatient hospital departments or as CORF services. When performed in the CORF setting, these services must be delivered by qualified personnel, that is, RTs and respiratory therapy technicians, as defined at § 485.70. The CORF benefit requires the physician to establish the respiratory therapy plan of care and mandates a 60-day recertification for therapy plans of care, including physical therapy (PT), occupational therapy (OT), speech language pathology (SLP), and respiratory therapy. As we stated in the December 31, 2002 final rule, we believe that specially trained professionals (that is, registered nurses, physical therapists and occupational therapists) can also provide these services. </P>
                    <P>These respiratory therapy G-codes were designed to provide more specific information about the medically necessary services being provided to improve respiratory function and to substitute for the physical medicine series of CPT codes 97000 through 97799, except when services are furnished and meet all the requirements for physical and occupational therapy services. </P>
                    <P>
                        <E T="03">Comment:</E>
                         While three commenters voiced concerns about the significant undervaluing of these codes, one commenter noted that the practice expense RVUs fail to recognize the intensity of services and the cost of monitoring and other equipment associated with providing these services. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We agree that the practice expenses, particularly the equipment, for G0237 and G0238 are not equivalent and that there are more resources required to provide the medically necessary services of G0238. The necessary monitoring equipment referenced by commenters were considered at the time G0327 was originally valued. The appropriate direct inputs will be added to the practice expense database. However, we identified the omission of therapeutic exercise equipment for G0238 and G0239 and we will also add this to the practice expense database. 
                    </P>
                    <HD SOURCE="HD2">Result of Evaluation of Comments </HD>
                    <P>We are assigning practice expense and malpractice RVUs to G0238 and G0239 and will add the additional items to the practice expense database. These codes are being valued in the nonphysician work pool as proposed. We will also ask the RUC or HCPAC to consider these codes. </P>
                    <HD SOURCE="HD3">4. Bone Marrow Aspiration and Biopsy through the Same Incision on the Same Date of Service. </HD>
                    <P>In the August 5, 2004 rule, we proposed a new add-on G-code, G0364 (proposed as G0XX1): Bone marrow aspiration performed with bone marrow biopsy through same incision on same date of service. The physician would use the CPT code for bone marrow biopsy (38221) and G0364 for the second procedure (bone marrow aspiration). </P>
                    <P>We believe that there is minimal incremental work associated with performing the second procedure through the same incision during a single encounter. We estimated that the time associated with this G-code is approximately 5 minutes based on a comparison to CPT code 38220 bone marrow aspiration which has 34 minutes of intraservice time and a work RVU of 1.08 work when performed on its own. We proposed 0.16 work RVUs for this new add-on G-code and malpractice RVUs of 0.04 (current malpractice RVUs assigned to CPT code 38220). For practice expense, we proposed the following practice expense inputs: </P>
                    <FP SOURCE="FP-1">— Clinical staff time: Registered nurse—5 minutes Lab technician—2 minutes </FP>
                    <FP SOURCE="FP-1">— Equipment: Exam table </FP>
                    <P>We also proposed a ZZZ global period (code related to another service and is always in the global period of the other service) for this add-on code since this code is related to another service and is included in the global period of the other service. </P>
                    <P>In the August 5, 2004 proposed rule, we also stated that if the two procedures, aspiration and biopsy, are performed at different sites (for example, contralateral iliac crests, sternum/iliac crest or two separate incisions on the same iliac crest), the −59 modifier, which denotes a distinct procedural service, is appropriate to use and Medicare's multiple procedure rule will apply. In this instance, the CPT codes for aspiration and biopsy are each being used. </P>
                    <P>
                        <E T="03">Comment:</E>
                         Many commenters supported creation of this G-code; however, all commenters stated that the time for this procedure (5 minutes) was substantially underestimated. Commenters recommended increasing the added incremental time associated with the aspiration to 15 minutes. One commenter noted that this time is needed for the actual aspiration procedure, approving the quality of the aspiration, collecting flow cytometry and chromosome studies, preparing additional slides, ordering appropriate lab tests on the slides, and performing the added recordkeeping and documentation. Another commenter provided a detailed description of the activities involved in this procedure. Commenters also recommended that the practice expense input for the nurse assisting with the procedure should be increased to 15 minutes.
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We continue to believe that the proposed 5 minutes of physician time, 5 minutes of registered nurse time, and 2 minutes of lab technician time reflect the additional effort involved when a bone marrow aspiration is performed in conjunction with a bone marrow biopsy through the same incision during a single encounter. It is our understanding that some of the activities attributed to the additional 15 minutes of physician work generally are performed by ancillary staff, for example, preparing slides. While we appreciate the information provided, we believe that the majority of the effort and specific tasks discussed are accounted for in the CPT code for bone marrow biopsy (38221) which is the primary code being billed. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         Two physician specialty societies, representing radiologists and interventional radiologists, questioned the need for the proposed code, because the multiple surgical discount rule that reduces payment for a subsequent lower valued service applies, thereby taking into account any savings in physician work. If we choose to proceed with the proposal, the commenter recommended the RVUs be consistent with those determined using the current values for CPT codes 38220 and 38221 and the multiple surgical discount rule. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         One of the primary reasons for our proposal for this G-code was that we believe that, even with the application of the multiple procedure reduction, we would be overpaying for these services when they are performed on the same day, at the same encounter and using the same incision. 
                    </P>
                    <HD SOURCE="HD2">Result Of Evaluation of Comments </HD>
                    <P>
                        We are finalizing our proposal and using new G-code G0364, Bone marrow aspiration performed with bone marrow biopsy through the same incision on the same date of service. Payment is based on the work and malpractice RVUs and practice expense inputs proposed and the global period for this service is “ZZZ”. 
                        <PRTPAGE P="66281"/>
                    </P>
                    <HD SOURCE="HD3">5. Q-Code for the Set-Up of Portable X-Ray Equipment </HD>
                    <P>The Q-code for the set-up of portable x-ray equipment, Q0092, is currently paid under the physician fee schedule and is assigned an RVU of 0.33. In 2004, this produces a national payment of $12.32. This set-up code encompasses only a portion of the resources required to provide a portable x-ray service to patients. In 2003, portable x-ray suppliers received total Medicare payments of approximately $208 million. More than half of these payments (approximately $116 million) were for portable x-ray transportation (codes R0070 and R0075). The portable x-ray set-up code (Q0092) generated approximately $19 million in payments. The remainder of the Medicare payments for portable x-ray services (approximately $73 million) were for the actual x-ray services themselves. </P>
                    <P>As discussed in the August 5, 2004 proposed rule, the Conference Report accompanying the Consolidated Appropriations Bill, H.R. 2673, (Pub. L. 108-199, enacted January 23, 2004) urged the Secretary to review payment for this code, and the portable x-ray industry has also requested that we reexamine payments for this code. </P>
                    <P>Q0092 is currently priced in the nonphysician work pool. At the time we modeled this change for the proposed rule, removing this code from the nonphysician work pool had an overall negative impact on payments to portable x-ray suppliers (as a result of decreases to radiology codes that remain in the nonphysician work pool) and a negative impact on many of the codes remaining in the nonphysician work pool. An alternative to national pricing of portable x-ray set-up would be to require Medicare carriers to develop local pricing as they do currently for portable x-ray transportation. We requested comments on whether we should pursue national pricing for portable x-ray set-up outside of the nonphysician work pool or local carrier pricing for 2005, or whether we should continue to price the service in the nonphysician work pool. </P>
                    <P>
                        <E T="03">Comment:</E>
                         Most commenters recommended removing portable x-ray from the nonphysician work pool, using the “existing data” from the American College of Radiology (ACR) supplemental practice expense survey as the practice expense per hour proxy. However, the National Association of Portable X-Ray Suppliers (NAPXP) requested additional time to review information they received from us just 3 days before the close of the comment period. This association requested that they be allowed to submit supplemental comments. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         ACR requested that we delay incorporating their survey data for 1 year. Using the data for one code, as proposed by commenters, would be inconsistent with that request. We believe it is inappropriate to use the new survey data for this code but no other code. Even if we removed the set-up code from the nonphysician work pool and calculated its practice expense RVU using the ACR data, the increase in payment for the portable x-ray set-up code would be largely offset by lower payment for x-ray services. Payments for other services in the nonphysician work pool would also decline affecting other specialties, such as radiology, radiation oncology, cardiology, allergy, audiology and others. Further, the portable x-ray set-up code is yet to be refined, and we believe that the 45 minutes of staff time that is used to determine its value is likely overstated. We believe it is preferable to address refinement of the code and pricing the service outside of the nonphysician work pool together. Therefore, in 2005, we are continuing to price this service within the nonphysician work pool. 
                    </P>
                    <P>The NAPXP requested more time to review the data we supplied them. NAPXP's comment implying that we withheld “data” from them is simply wrong. In an effort to explain the theoretical reasons for our statements that removing this service from the nonphysician work pool could lower overall payments to portable x-ray suppliers, we prepared an illustration for another association as a follow-up request after a meeting, where we were asked to explain our proposed rule analysis. The explanation contained no new data. Moreover, we provided the explanatory information to NAPXP as soon as they requested it. Since the information NAPXP complains about was illustrative only, we do not believe NAPXP has been prejudiced in any way. Moreover, we are willing to explain the information to NAPXP and to consider any comments they may have as we consider changes to the practice expense methodology for 2006. </P>
                    <HD SOURCE="HD3">6. Venous Mapping for Hemodialysis </HD>
                    <P>In the August 5, 2004 rule, we proposed a new G-code (G0XX3: Venous mapping for hemodialysis access placement (Service to be performed by operating surgeon for preoperative venous mapping prior to creation of a hemodialysis access conduit using an autogenous graft). Autogenous grafts have longer patency rates, a lower incidence of infection and greater durability than prosthetic grafts. Use of autogenous grafts can also result in a decrease in hospitalizations and morbidity related to vascular access complications. We stated that creation of this G-code will enable us to distinguish between CPT code 93971 (Duplex scan of extremity veins including responses to compression and other maneuvers; unilateral or limited study) and G0XX3 in order to allow us to track use of venous mapping for quality improvement purposes. </P>
                    <P>We also proposed that this G-code be billed only by the operating surgeon in conjunction with CPT codes 36819, 36821, 36825, and 36832 and that we would not permit payment for CPT code 93971 when this G-code is billed, unless code CPT 93971 was being performed for a separately identifiable clinical indication in a different anatomic region. </P>
                    <P>We proposed to crosswalk the RVUs for the new G-code from those of CPT code 93971 and also assigned this new G-code a global period of “XXX,” which means that the global concept does not apply. </P>
                    <P>
                        <E T="03">Comment:</E>
                         Commenters representing specialty societies and individual providers were generally supportive of the proposal for this new code, but expressed the following three primary concerns: 
                    </P>
                    <P>• Commenters did not agree with restricting this code to the operating surgeon, stating that such a restriction could limit access and serve as a barrier in providing this service. They also stated that this proposed restriction is not reflective of current practice, since nonsurgeons often perform this procedure. </P>
                    <P>• Commenters did not agree with the proposed descriptor. They indicated that the proposed descriptor did not reflect the procedure as it is now performed and suggested (a) alternate wording, such as “vascular mapping,” “autogenous AV fistula,” and “prosthetic graft,” “vessel mapping;” (b) that two G-codes should be created to distinguish between a complete bilateral and unilateral or limited studies. Other commenters noted that the proposal did not distinguish between mapping by venography or ultrasound (duplex), and some commenters suggested creating an additional G-code to distinguish between these procedures. </P>
                    <P>• Commenters stated that the comparison to CPT code 93971 in the proposed rule undervalues the service. While there are differences, the closer analogue in terms of time and resources required is CPT code 93990, Duplex scans of hemodialysis access. </P>
                    <P>
                        <E T="03">Response:</E>
                         We proposed the G-code to create the opportunity for us to analyze 
                        <PRTPAGE P="66282"/>
                        the relationship between venous mapping utilization and fistula formation. 
                    </P>
                    <P>Based on the comments we received, we are revising the code descriptor to enable clinicians, other than the operating surgeon, who provide care to ESRD patients the opportunity to bill for this service. </P>
                    <P>We believe that vessel mapping requires the assessment of the arterial and venous vessels in order to provide the information necessary for the creation of an autogenous conduit. Therefore, we are also revising payment for this code and will crosswalk it to CPT code 93990 for work, malpractice, and practice expense RVUs because these RVUs more appropriately reflect the work and resources of this new G-code. The G-code and descriptor for this service will be G0365, Vessel mapping of vessels for hemodialysis access (Services for preoperative vessel mapping prior to creation of hemodialysis access using an autogenous hemodialysis conduit, including arterial inflow and venous outflow). This code can only be used in patients who have not had a prior hemodialysis access prosthetic graft or autogenous fistula and is limited to two times per year. </P>
                    <P>We will not permit separate payment for CPT code 93971 when this G-code is billed, unless CPT code 93971 is being performed for a separately identifiable indication in a different anatomic region. We also note that other imaging studies may not be billed for the same site on the same date of service unless an appropriate “KO” modifier indicating the reason or need for the second imaging study is provided on the claim form. </P>
                    <P>We will follow the utilization closely this year to better understand whether this code is used as intended. </P>
                    <HD SOURCE="HD1">III. Provisions Related to the Medicare Modernization Act of 2003 </HD>
                    <HD SOURCE="HD2">A. Section 611—Preventive Physical Examination </HD>
                    <P>Section 611 of the MMA provides for coverage under Part B of an initial preventive physical examination (IPPE) for new beneficiaries, effective for services furnished on or after January 1, 2005, subject to certain eligibility and other limitations. </P>
                    <P>In the August 5, 2004 proposed rule, we described a new § 410.16 (Initial preventive physical examination: conditions for and limitations on coverage) that would provide for coverage of the various IPPE services specified in the statute. As provided in the statute, this new coverage allows payment for one IPPE within the first 6 months after the effective date of the beneficiary's first Part B coverage period, but only if that coverage period begins on or after January 1, 2005. To implement the statutory provisions, we proposed definitions of the following terms: </P>
                    <P>• Eligible beneficiary; </P>
                    <P>• An initial preventive physical examination; </P>
                    <P>• Medical history; </P>
                    <P>• Physician; </P>
                    <P>• Qualified NPP; </P>
                    <P>• Social History, and </P>
                    <P>• Review of the individual's functional ability and level of safety. </P>
                    <P>In keeping with the language of section 611 of the MMA, we defined the term “eligible beneficiary” to mean individuals who receive their IPPEs within 6 months after the date of their first Medicare Part B coverage period, but only if their first Part B coverage period begins on or after January 1, 2005. This section also defines the term “Initial Preventive Physical Examination” to mean services provided by a physician or a qualified NPP consisting of: (1) A physical examination (including measurement of height, weight, blood pressure, and an electrocardiogram, but excluding clinical laboratory tests) with the goal of health promotion and disease detection; and (2) education, counseling, and referral for screening and other covered preventive benefits separately authorized under Medicare Part B. </P>
                    <P>Specifically, section 611(b) of the MMA provides that the education, counseling, and referral of the individual by the physician or other qualified NPP are for the following statutory screening and other preventive services authorized under Medicare Part B: </P>
                    <P>• Pneumococcal, influenza, and hepatitis B vaccine and their administration; </P>
                    <P>• Screening mammography; </P>
                    <P>• Screening pap smear and screening pelvic exam services; </P>
                    <P>• Prostate cancer screening services; </P>
                    <P>• Colorectal cancer screening tests; </P>
                    <P>• Diabetes outpatient self-management training services; </P>
                    <P>• Bone mass measurements; </P>
                    <P>• Screening for glaucoma; </P>
                    <P>• Medical nutrition therapy services for individuals with diabetes or renal disease; </P>
                    <P>• Cardiovascular screening blood tests; and </P>
                    <P>• Diabetes screening tests. </P>
                    <P>Based on the language of the statute, our review of the medical literature, current clinical practice guidelines, and United States Preventive Services Task Force (USPSTF) recommendations, we interpreted the term “initial preventive physical examination” for purposes of this benefit to include all of the following service elements: </P>
                    <P>1. Review of the individual's comprehensive medical and social history, as those terms are defined in proposed § 410.16(a); </P>
                    <P>2. Review of the individual's potential (risk factors) for depression (including past experiences with depression or other mood disorders) based on the use of an appropriate screening instrument, which the physician or other qualified NPP may select from various available standardized screening tests for this purpose, unless the appropriate screening instrument is defined through the national coverage determination (NCD) process; </P>
                    <P>3. Review of the individual's functional ability and level of safety, as described in proposed § 410.16(a), (that is, at a minimum, a review of the following areas: Hearing impairment, activities of daily living, falls risk, and home safety), based on the use of an appropriate screening instrument, which the physician or other qualified NPP may select from various available standardized screening tests for this purpose, unless the appropriate screening instrument is further defined through the NCD process; </P>
                    <P>4. An examination to include measurement of the individual's height, weight, blood pressure, a visual acuity screen, and other factors as deemed appropriate by the physician or qualified NPP, based on the individual's comprehensive medical and social history and current clinical standards; </P>
                    <P>5. Performance and interpretation of an electrocardiogram; </P>
                    <P>6. Education, counseling, and referral, as appropriate, based on the results of the first five elements of the initial preventive physical examination; and </P>
                    <P>
                        7. Education, counseling, and referral, including a written plan provided to the individual for obtaining the appropriate screening and other preventive services, which are separately covered under Medicare Part B benefits; that is, pneumococcal, influenza, and hepatitis B vaccines and their administration, screening mammography, screening pap smear and screening pelvic examinations, prostate cancer screening tests, colorectal cancer screening tests, diabetes outpatient self-management training services, bone mass measurements, screening for glaucoma, medical nutrition therapy services, cardiovascular (CV) screening blood tests, and diabetes screening tests. 
                        <PRTPAGE P="66283"/>
                    </P>
                    <P>The proposed “medical history” definition includes the following elements: </P>
                    <P>• Past medical history and surgical history, including experience with illnesses, hospital stays, operations, allergies, injuries, and treatment. </P>
                    <P>• Current medications and supplements, including calcium and vitamins. </P>
                    <P>• Family history, including a review of medical events in the patient's family, including diseases that may be hereditary or place the individual at risk. </P>
                    <P>The proposed “physician” definition means for purposes of this provision a doctor of medicine or osteopathy (as defined in section 1861(r)(1) of the Act). </P>
                    <P>The proposed “qualified nonphysician practitioner” for purposes of this provision means a PA, NP, or clinical nurse specialist (CNS) (as authorized under sections 1861(s)(2)(K)(i) and 1861(s)(2)(K)(ii) of the Act and defined in section 1861(aa)(5) of the Act, or in regulations at § 410.74, § 410.75, and § 410.76). </P>
                    <P>The proposed “social history” definition includes, at a minimum, the following elements: </P>
                    <P>• History of alcohol, tobacco, and illicit drug use. </P>
                    <P>• Work and travel history. </P>
                    <P>• Diet. </P>
                    <P>• Social activities. </P>
                    <P>• Physical activities. </P>
                    <P>The proposed definition of “Review of the individual's functional ability and level of safety” includes, at a minimum, a review of the following areas: </P>
                    <P>• Hearing impairment. </P>
                    <P>• Activities of daily living. </P>
                    <P>• Falls risk. </P>
                    <P>• Home safety. </P>
                    <P>We also proposed conforming changes to specify an exception to the list of examples of routine physical examinations excluded from coverage in § 411.15(a)(1) and § 411.15(k)(11) for IPPEs that meet the eligibility limitation and the conditions for coverage that we are specifying under § 410.16, Initial preventive physical examinations. </P>
                    <P>With regards to the issue of payment for the IPPE, in the August 5, 2004 proposed rule we stated that there is no current CPT code that contains the specific elements included in the IPPE and proposed to establish a new HCPCS code to be used for billing for the initial preventive examination. As required by the statute, we indicated that this code includes an electrocardiogram, but does not include the other previously mentioned preventive services that are currently separately covered and paid under the Medicare Part B screening benefits. When these other preventive services are performed, they must be identified using the existing appropriate codes. </P>
                    <P>Proposed payment for this code was based on the following: </P>
                    <P>
                        • 
                        <E T="03">Work RVUs:</E>
                         We proposed a work value of 1.51 RVUs for G0344 (G0XX2 in proposed rule) based on our determination that this new service has equivalent resources and work intensity to those contained in CPT E/M code 99203, 
                        <E T="03">new patient, office or other outpatient visit</E>
                         (1.34 RVUs), and CPT code 93000 
                        <E T="03">electrocardiogram, complete</E>
                         (0.17 RVUs), which is for a routine ECG with the interpretation and report. 
                    </P>
                    <P>
                        • 
                        <E T="03">Malpractice RVUs:</E>
                         For the malpractice component of G0344, we proposed malpractice RVUs of 0.13 in the nonfacility setting based on the malpractice RVUs currently assigned to CPT code 99203 (0.10) and CPT code 93000 (0.03). In the facility setting, we proposed malpractice RVUs of 0.11 based on the current malpractice RVUs assigned to CPT code 99203 (0.10) and 93010 (an EKG interpretation with a value of 0.01). 
                    </P>
                    <P>
                        • 
                        <E T="03">Practice Expense RVUs:</E>
                         For the practice expense component of G0344, we proposed practice expense RVUs of 1.65 in the nonfacility setting based on the practice RVUs assigned to CPT code 99203 (1.14) and CPT code 93000 (0.51). In the facility setting, we proposed practice expense RVUs of 0.54 based on the practice expense RVUs assigned to CPT code 99203 (0.48) and 93010 (0.06). 
                    </P>
                    <P>Because some of the components for a medically necessary Evaluation and Management (E/M) visit are reflected in this new G code, we also proposed, when it is appropriate, to allow a medically necessary E/M service no greater than a level 2 to be reported at the same visit as the IPPE. That portion of the visit must be medically necessary to treat the patient's illness or injury or to improve the function of a malformed body member and should be reported with modifier—25. We also stated the physician or qualified NPP could also bill for the screening and other preventive services currently covered and paid by Medicare Part B under separate provisions of section 1861 of the Act, if provided during this IPPE. </P>
                    <P>The MMA did not make any provision for the waiver of the Medicare coinsurance and Part B deductible for the IPPE. Payment for this service would be applied to the required deductible, which is $110 for CY 2005, if the deductible is not met, and the usual coinsurance provisions would apply. </P>
                    <HD SOURCE="HD2">Analysis of and Response to Comments </HD>
                    <P>We specifically solicited public comments on the definition of the term “initial preventive physical examination,” with supporting documentation. For example, we indicated that we chose not to define the term, “appropriate screening instrument,” for screening individuals for depression, functional ability, and level of safety, as specified in the rule, because we anticipated that the examining physician or qualified NPP may want to use the test of his or her choice, based on current clinical practice guidelines. We believe that any standardized screening test for depression, functional ability, and level of safety recognized by the American Academy of Family Physicians, the American College of Physicians-American Society of Internal Medicine, the American College of Preventive Medicine, the American Geriatrics Society, the American Psychiatric Association, or the USPSTF, or other recognized medical professional group, would be acceptable for purposes of meeting the “appropriate screening instrument” provision. We asked that commenters making specific recommendations on this or any related issue provide documentation from the medical literature, current clinical practice guidelines, or the USPSTF recommendations. </P>
                    <P>
                        We received 71 public comments on the proposed rule regarding IPPE. Commenters included national and State professional associations, medical societies and medical advocacy groups, hospital associations, hospitals, managed care plans, physicians, senior advocacy groups, health care manufacturers, and others. Although a number of commenters expressed concern that the proposed rule was too prescriptive and not sufficiently targeted to prevention, a large majority of the commenters enthusiastically supported most of the coverage provisions of the proposed rule. Many of the commenters, however, suggested clarification and revision of the rule in a number of different areas, including the proposed definitions of “initial preventive physical examination,” “physician,” and “qualified nonphysician practitioner.” Commenters also raised questions regarding other issues, such as those relating to the need for us to educate Medicare beneficiaries and providers with respect to the new benefit, and to monitor the implementation of the new benefit. Finally, commenters offered suggestions and questions with regards to payment issues, evaluation and 
                        <PRTPAGE P="66284"/>
                        management services (E/M) and coinsurance and Part B deductible issues. 
                    </P>
                    <P>A summary of the comments and our responses are presented below. </P>
                    <P>
                        <E T="03">Comment:</E>
                         A number of commenters expressed concern that in the proposed rule, we had gone beyond the coverage criteria that were specified in the statute for the new benefit. They noted that the additional criteria was too prescriptive and would only add confusion and an additional burden for physicians in determining what medical services are necessary for each beneficiary they evaluate. Several commenters indicated that while the proposed definition for the scope of the benefit was well-intentioned, the beneficiary's physician or other provider was the best person to determine what medical services are necessary in providing a thorough physical and to be responsive to the individual's age, gender, and particular health risks. In general, they suggested that we not interfere in a physician's judgment by attempting to standardize by Federal regulations the specific medical services to be included under the new benefit. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         Section 611 of the MMA defines the scope of the IPPE benefit as physicians' services consisting of a physical examination (including measurement of height, weight, and blood pressure and an electrocardiogram) with the goal of health promotion and disease detection, as well as certain education, counseling, and referral services with respect to other statutory screening and preventive services also covered under the Medicare statute. We believe that the statutory parenthetical language, (including measurement of height, weight, and blood pressure and an electrocardiogram) recognizes that other services could be contained within the IPPE benefit. We are using the authority under section 1871(a) of the Act through the rulemaking process to provide clarity as to the specific services that are to be included under the new benefit. 
                    </P>
                    <P>We believe that adding these additional services will help to ensure that a full and complete IPPE is provided to each beneficiary who chooses to take advantage of the service and that all beneficiaries who decide to do this are treated in a relatively uniform manner throughout the country. With an estimated 200,000 individuals expected to enroll in Medicare Part B each month starting in January 2005, who will be eligible to receive the IPPE benefit, we believe that it is paramount that we promulgate a minimum list of required services important to the goals of health promotion and disease detection that must be included in the new benefit, and we are specifying those service elements in the final rule. </P>
                    <HD SOURCE="HD2">The “Initial Preventive Physical Examination” Definition (IPPE) (§ 410.16(a)) </HD>
                    <P>
                        <E T="03">Comment:</E>
                         Three commenters indicated that this new benefit presents a unique opportunity to offer Medicare beneficiaries with a visit focused on prevention at the start of their Part B enrollment. They suggested, that we shift our focus in service element 1 of the definition of the new IPPE from a comprehensive to a more targeted priority list of modifiable risk factors, screening tests, and immunizations that are supported by the strongest evidence of effectiveness, and have been proven to improve the health of beneficiaries. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We agree that the intent of the new benefit is to deliver clinical preventive services that are accepted and effective in helping to keep people healthy and reduce the burden of disease whenever possible. Therefore, we agree to revise the language in service element 1 to read as follows: “Review of the individual's medical and social history with particular attention to modifiable risk factors for disease.” 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         Three commenters indicated that the collection of information on a beneficiary's social history such as social activities, work and travel history, is a distraction and is not needed by the physician or other qualified NPP who is performing the preventive physical examination. The commenters suggest that we eliminate the proposed definition and not require the collection of this information. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We agree that information on work and travel history, and social activities may not be necessary for purposes of the new preventive physical examination and thus we are removing those elements from the minimum requirements for the “social history” definition. However, we believe it is important to retain three elements of the Social history definition in the final rule and they will be reflected in that document as follows: 
                    </P>
                    <P>• History of alcohol, tobacco, and illicit drug use. </P>
                    <P>• Diet. </P>
                    <P>• Physical activities. </P>
                    <P>
                        <E T="03">Comment:</E>
                         Several commenters requested that we add language to service element 1 to allow practitioners to ascertain information from individuals about additional disease or other diagnoses such as including questions regarding past diagnoses or treatment of cancer, diabetes, elevated blood sugar, height loss, previous fractures, and medical conditions that may increase a person's risk of coagulopathic disorders such as deep venous thrombosis (DVT).
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         In applying our definition of “past medical history” we expect that physicians and qualified NPPs performing the IPPE will be able to ask about an array of medical illnesses, including prior diagnoses and treatment of conditions such as cancer, diabetes, risk factors for osteoporosis such as height loss or previous fractures, and history of coagulopathic disorders such as DVT. Therefore, we do not see a need to expand the proposed definition as the commenters have suggested, and we have decided to leave it unchanged in the final rule. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         Three commenters asked us to add language to either service element 1 or 3 to allow practitioners to screen individuals for memory impairment. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         Currently, the USPSTF has found insufficient evidence to recommend for or against routine screening for dementia with standardized instruments in asymptomatic persons. However, the USPSTF notes that patients with problems in performing daily activities should have their mental status evaluated and clinicians should remain alert for possible signs of declining cognitive function. We included as part of the definition for service element 3, “Review of the individual's functional ability and level of safety,” a review of the patient's activities of daily living. While not exhaustive, this review will primarily aid physicians in identifying a patient's problems with regard to performing these activities and the role cognitive impairment may play in these deficits. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         One commenter proposed that we not use the NCD process to revise the content of the IPPE in the future. The NCD process would be too slow or cumbersome to allow us to keep the content of the examination consistent with current clinical practice. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         For service elements 2 and 3, which discuss the future use of the NCD process in determining appropriate screening instruments we will delete the following: “unless the appropriate instrument is defined through the NCD process.” We will add language that states available standardized screening tests must be recognized by national medical professional organizations. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         Several commenters requested that we clarify our intent as to whether the depression screening assessment in service element 2 will include consideration of the potential for depression as well as an assessment 
                        <PRTPAGE P="66285"/>
                        of an individual's current depression status. Another commenter asked us to clarify our intent with respect to the use of a screening instrument for persons with a current diagnosis of depression. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We agree with the commenters that the regulation language on depression screening needs to be clarified. We are revising service element 2 to read “review of the individual's potential (risk factors) for depression, including current or past experience with depression or other mood disorders, based on the use of an appropriate screening instrument for persons without a current diagnosis of depression, which the physician or other qualified NPP may select from various available standardized screening tests designed for this purpose and recognized by national medical professional organizations.” 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         Three commenters expressed the view that the proposed screening tests for falls risk and home safety in service element 3 were not supported by direct scientific evidence, and should be dropped from the IPPE benefit in the final rule. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         Falls are among the most common and serious problems facing elderly persons. They are associated with considerable morbidity such as hip fractures and overall reduced level of functioning. The USPSTF also notes that falls are the second leading cause of unintentional injury deaths in the United States. The death rate due to falls increases as a person ages. According to the National Center for Injury Prevention and Control, approximately one-half to two-thirds of all falls occur in and around a person's home. Therefore, discussing with patients home safety tips may reduce some home hazards. In addition, the USPSTF recommends counseling patients on specific measures to reduce the risk of falling, although direct evidence of effectiveness has not yet been established. Therefore, we believe that questioning and counseling patients to determine their risk of falling and home safety is warranted as part of the IPPE benefit. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         Several commenters from the audiology community have asked us to clarify the meaning of the proposed requirement in service element 3, which includes (among other things) a review of any hearing impairment. In addition, several commenters have requested that we clarify whether a hearing assessment is required as part of service element 3, or whether questions (or a questionnaire) advanced to an individual about any possible hearing problems would suffice for purposes of this part of the new benefit. The commenters ask for provider flexibility in meeting this requirement. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         The regulatory intent of service element 3 is that we expect that the physician or qualified NPP will engage in a dialogue with patients concerning these issues by asking the individual appropriate questions or using a written questionnaire to address hearing impairment, activities of daily living, falls risk, and home safety. We do not intend for actual screening instruments such as audiometric screening tests to be used. After questioning the individual, if abnormalities are identified, additional follow-up services may be warranted and may include education, counseling, and referral (if appropriate.) 
                    </P>
                    <P>Therefore, we are revising the language of service element 3 to read “review of the individual's functional ability and level of safety, based on the use of appropriate screening questions or a screening questionnaire which the physician or qualified NPP may select from various available screening questions or standardized questionnaires designed for this purpose and recognized by national medical professional organizations.” </P>
                    <P>Medically necessary diagnostic hearing tests, including hearing and balance assessment services, performed by a qualified audiologist are covered as other diagnostic tests under section 1861(s)(3) of the Act and would be separate from the new IPPE benefit. These services may be appropriate when a physician or other qualified NPP orders a diagnostic hearing test for the purpose of obtaining information necessary for the physician's diagnostic evaluation or to determine the appropriate medical or surgical treatment of a hearing deficit or related medical problem. However, coverage of this testing is excluded by virtue of section 1862 (a)(7) of the Act when the diagnostic information required to determine the appropriate medical or surgical arrangement is already known to the physician, or the diagnostic services are performed only to determine the need for the appropriate type of hearing aid. For further information about the application of the hearing test exclusion to diagnostic hearing tests and payment for these services, we suggest review of section 80.3 to 80.3.1 of the Medicare Benefit Policy Manual. </P>
                    <P>
                        <E T="03">Comment:</E>
                         Several commenters suggested that we expand the services to be included as part of service element 4 that was proposed for coverage under the IPPE benefit to include: (1) Palpitation/auscultation of carotid arteries; (2) palpitation/auscultation of abdominal aorta; and (3) the ankle-brachial index (ABI) test for peripheral arterial disease (PAD). 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         Currently, routine screening of asymptomatic persons for carotid artery stenosis via palpation/auscultation of the carotid arteries or carotid ultrasound is not recommended by organizations such as the USPSTF, which provides guidelines on this issue. Therefore, we are not adding routine screening of asymptomatic individuals for carotid artery stenosis to service element 4 in the absence of evidence of the effectiveness of the screening. In addition, the USPSTF has determined that there is insufficient evidence to recommend for or against routine screening of asymptomatic adults for abdominal aortic aneurysm (AAA) by palpation/auscultation or ultrasound of the abdominal aorta so we are not adding that type of screening to service element 4. 
                    </P>
                    <P>Finally, the USPSTF does not recommend routine screening for PAD in asymptomatic persons. However, they also state that clinicians, should be aware of symptoms and risk factors for PAD and evaluate patients accordingly. Therefore, routine screening for PAD with the use of the ABI will not be required as part of the initial preventive physical examination. </P>
                    <P>
                        <E T="03">Comment:</E>
                         One commenter asked for clarification on whether the proposed regulatory language “and other factors deemed appropriate by the physician or qualified nonphysician practitioner,” as specified in service element 4, would permit inclusion of coverage of a screening for chronic obstructive pulmonary disease (COPD) through spirometric testing under the IPPE benefit. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         The intent of this language for the actual physical examination portion of the IPPE benefit is to leave to the discretion of the physician or other qualified NPP whether to perform commonly utilized physical examination measures such as auscultation of the heart or lungs on a particular patient, if needed. Spirometry as a screening test for COPD, however, would not be considered to fall within the scope of the physical examination element of the IPPE benefit. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         A number of commenters suggested that we add an assessment of abdominal obesity or alternatively the calculation of the body mass index (BMI) to the vital signs part of service element 4 to help in determining if an individual is at risk for a heart attack, diabetes, or other medical problems. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         By requiring measurement of height and weight as part of the IPPE in element 4 (an examination to include 
                        <PRTPAGE P="66286"/>
                        measurement of an individual's height, weight, blood pressure), we believe that the physician or other qualified NPP performing the IPPE will use that information to determine an individual's BMI if necessary. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         Three commenters expressed concern about the wide latitude given to physicians and other qualified NPPs providing the IPPE benefit to select whichever screening test they prefer to use in connection with the assessment of visual acuity. The commenters believe that setting vague boundaries around what constitutes an appropriate screening instrument could open the door for inappropriate use of preventive services. To avoid this, the commenters recommend narrowly defining the appropriate screening instrument for visual acuity in service element 4 by specifying the use of the Snellen test for that purpose. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We agree that the Snellen test is a widely available test used to assess a person's visual acuity. Other similarly available tests for visual acuity also exist, however, and may convey similar results for individual physicians and other clinicians. While we expect that many physicians will utilize the Snellen test in assessing a beneficiary's visual acuity for the purpose of this new benefit, we are not mandating the use of the Snellen test or any other specific visual acuity test in order to meet the requirements of element 4 in the final rule. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         One commenter noted that the proposed rule allows for coverage of the assessment in service element 4 of “other factors as deemed appropriate based on the individual's comprehensive medical and social history.” The commenter expressed the view that the quoted language might result in the possibility that virtually any patient's abnormality identified during the preventive physical examination might lead to further evaluation of the patient and a cascade of diagnostic workup of questionable health benefit to the patient and potentially of great cost to the Medicare program. In view of these concerns, the commenter recommended using more restrictive language that would allow for additional assessment of other factors only when they are supported by evidence-based clinical practice guidelines. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         Our purpose in proposing the specific quoted language referenced in service element 4 was to allow for the physician or other qualified NPP to perform a limited physical examination of those key elements such as height, weight, blood pressure, and a visual acuity screen that may be important in detecting disease. However, we have specified that additional physical examination measures may be performed if deemed appropriate based on the issues identified by the physician or other clinician in the review of service elements 1 to 3. While we will not specify in the final rule that these additional measures must be supported by evidence-based practice guidelines, we will state that the practitioner performing the preventive examination follow current clinical standards and those guidelines, of course, may include the evidence-based guidelines referenced by the commenter. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         One commenter recommends that we include in our guidelines for the IPPE benefit information that informs the physician or other qualified NPP of: (1) The need to refer patients to occupational therapists when a more extensive evaluation of activities of daily living, falls risk, and home safety is warranted; and, (2) when, such referrals would be medically appropriate. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         As part of the final rule, service element 6 of the IPPE benefit will require, education, counseling, and referral, as appropriate, based on the individual's results of the previous 5 elements of the IPPE benefit. However, appropriate referral of a patient to an occupational therapist is left to the discretion of the physician or other qualified NPP who is treating the patient for the medical problem that is identified, subject to contractors' medical necessity review. We do not believe there is a need for us to issue guidelines to our contractors on this point. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         Several commenters indicated that they were concerned about use of the term “counseling” in service elements 6 and 7 of the definition of the IPPE because it lacked sufficient clarity. The commenters indicated that counseling may include varying amounts of time depending upon the intensity of the type of service provided, the ability of the individual receiving the counseling to understand the information that is being communicated, etc. The commenters suggested that either we not use the term counseling or clarify its meaning in the final rule. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         Use of the term counseling in connection with service element 7 is mandated by section 611 of the MMA, and thus, it is appropriate to use the term in the final rule. However, we would like to clarify this issue in connection with both service elements 6 and 7 of the new benefit. In most cases, we do not expect that the physician or other qualified NPP performing the service should need to spend more than a few minutes of brief education and counseling with a new beneficiary on appropriate topics as required by element 7. Nonetheless, it is possible that it may be necessary to spend more than a few minutes on the education and counseling required by element 6. As the commenters have indicated, the education and counseling required may involve varying amounts of time depending upon the medical problem or problems that are being considered, based on the results of elements 1 to 5, and the intensity of the service that is believed to be medically necessary at that time. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         Three commenters indicated that they support proposed service element 6 on “education, referral, and counseling deemed appropriate based on the results of the review and evaluation of services,” in service elements 1 to 5 because it offers an unprecedented opportunity to counsel beneficiaries about health behaviors (for example, stopping smoking, losing weight). Nonetheless, they were concerned about possible over-utilization of services that might result from that provision, and suggest that we clarify that these education, counseling and referral efforts be concordant with evidence-based practice guidelines. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We will not specify in the final rule that education, counseling, and referral efforts must be consistent with evidence-based practice guidelines. We expect that physicians and other qualified NPPs will provide appropriate education, counseling, and referral that utilizes evidence-based practice guidelines and current clinical standards. In addition, follow-up care obtained outside of the IPPE Benefit must be reasonable and necessary based on Section 1862(a)(1)(A) of the Act. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         A number of commenters requested that we clarify the written plan provision of service element 7 that was included in the proposed rule. Several commenters indicated that two problems they see with this requirement are: (1) It is not clearly defined and thus could impose a significant burden on physicians and other clinicians, if it is not more carefully written; and, (2) it does not acknowledge that alternative mechanisms may already be in place that could better facilitate coordination of care for these beneficiaries than the proposed written plan requirement. For example, one commenter suggests that some physicians and other clinicians may currently be using electronic technology to track the delivery of preventive services and should not be 
                        <PRTPAGE P="66287"/>
                        required to file written plans. Instead, the commenter recommends that we craft language to require physicians to demonstrate a system for ensuring that beneficiaries receive recommended screening and preventive services and allow physicians flexibility to determine the design and medium that such a system would employ. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We agree that the term written plan may not offer a sufficiently clear description of our intentions in requiring the physician or other qualified NPP who also performs the IPPE to carry out the statutory mandate that eligible beneficiaries be provided with education, counseling, and referral for screening and other preventive services described in section 1861(ww)(2) of the Act. Our intent in the proposed rule was that each physician or other qualified NPP provide their eligible beneficiaries at the time of the examination with appropriate education, counseling, and referral(s), including a brief written plan such as a checklist, which is provided to the beneficiary for obtaining the appropriate screening and/or other preventive services that are covered as separate Medicare Part B benefits to which he or she is entitled. We acknowledge that physicians or qualified NPPs may have an alternative mechanism in place to ensure that beneficiaries receive recommended screening and other preventive services that does not provide for a written plan to be provided to the beneficiary. However, the intent of the written plan requirement is to promote and encourage beneficiary participation in the health care process by making them aware, briefly in writing of the screening and prevention services for which they are entitled under the Medicare Part B program. 
                    </P>
                    <P>In conclusion, we will revise service element 7 to read “education, counseling, and referral, including a brief written plan such as a checklist, be provided to the individual for obtaining appropriate screening and other preventive services, which are separately covered under Medicare Part B benefits.” </P>
                    <HD SOURCE="HD2">The “Physician” Definition (§ 410.16(a)) </HD>
                    <P>
                        <E T="03">Comment:</E>
                         One commenter expressed concerns regarding the definition of a physician. The commenter expressed concern that the proposed rule limits the type of practitioner who is considered qualified to perform the new preventive physical examination. The commenter states that this restriction was not specified by the Congress in section 611 of the MMA or its accompanying conference committee report, and suggests that it should be revised to allow all practitioners, including doctors of podiatric medicine, who are defined as a physician under section 1861(r) of the Act, to be considered qualified to perform the preventive physical examination. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         Section 611 of the MMA amended the statute to provide that payment for the IPPE must be made under the Medicare physician fee schedule, as provided in section 1848(j)(3) of the Act, but it did not specifically define what type of physician is eligible for performing this examination. In developing the proposed rule on which physicians are considered qualified to perform the IPPE, we considered the various types of physicians that are identified in section 1861(r)(2), (r)(3), (r)(4), and (r)(5) of the Act. These include doctors of dental surgery, doctors of podiatric medicine, doctors of optometry, and chiropractors, whose scope of medical practice is generally limited by State law to a particular part (or parts) of the human anatomy. 
                    </P>
                    <P>These state licensing restrictions would likely make it difficult for those practitioners to perform all of the services required. Based on this information, we are leaving the definition of a physician unchanged in the final rule. </P>
                    <HD SOURCE="HD2">The “Qualified Nonphysician Practitioner” Definition (§ 410.16(a)) </HD>
                    <P>
                        <E T="03">Comment:</E>
                         One commenter indicated concern that in the proposed rule certified nurse-midwives (CNMs) are not eligible to furnish the new preventive physical examinations, but physicians and certain other NPPs are eligible to provide those services to Medicare beneficiaries. The commenter indicates that CNMs are fully qualified to provide physical examination and checkups covered by the statute and that they do so on a daily basis as a basic component of the care they provide their clients. The commenter states that we may be constrained by the statute as enacted by Congress on this subject, but suggests that we should review the issue and if possible revise the proposed rule to include CNMs among those who are considered to be eligible to provide the new service in the final rule. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         Section 611 of the MMA amended the statute to provide that in addition to physicians certain NPPs, that is, PAs, NPs, and CNS (as authorized under section 1861(s)(2)(K)(i) and (ii) of the Act, and defined in section 1861(aa)(5) of the Act, or in regulations at § 410.74, § 410.75, and § 410.76) will be able to furnish the new preventive physical examination to eligible beneficiaries effective January 1, 2005. Thus, Congress did not specifically authorize CNMs to perform the IPPE. Unless CNMs are able to qualify as one of these other types of NPPs designated by the statute for purposes of the new IPPE benefit, they will not be eligible to provide this service to beneficiaries for Medicare Part B coverage purposes. 
                    </P>
                    <HD SOURCE="HD2">Other Issues </HD>
                    <P>
                        <E T="03">Comment:</E>
                         One commenter requested that we clarify application of the proposed IPPE definition to managed care plans where preventive physical examinations are available to Medicare enrollees on an annual basis and they are not limited to a one-time benefit. Generally in the case of managed care plans, it is indicated that the extent of their typical annual preventive examination is determined by the enrollee's physician or other treating physician, depending upon the patient's history and clinical indications. The commenter asks that we allow managed care plans greater flexibility in providing their Medicare enrollees with the various service elements described in the proposed rule. Alternatively, the commenter requests that we clarify in the final rule that managed care plans will need to provide their Medicare enrollees with all elements of the new benefit only if requested to do so by a particular Medicare enrollee. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         Section 611 of the MMA requires that IPPEs be made available to all Medicare beneficiaries who first enroll in Medicare Part B on or after January 1, 2005, and who receive that benefit within 6 months of the effective date of their initial Part B coverage period. The new statute does not allow for any exceptions to be made to the coverage of IPPEs for beneficiaries who are members of managed care plans. In fact, section 1852(a) of the Act provides that generally each managed care plan must, at a minimum, provide to its Medicare members all of those items and services (other than hospice care) for which benefits are available under Parts A and B for individuals residing in the area served by the plan. Nonetheless, if a particular Part B member of the plan chooses not to take advantage of the IPPE benefit, for example, because it would duplicate an annual preventive physical exam that has already been provided to that member, the plan would not be obligated to provide the IPPE to that member. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         One commenter noted that while the screening benefits listed in paragraph (A)(1) on 
                        <E T="04">Federal Register</E>
                          
                        <PRTPAGE P="66288"/>
                        page 47514 (vol. 69, No. 150) includes “(5) colorectal cancer screening test,” the list of screening benefits described in the same section, paragraph (7) on page 47515 does not include that type of cancer screening test. The commenter requests that we include colorectal cancer screening in the list of screening services described on page 47515 of the Physician Fee Schedule Proposed Rule and any other sections of any proposed rule in which covered screening benefits are listed to ensure there is no confusion regarding what services should discussed with patients during the IPPE. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We agree with the commenter that there was an error of omission relative to colorectal cancer screening in the language in the preamble to the proposed rule in the list of screening benefits described on page 47515 of the Physicians Fee Schedule, and we have corrected that oversight in this final rule. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         One commenter requests that we clarify the part of the definition of the IPPE (service element 7) that refers to the provision of education, counseling, and referral of the individual for coverage of bone mass measurements by adding the term “Dual Energy X-Ray Absorptiometry” (DEXA) to that provision. The commenter states that DEXA testing is the most accurate method available for diagnosis of osteoporosis and that early detection of this condition paramount for preventing further bone loss and eventual fractures. The commenter is concerned that unless this is clarified in the final rule, local Medicare contractors may exclude coverage for the DEXA test as part of the IPPE benefit. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         Our existing regulations governing bone mass measurements are published in § 410.31. While we agree that the DEXA scan is a very commonly used method for the initial diagnosis of osteoporosis, we do not believe that it would be appropriate to add any specific reference to the DEXA test in the IPPE definition because it may be perceived as endorsing one test over another. We do not believe this would be appropriate. Physicians and other qualified NPPs who perform IPPE services may provide appropriate education, counseling, and referral of their Medicare patients for the bone density tests. The counseling and referral may include choosing the appropriateness of the diagnostic modalities for the particular patient. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         A number of commenters have asked us to provide information to Medicare physicians and qualified NPPs performing the IPPE for appropriate referral of their patients when treatment or a more extensive evaluation of patients is needed as part of service element 6. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         As part of the final rule, under service element 6, providers are required to furnish their patients with education, counseling, and referral, as appropriate, based on the individual's results of service elements 1-5 of the IPPE service. However, appropriate referral of a patient, of course, is left to the discretion of the physician or other qualified NPP who is treating the patient for the medical problem that is identified. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         One commenter asked us how we plan to monitor the effectiveness of the IPPE benefit over the next several years. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         As indicated in the final rule, we have established unique billing codes for the IPPE service which physicians and other qualified NPPs must use in billing Medicare Part B for the new service. Establishing those codes will allow us to monitor over time the extent to which the eligible Medicare Part B population is utilizing the new service, which will be of interest to our program administrators, members of the Congress, and the general public. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         One commenter asked how providers of IPPE services will know if a particular beneficiary is eligible to receive the new benefit due to the statutory time and coverage frequency (one-time benefit) limitations. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         The statute provides for coverage of a one-time IPPE benefit that must be performed for new beneficiaries by qualified physicians or certain specified NPPs within the first 6 months period following the effective date of the beneficiary's first Part B coverage. Since physicians or other qualified NPPs may not have the complete medical history for a particular new beneficiary, including information on possible use of the one-time benefit, these clinicians are largely relying on their own medical records and the information the beneficiary provides to them in establishing whether or not the IPPE benefit is still available to a particular individual and was not performed by another qualified practitioner. Since a second IPPE will always fall outside the definition of the new Medicare benefit, an advance beneficiary notice (ABN) need not be issued in those instances where there is doubt regarding whether the beneficiary has previously received an IPPE. The beneficiary will always be liable for a second IPPE no matter when it is conducted. However, for those instances where there is sufficient doubt as to whether the statutory 6-month period has lapsed, the physician or other qualified NPP should issue an ABN indicating that Medicare may not cover and pay for the service. If the physician or other qualified NPP does not issue an ABN and Medicare denies payment because the statutory time limitation for conducting the initial IPPE has expired, then the physician or other qualified NPP may be held financially liable. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         Several commenters asked that we provide explicit instructions and guidelines, respectively, to providers and beneficiaries regarding the details of what will be included in the new benefit, the eligibility requirements, and how providers must bill Medicare for the new service. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         Medicare will release appropriate manual and transmittal instructions and information from our educational components for the medical community, including a MedLearn Matters article and fact sheets like the “2005 Payment Changes for Physicians and Other Providers: Key News From Medicare for 2005”. The medical community can join this effort in educating physicians, qualified NPPs, and beneficiaries by distributing their own communications, bulletins or other publications. 
                    </P>
                    <P>
                        In addition, we have specifically included information on the new IPPE benefit in the 2005 version of the 
                        <E T="03">Medicare and You Handbook</E>
                         and the revised booklet, 
                        <E T="03">Medicare's Preventive Services.</E>
                         A new 2-page fact sheet on all of the new preventive services, including the IPPE benefit, is currently under development, and a bilingual brochure for Hispanic beneficiaries will also be available in the new future. This information will be disseminated by our regional offices, State Health Insurance Assistance Programs (SHIPs), and various partners at the national, State, and local levels. Information on the new benefit will also be made available to the public through medicare.gov, the cms.gov partner Web site, 1-800-MEDICARE, numerous forums hosted by CMS, and conference exhibits and presentations. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         Many of the major physician specialty societies believe the payment, as proposed, is undervalued for what is believed to be a labor-intensive IPPE. They request that we use the existing CPT preventive medicine services code series rather than creating a new G-code. These codes have higher RVUs than the office or other outpatient visit code 99203. For example, preventive medicine services visit code 99387 has total nonfacility RVUs of 4.00 while the corresponding value for 99203 is 2.58. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         The existing CPT preventive medicine services codes 
                        <PRTPAGE P="66289"/>
                        (99381-99397) are not covered by Medicare. In accordance with section 1862(a)(1)(A) of the Act that requires us to pay only for services that are reasonable and necessary for the treatment of an illness or injury or to improve the function of a malformed body member, we have not covered E/M visits for screening purposes. 
                    </P>
                    <P>The IPPE is intended to target selected modifiable risk factors and secondary prevention opportunities shown by evidence to improve the health and welfare of the beneficiary, and is less focused on a comprehensive physical examination compared to the typical service provided in accordance with CPT code 99397. We equated the resources anticipated with this service to the existing new office or other outpatient visit. For CPT code 99203 the RUC survey data shows 53 physician minutes (including pre-service time, intra-service time and post-service time) with 51 minutes of staff time. We believe the IPPE will reflect these time approximations. We will be looking at the data and consulting with the medical community after initial experience with this new benefit to determine if this payment has been valued appropriately. </P>
                    <P>
                        <E T="03">Comment:</E>
                         Two commenters suggested that we allow the IPPE either on a yearly basis or every decade after the initial evaluation. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         The IPPE was specifically legislated as a one time only benefit for the beneficiary newly enrolled in the Medicare program. This visit familiarizes the beneficiary with a physician or qualified NPP who will highlight the assessments available to help prevent and detect disease and also make available the educational, counseling and referral opportunities to the new Medicare recipient. Our policy anticipates physicians will make appropriate and individualized referrals for the beneficiary. Expanding the number of routine physicals would require additional legislation (See section 1862(a)(7) of the Act). 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         Many commenters asked if the IPPE may be provided without performing the EKG at the same visit. They asked to have the EKG component unbundled from the evaluation and management component that had been specified in the proposed rule for the IPPE service since a physician may not have the equipment and capability of providing EKG services to their patients in the office suite or clinic. Additionally, others asked if a physician would be denied payment for the IPPE if the screening EKG was not performed because a diagnostic EKG was performed in a recent visit or if a diagnostic EKG was warranted at the IPPE visit. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         Section 611 of the MMA does require a screening EKG to be performed as part of the IPPE visit. We recognize that there are a number of primary care physicians or other clinicians furnishing the service who may want to refer their beneficiaries to outside practitioners or entities for performance and interpretation of the EKG service rather than performing it themselves. Therefore, if an individual physician or other qualified NPP does not have the capacity to perform the EKG in the office suite, then alternative arrangements will need to be made with an outside physician or other entity in order to make certain that the EKG is performed. In circumstances where the primary care physician or qualified NPP refers the beneficiary to an outside physician or entity for the EKG service, we expect that the primary care physician or qualified NPP will incorporate the results of the EKG into the beneficiary's medical record to complete the IPPE. Both components of the IPPE, the examination portion and the EKG, must be performed for either of the components to be paid. Billing instructions for physicians, qualified NPPs and providers will be issued. In order to address these potentially occurring scenarios to complete the IPPE and EKG we have created the following HCPCS codes: 
                    </P>
                    <P>
                        • G0344:
                        <E T="03"> Initial preventive physical examination; face-to-face visit services limited to new beneficiary during the first six months of Medicare enrollment</E>
                    </P>
                    <P>
                        • G0366: 
                        <E T="03">Electrocardiogram, routine ECG with at least 12 leads with interpretation and report, performed as a component of the initial preventive physical examination</E>
                    </P>
                    <P>A physician or qualified NPP performing the complete service would report both G0344 and G0366. </P>
                    <P>
                        • G0367:
                        <E T="03"> tracing only, without interpretation and report, performed as a component of the initial preventive physical examination</E>
                    </P>
                    <P>
                        • G0368:
                        <E T="03"> interpretation and report only, performed as a component of the IPPE</E>
                    </P>
                    <P>RVUs for payment for these new HCPCS codes will be crosswalked from the following CPT codes: </P>
                    <P>
                        • G0344 will crosswalk from CPT code 99203 
                        <E T="03">(Office or other outpatient visit)</E>
                    </P>
                    <P>
                        • G0366 will crosswalk from CPT code 93000 
                        <E T="03">(Electrocardiogram, routine ECG with at least 12 leads; with interpretation and report)</E>
                    </P>
                    <P>
                        • G0367 will crosswalk from CPT code 93005 
                        <E T="03">(Electrocardiogram, routine ECG with at least 12 leads; tracing only, without interpretation and report)</E>
                    </P>
                    <P>
                        • G0368 will crosswalk from CPT code 93010 
                        <E T="03">(Electrocardiogram, routine ECG with at least 12 leads; interpretation and report only)</E>
                    </P>
                    <P>Note that HCPCS codes G0366 and G0367 are not payable under the physician fee schedule in the facility setting. </P>
                    <P>To comply with MMA the IPPE must include the EKG regardless of whether a diagnostic EKG was recently performed. An EKG performed by the physician or qualified NPP during the IPPE visit must be reported with HCPCS code G0366. Medicare does not cover a screening EKG alone. </P>
                    <P>
                        <E T="03">Comment:</E>
                         One commenter asked if physicians and qualified NPP who see patients in Federally Qualified Healthcare Centers (FQHCs) will be able to provide and bill under the FQHC all-inclusive rate. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         Physicians and other qualified NPPs in RHCs and FQHCs may provide this new benefit and follow normal procedures for billing for RHCs and FQHC services. Payment for the professional services will be made under the all-inclusive rate. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         Many physician specialty societies did not agree with our proposal to limit the level of a medically necessary E/M visit when performed and billed with the IPPE. They contend that most Medicare patients, even if known to their physician, come to the IPPE visit with multiple chronic problems often necessitating immediate evaluation and treatment at a level of care equal to a level 4/5 E/M visit code. They also state that current Medicare policy does permit a medically necessary E/M visit at whatever level is appropriate when the noncovered preventive medicine services (CPT codes 99381-99397) are performed. They ask that we eliminate the restriction for the level of service for a medically necessary E/M visit performed at the same visit as the IPPE visit. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         The physician will need to schedule time with the beneficiary identifying the available preventive and educational opportunities. A level 2 new or established patient office or other outpatient visit code was proposed because we believe there is a substantial overlap of practice expense, malpractice expense and physician work in both history taking and examination of the patient with the IPPE and another E/M service. We do not want to prohibit the use of an appropriate level of service when it is necessary to evaluate and treat the beneficiary for acute and chronic 
                        <PRTPAGE P="66290"/>
                        conditions. At the same time, we believe the physician is better able to discuss health promotion, disease prevention and the educational opportunities available with the beneficiary when the health status is stabilized and the beneficiary is physically receptive. 
                    </P>
                    <P>We will remove the restriction limiting the medically necessary E/M service to a level 2 visit code. CPT codes 99201 through 99215 may be used depending on the circumstances and appended with CPT modifier “25 identifying the E/M visit as a separately identifiable service from the IPPE code G0344 reported. </P>
                    <P>We do not believe this scenario will be the typical occurrence and, therefore, we will monitor utilization patterns for the level 4/5 new or established office or other outpatient visit codes being reported with the IPPE. If there are consistent data that demonstrate high usage of level 4/5 E/M codes we may need to revise the policy. </P>
                    <P>
                        <E T="03">Comment:</E>
                         Two commenters asked if we would permit separate payment for a digital rectal exam (DRE) when performed on the same day as the initial preventive physical examination. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         Currently Medicare does not make separate payment for DRE (code G0102) when performed on the same day as an E/M service. We will maintain the current policy and not pay separately for a DRE performed during the IPPE visit. A DRE is usually furnished as part of an E/M service and is bundled into the payment for an E/M service when a covered E/M service is furnished on the same day as a DRE. It is a relatively quick and simple procedure and if it is the only service furnished or is provided as part of an otherwise noncovered service it would be payable if coverage requirements are met. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         Several commenters requested guidance on documentation. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         It is expected that the physician will use the appropriate screening tools. As for all E/M services, the 1995 and 1997 E/M documentation guidelines must be followed for recording information in the patient's medical record. The screening tools used, EKG documentation, referrals and a written plan for the patient also must be included in the patient's medical record. These forms and methods of documentation mirror those that would be used in typical physician practice with patient visits and do not add an additional burden to the physician. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         Several commenters expressed concern that the non-waived deductible and coinsurance will be a disincentive to the beneficiary having the IPPE. They are concerned that some beneficiaries will not avail themselves of the opportunity of the IPPE visit because of the beneficiary's cost share. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         The MMA did not waive the deductible and coinsurance, therefore, we must implement the provision as written. 
                    </P>
                    <HD SOURCE="HD2">Result of Evaluation of Comments </HD>
                    <P>In view of the comments, we have decided to make several revisions in § 410.16(a) relative to service elements 1, 2, and 3. We are revising § 410.16(a)(1)(i) language in service element 1 to read as follows: “Review of the individual's medical and social history with particular attention to modifiable risk factors for disease.” </P>
                    <P>We are clarifying the regulation language on depression screening (service element 2) by revising § 410.16(a)(1)(ii) to specify that review of the individual's potential (risk factors) for depression, including current or past experience with depression or other mood disorders, based on the use of an appropriate screening instrument for persons without a current diagnosis of depression, which the physician or other qualified NPP may select from various available standardized screening tests designed for this purpose and recognized by national medical professional organizations. To allow for a certain amount of provider flexibility in meeting the requirements of the regulatory intent of service component 3 we are revising § 410.16(a)(1)(iii) to specify that review of the individual's functional ability and level of safety, based on the use of appropriate screening questions or a screening questionnaire, which the physician or qualified NPP may select from various available screening questions or standardized questionnaires designed for this purpose and recognized by national medical professional organizations. </P>
                    <P>To clarify the requirements of the regulatory intent of service component 7 we are revising § 410.16(a)(1)(vii) to specify that education, counseling, and referral, including a brief written plan such as a checklist be provided to the individual for obtaining the screening and other preventive services for the individual that are covered as separate Medicare Part B benefits. </P>
                    <P>The “social history” definition in the final rule will be revised to include 3 elements: </P>
                    <P>• History of alcohol, tobacco, and illicit drug use. </P>
                    <P>• Diet. </P>
                    <P>• Physical activities. </P>
                    <P>With regard to payment of the IPPE, we will use the new HCPCS codes and payment will be based on the RVUs of the CPT codes crosswalked as stated above. We will not finalize our proposal to allow a medically necessary E/M service no greater than a level 2 to be reported at the same visit as the IPPE. </P>
                    <HD SOURCE="HD2">B. Section 613—Diabetes Screening </HD>
                    <P>Section 613 of the MMA adds section 1861(yy) to the Act and mandates coverage of diabetes screening tests. </P>
                    <P>The term “diabetes screening tests” is defined in section 613 of the MMA as testing furnished to an individual at risk for diabetes and includes a fasting blood glucose test and other tests. The Secretary may modify these tests, when appropriate, as the result of consultations with the appropriate organizations. In compliance with this directive, we consulted with the American Diabetes Association, the American Association of Clinical Endocrinologists, and the National Institute for Diabetes and Digestive and Kidney Diseases. </P>
                    <HD SOURCE="HD3">1. Coverage </HD>
                    <P>We proposed in § 410.18 that Medicare cover—</P>
                    <P>• A fasting blood glucose test; and </P>
                    <P>• Post-glucose challenge tests; either an oral glucose tolerance test with a glucose challenge of 75 grams of glucose for non-pregnant adults, or a 2-hour post-glucose challenge test alone. </P>
                    <P>We would not include a random serum or plasma glucose for persons with symptoms of uncontrolled diabetes such as excessive thirst or frequent urination in this benefit because it is already covered as a diagnostic service. This language is not intended to exclude other post-glucose challenge tests that may be developed in the future, including panels that may be created to include new diabetes and lipid screening tests. We also would include language that would allow Medicare to cover other diabetes screening tests, subject to a NCD process. </P>
                    <P>The statutory provision describes an “individual at risk for diabetes” as having any of the following risk factors: </P>
                    <P>• Hypertension. </P>
                    <P>• Dyslipidemia. </P>
                    <P>• Obesity, defined as a body mass index greater than or equal to 30 kg/m2. </P>
                    <P>• Previous identification of an elevated impaired fasting glucose. </P>
                    <P>• Previous identification of impaired glucose tolerance. </P>
                    <P>• A risk factor consisting of at least two of the following characteristics: </P>
                    <P>+ Overweight, defined as a body mass index greater than 25 kg/m2, but less than 30. </P>
                    <P>
                        + A family history of diabetes. 
                        <PRTPAGE P="66291"/>
                    </P>
                    <P>+ A history of gestational diabetes mellitus or delivery of a baby weighing greater than 9 pounds. </P>
                    <P>+ 65 years of age or older. </P>
                    <P>For individuals previously diagnosed as diabetic, there is no coverage under this statute. </P>
                    <P>The statutory language directs the Secretary to establish standards regarding the frequency of diabetes screening tests that will be covered and limits the frequency to no more than twice within the 12-month period following the date of the most recent diabetes screening test of that individual. </P>
                    <P>We proposed that Medicare beneficiaries diagnosed with pre-diabetes be eligible for the maximum frequency allowed by the statute, that is, 2 screening tests per 12 month period. We defined “pre-diabetes” as a previous fasting glucose level of 100-125 mg/dL, or a 2-hour post-glucose challenge of 140-199 mg/dL. This definition of pre-diabetes was developed with the assistance of the American Association of Clinical Endocrinologists, concurs with the Centers for Disease Control and Prevention (CDC) definition, and complements the definition of diabetes that we published November 7, 2003 (68 FR 63195). </P>
                    <HD SOURCE="HD3">2. Payment </HD>
                    <P>We proposed to pay for diabetes screening tests at the same amounts paid for these tests when performed to diagnose an individual with signs and symptoms of diabetes. We would pay for these tests under the clinical laboratory fee schedule. We proposed to pay for these tests under CPT code 82947 Glucose; quantitative, blood (except reagent strip), CPT code 82950, post glucose dose (includes glucose), and CPT code 82951 Glucose; tolerance test (GTT), three specimens (includes glucose). To indicate that the purpose of the test is for diabetes screening, we would require that the laboratory include a screening diagnosis code in the diagnosis section of the claim. We proposed V77.1 special screening for diabetes mellitus as the applicable ICD-9-CM code for this purpose. Because laboratories are required and accustomed to submitting diagnosis codes when requesting payment for testing, we believe including a screening diagnosis code is appropriate for this benefit. </P>
                    <P>
                        <E T="03">Comment:</E>
                         One commenter questioned whether there is statutory authority to expand eligibility for individuals. Adding that, section 613 of the MMA gives authority for additional test and frequency, not additional individuals. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         There is no statutory authority to expand eligibility for individuals. Section 613 of the MMA establishes coverage for beneficiaries who are at risk for developing diabetes. Beneficiaries who are pre-diabetic fall within 1861(yy)(2)(D) or (E) and are at an increased risk for developing diabetes. This increased risk separates them from the general at-risk population and requires the course of their care to be managed closer and more frequently. 
                    </P>
                    <P>For individuals not meeting the “pre-diabetes” criteria, we proposed that one diabetes screening test be covered per individual per year. </P>
                    <P>
                        <E T="03">Comment:</E>
                         Several comments were received that recommended we provide physicians with clear guidance about Medicare's covered services to help patients control their diabetes. The commenters also asked that we inform providers about other covered services, such as Hgb1AC tests, that will help patients avoid painful diabetes-related complications. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We will be releasing two publications. The 
                        <E T="03">Dear Doctor Package</E>
                         publication, which includes the “2005 FACT SHEET”, will be sent to the contractors on a CD on or about October 15, 2005 and distributed to the providers by November 15, 2005. The 
                        <E T="03">Medicare Coverage of Diabetes Services and Supplies</E>
                         publication was originally written in 2002. It was revised in 2003 to update the Part B premium amount and is being revised again this year to update the premium amount and to include any information relevant to the MMA. This document will be available on the CMS Web site and at 1-800-MEDICARE. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         We received several comments suggesting that screening should not require a physician's prescription or referral in order to be covered under Medicare Part B. This approach would follow the successful precedent established by us with other screening tests such as mammograms. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         The legislative history on mammography did result in us allowing self-referral for mammograms. However, Medicare rules have required that laboratory tests for screening or other diagnoses must be ordered by licensed health care practitioners, specifically physicians, PAs, NPs, or CNSs. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         Comments were received recommending that the final rule include coverage of one annual diabetes screening for all Medicare beneficiaries. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         The benefit of screening all Medicare beneficiaries is not supported by current evidence. We plan risk-based frequency limitations of coverage for diabetes screening based upon the statute requirements. Furthermore, we believe beneficiaries with pre-diabetes may warrant a more frequent follow-up and this is permitted at the professional judgment of the health care practitioner. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         We received a few comments suggesting the addition of the C-peptide test, as it is sometimes useful in Type 1 or Type 2 diabetes. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We believe that C-peptide testing is appropriate for diagnostic evaluation, but not for screening. It is currently covered under the general lab benefit as a diagnostic test when it is medically necessary. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         The American Society for Clinical Pathology (ASCP) has urged us to add CPT 82950 glucose; post glucose dose (includes glucose). This test is more frequently used to screen for diabetes. GTT is a more definitive test usually requested when questionable results from random, fasting or postprandial glucose levels are obtained. As written, the proposed rule appears to exclude 82950 as a screening test. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We appreciate attention being drawn to the apparent exclusion of CPT code 82950, which was not our intention and we have corrected that omission. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         A commenter suggested that due to increased incidence of obesity in recent years that family history of diabetes be defined as persons with Type 2 Diabetes in one or more first or second-degree relatives. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         The comments received did not provide a clear consensus on the definition of family history of diabetes. Thus the definition of family history of diabetes will be left to the professional judgment of the treating physician or qualified non-physician practitioner based on the beneficiary's medical history and best practice standards. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         The American Clinical Laboratory Association (ACLA) believes that the other codes on the NCD routine screening list that currently result in a diabetes denial on the basis of routine screening should be covered under the new diabetes screening benefit. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We believe the majority of individuals who will seek care under this benefit will conform to the V77.1 code. We are willing to review a sample of claims and determine if other specific codes are appropriate code for this benefit. Codes that need to be considered for this new benefit can be brought to our attention through the national coverage determination process for laboratories. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         A comment was received recommending that the proposed rule be clarified to refer to a “fasting blood glucose test” rather than a “fasting plasma glucose test” since the CPT code 
                        <PRTPAGE P="66292"/>
                        does not differentiate between blood and plasma. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We agree with the recommendation to change the term “fasting plasma glucose test” to “fasting blood glucose test”. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         A comment was received recommending additional diabetes screening tests be added through a less formal process of consultation with manufacturers, health care providers, patients, and other stakeholders, as contemplated by Congress. The commenter further stated that the NCD process is complex and time consuming, delaying the coverage of new tests. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We believe the evidence-based NCD process is an effective process to review and analyze items and services as potential benefits for Medicare beneficiaries. Because the NCD process allows for public comment before we make any changes, we believe this is the appropriate process for any future changes. Further, we may not be able to accept every stakeholder's recommendation because of instructional, coding, or claims issues which must be resolved before any benefit can be implemented. 
                    </P>
                    <HD SOURCE="HD2">Result of Evaluation of Comments</HD>
                    <P>
                        Our review of the comments has led to the elimination of the word “plasma” from the term “fasting plasma glucose test.” The word “plasma” will be replaced with the term “blood”. We have corrected the unintentional omission of CPT code 82950, post glucose dose (includes glucose) as a diabetes screening test. The providers and beneficiaries are reassured that there will be clear guidance on covered services by way of two publications: The 
                        <E T="03">Dear Doctor Package</E>
                        , which includes the “2005 Fact Sheet” and 
                        <E T="03">Medicare Coverage of Diabetes Services and Supplies</E>
                        . We continue to promote healthcare practitioner autonomy with our policy of risk-based frequency limitations on items and services provided to our beneficiaries. We recognize the differing opinions with regard to the usage of the NCD process to review potential new items and services such as new diabetes screening tests for our beneficiaries. To provide transparency, timeliness and fairness, a formal process is necessary. Historically, the NCD process has been open to all interested parties and has proven to be an effective process. 
                    </P>
                    <P>Based on reasoning from the responses to the comments we received, at this time we will not be accepting the following suggestions. </P>
                    <P>• Reversing policy requiring a physician's or a qualified non-physician's prescription or referral for diabetes screening tests. </P>
                    <P>• Providing coverage of one annual diabetes screening test for all Medicare beneficiaries. </P>
                    <P>• Adding coverage of C-peptide test as a screening test. </P>
                    <P>• Bypassing the current NCD process for a less formal process to add additional diabetes screening tests. </P>
                    <HD SOURCE="HD2">C. Section 612—Cardiovascular Screening </HD>
                    <P>Section 612 of the MMA adds section 1861(xx) to the Act and provides for Medicare coverage of cardiovascular (CV) screening blood tests for the early detection of CV disease or abnormalities associated with an elevated risk for that disease effective on or after January 1, 2005. </P>
                    <P>
                        Upon reviewing the USPSTF reports, the scientific literature and comments of professional societies, trade associations, the industry, and the public, we proposed in the August 5, 2004 
                        <E T="04">Federal Register</E>
                        , that the benefit for CV screening would include the use of three clinical laboratory tests to detect early risk for CV disease. Since the three tests, a total cholesterol, a HDL-cholesterol, and a triglycerides test, could be ordered as a lipid panel or individually, the frequency was limited to one of each individual test or combination as a panel every 5 years. 
                    </P>
                    <P>When we researched the benefit, some scientific experts proposed that the use of only the total cholesterol test as a single test every 2 years was adequate. After reviewing the literature and comments, we concluded that each test in the lipid panel is important since each test predicts the risk for CV disease independently. It would be prudent, therefore, to promote the benefit as three separate tests every 5 years. The decision to limit the frequency to 5 years, rather than more frequent testing every 2 years was due to information found in the Clinical Considerations of the USPSTF which indicate that the cholesterol values of elderly persons, who are the majority of the Medicare population, change slowly as they age. We also proposed that any changes to the list of tests could be made after a review of recommendations by the USPSTF and the use of the NCD process. </P>
                    <P>We proposed that for the claims processing and payment system, the coding of the tests would be made using the CPT codes available for the lipid panel or the three tests individually coded with the use of V codes to identify the tests were ordered for screening purposes. We also stated that we would pay for these CV screening tests at the same amounts paid for these tests to diagnose an individual with signs of CV disease and that these would be paid under the clinical laboratory fee schedule. The proposed coverage requirements were set forth in new § 410.17. </P>
                    <P>In response to the proposed rule, we received letters and e-mails from 28 commenters representing professional societies, trade groups, the industry, and individuals, who wrote on 26 different issues. One commenter represented 14 medical societies. Each commenter had many concerns and the comments were grouped into 26 areas of concern. </P>
                    <P>
                        <E T="03">Comment:</E>
                         Three commenters expressed concern that many laboratories perform direct measurement LDL reflexively when triglycerides exceed certain parameters. The commenters are concerned that if screening direct measurement LDL is statutorily excluded then the Medicare beneficiaries would be liable for these tests without prior notice. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         Section 410.32 requires that tests be ordered by a treating physician and used in the management of the patient. We have interpreted this provision to restrict the furnishing of reflex testing to situations where it is clear that the physician is ordering reflex testing at specific parameters and where the physician has an option to order the test without the reflex portion. Thus, laboratories must offer physicians the ability to order a lipid panel without the option to perform the direct measurement LDL. We strongly encourage physicians to order lipid panels without the direct measurement LDL reflex option to protect Medicare beneficiaries from incurring a charge for this service without advanced notice. 
                    </P>
                    <P>
                        If the screening lipid panel results indicate a triglyceride level that indicates the need for a direct measurement LDL, the physician may order this test once the results of screening lipid panel are reported. The NCD for lipid testing includes coverage of direct measurement LDL for patients with hyperglyceridemia. 
                        <E T="03">[http://www.cms.hhs.gov/ mcd/viewncd.asp ?ncd_id=190.23&amp;ncd_ version=1&amp;show=all]</E>
                    </P>
                    <P>
                        We do not require the patient to physically return to the treating physician for an office visit and ordering of subsequent testing. Physicians may order such tests based on the results of the CV screening. The Medicare law and regulations do not prohibit the use of the same sample of blood to be used for direct measurement LDL following a lipid panel with very high triglycerides. Laboratories may archive the initial specimen and use it 
                        <PRTPAGE P="66293"/>
                        for subsequently ordered medically necessary direct measurement LDL. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         One commenter suggested that if the direct LDL cholesterol is included in the CV risk screening benefit, we must provide guidance to laboratories regarding whether or not the direct LDL must be billed with the −59 modifier for the charge to be reimbursed. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         Since the direct LDL cholesterol is not being added to the CV screening benefit, there is no change to the billing. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         One commenter requested that the V codes (V81.0, V81.1, and V81.2) be added to the Lipid NCD and that the NCD Edit Software be modified to accept these V codes (V81.0, 81.1, and 81.2) on a frequency basis. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         The Laboratory NCD Edit Module will be modified to accept the V codes for matching the CPT codes with the ICD-9-CM code for those tests within the lipid NCD that are part of this statutory benefit. The entire lipid NCD is not open for modification. The frequency is determined by the NCD process and implemented through changes to the claims processing system to edit the patient history and coding. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         One commenter asked that Medicare contractors provide explicit instructions to physicians to provide the necessary V codes (or their corresponding narratives) since screening is normally non-covered. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We will release the appropriate manual, transmittal instructions and information from our educational components for the medical community including a MedLearn Matters article and fact sheets such as the “2005 Payment Changes for Physicians and Other Providers: Key News From Medicare for 2005.” Laboratories can join this effort to educate physicians and beneficiaries by distributing their own communication, bulletins or other publications. Some of this information will also be part of the “Welcome to Medicare Preventive Services Package.” 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         Three commenters recommended that high sensitivity C-reactive protein (hsCRP) be considered as a test for this benefit since the AHA and CDC issued a Class IIa recommendation stating that hsCRP measurements for risk stratification add important information to the “classic” cholesterol and HDL measurement. They cited that given Congressional intent, we should include this measure in its list of “approved” screening tests and, if not, that we immediately request that USPSTF conduct a formal review of hsCRP as a screening test. Four commenters recommended the addition of the ABI test. Another requested the inclusion of the 12-lead ECG, the echocardiogram, and tests for carotid artery disease. Another requested the coverage of blood pressure screening. Finally, another commenter suggested that we allow the broadest access and maximize the potential for tests. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We appreciate the commenters' suggestions to include hsCRP and the other tests. In our efforts to develop the proposed rule, many tests were considered for inclusion in the list of screening tests for this benefit. There was insufficient evidence to include any additional tests beyond the lipid panel tests. The information we received in the development of the proposed rule did not support the inclusion of these additional tests but we invite the public to submit scientific literature for our consideration. Other new types of CV screening blood tests may be added under this new screening benefit if we determine them appropriate through a subsequent NCD. 68 FR 55634 (Sept 26, 2003) or 
                        <E T="03">http://www.cms.hhs.gov/coverage/8a.asp].</E>
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         Two commenters recommended that we add HCPCS codes for the Lipid Panel and components as waived tests since they are performed in physician offices and other sites with Clinical Laboratory Improvement Amendments (CLIA) Certificates of Waiver. 
                    </P>
                    <P>
                        <E T="03">Responses:</E>
                         Under CLIA, a facility with a CLIA certificate of waiver can only perform those tests that are approved by the FDA as waived tests. We update the list of waived tests and their appropriate CPT codes on a quarterly basis through our program transmittal process. When we program the claims system to look for the AMA CPT codes for Lipid Panel or any of the three tests which make up the panel, the system will recognize those waived tests performed using the same code plus the QW modifier that are medically necessary. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         Two commenters requested clarification of the frequency limits for the three tests considered for this benefit. They asked if we would cover: (1) A lipid panel; (2) one or more component tests making up the lipid panel once every 5 years; or (3) each of the 4 HCPCS codes listed every 5 years. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         The intent of the benefit is to screen for CV disease. Since we believe most physicians would order the Lipid Panel as a single test, our intention was to cover the panel. We recognize that physicians may have different approaches to reaching their decision to treat, and therefore, we have to make available the possibility that physicians could order the individual tests which make up the panel. No matter how the physician(s) order the tests, our intention is to cover each of the 3 component tests (that is, a total cholesterol, a triglycerides test, and an HDL cholesterol) once every 5 years. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         Two commenters asked that we clarify the reasons for having V codes for screening tests added from the MMA rather than the past practice of developing G codes (unique HCPCS codes; temporary codes). This commenter believed that the change to V codes would cause confusion to the databases like the Physician/Supplier Procedure Summary Master File. This confusion would result in improperly filed provider claims and this would lead to a different and confusing method of processing claims. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         The decision to use ICD-9-CM codes rather than continue to add G codes was made because we try to utilize existing coding structures where possible and create G codes if there is a specific programmatic need. The laboratory community has lobbied against the use of G codes for a few years. Also the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Standardization Requirements are working toward phasing out G codes, which are CMS only codes. The claims processing and editing systems are expected to be adjusted to manage this change. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         Five commenters questioned the reasons for establishing limits on the frequency of this benefit since this places great legal, administrative, and financial burden for providers to manage this type of information. One commenter suggested the use of a chit that beneficiaries would receive and redeem for testing so laboratories would not need to keep records. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         The statute requires a frequency limit. Since laboratories may not have the complete medical history for individuals, including their history of CV screening tests, they are largely relying on the physician's order in establishing whether the test is medically necessary and covered by Medicare. However, relying on the physician's order does not provide the laboratory with proof that the CV screening test is medically necessary since the beneficiary may be treated by multiple physicians who may have ordered these tests independently within the 5 year coverage window. If the laboratory has sufficient doubt, the laboratory may issue an Advanced Beneficiary Notice (ABN) to the beneficiary indicating that Medicare may not cover the CV screening test. If the laboratory does not issue an ABN to 
                        <PRTPAGE P="66294"/>
                        the beneficiary who has received more that one CV screening test during the previous five years, the laboratory may be financially liable for the cost of the test. Laboratories are not required to issue an ABN if the physician has already issued one. 
                    </P>
                    <P>In addition, section 40.3.6.4(C) titled “Frequency Limited Items and Services” of Chapter 30 of Pub 100-4 of the “Internet Only Manual” provides additional guidance for those instances where Medicare has imposed frequency limitations on items or services. This section instructs providers that the provider may routinely give ABNs to beneficiaries and that whenever such a routine ABN is provided to a beneficiary, the ABN must include the frequency limitation as the reason for which Medicare will deny coverage. </P>
                    <P>
                        <E T="03">Comment:</E>
                         Several commenters, including the ACR and the SIR, offered their assistance to us when we determine whether noninvasive testing for CV disease is necessary. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         Since the organizations that suggested noninvasive tests for inclusion in this benefit provided the materials for our review, it is not necessary for us to seek outside assistance. We appreciate the commenters' offer of assistance. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         Four commenters suggested that the CV screening benefit stipulate an age for the population to be tested. We reviewed the USPSTF recommendation that promoted testing for men 35 years and older and women 45 years and older. The commenters believe this age range should be lowered to include those aged 20 years and older and asked us to consider including younger people in this benefit. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         The statutory change for this benefit did not include an age for the person to be tested. While some of the USPSTF recommendations included an age or an age range, none was selected for the proposed rule. Since the majority of the individuals in Medicare are generally 65 and older, the belief was that we are looking at an older population rather than concentrating our resources on the younger beneficiaries who may also be disabled and Medicaid eligible or could be eligible for other services due to other complications of CV disease. While there may be individuals younger than 65 years of age that could benefit from this testing, this benefit is intended for those entitled to Medicare. Therefore, any patient entitled to Medicare would be covered for this benefit as specified in this rule. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         One commenter noted that if the patient did not fast for the screening test (fasting may be difficult for some patients), the calculation of LDL cholesterol may be inaccurate. This commenter recommended that for screening purposes, an alternative to repeating the full lipoprotein profile in the fasting state would be a follow-up direct measurement of LDL cholesterol. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         If a patient cannot fast and the physician believes the patient's medical history and circumstances suggest the beneficiary is at risk of CV disease, then any additional testing beyond an initial screening would need to be done under the diagnostic clinical laboratory benefit. Under the screening benefit, a repeated full lipoprotein profile (fasting) or a second LDL cholesterol (fasting) would not be covered for anyone who failed to fast when they had their first set of tests. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         Several commenters suggested that the tests that the USPSTF approves for CV screening blood tests be automatically adopted and covered by Medicare for the purposes of this benefit. We would not need to use the NCD process to add tests to this benefit. Immediate adoption of USPSTF recommendations will remove us from our own lengthy review. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         While the USPSTF process is well established, we believe it is prudent to review any recommendations from the USPSTF before implementing them. In the proposed rule, we asked the public how we should make changes for this benefit. Because the national coverage determination process allows for public comment before we make any changes, we believe this is the most appropriate basis for any future changes. Further, we may not be able to accept every USPSTF recommendation because of instructional, coding or claims issues that must be resolved before any benefit can be implemented. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         Several commenters questioned whether the screening benefit for CV disease included noninvasive tests or whether it was limited only to blood tests. Further, they recommended that the adoption of noninvasive tests be tied to recommendations of the USPSTF or to an NCD. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We interpreted this portion of the screening benefit to permit noninvasive tests for which there was a blood test recommended by the USPSTF (for example, there is a blood test for cholesterol and if a noninvasive test was developed that detected characteristics of cholesterol, could provide a meaningful (comparison) result and accurate reading) then the noninvasive test could be considered for inclusion in the screening benefit. Noninvasive tests would not be immediately included but would be subject to a review before adoption. When it is time to consider the addition of tests or changes to the list of tests, we will consider any changes through an NCD. This benefit is not limited only to blood tests. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         One commenter recommended that we include a fasting blood glucose test as part of the CV screening blood benefit and that we cover this test every 2 years for beneficiaries over 45 and for younger beneficiaries who are obese or have a family history of diabetes. Fasting blood glucose is inherently a CV screening test because diabetes carries increased risk of CV disease. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         While some people who have diabetes exhibit other factors associated with CV disease, we do not see the necessity to adjust the CV screening benefit to include a fasting blood glucose test. The diabetes screening benefit should be able to identify these individuals. Medicare does not plan to duplicate tests when they are available through other screening programs. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         One commenter requested the inclusion of V70.0 for routine examination to be added as one of the ICD-9-CM codes to be covered for screening for CV screening blood tests. They asked that the NCD on lipid panel be reviewed for any codes that were previously denied as routine screening in the past, and that these codes be considered for inclusion under this new benefit. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We believe the majority of individuals who will seek care under this benefit will fit the V81.0, V81.1, or V 81.2 codes. We are willing to review a sample of claims and determine if V70.0 is an appropriate code for this benefit. At this time, we are unable to add V70.0 to the instructions being cleared. Codes that are to be considered for this new benefit must be brought to our attention through the national coverage determination process for laboratories. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         One commenter suggested that the proposed § 410.17 include reference to whether beneficiaries will incur out-of-pocket costs for CV screening blood tests. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         Section § 410.17 is specific to coverage instructions for screening tests for the early detection of CV disease. We do not believe it is necessary to revise § 410.17 to include payment instructions. We have indicated that Medicare would pay for the tests under the clinical laboratory fee schedule. Currently under this payment system, beneficiaries do not incur copayments and deductibles in accordance with section 1833(a)(1)(D)(i) of the Act, and is included in 
                        <PRTPAGE P="66295"/>
                        instructions at Medicare Claims Processing Manual, Pub. 100-04, chapter 16, § 30.2. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         Two commenters asked us to clarify why we chose 5 years as the timeframe for the benefit, rather than the 2 years allowed by the statute. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         Our primary goal was to allow testing for the population that needed to be screened. In the preamble to the proposed rule, we stipulated that the Clinical Considerations of the USPSTF indicate, while screening may be appropriate in older people, repeated screening is less important because lipid levels are less likely to increase after age 65. Screening individuals more often than necessary might lead to unnecessary expenses and treatment. The scientific literature indicates that lipid levels in the elderly are fairly stable. Therefore, we proposed screening once every 5 years and have not received sufficient evidence to change this position. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         Two commenters suggested that a two-tiered benefit be developed that would allow lipid profile screening tests at least every 5 years for beneficiaries when risk factors are not evident and a second group be screened at least every 2 years. The second group would include individuals who have modifiable risk factors (for example, tobacco smoking, high blood pressure, physical inactivity, obesity, and diabetes mellitus) and non-modifiable risk factors (such as age, gender, race, and family history). 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         While the CV screening benefit could be expanded to include individuals other than those mentioned in the proposed rule, preventive benefits were added to the Medicare Program on a limited basis as science and technology permit them. Since some of the individuals in the second group already would be screened through the IPPE and the Diabetes Screening Benefit, we are not developing a second tier at this time. We believe expanding this to a second tier would waste precious resources of time and money and not contribute to lowering the risk factors for individuals with CV disease. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         One commenter questioned why we proposed to use the NCD process as the method of making changes to the list of tests covered by the CV screening blood test benefit. The commenter wrote that the MMA does not require that the NCD process be utilized. They indicated that there is no need for us to conduct our own assessment since a thorough evaluation of the test was to be done by the USPSTF in determining that the test is one that it recommends. The commenter objected to the use of the NCD process for consideration of new tests because of the significant delays that mark this process. The commenter also stated that all that would be needed for us to approve the coverage of additional CV screening tests is the recommendation of the USPSTF. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         In establishing the benefit for CV screening blood tests, the Congress gave the Secretary the authority to determine which tests would be covered by this benefit. We do not believe it would be proper to delegate this function to USPSTF or any other entity. In the proposed rule, we proposed the tests to be covered for the new benefit when it becomes effective January 1, 2005 and at the same time, we offered the NCD process for changes to this benefit. We proposed that future tests would be added after reviewing the recommendations of the USPSTF and the use of the NCD process. The NCD process actually has several methods for evaluating which tests we may eventually cover. The NCD process includes an application for a new coverage issue, a reconsideration of an existing policy, or a coding change for laboratory tests. We believe the use of the NCD process is a worthwhile endeavor since it is a public process and less time consuming than rulemaking. The use of an NCD is authorized by Section 1871 of the Act. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         One commenter suggested that we include triglycerides as a test for the CV screening blood test benefit since the 2001 USPSTF recommendations for screening for lipid disorders associated with CV disease only includes measurement of total cholesterol and high-density lipoprotein cholesterol (HDL-C). 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We have included the triglycerides test as one of the tests for screening for CV disease. For some individuals, triglycerides may detect a risk factor for CV disease. That is why it was more prudent to select a lipid profile that includes the three tests (total cholesterol, HDL-C, and the triglycerides) rather than to indicate the use of individual tests with different test intervals and different ordering patterns. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         One commenter requested that the frequency limit for lipid testing of 5 years be waived if the patient develops a risk factor, such as diabetes, a marked weight gain, etc. in the interval. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         A patient screened for lipid testing could also meet the requirements for screening under the diabetes screening benefit. If a patient developed further risk factors which negate the need for continued screening under the CV screening blood test benefit, their additional signs or symptoms would probably cause the person to need to seek treatment which would be covered under other benefits including diagnostic clinical laboratory testing. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         One commenter questioned whether § 410.16 that permits qualified nurse practitioners and others to order CV screening tests under the physical examination (section 611 of the MMA) is inconsistent with § 410.17 that requires that the laboratory tests be ordered by the treating physician (§ 410.32(a)). 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         Section 410.16 addresses services by NPs because of conforming changes made in section 611(d) of the MMA. Section 410.32(a)(3) permits certain NPPs to furnish services that would be physicians' services if furnished by a physician and who are operating within the scope of their authority under State law and within the scope of their Medicare statutory benefit. We believe that the statute permits the use of NPPs to order tests described under § 410.17 without a change in the statute. The general rule for laboratory tests is that the tests must be ordered by the treating physician and in the instance of screening tests, the treating NPP may be regarded as a physician for this purpose. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         One commenter believed that screening every 5 years was too long a period between tests and that the data we collect be used to allow more frequent testing. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We have heard from commenters that the frequency limitation of keeping records for the 5 years is difficult because of storage, access and retrieval, and orders from multiple physicians. Change in the frequency (that is, the number of times a patient can be tested during a given timeframe) will be considered if the scientific literature supports it. We do not believe we are permitted to change the frequency based solely upon the logistical difficulties in collecting, consolidating, and maintaining administrative data. Modifying the benefit to permit more frequent testing will not resolve these administrative difficulties. However, we will take this recommendation under advisement as we continue to consider the associated clinical data, but will not make any changes for the final rule. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         One commenter requested that blood be removed from the title of this benefit for the final rule. The commenter believed the narrow focus on blood would restrict the types of tests that would be administered for detecting CV disease. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         In developing the proposed rule, we included blood in the title of this benefit to be consistent with the 
                        <PRTPAGE P="66296"/>
                        history of this benefit and to distinguish the tests in the benefit. We believe that noninvasive tests could be covered and this benefit is not limited only to blood tests. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         One commenter suggested that the CV screening benefit include an appropriate screening instrument. As with depression, the examining physician has a test based on clinical practice guidelines to use as a tool for assessing the patient. Since the American Heart Association (AHA) and the ACC Guidelines for PAD are expected to be published in 2005, the commenter is requesting that we adapt the patient assessment and include these guidelines under the CV screening benefit. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         Since the publication of the AHA and ACC Guidelines has not taken place, it would be difficult to evaluate this document and how physicians would use this in the course of examining a patient. Physicians may use their best judgment for how they assess an individual patient and whether additional specific tests from the AHA and ACC guidelines would be more helpful than what is already included in the screening benefit for CV disease is not something we can conclude at this time. The NCD process is available when additional tests should be considered. 
                    </P>
                    <HD SOURCE="HD2">Result of Evaluation of Comments </HD>
                    <P>After reviewing all the comments, we have plans to include the V codes (V81.0, V81.1 and V81.2) in the Laboratory Edit Module, and to release manual and transmittal instructions and information to smooth the transition for the new benefit. Providers who routinely give ABNs to beneficiaries must include in the ABN that the frequency limitation is the reason for which Medicare will deny coverage. A patient who has an ABN and exceeds the frequency limitation may incur out-of-pocket charges. We will finalize the changes to § 410.17 as proposed. </P>
                    <HD SOURCE="HD2">D. Section 413—Physician Scarcity Areas and Health Professional Shortage Areas Incentive Payments </HD>
                    <P>[If you choose to comment on issues in this section, please include the caption “HPSA Zip Code Areas” at the beginning of your comments.] </P>
                    <P>Section 413(a) of the MMA provides a new 5 percent incentive payment to physicians furnishing services in physician scarcity areas (PSAs). The MMA added a new section 1833(u) of the Act that provides for paying primary care physicians furnishing services in a primary care scarcity county and specialty physicians furnishing services in a specialist care scarcity county an additional amount equal to 5 percent of the amount paid for these services. </P>
                    <P>Section 1833(u) of the Act defines the two measures of physician scarcity as follows: </P>
                    <P>1. Primary care scarcity areas—determined by the ratio of primary care physicians to Medicare beneficiaries. A primary care physician is a general practitioner, family practice practitioner, general internist, obstetrician, or gynecologist. </P>
                    <P>2. Specialist care scarcity areas—determined by the ratio of specialty care physicians to Medicare beneficiaries. The specialist care PSA ratio includes all physicians other than primary care physicians as defined in the definition of primary care scarcity areas. </P>
                    <P>To identify eligible primary care and specialist care scarcity areas, we ranked each county by its ratio of physicians to Medicare beneficiaries. In accordance with the statute, in the list of primary care and specialist care scarcity counties, only those counties with the lowest ratios that represent 20 percent of the total number of Medicare beneficiaries residing in the counties were considered eligible for the 5 percent incentive payment. In accordance with the section 1833(u) of the Act, we also treated a rural census tract of a metropolitan statistical area (as determined under the most recent modification of the Goldsmith Modification) as an equivalent area (that is, equal to a full county). </P>
                    <P>
                        Consistent with section 1833(u)(4)(C) of the Act, all PSAs were assigned their 5-digit zip code area so that we may automatically provide the 5 percent incentive payment to eligible physicians. For zip codes that cross county boundaries, we used the dominant county of the postal zip code (as determined by the U.S. Postal Service) to identify areas eligible to receive the 5 percent payment. Section 1833(u)(4)(C) of the Act also requires us to publish a list of eligible areas as part of the proposed and final physician fee schedule rules for the years for which PSAs are identified or revised and to post a list of PSAs on our Web site. 
                        <E T="03">See</E>
                         Addenda J and H for the zip codes of primary care and specialist care PSAs. The PSA lists by zip code and county are also available on our Web site at 
                        <E T="03">http://www.cms.hhs.gov/providers/bonuspayment.</E>
                         Since we are publishing these lists for the first time in this final rule with comment period, we are accepting comments for 60 days after the date of publication of this regulation on the zip codes and counties qualifying as physician scarcity areas and will address the comments in next year's fee schedule. 
                    </P>
                    <P>
                        In addition to creating of the 5 percent PSA incentive payment, section 413 of the MMA amended section 1833(m) of the Act to mandate that we pay the 10 percent health professional shortage areas (HPSA) incentive payment to eligible physicians in full county HPSAs without any requirement that the physician identify the HPSA area. We can only achieve this result by assigning zip codes to eligible areas. 
                        <E T="03">See</E>
                         Addenda I and K for the lists of eligible primary care and mental health HPSAs by zip code. Consistent with the Act, we have also posted a list of links on our Web site at 
                        <E T="03">http://www.cms.hhs.gov/providers/bonuspayment</E>
                         to assist those physicians located in eligible areas where automation is not feasible, that is, the eligible area could not be assigned a zip code. 
                    </P>
                    <P>In the August 5, 2004 proposed rule, we proposed conforming changes to our regulations to add § 414.66 to provide a 5 percent incentive payment to eligible physicians furnishing covered services in eligible PSAs. We also proposed conforming changes to our regulations to add § 414.67 to codify the 10 percent incentive payment to eligible physicians furnishing covered services in eligible HPSAs, established under the Omnibus Budget Reconciliation Act of 1987 (OBRA) (Pub. L. 100-203), previously implemented through manual issuance. </P>
                    <P>We received 23 letter comments on the bonus payment provisions of section 413 of the MMA. A summary of those comments and our responses follows: </P>
                    <P>
                        <E T="03">Comment:</E>
                         One commenter questioned the rationale behind using zip codes for the purpose of identifying eligible areas for physician bonuses. The commenter believes that zip codes are less accurate than political boundaries (counties, census civil divisions, and census tracts). 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         The statute requires the identification of PSAs on a county basis, except for rural areas (using the Goldsmith Modification). At this time, we can only determine physician scarcity for Goldsmith areas at the zip code level since the Medicare beneficiary data is currently unavailable at the census tract level. 
                    </P>
                    <P>Automation of physician bonus payments can only be achieved by assigning zip codes to eligible areas. That is, the zip code place of service is the only data element reported on the Medicare claim form that would allow automation. </P>
                    <P>
                        <E T="03">Comment:</E>
                         A commenter believes that our proposal to identify qualified PSAs and HPSAs by zip code for automatic payment purposes is problematic 
                        <PRTPAGE P="66297"/>
                        because zip codes cross county lines. The commenter suggested that a more user-friendly option would be to add a county identifier to the claim form. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         The addition of a county code would not resolve the issue of identifying the claims that would have a bonus because not all designated HPSAs and PSAs are full counties. We cannot identify, for an automated payment, services furnished in counties that are only partially designated and Goldsmith areas that are not full counties. In addition, there currently is no place on the standard electronic claims form to accommodate the entry of a county code. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         A commenter requested clarification regarding circumstances when automation of bonus payments is not feasible. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         When the boundaries of zip code areas precisely overlay with the boundaries of eligible HPSAs and PSAs, automation of bonus payments is feasible. In other words, eligible physicians furnishing services to Medicare patients within these zip code areas will automatically receive their bonus payments. We can also automate bonus payments within zip code areas that cross outside of qualified county boundaries as long as the zip code, as determined by the U.S. Postal Service, is dominant to the qualified scarcity county. We cannot automate bonus payments when boundaries of zip code areas only partially coincide with the boundaries of HPSAs and PSAs. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         One commenter requested clarification regarding the application of the billing modifier in determining physician eligibility. The commenter inferred from the proposed rule that, if the zip code is not posted as a qualified area, an eligible physician could still receive a bonus payment if a modifier is used. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         Eligible physicians furnishing covered services in a portion of an eligible PSA, which cannot be properly assigned a zip code to permit automation of the bonus payment, would need to include the new physician scarcity modifier on the Medicare claim in order to receive the bonus payment. Lists of the zip codes that are eligible for the automated payment, as well as a list of the counties that are eligible to receive the PSA bonus are available on our Web site at 
                        <E T="03">http://www.cms.hhs.gov/providers/bonuspayment.</E>
                         If a service is provided in a zip code area that is not listed on the automated payment files, but is within a designated physician scarcity county, the physician must submit the “AR” billing modifier with the service in order to receive the bonus payment. Separate lists for the primary care PSAs and the specialty care PSAs are provided on our Web site for both the automated zip codes and the counties. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         A commenter requested clarification on what ratios would be used to identify PSAs. The Health Resources and Services Administration (HRSA) uses a national ratio of 3,500:1, or 3,000:1 if high needs are shown. The commenter requested information on which ratios would be used to determine PSAs for specialty providers, and whether the ratios would be different for different specialty care providers. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         Only those counties with the lowest primary care ratios that represent 20 percent of the total number of Medicare beneficiaries residing in the counties will be considered eligible for the 5 percent incentive payment. In other words, we ranked each county by its ratio of physicians to beneficiaries and then designated counties as scarcity areas with the lowest ratios until 20 percent of the Medicare population was reached. A separate specialist physician ratio was calculated to identify specialist care PSAs using the same methods stated. The statutory mandate precludes us from adopting a national physician-to-patient ratio similar to the HPSA designations. By statute, the 20 percent population threshold must serve as the qualifying condition for all counties/rural areas. 
                    </P>
                    <P>For calculating the ratios, section 1833(u)(6) of the Act, as added by the MMA, defines a primary care physician as a general practitioner, family practice practitioner, general internist, obstetrician, or gynecologist. In accordance with the statute, all other physicians were grouped together as specialists for purposes of determining the specialist care PSA list. </P>
                    <P>
                        <E T="03">Comment:</E>
                         A commenter requested clarification regarding the frequency of updating the eligible zip code list for automatic HPSA bonus payments and its impact on otherwise eligible physicians. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         Determination of zip codes eligible for automatic HPSA bonus payment will be made on an annual basis, and there will not be any mid-year updates. We will effectuate revisions made to designations by HRSA the following year for purposes of automatic bonus payments. Consequently, if HRSA changes to the HPSA designations remove physicians in those areas from receiving automatic payment, the zip code areas will remain eligible until the next year when we remove the zip code from our approved list. 
                    </P>
                    <P>Eligible physicians furnishing covered services in newly-designated HPSAs are permitted to add a modifier to their Medicare claims to collect the HPSA incentive payment until our next annual posting of eligible zip codes for automation of bonus payments. In cases where a zip code cannot be properly assigned to the newly-qualified HPSA, physicians furnishing services in the area must continue to bill for the incentive payments using the appropriate modifier. </P>
                    <P>
                        <E T="03">Comment:</E>
                         A commenter requested that we provide FQHCs with the 5 percent PSA incentive payment. Since the statute does not explicitly exclude other physicians' services (that are billed on an all-inclusive basis), such as those provided in FQHCs or RHCs, the commenter stated that we should extend the new 5 percent bonus payment to FQHC physicians. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         As defined in section 1861(aa) of the Act, FQHC and RHC services are not physicians' services, even though physicians' services are frequently a component of the services furnished in these facilities. The services are rather identified as FQHC services. Therefore, services furnished by these providers are not eligible for the incentive payment. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         A commenter has questioned our proposal not to apply the new 5 percent physician incentive payment to the technical component of physicians' services. The commenter stated that extending the new bonus payment to both the professional and technical component of the physicians' services is consistent with Congressional intent and would simplify claims processing. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         Section 1833(u) of the Act provides for incentive payments for physicians' services furnished in PSAs. We note that the statute contains two definitions of physicians' services. The first, which appears at section 1861(q) of the Act, defines physicians' services as “professional services performed by physicians including surgery, consultation, and home, office, and institutional calls.” The second, which refers to services paid under the physician fee schedule, is found at section 1848(j)(3) of the Act and contains a broader definition of physician services. However, that definition applies only for purposes of section 1848 of the Act. 
                    </P>
                    <P>
                        Since the incentive payment is not included in section 1848 of the Act, the definition of physicians' services specified in section 1861(q) of the Act is the definition that applies. Thus, we believe the best reading of the statute is that only 
                        <E T="03">professional</E>
                         services furnished 
                        <PRTPAGE P="66298"/>
                        by physicians are eligible for incentive payments. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         A commenter recommended that we extend the HPSA bonus payment to all physicians, regardless of their specialty, when their services are furnished within a mental health HPSA. The commenter believes there is no statutory basis to limit incentive payments just to psychiatrists within mental health HPSAs. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We provide HPSA bonus payments in primary medical care HPSAs to all physicians regardless of specialty (including psychiatrists) in light of the fact that there is significant overlap between primary medical care HPSAs and mental health HPSAs. Furthermore, most primary medical HPSAs, especially in rural areas, also have shortages of specialists. Consequently, there is no apparent need to distinguish between physician specialties within primary medical care HPSAs for determining physician eligibility for bonus payment purposes. However, in the situation where the mental health HPSA does not overlap with a primary medical care HPSA, we allow only psychiatrists to collect the incentive payment. Within these stand-alone mental health HPSAs, there is an adequate supply of physicians for the provision of medical services and a shortage only of those providing mental health services. Therefore, it would be inconsistent with the HPSA incentive payment provisions, as well as an inappropriate use of the Medicare Trust Fund, to pay bonuses to physicians who furnish medical services in service areas without shortages of primary medical services. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         A commenter requested that we count only those practicing physicians who treat Medicare patients when determining the ratio of beneficiaries to practicing physicians. To count all practicing physicians, including those who do not treat Medicare patients would undermine the intent of the provision. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         The statute does not permit us to count only Medicare participating physicians to determine PSAs. The statute explicitly requires that we calculate the primary and specialist care ratio by the number of physicians in the active practice of medicine or osteopathy within the county or rural area. Therefore, we must include in the physician tally all actively practicing physicians when determining PSAs. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         A commenter asked that we clarify our methods for determining the number of primary care and specialty care physicians to calculate the physician-to-beneficiary ratio for identifying PSAs. The commenter suggested that we use only the number of practicing physicians when determining the beneficiary to physician ratio, that is, distinguish between licensed physicians and practicing physicians when determining ratios of primary care and specialty care since some physicians continue to be licensed after they retire. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         As required by section 413 of the MMA, the determination of eligible PSAs is based on the ratio of “active practice” physicians to Medicare beneficiaries within a county or rural area (using the Goldsmith Modification). The physician data source used in calculating scarcity areas is contained in the following: 
                    </P>
                    <P>• The 2001 Physician Characteristics file; and </P>
                    <P>• The 2001 Physician Address file. </P>
                    <P>These data are a compilation of: </P>
                    <P>• The December 2001 AMA Master file; </P>
                    <P>• The December 2001 American Osteopathic Association (AOA) Physician file; and </P>
                    <P>• The National Health Service Corps 2001 participant listing. </P>
                    <P>These physician data files allow for the identification of the physician's active status. Some of the key status indicators to identify practicing physicians include “clinically active” and “Federal employment” status. Clinically active status was determined using the type of practice, professional employment, and major professional activity fields from AMA and AOA. For example, determining non-active status is based on physicians who— </P>
                    <P>(1) Are involved in administration, medical teaching, research, and other non-patient care activities; or </P>
                    <P>(2) Have self-identified as fully retired or otherwise inactive. </P>
                    <P>We believe that the indicator field of “fully retired or otherwise inactive” addresses the specific issue of a physician maintaining his or her license after he or she retires. </P>
                    <P>
                        <E T="03">Comment:</E>
                         A commenter expressed concern about our use of the AMA database to determine the number of licensed physicians engaged in direct patient care in each State. The commenter claims that the AMA database overstates the number of practicing physicians in the State of California by at least 10,000 physicians. In light of this concern, the commenter stated that we should use State medical board licensing information rather than the AMA database in determining the physician counts. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         The physician data source used in calculating scarcity areas is contained in the 2001 Physician Characteristics file and the 2001 Physician Address file. These data are a compilation of the December 2001 AMA Master file, the December 2001 AOA Physician file, and the National Health Service Corps 2001 participant listing. We made the decision to use the AMA Master file as well as the other files as the sources of physician data in scarcity calculations because there is no other adequate source of national physician data. It may be possible to obtain physician data from each individual State agency, but doing so would entail considerable administrative and technical difficulties. Furthermore, methods of gathering and compiling data may be inconsistent in different States. State agencies may vary greatly in terms of the methods used to update physician databases, the frequency of updates, how the data are stored, the type of information collected, and so forth. In addition, States may use their own classification systems for physician specialties, types of practice, and other key information, and these systems may change over time. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         A commenter encouraged us to implement similar incentive payment programs for non-physician practitioners, for example, Certified Registered Nurse Anesthetists and physician assistants. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We do not have the authority to provide bonus payments to non-physicians. Sections 1833(m) and 1833(u) of the Act authorize bonus payments only to physicians. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         A commenter requested that we immediately publish the already identified PSAs by zip code and specify the specialties in short demand within each eligible PSA. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         Lists of the zip codes that are eligible for the automated payment, as well as a list of the counties that are eligible to receive the PSA bonus, are now available on our Web site at 
                        <E T="03">http://www.cms.hhs.gov/providers/bonuspayment.</E>
                         See Addenda J and H for the zip code list of PSAs for primary care and specialist care. 
                    </P>
                    <P>We have forwarded to the Health Resources and Services Administration the request for identification of specialties in short supply within PSAs. That Agency has responsibility for physician manpower issues. </P>
                    <P>
                        <E T="03">Comment:</E>
                         A commenter requested that the list of scarcity areas should be made interim in the final fee schedule rule in order to give physicians sufficient time to review and comment on the proposal. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         Although we made these lists public on our Web site on October 1, 2004, we will accept comments for 60 days after the date of publication of this regulation on the zip codes and counties 
                        <PRTPAGE P="66299"/>
                        qualifying as physician scarcity areas and will address the comments in next year's fee schedule. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         A commenter expressed appreciation for our effort to fairly implement the incentive payments to physicians in scarcity areas. As this new incentive payment program is implemented, physicians must be informed that this bonus is available, and it must be simple for them to receive the bonus. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We have already made available on our Web site at 
                        <E T="03">http://www.cms.hhs.gov/providers/bonuspayment</E>
                         the lists of the zip codes that are eligible for the automated payment, as well as a list of the counties that are eligible to receive the PSA bonus. We have also issued a 
                        <E T="03">Medlearn</E>
                         article to educate the physician community regarding Medicare physician incentive payment programs. For a copy of this provider education article go to: 
                        <E T="03">http://www.cms.hhs.gov/medlearn/matters/mmarticles/2005/SE0449.pd.</E>
                         Lastly, Medicare's contractors have established their own Web site links for the HPSA incentive payment program to facilitate the payment of these bonuses to eligible physicians. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         A commenter expressed support of our proposed changes relating to incentive payments for services provided in areas designated as HPSAs and PSAs. The commenter also commended us for our prompt implementation of section 413 of the MMA. Another commenter expressed appreciation that the new 5 percent incentive is available to specialists in counties with short supply of these physicians. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We appreciate this positive feedback from the provider community. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         A commenter has questioned the rationale for our policy of imposing, as a condition of eligibility, the requirement that the specific location at which the service is furnished must be considered a HPSA or PSA. Since physicians do not always reside in the county where they provide services, identifying PSAs on one basis and paying for them on another basis may be problematic. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         According to section 1833 of the Act, we make bonus payments for physicians' services furnished in an eligible HPSA or PSA. Thus, the place of service controls the availability of the bonus. A physician providing a service in his or her office, a patient's home, or in a hospital may receive the incentive payment only if the service occurs within an eligible shortage or scarcity area. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         One commenter believes that podiatric physicians, who are considered specialists, should be among those eligible to receive the additional 5 percent incentive payment. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         Section 1833(u) of the Act, as added by the MMA, specifically defines “physician” as one described in section 1861(r)(1) of the Act. Therefore, we do not have authority to make bonus payments to podiatrists. 
                    </P>
                    <P>
                        <E T="03">Commenter:</E>
                         A commenter expressed concern that our systems had trouble implementing the HPSA bonuses under Method II for Critical Access Hospital (CAH) participation, and some providers have waited more than two years for increased Medicare payments. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         Although some fiscal intermediaries may not have been accustomed to processing physician claims, these systems were updated and the problems resolved as of July 1, 2004. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         A commenter from California requested that physicians who provide Medicare services only through managed care not be included in our calculations. The commenter believes that including physicians who only treat managed care patients in the count to determine physician scarcity areas will lead to a gross overstatement of the number of physicians available to provide care to fee-for-service Medicare patients. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We do not believe that we have the legal authority to exclude managed care physicians from the ratio calculations. Moreover, excluding managed care physicians in the county-wide physician tally would not change PSAs in California based on our calculations. In fact, excluding the managed care physicians would make five eligible areas ineligible. 
                    </P>
                    <HD SOURCE="HD2">Result of Evaluation of Comments </HD>
                    <P>We are finalizing § 414.66 and § 414.67 as proposed. We are accepting public comments on the zip code areas. </P>
                    <HD SOURCE="HD2">E. Section 303—Payment for Covered Outpatient Drugs and Biologicals </HD>
                    <HD SOURCE="HD3">1. Average Sales Price (ASP) Payment Methodology </HD>
                    <HD SOURCE="HD2">a. Background </HD>
                    <P>Medicare Part B covers a limited number of prescription drugs and biologicals. For the purposes of this proposed rule, the term “drugs” will hereafter refer to both drugs and biologicals. Medicare Part B covered drugs generally fall into the following three categories: </P>
                    <P>• Drugs furnished incident to a physician's service. </P>
                    <P>• Durable medical equipment (DME) drugs. </P>
                    <P>• Drugs specifically covered by statute (for example, immunosuppressive drugs). </P>
                    <P>Section 303(c) of the MMA revises the payment methodology for Part B covered drugs that are not paid on a cost or prospective payment basis. In particular, section 303(c) of the MMA amends Title XVIII of the Act by adding section 1847A, which establishes a new ASP drug payment system. In 2005, almost all Medicare Part B drugs not paid on a cost or prospective payment basis will be paid under this system. </P>
                    <P>The new ASP drug payment system is based on data submitted to us quarterly by manufacturers. Payment amounts will be updated quarterly based on the manufacturer's ASP calculated for the most recent calendar quarter for which data are available. We intend to implement the quarterly pricing changes through program instructions or otherwise, as permitted under Section 1847A(c)(5)(C). For calendar quarters beginning on or after January 1, 2004, the statute requires manufacturers to report their ASP data to us for almost all Medicare Part B drugs not paid on a cost or prospective payment basis. Manufacturers' submissions are due to us not later than 30 days after the last day of each calendar quarter. </P>
                    <P>The methodology for developing Medicare drug payment allowances based on the manufacturer's submitted ASP data is described in this final rule and reflected in final revisions to the regulations at § 405.517 and new Subpart K in part 414. Several comments discussed aspects of the manufacturers' calculation of ASP that are beyond the scope of this final rule. We did not propose any changes to the regulations concerning the manufacturer's calculation of ASP. We also received other comments regarding the use of the least costly alternative (LCA) methodology when pricing drugs, and requests for new HCPCS codes for drugs and coverage of compounded drugs. These comments are also outside the scope of this final rule. We did not propose any changes to the LCA policy, the HCPCS process, or coverage of compounded drugs. </P>
                    <HD SOURCE="HD2">b. Provisions of the Final Rule </HD>
                    <HD SOURCE="HD3">i. The ASP Methodology </HD>
                    <P>Effective 2005, payment for certain drugs and biologicals not paid on a cost or prospective payment basis furnished on or after January 1, 2005 will be based on an ASP methodology. </P>
                    <P>
                        As described in section 1847A(b)(3)(A) of the Act for multiple source drugs and section 1847A(b)(4)(A) for single source drugs, the ASP for all 
                        <PRTPAGE P="66300"/>
                        drug products included within the same billing and payment code [or HCPCS code] is the volume-weighted average of the manufacturers' average sales prices reported to us across all the NDCs assigned to the HCPCS code. Specifically, section 1847A(b)(3)(A) of the Act and section 1847A(b)(4)(A) of the Act require that this amount be determined by— 
                    </P>
                    <P>• Computing the sum of the products (for each National Drug Code assigned to those drug products) of the manufacturer's average sales price and the total number of units sold; and </P>
                    <P>•  Dividing that sum by the sum of the total number of units sold for all NDCs assigned to those drug products. </P>
                    <P>Section 1847A(b)(1)(A) of the Act requires that the Medicare payment allowance for a multiple source drug included within the same HCPCS code be equal to 106 percent of the ASP for the HCPCS code. This payment allowance is subject to applicable deductible and coinsurance. The payment limit is also subject to the two limitations described below in section III.E.1.b.v of this preamble concerning widely available market prices and average manufacturer prices in the Medicaid drug rebate program. As described in section 1847A(e) of the Act, the payment limit may also be adjusted in response to a public health emergency under section 319 of the Public Health Service Act in which there is a documented inability to access drugs and a concomitant increase in the price of the drug which is not reflected in the manufacturer's average sales price. </P>
                    <P>Section 1847A(b)(1)(B) of the Act requires that the Medicare payment allowance for a single source drug HCPCS code be equal to the lesser of 106 percent of the average sales price for the HCPCS code or 106 percent of the wholesale acquisition cost of the HCPCS code. This payment allowance is subject to applicable deductible and coinsurance. The payment limit is also subject to the two limitations described below in section III.E.1.b.v concerning widely available market prices and average manufacturer prices in the Medicaid drug rebate program. As described in section 1847A(e) of the Act, the payment limit may also be adjusted in response to a public health emergency under section 319 of the Public Health Service Act. </P>
                    <P>
                        <E T="03">Comment:</E>
                         One commenter suggested that we implement the ASP methodology on a pilot basis prior to a national rollout. A physician interest group recommended that we delay the implementation of the ASP payment system for at least one year. The interest group stated that we should inform physicians of the ASP for all covered drugs before the final rule is issued and allow physicians to comment on the proposed rates after an informed and complete review process. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         The law requires that the new ASP-based drug pricing system be implemented January 1, 2005. The January 1, 2005 prices will be based on the data submitted to us no later than 30 days after the end of the third calendar year quarter of 2004. Given the requirements surrounding the timing of the promulgation of the physician fee schedule final rule, we will not have the January 1, 2005 prices available before the publication of the final rule. However, our goal is to provide as much information on Medicare Part B drug payment rates as possible as early as possible prior to the January 1, 2005 effective date of those rates. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         A provider asked that we earmark funds to enable physicians to transition from the AWP-15 percent payment system to the ASP + 6 percent payment system. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We do not have statutory authority to create such a transition fund. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         One commenter stated that the ASP plan does not account for price increases in a timely manner. Another commenter expressed concern that because ASP modifications lag by at least two calendar quarters, market prices would not be reflected in a drug's payment limit for at least six months after a pricing adjustment. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         The ASP methodology is based on average sales prices reported by manufacturers quarterly. Manufacturers must report to us no later than 30 days after the close of the quarter. We implement these new prices through program instructions or otherwise at the first opportunity after we receive the data, which is the calendar quarter after receipt. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         Some commenters expressed concern that the ASP + 6 percent payment methodology would discourage providers from using generic drugs and would increase the tendency to use newer or more expensive agents. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         It is true that the higher the average sales price of a drug, the greater amount of money represented by 6 percent of that price. However, Section 1847A specifies that payment is at 106 percent of ASP. The law requires the use of the new ASP + 6 percent payment system except in the limited instances described below in Sections V and VI. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         Several commenters suggested that we should establish a mechanism to provide the public with an opportunity to identify errors in the ASP-based payment rates before the start of the calendar quarter in which the rates are effective. They believe that this mechanism would minimize errors by permitting posting of the rates several weeks prior to the effective date. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         Our goal is to provide as much information on Medicare Part B drug payment rates as possible as early as possible prior to the effective date of those rates. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         A physician specialty group recommended that we use our inherent reasonableness authority to increase drug payments up to 15 percent where necessary to make the Medicare payment level sufficient to cover the price of drugs charged by specialty distributors that service the physician office market. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We do not have sufficient data to determine whether our inherent reasonableness authority would apply in this instance. Even if our inherent reasonableness authority were triggered, our data are insufficient to determine whether the adjustment the commenters request would be appropriate. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         Several commenters urged us to weigh the full range of potential consequences to patient care, especially in the oncology setting, with the implementation of the ASP payment methodology. They recommended that we take into consideration concerns such as the potential inability of providers to purchase drugs below the new reimbursement rate, the inability of oncologists to provide access to important under-reimbursed support services, and the disproportionate impact of these changes on rural providers necessitating a shift in care of sick cancer patient from community settings to the hospital. Some commenters suggested that we place a form on its Web site enabling beneficiaries to identify access problems. One commenter suggested that we perform a 1-year monitoring study to evaluate the quality of care issues and delay implementation until the results of the study are known. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         Although we do not expect access problems under the new ASP + 6 percent payment system, we will be monitoring patient access through our 1-800-MEDICARE line, regional office staff, claims analysis, and other environmental scanning activities. We will work with Congress if access issues arise. The law requires that the new ASP-based drug pricing system be implemented January 1, 2005. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         Several commenters expressed concern regarding the statements on joining group purchasing organizations (GPOs) to improve their purchasing power. They indicate that 
                        <PRTPAGE P="66301"/>
                        the size of the discount is based on the individual GPO member's purchases, not the combined purchases of the GPO members. Thus, membership in a GPO would not necessarily result in a greater discount. They also point out that retail pharmacies do not have access to GPO purchasing arrangements. One commenter requested that we offer more tangible suggestions for obtaining drugs at the ASP +6 percent price other than encouraging physicians to participate in purchasing groups. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         The law requires that the new ASP-based drug pricing system be implemented January 1, 2006. A recent survey of oncology practices performed by the American Society of Clinical Oncology indicated that the purchase price of drugs is not necessarily driven by practice size. It would appear that smaller purchasers are on average sometimes able to achieve similar drug pricing to larger purchasers. The OIG is conducting a study due not later than October 1, 2005, on the ability of different size physician practices in the specialties of hematology, hematology/oncology, and medical oncology to obtain drugs at 106 percent of the average sales price. We are currently conducting another MMA-mandated study of sales of drugs to large volume purchasers that is due not later than January 1, 2006. We will seek to work with physicians, providers, and suppliers on ways to encourage prudent purchasing, including to the extent practicable the dissemination of information on lower cost suppliers of Medicare Part B drugs. We would welcome suggestions on ways to accomplish this goal. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         One commenter suggested that classes of trade should be taken into account when establishing ASP payment rates. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         The law does not permit the exclusion of or differentiation by classes of trade in the calculation of the ASP payment rates, except for the specific statutory exceptions described in the Medicaid best price calculation under sections 1927(c)(1)(C)(i) and 1927(c)(1)(C)(ii)(III) of the Act. The statute specifies a payment rate of 106 percent of ASP. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         A drug manufacturer urges us to reject any requests to publish the NDC-specific ASPs as the publishing of the rates would facilitate inappropriate conduct. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         The law does not permit the disclosure of NDC level ASPs in a form that discloses the identity of a specific manufacturer or prices charged by the manufacturer except in accordance with Section 1927(b)(3)(D) of the Act. That provision permits the disclosure of such data as the Secretary determines to be necessary to effectuate the provisions of section 1847A of the Act. 
                    </P>
                    <HD SOURCE="HD3">v. Limitations on ASP </HD>
                    <P>Section 1847A(d)(1) of the Act states that “The Inspector General of the Department of Health and Human Services shall conduct studies, which may include surveys, to determine the widely available market prices of drugs and biologicals to which this section applies, as the Inspector General, in consultation with the Secretary, determines to be appropriate.” Section 1847A(d)(2) of the Act states that “Based upon such studies and other data for drugs and biologicals, the Inspector General shall compare the average sales price under this section for drugs and biologicals with— </P>
                    <P>• The widely available market price for such drugs and biologicals (if any); and </P>
                    <P>• The average manufacturer price (as determined under section 1927(k)(1)) for such drugs and biologicals.” </P>
                    <P>Section 1847A(d)(3) of the Act states that “The Secretary may disregard the average sales price for a drug or biological that exceeds the widely available market price or the average manufacturer price for such drug or biological by the applicable threshold percentage (as defined in subparagraph (B)).” Section 1847A(d)(3)(B) states that “the term ‘applicable threshold percentage’ means—</P>
                    <P>• In 2005, in the case of an average sales price for a drug or biological that exceeds widely available market price or the average manufacturer price, 5 percent; and </P>
                    <P>• In 2006 and subsequent years, the percentage applied under this subparagraph subject to such adjustment as the Secretary may specify for the widely available market price or the average manufacturer price, or both.” </P>
                    <P>Section 1847A(d)(3)(C) of the Act states that “If the Inspector General finds that the average sales price for a drug or biological exceeds such widely available market price or average manufacturer price for such drug or biological by the applicable threshold percentage, the Inspector General shall inform the Secretary (at such times as the Secretary may specify to carry out this subparagraph) and the Secretary shall, effective as of the next quarter, substitute for the amount of payment otherwise determined under this section for such drug or biological the lesser of— </P>
                    <P>• The widely available market price for the drug or biological (if any); or </P>
                    <P>• 103 percent of the average manufacturer price (as determined under section 1927(k)(1)) for the drug or biological.” </P>
                    <P>
                        <E T="03">Comment:</E>
                         One commenter urged us to provide further guidance on the widely available market price (WAMP) methodology, specifically how the OIG will compare ASP to WAMP. The commenter also requested guidance on how WAMP will be determined in the case of multiple drugs represented by a single J-code. Other commenters stated that we should provide greater guidance for how it will substitute WAMP for ASP. These commenters also suggested that we provide guidance on how it will treat quarterly oscillations between ASP and WAMP. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         The OIG is developing its methodology regarding the widely available market price. Because the determination of WAMP is within OIG's purview, we believe it is premature to address the implementation issues prior to the OIG establishing its methodology and conducting its first review. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         Several commenters recommend that we make adjustments where there is a disparity between the ASP-based payment limit and the physician acquisition cost. These commenters recommended that we raise the payment rate if the WAMP is higher than ASP. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         Section 1847A of the Act does not provide authority to increase the ASP-based payment system based on the review of the OIG. 
                    </P>
                    <HD SOURCE="HD3">vi. Payment Methodology in Cases Where the Average Sales Price During the First Quarter of Sales Is Unavailable </HD>
                    <P>Section 1847A(c)(4) of the Act states that “In the case of a drug or biological during an initial period (not to exceed a full calendar quarter) in which data on the prices for sales for the drug or biological is not sufficiently available from the manufacturer to compute an average sales price for the drug or biological, the Secretary may determine the amount payable under this section for the drug or biological based on— </P>
                    <P>• The wholesale acquisition cost; or </P>
                    <P>• The methodologies in effect under this part on November 1, 2003, to determine payment amounts for drugs or biologicals.” </P>
                    <P>
                        <E T="03">Comment:</E>
                         Several commenters requested that we provide guidance on how the payment rate for a new drug in its second calendar quarter will be determined. They recommend that we utilize the same methodology for the 2nd quarter payment as for the 1st quarter; that is, use the WAC or methodologies in effect on November 1, 2003. 
                        <PRTPAGE P="66302"/>
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         Pursuant to section 1847A(c)(4) of the Act, during an initial period (not to exceed a full calendar quarter) where data on prices for sales for a drug are not sufficiently available from the manufacturer to compute an ASP, we will pay based on WAC or the methodologies in effect on November 1, 2003 for a limited period. This time period will start on the date that sales of the drug begin and end at the beginning of the quarter after we receive information from the manufacturer regarding ASP for the first full quarter of sales. 
                    </P>
                    <HD SOURCE="HD2">c. Payment for Influenza, Pneumococcal, and Hepatitis B Vaccines </HD>
                    <P>Section 1841(o)(1)(A)(iv) of the Act requires that influenza, pneumococcal, and hepatitis B vaccines described in subparagraph (A) or (B) of section 1861(s)(10) of the Act be paid based on 95 percent of the average wholesale price (AWP) of the drug. The AWP payment rates for these vaccines will be updated quarterly. No commenters objected. </P>
                    <HD SOURCE="HD2">d. Payment for Drugs Furnished During 2005 in Connection With the Furnishing of Renal Dialysis Services if Separately Billed by Renal Dialysis Facilities </HD>
                    <P>Section 1881(b)(13)(A)(ii) of the Act indicates that payment for a drug furnished during 2005 in connection with the furnishing of renal dialysis services, if separately billed by renal dialysis facilities, will be based on the acquisition cost of the drug as determined by the Inspector General(IG) report to the Secretary required by section 623(c) of the MMA or, insofar as the IG has not determined the acquisition cost with respect to a drug, the Secretary shall determine the payment amount for the drug. In the report, “Medicare Reimbursement for Existing End-Stage Renal Disease Drugs,” the IG found that, on average, in 2003 the four largest chains had drug acquisition costs that were 6 percent lower than the ASP of 10 of the top drugs, including erythropoietin. A sample of the remaining independent facilities had acquisition costs that were 4 percent above the ASP. Based on this information, the overall weighted average drug acquisition cost for renal dialysis facilities is 3 percent lower than the ASP. Therefore, we proposed that payment for a drug or biological furnished during 2005 in connection with renal dialysis services and separately billed by renal dialysis facilities will be based on the ASP of the drug minus 3 percent. We proposed to update this quarterly based on the ASP reported to us by drug manufacturers. </P>
                    <P>We received numerous comments regarding our proposed payments rate of ASP minus 3 percent. Those comments and responses are provided below. </P>
                    <P>
                        <E T="03">Comment:</E>
                         Commenters questioned the basis for our decision to pay for separately reimbursed drugs at a rate of ASP minus three percent. These commenters stated that ASP minus 3 percent was not acquisition cost as determined by OIG and did not reflect the acquisition cost relationship between these drugs. Some commenters questioned the relationship between the ASP definition used by the OIG and the current definition. Commenters stated that we should base the payment rates on the acquisition cost of each drug as reported by the OIG updated to 2005 rather than an ASP-based formula. Some commenters indicated that the acquisition cost should be updated to 2005 and suggested an update using the same annual factor used for budget neutrality calculations. For drugs not included in the OIG report, some commenters suggested that we use the same methodology for most other Medicare Part B drugs, namely ASP plus 6 percent. Commenters indicated we should consider two tiers of payment based on provider size to minimize the discrepancy between large and small providers or in the absence of two tiers base the payment on the acquisition cost of the facilities not owned or managed by the four largest providers. Commenters also asked for clarification of the payment basis for separately billable ESRD drugs other than EPO billed by hospital based ESRD facilities since these drugs historically were not paid based on AWP but rather based on reasonable cost. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We agree with the commenters who suggested we base the 2005 payment rates for separately billable ESRD drugs on the actual dollar value of the acquisition costs as determined by the IG rather than the acquisition costs relative to the ASP. We also agree that we should update the IG acquisition costs to calculate 2005 rates. After consideration of the available price data, we have determined that the Producer Price Index (PPI) for prescription preparations is the most appropriate price measure for updating EPO and other separately billable drugs from 2003 to 2005. The PPI for prescription preparations is released monthly by the Bureau of Labor Statistics, and reflects price changes at the wholesale or manufacturer stage. By comparison, the Consumer Price Index (CPI) for prescription drugs reflects price changes at the retail stage. Because EPO and many of the separately billable drugs used by dialysis facilities are purchased directly from the manufacturer, the use of a price index that measures wholesale rather than retail prices is more appropriate. The PPI for prescription drugs is the measure used in the various market baskets that update Medicare payments to hospitals, physicians, skilled nursing facilities, and home health agencies. In addition, the PPI for prescription drugs was recommended for use in the proposed composite rate market basket detailed in the 2003 Report to Congress. 
                    </P>
                    <P>Based on historical data through the second quarter of 2004, we used the Global Insight Inc. forecast of the PPI for prescription drugs to determine the update factors for 2004 and 2005. We feel the use of an independent forecast, in this case from Global Insight Inc., is superior to using the Naational Health Expenditure projections for drug prices (which is the CPI for prescription drugs) and is consistent with the methodology used in projecting market basket increases for Medicare prospective payment systems. </P>
                    <P>
                        We also agree with those commenters who suggested that the drugs not contained in the IG study should be paid at ASP plus 6 percent. We believe it is appropriate for the payment amount for these drugs when separately billed by ESRD facilities during 2005 to be the same as the payment amount for other entities that are paid by Medicare on other than a cost or prospective payment basis. We do not agree with commenters that we should establish separate drug payment rates for large and small providers. For reasons discussed in the section of this final rule on the ESRD composite rate, we believe it is appropriate to establish a single add-on payment to the composite rate and therefore appropriate to establish the same drug payment rates for both large and small providers. We do not believe it is appropriate to base the payment amount on only the higher acquisition cost of the facilities not owned or managed by the four largest providers and not take into account the acquisition costs of the largest four providers who represent the majority of the drug expenditures. Section 1881(b)(13)(A)(ii) of the Social Security Act refers to “the acquisition cost of the drug or biological” and not the acquisition costs of the drug or biological. In accordance with the statute and our understanding of Congressional intent for 2005, we believe it is more appropriate to base the 2005 payment amounts on a weighted average of the acquisition costs of the four largest providers and the other 
                        <PRTPAGE P="66303"/>
                        facilities rather than base the 2005 payment amounts solely on the acquisition costs of the other facilities. 
                    </P>
                    <P>In response to the commenters who requested clarification of the payment basis for separately billable ESRD drugs other than EPO billed by hospital-based ESRD facilities, we did not propose changes to the reasonable cost payment basis for these drugs. The OIG did not study separately billable ESRD drugs other than EPO billed by hospital-based ESRD facilities and accordingly, we did not propose to change the payment basis for these drugs. </P>
                    <HD SOURCE="HD2">e. Payment for Infusion Drugs Furnished Through an Item of DME </HD>
                    <P>In 2005, section 1841(o)(1)(D)(i) of the Act requires that an infusion drug furnished through an item of DME covered under section 1861(n) of the Act be paid 95 percent of the average wholesale price for that drug in effect on October 1, 2003. No commenters objected. </P>
                    <HD SOURCE="HD3">2. Drug Administration Payment Policy and Coding Effective in 2005 </HD>
                    <P>Section 1848(c)(2)(J) of the Act (as added by section 303(a) of the MMA) requires the Secretary to promptly evaluate existing drug administration codes for physicians' services to ensure accurate reporting and billing for those services, taking into account levels of complexity of the administration and resource consumption. According to section 1848(c)(2)(B)(iv) of the Act (as amended by section 303(a) of the MMA), any changes in expenditures in 2005 or 2006 resulting from this review are exempt from the budget neutrality requirement of section 1848(c)(2)(B)(ii) of the Act. The statute further indicates that the Secretary shall use existing processes for the consideration of coding changes and, to the extent changes are made, shall use those processes to establish relative values for those services. The Secretary is also required to consult with physician specialties affected by the provisions that change Medicare payments for drugs and drug administration. </P>
                    <P>The AMA's CPT Editorial Panel established a workgroup, with representatives from affected specialties that met earlier this year to develop recommendations to the CPT Editorial Panel in August. Based on these recommendations, that panel adopted several new drug administration codes and revised several existing codes. Subsequently, the AMA's Relative Value Update Committee (RUC) met at the end of September to make recommendations to us on the practice expense resource inputs and work relative values for the new and revised drug administration codes. </P>
                    <P>We indicated in the proposed rule that we would consider whether it is necessary for us to make coding changes effective January 1, 2005 through the use of G-codes (because the 2005 CPT book will have already been published), and we requested public comment. As described in detail below, we are establishing new G-codes for 2005 that correspond with the new CPT codes that will become active in 2006. These new G-codes are interim until 2006. </P>
                    <P>The new CPT codes can be categorized into the following three categories of drug administration services: infusion for hydration; nonchemotherapy therapeutic/diagnostic injections and infusions other than hydration; and chemotherapy administration (other than hydration) which includes infusions/injections. There are some important changes in the new codes relative to current drug administration coding. The infusion of substances such as monoclonal antibody agents or other biologic response modifiers is reported under the chemotherapy codes, instead of the nonchemotherapy infusion codes, as is currently the case. There are also new codes in both the chemotherapy and nonchemotherapy sections for reporting the additional sequential infusion of different substances or drugs. </P>
                    <P>As we stated in the proposed rule, we plan to analyze any shift or change in utilization patterns once the payment changes for drugs and drug administration required by MMA go into effect. While we do not believe the changes will result in access problems, we plan to continue studying this issue. We also note that the MMA requires the Medicare Payment Advisory Commission (MedPAC) to study how the changes in payments for drugs and drug administration affect other specialties. </P>
                    <P>We received many comments on various aspects of coding and payment for drug administration services in response to the proposed rule. We are also responding below to comments we received on the January 7, 2004 interim final rule with comment period that announced the provisions of section 303 of the MMA affecting drug administration services that took effect in 2004 (69 FR 1094). Specifically, section 303 of the MMA required the following changes in 2004: a transitional adjustment that increases payments for specific drug administration services by 32 percent in 2004 (and 3 percent in 2005); establishing work RVUs for certain drug administration services equal to the work RVUs for a level 1 office medical visit for an established patient; the incorporation of supplemental survey data in the calculation of the practice expense RVUs for drug administration codes; and allowing oncologists to bill for multiple drug administrations by the “push” technique on a single day. </P>
                    <P>
                        <E T="03">Comment:</E>
                         Many commenters supported the efforts to promptly evaluate existing drug administration codes to ensure accurate reporting and billing for services. They support our proposal to use G-codes until the new CPT codes are active. They asked us to adopt the recommendations of the CPT Editorial Panel for new drug administration codes. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We appreciate the support of the commenters of all of the efforts to expeditiously review and update these codes. We also would like to specifically recognize the efforts of the CPT Editorial Panel's Drug Administration Workgroup to develop the new CPT codes, the Editorial Panel for its consideration and approval of the new codes, and the RUC for its similar efforts to develop recommendations for the inputs for the new codes. 
                    </P>
                    <P>We have reviewed the recommendations of the CPT Editorial Panel and, with one exception noted below, agree with their new and revised codes for drug administration for 2005. Because the new CPT codes will not be included in the 2005 CPT, we have decided to establish G-codes, where applicable. At this time, we anticipate these new G-codes will be temporary until the new CPT codes become active January 1, 2006. </P>
                    <P>A listing of the old CPT codes and their corresponding G-codes are in the table below. Some of the old CPT codes will correspond to more than one G-code, and there are codes that will allow physicians to bill for services that previously did not have a code or were bundled into other services. </P>
                    <P>
                        The drug administration codes are divided into three categories: infusion codes for hydration; codes for therapeutic/diagnostic injections; and chemotherapy administration codes. The descriptions of the codes below are taken primarily from the AMA CPT Editorial Panel. We are including these specific descriptions here in order to provide as much information as possible about the new G-codes prior to their implementation on January 1, 2005. However, we anticipate that we will issue further instructions regarding the appropriate use of these G-codes, including clarifications, interpretations, and other modifications to the following guidance (apart from the G-codes 
                        <PRTPAGE P="66304"/>
                        themselves) as part of any instructions issued through a subregulatory process. 
                    </P>
                    <P>The codes for hydration (G0345 and G0346 in the table below) are for reporting hydration intravenous (IV) infusions consisting of a prepackaged fluid and electrolytes. These codes are not used to report infusion of drugs or other substances. The codes for chemotherapy administration are to be used for reporting the administration of non-radionuclide anti-neoplastic drugs, and anti-neoplastic agents provided for treatment of noncancer diagnoses, or substances such as monoclonal antibody agents and other biologic response modifiers. The remaining codes are for reporting injections and infusions for all drug administrations that were previously reported using CPT codes 90780-90788, 96400, and 96408-96414 (other than those described above as hydration or chemotherapy). </P>
                    <GPH SPAN="3" DEEP="610">
                        <PRTPAGE P="66305"/>
                        <GID>ER15NO04.503</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="167">
                        <PRTPAGE P="66306"/>
                        <GID>ER15NO04.504</GID>
                    </GPH>
                    <P>The following coding guidance is based on the CPT Editorial Panel's explanatory language for the new CPT codes. As noted above, we plan to issue further guidance as needed. </P>
                    <P>Infusions that were previously reported under CPT code 90780 (non-chemotherapy infusion, 1st hour) will be billed under one of three G-codes beginning January 1, 2005. The first hour of a hydration infusion will be billed under G0345. The first hour of infusion of a nonchemotherapy drug other than hydration will be billed under G0347. The first hour of infusion of anti-neoplastic agents provided for treatment of noncancer diagnoses or substances such as monoclonal antibody agents and other biologic response modifiers is billed under G0359. </P>
                    <P>Similarly, services that were previously reported under CPT code 90781 (non-chemotherapy infusion, each additional hour) will be billed under one of four G-codes beginning January 1, 2005. Each additional hour of a hydration infusion will be billed under G0346. Each additional hour of a nonchemotherapy infusion will be billed under G0348. Currently, if a second (or other subsequent) nonchemotherapy drug is administered sequentially, the physician would bill code 90781 for the additional hour of infusion. Under the new G-codes, the physician will bill G0349, the sequential administration of a second or subsequent nonchemotherapy drug. In addition, each additional hour of the infusion of anti-neoplastic agents for the treatment of noncancer diagnoses or substances such as monoclonal antibodies and other biological modifiers is billed under G0360. </P>
                    <P>Injections that were previously billed under CPT code 90782 will now be billed under HCPCS code G0351. Physicians should use HCPCS code G0352 for injections previously billed under CPT code 90783. Nonchemotherapy drugs administered by IV push (currently using CPT code 90784) should now be billed under HCPCS code G0353. The CPT book does not currently contain a code for physicians to bill a second (or other subsequent) nonchemotherapy drug administered by IV push. The CPT Editorial Panel created a new code for each additional nonchemotherapy drug administered by IV push. For 2005, the physician should bill HCPCS code G0354. </P>
                    <P>The CPT coding system will be deleting code 90788 (Intramuscular injection of antibiotic) in 2006. We are maintaining CPT code 90788 as an active code until it is changed in the CPT coding system and instructions are provided on the code to bill in its place beginning January 1, 2006. </P>
                    <P>Chemotherapy injections, previously billed under the CPT code 96400, will now be billed using one of two new G-codes. For injection of nonhormonal anti-neoplastic drugs, the physician should bill HCPCS code G0355. For injection of hormonal anti-neoplastic drugs, the physician should bill HCPCS code G0356. CPT is not recommending any changes to CPT codes 96405 (Chemotherapy administration; intralesional, up to and including 7 lesions) and 96406 (more than 7 lesions), and these codes will remain active for Medicare in 2005. </P>
                    <P>Chemotherapy drugs administered by IV push (currently billed under CPT code 96408, or, if the drug meets the expanded definition of chemotherapy including monoclonal antibodies or other biologic response modifiers, currently billed under CPT code 90784) should be billed using G0357 for the initial drug administered. In 2004, Medicare paid for the second (or other subsequent) chemotherapy drug administered by IV push under CPT code 96408. CPT will be establishing a code that recognizes the resource inputs associated with each additional chemotherapy drug administered by IV push. For 2005, the analogous code to bill the second (or other subsequent) chemotherapy drug administered by IV push is G0358. </P>
                    <P>The first hour of chemotherapy administration, previously billed under CPT code 96410, should now be billed under CPT code G0359. Each additional hour of chemotherapy (previously billed under CPT code 96412) should now be billed under CPT code G0360. CPT is also recommending a new code for the first hour of a different chemotherapy drug administered sequentially by infusion. If a second chemotherapy drug is administered sequentially, the physician should bill for HCPCS G0362 for the first hour of infusion of the second drug. All additional hours (up to eight total hours) of chemotherapy infusion should be billed using HCPCS code G0360. Prolonged chemotherapy infusions (8 hours or more, previously billed under code 96414) should be billed in 2005 using HCPCS code G0361. </P>
                    <P>
                        For three codes (G0350, G0354, G0363), the table above has an “N/A” listed in the “Old CPT” column, meaning there were no CPT codes that existed explicitly for these services. These services will now be billable under the new coding system. For instance, CPT will be establishing a code for a “concurrent infusion.” A concurrent infusion refers to the simultaneous infusion of two nonchemotherapy drugs. We are using temporary code G0350 for this service. Code G0350 is an add-on code. It must be reported as an “add-on” or with another code and our payment reflects the incremental resources associated with infusing the second drug. For example, if two nonchemotherapy drugs are infused concurrently, the physician bills G0347 for the initial drug infused and G0350 as an add-on. 
                        <PRTPAGE P="66307"/>
                    </P>
                    <P>As indicated above, HCPCS code G0354 is a new code for each additional sequentialnonchemotherapy drug administered by IV push. HCPCS code G0354 is also an add-on code. In general, G0354 will be an add-on to G0353. However, it is possible that a nonchemotherapy drug administered by IV push may follow the administration of a chemotherapy drug administered by IV push, and HCPCS code G0354 would then be an add-on to HCPCS code G0357. </P>
                    <P>HCPCS code G0363 is a new code for irrigation of an implanted venous access device. There is currently no code to describe this service. Medicare will pay for G0363 if it is the only service provided that day. If there is a visit or other drug administration service provided on the same day, payment for this service is bundled into payment for the other service. </P>
                    <P>We are creating the following new add-on G-codes: G0346, G0348, G0349, G0350, G0354, G0358, G0360 and G0362. As indicated above, add-on codes must be billed with other codes, and our payment reflects the incremental resources associated with providing the additional service. The initial codes that these add-on codes could potentially be billed with include: G0345, G0347, G0353, G0357 and G0359. If a combination of chemotherapy, nonchemotherapy drugs, and/or hydration is administered by infusion sequentially, the initial code that best describes the service should always be billed irrespective of the order in which the infusions occur. </P>
                    <P>
                        <E T="03">Comment:</E>
                         In the January 7, 2004 interim final rule with comment, we revised our payment policy for pushes of chemotherapy drugs to allow for payment of multiple pushes of different chemotherapy agents in one day. A commenter asked that we revise our policy for multiple pushes of nonchemotherapy agents, to allow multiple billings on a single day. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         The CPT/RUC recommendations address this comment. New codes have been created to account for the resources associated with multiple chemotherapy and nonchemotherapy drugs administered by IV push. HCPCS code G0353 is used for the initial IV push of a nonchemotherapy drug, while HCPCS code G0354 is used for each additional push of a nonchemotherapy drug. For chemotherapy drugs administered by IV push, HCPCS code G0357 is used for the first drug administered, while HCPCS code G0358 is used for each additional drug. 
                    </P>
                    <P>We also note that existing CPT codes 90782-90788 (Therapeutic, prophylactic or diagnostic injections) currently have a status indicator of “T”, which means that payment for the service is bundled unless it is the only service billed by the physician for the patient that day. However, based on the RUC recommendations and the resulting values for the injection services, we are making the status indicator on HCPCS codes G0351—G0354 an “A”, which will allow them to be separately paid even if another physician fee schedule service is billed for the same patient that day. </P>
                    <P>
                        <E T="03">Comment:</E>
                         A commenter stated that, given the increased work and practice expense RVUs for drug administration codes, it follows that both the work and practice expense RVUs for the immunization administration codes (90471, 90472, 90473, and 90474) should also be increased. The commenter argued that the service involved in administering vaccines is more intense/complex than the service involved in the drug infusion codes. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We agree with the commenter that the physician work and practice expenses associated with administering injections are similar to immunizations. In addition, we would point out that we currently pay for vaccine administrations (G0008-G0010) based on crosswalking the RVUs to CPT code 90471. Therefore, any changes to the physician work and practice expense RVUs for code 90471 would also affect payments for vaccine administrations. 
                    </P>
                    <P>Because we agree these services should be similar in the amount of physician work involved, we are assigning the physician work value recommended by the RUC for code 90782 (G-code G0351) to code 90471 and HCPCS G-codes G0008-G0010. We are combining the utilization data for all of these codes to determine a single practice expense RVU that will be applied to each of these codes. </P>
                    <P>We are also assigning a work RVU of 0.15 to code 90472. Codes 90473 (Immunization administration by intranasal or oral route; one vaccine (single or combination vaccine/toxoid)) and 90474 (Each additional vaccine (single or combination vaccine/toxoid)) are currently not covered. We are changing the status of these codes to “R”, or restricted, meaning they are payable under some circumstances after carrier review. These codes will be carrier priced. </P>
                    <P>
                        <E T="03">Comment:</E>
                         If a patient receives chemotherapy infusions, CPT code 96410 is used to report the infusion of the first drug up to one hour. Chemotherapy drugs are usually administered sequentially. Thus, if a patient receives the administration of a second chemotherapy drug at the same treatment session, CPT code 96412 is used to report the infusion of the second drug for each additional hour of infusion. In 2004, the national payment, including the transitional payment adjustment of 32 percent, for CPT code 96410 is $217. The comparable payment for CPT code 96412 is $48. 
                    </P>
                    <P>Commenters pointed out that this policy does not take into account the levels of complexity of administration and resource consumption. The administration of multiple drugs requires additional preparation time, supplies, and patient education, not currently accounted for in CPT code 96412. </P>
                    <P>
                        <E T="03">Response:</E>
                         The CPT/RUC recommendations addressed this issue. We are implementing new code G0362, Chemotherapy administration, intravenous technique; each additional sequential infusion, up to one hour. This code will allow, effective January 1, 2005, physicians to begin to bill for the first hour of chemotherapy of the second chemotherapy drug administered. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         Several commenters requested clarification that the changes to the drug administration codes resulting from the CPT changes and our G-codes would be exempted from budget neutrality by the provision at section 1848(c)(2)(B)(iv)(III), as added by MMA section 303(a)(1). This provision stipulates that the evaluation of the existing drug administration codes described above as leading to the interim G-codes and the new CPT codes for 2006, is to be exempt from budget neutrality. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         The commenters are correct that the additional expenditures that result from the interim G-code changes we are implementing in this rule are exempt from budget neutrality. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         Several commenters asked that we continue payment for drug administration codes at the 2004 levels, which included the 32 percent transitional payment adjustment, instead of paying at the 3 percent transitional payment adjustment for 2005, or adopt other measures. For example, commenters suggested temporary codes to offset the large reductions that would otherwise go into effect in 2005. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         Section 303(a)(4) of the MMA is very specific on the application of the transitional payment adjustments in 2004 and 2005. We do not have the legal authority to continue payments based on the 2004 payment levels. In 2005, the transitional adjustment percentage for drug administration 
                        <PRTPAGE P="66308"/>
                        decreases from 32 percent to 3 percent. No transitional percentage is applied in 2006 or subsequent years. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         One commenter requested additional temporary G-codes to offset the payment reductions for oncologists that would otherwise go into effect in 2005. According to this commenter, the payment amount associated with each of these codes would be a percentage add-on amount sufficient to offset the reductions in drug margins and payments for drug administration services. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We have worked extensively with the major associations representing oncologists and their patients to ensure that Medicare continues to pay appropriately for these extremely critical services. The payment changes we made for 2004, the new G-codes, and allowing additional payment for injections and additional infusions, either have already increased, or will increase, payments for drug administration services. The impacts of these changes are discussed extensively in the impact analysis section of this final rule. 
                    </P>
                    <P>In addition, as we indicated above, we plan to analyze any shift or change in utilization patterns once the payment changes for drugs and drug administration required by MMA go into effect. While we do not believe the changes will result in access problems, we plan to continue studying this issue. </P>
                    <P>
                        <E T="03">Comment:</E>
                         One commenter expressed concern that the reductions in payments to oncologists described in the proposed rule could make it difficult, if not impossible, for many patients to continue to access cancer care in nonhospital community settings. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         As noted above, we have taken several steps to increase payments for drug administration services in this final rule. We recognize that oncology patients in the Medicare population undergoing chemotherapy face serious and unique issues and problems related to quality of care throughout the life cycle of their disease process; from the time of first diagnosis, through treatment, until the patient experiences an end to medical (including hospice) care. Patients, national cancer organizations, and medical providers have identified certain factors that they believe affect the comfort and ultimately the care for cancer patients in the physician office setting. 
                    </P>
                    <P>We believe that the goals and objectives of optimal treatment include reviewing and analyzing pain control management, minimization of nausea and vomiting, explaining treatment options, outlining existing chemotherapy regimens, assessing quality of life, assessing patient symptoms and complaints, supporting and educating caregivers, and avoidance of unnecessary Emergency Department visits and inpatient hospitalizations. Further, we believe that clinicians armed with appropriate assessments can proactively intervene with medical treatment and nonmedical assistance to help ameliorate some of the distressing and unpleasant, but frequent and predictable, events that may accompany certain cancers and chemotherapeutic regimens used to combat cancer. </P>
                    <P>The Secretary has been given the authority under sections 402(a)(1)(B) and 402(a)(2) of the Social Security Act Amendments of 1967 (Pub. L. 90-248), as amended, to develop and engage in experiments and demonstration projects to provide incentives for economy, while maintaining or improving quality in provision of health services. In order to identify and assess certain oncology services in an office-based oncology practice that positively affect outcomes in the Medicare population, we will initiate a one-year demonstration project for CY 2005. While we encourage optimal care in all facets of treatment, the focus of the demonstration project will be on three areas of concern often cited by patients: pain control management, the minimization of nausea and vomiting, and the reduction of fatigue. </P>
                    <P>Practitioners participating in the project must provide and document specified services related to pain control management and minimization of nausea and vomiting, and the reduction of fatigue. To facilitate the collection of this information, we have established 12 new G-codes to be reported by program participants. </P>
                    <HD SOURCE="HD2">G-Codes for Assessment of Nausea and/or Vomiting </HD>
                    <P>
                        <E T="03">G9021: Chemotherapy assessment for nausea and/or vomiting, patient reported, performed at the time of chemotherapy administration; assessment level one: not at all (for use in a Medicare-approved demonstration project).</E>
                    </P>
                    <P>
                        <E T="03">G9022: Chemotherapy assessment for nausea and/or vomiting, patient reported, performed at the time of chemotherapy administration; assessment level two: a little (for use in a Medicare-approved demonstration project).</E>
                    </P>
                    <P>
                        <E T="03">G9023: Chemotherapy assessment for nausea and/or vomiting, patient reported, performed at the time of chemotherapy administration; assessment level three: quite a bit (for use in a Medicare-approved demonstration project).</E>
                    </P>
                    <P>
                        <E T="03">G9024: Chemotherapy assessment for nausea and/or vomiting, patient reported, performed at the time of chemotherapy administration; assessment level four: very much (for use in a Medicare-approved demonstration project).</E>
                    </P>
                    <HD SOURCE="HD2">G-Codes for Assessment for Pain </HD>
                    <P>
                        <E T="03">G9025: Chemotherapy assessment for pain, patient reported, performed at the time of chemotherapy administration, assessment level one: not at all (for use in a Medicare-approved demonstration project).</E>
                    </P>
                    <P>
                        <E T="03">G9026: Chemotherapy assessment for pain, patient reported, performed at the time of chemotherapy administration, assessment level two: a little (for use in a Medicare-approved demonstration project).</E>
                    </P>
                    <P>
                        <E T="03">G9027: Chemotherapy assessment for pain, patient reported, performed at the time of chemotherapy administration assessment level three: quite a bit (for use in a Medicare-approved demonstration project).</E>
                    </P>
                    <P>
                        <E T="03">G9028: Chemotherapy assessment for pain, patient reported, performed at the time of chemotherapy administration, assessment level four: very much (for use in a Medicare-approved demonstration project).</E>
                    </P>
                    <HD SOURCE="HD2">G-Codes for Assessment for Lack of Energy (Fatigue) </HD>
                    <P>
                        <E T="03">G9029: Chemotherapy assessment for lack of energy (fatigue), patient reported, performed at the time of chemotherapy administration, assessment level one: not at all (for use in a Medicare approved demonstration project).</E>
                    </P>
                    <P>
                        <E T="03">G9030: Chemotherapy assessment for lack of energy (fatigue), patient reported, performed at the time of chemotherapy administration, assessment level two: a little (for use in a Medicare approved demonstration project).</E>
                    </P>
                    <P>
                        <E T="03">G9031: Chemotherapy assessment for lack of energy (fatigue), patient reported, performed at the time of chemotherapy administration, assessment level three: quite a bit (for use in a Medicare approved demonstration project).</E>
                    </P>
                    <P>
                        <E T="03">G9032: Chemotherapy assessment for lack of energy (fatigue), patient reported, performed at the time of chemotherapy administration, assessment level four: very much (for use in a Medicare-approved demonstration project).</E>
                    </P>
                    <P>
                        The codes correspond to four patient assessment levels (“not at all,” “a little,” “quite a bit,” or “very much”) for each of the following three patient status factors: nausea and/or vomiting; 
                        <PRTPAGE P="66309"/>
                        pain; and lack of energy (fatigue). These levels, based on the Rotterdam scale, were chosen since they appear to be less burdensome for the practitioner and more easily understood by the patient. Participating practitioners must bill the applicable G-codes for each patient status factor (that is, one G-code each for patient comfort assessment factors: nausea and/or vomiting; pain; and fatigue) assessed during a chemotherapy encounter in order to receive payment under the demonstration. A G-code for each patient status factor must appear on the claim for payment to be made under the demonstration project. A patient chemotherapy encounter is defined as chemotherapy administered through intravenous infusion or push, limited to once per day. During the course of the demonstration, an additional payment of $130 per encounter will be paid to participating practitioners for submitting the patient assessment data as described above. 
                    </P>
                    <P>Any office-based physician or nonphysician practitioner operating within the State scope of practice laws who takes care of and administers chemotherapy to oncology patients in an office setting is eligible to participate in this demonstration project. By billing the designated G-codes, the practitioner self-enrolls in the project and agrees to all of the terms and conditions of the demonstration project. </P>
                    <P>This information will help us to work with those who care for cancer patients to determine ways to improve the quality of care and quality of life for patients as demonstrated by measuring objective parameters and the medical response to those standardized measurements. The evaluation of the project will be based on data reported to us by the practitioners and the use of our administrative claims data to examine Emergency Department visits and inpatient hospitalizations. </P>
                    <P>We anticipate that further information regarding this demonstration project will be forthcoming after publication of this final rule. </P>
                    <P>
                        <E T="03">Comment:</E>
                         Commenters pointed out that, under the MMA, we added physician work RVUs to specified drug administration codes equivalent to a level 1 established office visit. They indicated that we should also have increased the practice expense inputs for the same drug administration codes to account for the practice expense inputs associated with a level 1 established office visit. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         Section 1848(c)(2)(H)(iii) of the Act (as added by 303(a)(1)(B) of the MMA) specified that we increase the work RVUs for drug administration services equal to the work RVUs for a level 1 established patient office visit (CPT code 99211). As indicated in the January 7, 2004 
                        <E T="04">Federal Register</E>
                         (69 FR 1093), we established work RVUs of 0.17 for specific CPT codes that met the statutory definition of “drug administration services.” 
                    </P>
                    <P>However, the legislation did not direct us to also increase the practice expense RVUs of the drug administration codes to include the clinical staff time associated with a level 1 office visit. The practice expense inputs of the existing CPT codes for drug administration were refined in 2002. We believe the recommendations from the PEAC included the typical clinical staff time associated with each drug administration service. </P>
                    <P>The CPT Editorial Panel approved new and revised codes for drug administration services for 2005. Depending upon the service, the RUC is recommending work RVUs for the new drug administration codes that may equal, exceed or be less than 0.17. Although section 1848(c)(2)(H)(iii) of the Act requires that the work RVUs for drug administration services shall equal those of a level 1 office medical visit, new subparagraph (J) requires the Secretary to “promptly evaluate existing drug administration codes for physicians' services”. The statute further indicates that the “Secretary shall use existing processes for the consideration of coding changes and * * * in establishing relative values * * * ” </P>
                    <P>Because we typically use the CPT and RUC processes to establish codes and relative values, we believe the statute gives us authority to establish work RVUs at a level other than those of a level 1 established patient office visit. Therefore, for 2005, we are accepting the RUC recommendations for the interim G-codes even though they result in work RVUs that are different than 0.17. </P>
                    <P>
                        <E T="03">Comment:</E>
                         Several organizations and physicians commented that the Medicare payments for the chemotherapy codes do not include payment for many services provided by an oncology practice. These services include support services such as nutrition counseling, social work services, case management, psychosocial counseling, and educational services provided by an oncology nurse to the patient. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         Under certain circumstances, Medicare does make explicit payment for clinical social worker and medical nutrition therapy services. Medicare can pay separately for the services of clinical psychologists (CPs), clinical social workers (CSWs), and nurse practitioners (NPs), clinical nurse specialists (CNS) and physician assistants (PAs). 
                    </P>
                    <P>CPs can bill directly for services and supplies they are legally authorized by the State to perform that could also be furnished by a physician or incident to a physician's service. Payment for CP services is made at 100 percent of the physician fee schedule for services they are authorized to provide that are comparable to those of a physician. </P>
                    <P>CSWs can furnish services for the diagnosis and treatment of mental illnesses that they are legally authorized by the State to provide. Payment for CSW services is made at 75 percent of the CP fee schedule, which is 100 percent of the physician fee schedule. </P>
                    <P>NPs, CNSs and PAs can bill for mental health services consistent with their authority under law to furnish physician services. They may also bill for services furnished incident to their own professional services that fall under the State scopes of practice. Payment for these services is made at 85 percent of the physician fee schedule. Medicare will pay for medical nutrition therapy services provided by a registered dietitian or nutrition professional for a beneficiary with diabetes or renal disease. Based on a comment on our August 20, 2003 proposed rule (68 FR 50428), we understand that social worker services could involve different tasks (“helping patients with their health insurance, filling and refilling prescriptions”) than those that are explicitly paid for by Medicare. However, we believe Medicare does pay for these services indirectly through the practice expense RVUs for drug administration services. If these services are typically provided to cancer patients, we believe the RUC could consider whether it is possible for resource inputs for these types of staff to be incorporated into the new drug administration codes. We also believe that the RUC could consider whether these types of staff activities are unique to physicians who provide drug administration or if they apply to other physicians' services as well. </P>
                    <P>
                        <E T="03">Comment:</E>
                         Current CPT code 96412 (infusion techniques, one to 8 hours, each additional hour) is an add-on code, billed in addition to the primary code, 96410 (the first hour of chemotherapy). There is no national coding policy that explains how this add-on code is to be reported if less than a full hour of chemotherapy infusion is provided. A commenter pointed out that the Medicare carriers have different policies for reporting this service. Some carriers require the infusion to extend at least 16 minutes into the subsequent hour before 
                        <PRTPAGE P="66310"/>
                        an add-on code can be billed, and others impose a 31 minute requirement. The commenter asked that we establish a uniform policy for the carriers to follow. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         The CPT Editorial Panel addressed this issue as part of its review of the drug administration codes. Effective in 2006, the add-on code is to be used for “infusion intervals of greater than thirty minutes beyond one hour increments”. We are adopting this policy for chemotherapy administration codes furnished on or after January 1, 2005. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         The nonchemotherapy subcutaneous injection is currently reported and paid under CPT code 90782, while a chemotherapy subcutaneous injection is currently reported under CPT code 96400. Some commenters recommended that we permit billing for nonchemotherapy injections for cancer patients to be made under CPT code 96400. They believe this code more appropriately reflects the practice expenses related to supportive care for chemotherapy. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         The CPT Editorial Panel explicitly addressed this issue by creating separate drug administration codes for hydration, nonchemotherapy infusions and injections, and chemotherapy infusions and injections. It further expanded the definition of chemotherapy to include those drugs where the resource costs associated with the drug administration are similar to those administered as anti-neoplastics. Other drugs administered in support of chemotherapy, such as anti-emetics and drugs to prevent anemia, are billed using the injection code, G0351, which replaces CPT code 90782 (consistent with the CPT recommendations). We have reviewed the practice expense inputs for this code from the RUC and accepted their recommendation. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         Some commenters asked that complex non-oncology infusions, such as Remicade, be paid at the same level as chemotherapy infusions. They indicate that these nonchemotherapy infusions have similar complexity and resource use as chemotherapy infusions. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         The CPT recommendations address this issue. The codes for chemotherapy administration are for reporting the administration of non-radionuclide, anti-neoplastic drugs, anti-neoplastic agents provided for treatment of noncancer diagnoses or substances such as monoclonal antibody agents, and other biologic response modifiers. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         Some commenters inquired about the recognition of a severe drug reaction management code that could be used during the administration of high complexity biologic medications and less frequently during other drug administrations or chemotherapy services. While the CPT Drug Administration Workgroup supported the creation of a severe drug reaction management code, the CPT Editorial Panel did not approve this code. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We recognize that considerable physician effort may be required to monitor and attend to patients who develop significant adverse reactions to chemotherapy drugs, or otherwise have complications in the course of chemotherapy treatment. Physicians may not be aware that these services can be billed using existing CPT codes. The following scenarios are examples where existing codes may be used in addition to the routine billing for the physician's care of a cancer patient: 
                    </P>
                    <P>• Bill for the Physician Visit. If a patient has a significant adverse reaction to drugs during a chemotherapy session and the physician intervenes, the physician could bill for a visit in addition to the chemotherapy administration services. </P>
                    <P>• Bill for the Higher-Level Physician Visit. If the patient had already seen the physician prior to a chemotherapy session for a problem that is unrelated to the supervision of the administration of chemotherapy drugs, the physician may bill a visit for a significant adverse drug reaction. The total time, resources, and complexity of the physician's interaction with the patient may justify a higher level of visit service. </P>
                    <P>• Bill for a Prolonged Service. If the patient had a physician visit prior to the chemotherapy session and experienced a significant adverse reaction to drugs on the same day, the physician can bill a prolonged service code in addition to the physician visit. There are several code combinations to use depending on the number of minutes involved. The physician must have a face-to-face encounter with the patient and must spend at least 30 minutes beyond the threshold or typical time for that level of visit for the physician to bill for the prolonged service code. </P>
                    <P>• Bill for Critical Care Service. If the patient had a physician visit prior to the chemotherapy session and experienced a life-threatening adverse reaction to the drugs, the physician could bill for a critical care service in addition to the visit if the physician's work involves at least 30 minutes of direct face-to-face involvement managing the patient's life-threatening condition. Examples of life-threatening conditions are: central nervous failure, circulatory failure, shock, renal, hepatic, metabolic, and/or respiratory failure. </P>
                    <P>These instructions are published here for informational purposes, and we anticipate that we will issue further instructions regarding the appropriate use of these G-codes including clarifications, interpretations and other modifications to the following guidance as part of any instructions issued through a subregulatory process. </P>
                    <P>
                        <E T="03">Comment:</E>
                         The American Urological Association (AUA) commented in response to the January 7, 2004 interim final rule to ask us to include the following codes in the MMA-mandated evaluation of existing drug administration codes for physicians' services to ensure accurate reporting and billing for such services: CPT codes 11980, 11981, 11982, 11983, 51700, 51720, 54200, 54231, and 54235. The AUA asked that we consider applying the transitional adjustment payment to these codes for 2005. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We presented these codes to the CPT Drug Administration Workgroup. After subsequent discussion with representatives of the AUA, the AUA withdrew these codes from consideration by the workgroup. 
                    </P>
                    <P>These codes are not subject to the “transitional adjustment payment provision” because they are not included in the definition of “drug administration codes.” </P>
                    <P>
                        <E T="03">Comment:</E>
                         Ophthalmologists frequently perform the procedure photodynamic therapy (CPT code 67221 and 67225) by infusing the drug Visudyne. While separate payment is allowed for the drug, the infusion is considered an integral part of the photodynamic therapy code. Thus, the physician is not allowed to bill a separate code for the infusion of the drug. 
                    </P>
                    <P>According to one commenter, Visudyne is also a drug used in cancer chemotherapy. The commenter pointed out that when Visudyne is provided for photodynamic therapy, ophthalmologists incur drug administration costs similar to oncologists who use infused drugs. </P>
                    <P>The AAO asked why we did not include CPT codes 67221 and 67225 among the drug administration codes that benefited under the MMA. </P>
                    <P>
                        <E T="03">Response:</E>
                         In this instance, the infusion of the drug is an integral part of the surgical procedure and it was valued by the RUC and CMS that way. The code of which it is a part is not considered a drug administration code under section 303 of the MMA. 
                    </P>
                    <HD SOURCE="HD3">3. Blood Clotting Factor </HD>
                    <P>
                        For clotting factors furnished on or after January 1, 2005, we proposed to establish a separate payment of $0.05 
                        <PRTPAGE P="66311"/>
                        per unit to hemophilia treatment centers, homecare companies and other suppliers for the items and services associated with the furnishing of blood clotting factor. Section 303(e)(1) of the MMA requires the Secretary, after review of the January 2003 report to the Congress by the Comptroller General of the United States, to establish a furnishing fee for the items and services associated with the furnishing of blood clotting factor. 
                    </P>
                    <P>Based on a review of the Government Accountability Office (GAO) report and data received from various clotting factor providers, we proposed a furnishing fee in order to cover the administrative costs associated with supplying the clotting factor. As outlined in the MMA, any separate payment amount established may include the mixing and delivery of factors, including special inventory management and storage requirements, as well as ancillary supplies and patient training necessary for the self-administration of these factors. The MMA states that, in determining the separate payment, the total amount of payments and these separate payments must not exceed the total amount of payments that would have been made for the factors if the amendments in section 303 of the MMA had not been enacted. </P>
                    <P>As indicated in the GAO report, “[w]hen Medicare's payment for clotting factor more closely reflects acquisition costs, we recommend that the Administrator establish a separate payment for providers based on the costs of delivering clotting factor to Medicare beneficiaries.” Effective upon implementation of the ASP-based payment rates, payment for blood clotting factors will more closely reflect acquisition costs, since payment will be based on the average sales price as reported by drug manufacturers plus 6 percent. </P>
                    <P>Therefore, we stated in the August 5, 2004 proposed rule that in the absence of additional data we believe that a furnishing fee of $0.05 per unit for the cost of delivering clotting factor is an appropriate amount. However, we also sought updated data and comments on the GAO report, as well as information on the fixed and variable costs of furnishing clotting factor. We recognized that there may be alternatives to a fee, which varies entirely based on the number of units of clotting factor furnished. We indicated we would closely examine all data and information submitted in order to make a final determination with respect to the appropriateness of the $0.05 per unit amount. </P>
                    <P>We received comments from various sources including, but not limited to, hemophilia treatment centers, hemophilia coalitions, and other suppliers of clotting factors regarding our request for additional data and information on the appropriateness of our proposed fee. The comments and responses are provided below. </P>
                    <P>
                        <E T="03">Comment:</E>
                         Many commenters recommended that we incorporate cost information received from homecare providers and any updated cost data from hemophilia treatment centers in determining the separate furnishing fee payment amount for 2005. The commenters cited an industry-sponsored survey of full-service hemophilia homecare companies that recommended a furnishing fee of $0.20 per unit. This survey collected CY 2003 data from three hemophilia homecare suppliers that the commenter indicated supplied 42 percent of all Medicare hemophilia patients. Commenters also stated that the GAO report was inadequate to serve as the basis for determining the separate payment for clinically appropriate items and services related to furnishing blood clotting factor. They questioned the accuracy of the recommended payment range in the GAO report, given what they viewed as an insufficient sample size; that is, the GAO report received data from only 4 hemophilia treatment centers and lacked any cost data from national or regional full-service hemophilia homecare providers. These commenters also indicated that the GAO survey may have included homecare companies that purchase clotting factor at a lower price through the Public Health Service's 340B program. More information on the 340B program is available on the Health Resources and Services Administration's Web site at 
                        <E T="03">http://bphc.hrsa.gov/opa/howto.htm.</E>
                         The commenters also stated that the GAO report focused solely on estimating providers' blood clotting factor delivery costs, which the GAO defined as inventory management, storage, shipping, and the provision of ancillary supplies. According to the commenters, the MMA directed us to establish a separate payment for items and services related to the furnishing of blood clotting factor that takes into consideration a wider range of items and services than the delivery costs addressed in the GAO report, for example patient education. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We agree with the commenters that full-service hemophilia homecare companies provide services that may be of benefit to Medicare beneficiaries with hemophilia, such as disease and patient management activities. However, we do not believe that the scope of the furnishing fee includes these services. As noted above, Section 303(e) specifies the items and services that may be taken into consideration in setting the furnishing fee. Disease and patient management activities are not included in the items and services specified in Section 303(e). However, these activities may be more appropriately addressed through a future phase of the new Medicare Chronic Care Improvement Program. 
                    </P>
                    <P>
                        The new Medicare Chronic Care Improvement Program is an important component of the MMA and demonstrates a commitment to improving and strengthening the traditional fee-for-service Medicare program. This program is the first large-scale chronic care improvement initiative under the Medicare fee-for-service program. We will select organizations that will offer self-care guidance and support to chronically ill beneficiaries. These organizations will help beneficiaries manage their health and adhere to their physicians' plans of care, and help ensure that they seek or obtain medical care that they need to reduce their health risks. More information regarding this program is available on the CMS Web site at 
                        <E T="03">http://www.cms.hhs.gov/medicarereform/ccip/.</E>
                    </P>
                    <P>With regard to the other costs identified in the comments and in the industry-sponsored survey, we also do not believe the scope of a furnishing fee includes costs associated with sales and marketing. We do not believe it is appropriate to build an explicit profit margin into the furnishing fee, but rather have the margin associated with the furnishing fee result from efficient furnishing of clotting factor. We agree with the commenters that the GAO report did not include amounts for education and that these are appropriate for the furnishing fee. Therefore, after removing the costs associated with sales and marketing, an explicit profit margin, and patient management, the resulting figure from the homecare survey is $0.14 per unit of clotting factor. We are establishing the furnishing fee for 2004 at $0.14 per unit of clotting factor. For years after 2005, the MMA specifies that the furnishing fee for clotting factor must be updated by the percentage increase in the consumer price index for medical care for the 12-month period ending with June of the previous year. </P>
                    <P>
                        <E T="03">Comment:</E>
                         One commenter recommended that the beneficiary's 20 percent coinsurance not be applicable to this separate payment. The commenter indicated that the additional financial 
                        <PRTPAGE P="66312"/>
                        burden would limit many beneficiaries' access to this lifesaving product. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         Under provisions designed to protect the Medicare program from fraud and abuse, a broad waiver of beneficiary cost sharing of the type the commenter recommends would not be permitted. However, we make no statement regarding the applicability of existing statutory and regulatory provisions that may allow for the waiver of cost sharing in certain cases. 
                    </P>
                    <HD SOURCE="HD3">4. Supplying Fee </HD>
                    <P>Section 1842(o)(6) of the Social Security Act requires the Secretary to pay a supplying fee (less applicable deductible and coinsurance) to pharmacies for immunosuppressive drugs described in section 1861(s)(2)(J) of the Act, oral anticancer chemotherapeutic drugs described in section 1861(s)(2)(Q) of the Act, and oral anti-emetic drugs used as part of an anticancer chemotherapeutic regimen described in section 1861(s)(2)(T) of the Act, as determined appropriate by the Secretary. In the interim final rule published on January 7, 2004 (69 FR 1084), we considered this fee to be bundled into the current payment for these drugs for 2004 and did not establish a separately billable supplying fee. </P>
                    <P>Effective January 1, 2005, we proposed to establish a separately billable supplying fee of $10 per prescription for immunosuppressive drugs, oral anti-cancer chemotherapeutic drugs and oral anti-emetic drugs. We based this proposed fee on information provided by retail chain pharmacies on the costs of supplying these drugs to non-Medicare patients combined with steps to reduce the administrative burden associated with billing Medicare. </P>
                    <P>We also sought data and information on the additional services pharmacies provide to Medicare beneficiaries, the extent to which oral drugs can be furnished without these additional services and the extent to which such services are covered under Medicare. Additionally, we requested comments concerning whether the supplying fee should be somewhat higher during the initial month following a Medicare beneficiary's transplant to the extent that additional resources are required for example, due to more frequent changes in prescriptions for immunosuppressive drugs. </P>
                    <P>
                        <E T="03">Comment:</E>
                         Several commenters stated that they were not in a position to determine whether the proposed $10.00 supplying fee was adequate since they did not know the actual 2005 payment rates for Part B drugs. These commenters indicated that the supplying fee needed to cover return on investment, the costs of supplying the drugs, and make up for any differences between the product costs and the ASP based payment for the drug. Some commenters indicated that aside from the adequacy of the ASP-based payment for the drug, a $10.00 supplying fee appeared to be too low. These commenters indicated that the average cost to a retail pharmacy to dispense a non-Medicaid third party or cash paying prescription ranges anywhere from $7.50-$8.00. The commenters indicated that Medicare should pay at least $2.00-$2.50 more per prescription since costs associated with supplying Medicare prescriptions are higher. 
                    </P>
                    <P>We received a comment from a large retail pharmacy indicating that a supplying fee of $25 would be adequate to cover the higher costs of dispensing Medicare Part B oral drugs. </P>
                    <P>We received comments from specialty immunosuppressive pharmacies that included information from a recent survey of their supplying costs. The survey indicated that the cost for specialty pharmacies to dispense Medicare Part B immunosuppressants is $35.48 per prescription. The specialty immunosuppressive pharmacies indicated that they provide services not typically provided by retail chain drug stores or large mail-order pharmacy benefit management companies. These services include direct patient care through pro-active pharmacist contact, expeditious processing and turnaround of medication orders, direct billing of Medicare and coordination of benefits on behalf of transplant patients to reduce the costs to the patients, and maintaining expensive immunosuppressant in stock to ensure timely receipt when needed by beneficiaries. These pharmacies also indicated that the retail chains typically do not supply immunosuppressive drugs or file Medicare claims. </P>
                    <P>Several commenters indicated that the lack of on-line adjudication for Medicare claims was one of the major drivers, among other reasons, for the additional costs of supplying Medicare prescription. </P>
                    <P>
                        <E T="03">Response:</E>
                         We agree that the cost of supplying Medicare Part B oral drugs is higher than many other payers because of the lack of on-line adjudication for Medicare Part B oral drug claims. Due to operational issues, we do not anticipate the establishment of an on-line adjudication system in the near future. Accordingly, we believe it is appropriate to establish a supplying fee higher than the fees paid by some other payers with on-line adjudication. We note that many other payers with on-line adjudication have fees in the range of $5-$10 per prescription. We note that this is consistent with the approximately $8 cost for non-Medicaid dispensing stated by some commenters and described earlier. Other than administrative costs associated with billing Medicare Part B for oral drugs, we do not agree with commenters that the supplying fee for these drugs should exceed the dispensing fees of other payers because we do not believe there are other significant differences between supplying Medicare Part B and other oral drugs. We also do not agree that the supplying fee should include product costs. Product costs are paid through the ASP + 6 percent drug payment system. For the additional burden associated with billing Medicare Part B for oral drugs, we note the commenters who suggested an additional fee of approximately $2 for Medicare billing costs. Added to the $8 non-Medicaid fee described above, this would result in a supplying fee of approximately $10. We also note the survey of the specialty immunosuppressive pharmacies that indicated Medicare claims processing costs of approximately $8. This same survey also indicated total personnel costs of approximately $9, a portion of which we assume is attributable to the additional work associated with Medicare billings because the comments indicated Medicare billing was labor-intensive. Using the $5 to $10 figures for payers with on-line adjudication described above, the specialty pharmacy data on Medicare claims processing costs and personnel costs, we developed a range of possible supplying fees based on the specialty pharmacy data. Depending upon the portion of the personnel costs associated with Medicare billings, this would result in a supplying fee between a minimum of $13 (= $5 + $8) and a maximum of $27 (= $10 + $8 + $9). The comment of the large chain pharmacy recommending a $25 supplying fee indicated that this amount would be adequate to cover the costs of supplying Medicare Part B drugs including the additional costs of processing Medicare claims; however, this amount included a margin for profit. We do not believe it is appropriate to build an explicit profit margin into the supplying fee, but rather have the margin associated with the supplying fee result from efficient supplying of these drugs. Although the profit margin included in the $25 was not explicitly stated in the comment, if we assume a 5 percent margin, then a supplying fee of approximately $24 would cover the large chain pharmacy's 
                        <PRTPAGE P="66313"/>
                        costs of supplying Medicare Part B drugs. We are not indicating that 5 percent is an appropriate margin. 
                    </P>
                    <P>There was variability in the submitted comments with respect to an appropriate supplying fee. On the low end, analysis of the submitted comments would indicate a supplying fee of $10. On the high end, the analysis would indicate a supplying fee of $27. Given the variability in the values and assumptions included in various calculations, we do not think it is appropriate to simply take the rounded midpoint of this range, $19, as the supplying fee. However, we do not think it appropriate to take the maximum amount of this range, $27, given that it is unlikely that all of the personnel costs indicated in the specialty pharmacy survey are related to the costs of billing for oral Medicare Part B drugs. The amount in the comment from the large chain pharmacy, after adjusting for a possible profit margin, or $24, is consistent with our belief that not all of the additional personnel costs identified in the specialty pharmacy survey are related to the costs of billing for oral Medicare Part B drugs. We are therefore establishing a per prescription supplying fee of $24 as the value consistent with both the large retail pharmacy comment (after making an adjustment for built-in profit margins) and the higher end of the broad range of the specialty pharmacy survey. Although we believe that a $24 supplying fee coupled with the ASP-based drug payment will not result in any access problems for Medicare beneficiaries, we will monitor access as we implement the new ASP-based payment system. </P>
                    <P>
                        <E T="03">Comment:</E>
                         Some commenters recommended that we update the supplying fee annually. Some commenters indicated this fee should be updated by the average annual increase in the costs of pharmacies supplying these drugs to Medicare beneficiaries (costs such as rent, utilities and salaries), but no less than the increase in the medical care inflation index for the most recent twelve months for which it can be calculated before the next calendar year. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We will study the issue of appropriate future increases for the supplying fee and proceed, as necessary, through notice and comment rulemaking. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         A specialty organization suggested that we develop a sliding supplying fee, which would be calculated as a percentage of the cost that the pharmacy incurred in acquiring a particular drug. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We do not agree that the supplying fee should vary by product costs. Product costs are paid through the ASP-based drug payment system. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         Several commenters agreed with our suggestion to increase the supplying fee in the first month following a transplant, but recommended that we extend this increase to at least the first 3 months following the transplant. One commenter suggested that extra resources are associated with frequent changes in prescriptions during the initial month following a beneficiary's organ transplant. One commenter recommended a fee of $50 for an initial prescription fill. However, one commenter advocated against a supplying fee that distinguished between new and refill prescriptions stating that it would be impractical, of questionable benefit and would discourage long-term pharmacy-patient relationships as pharmacy providers would only have an incentive to serve patients in the short term. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We agree that additional costs are most likely to occur nearer the time when the beneficiary has a transplant. In order to recognize these costs, we are establishing a higher supplying fee of $50 for the supplying of the initial oral immunosuppressive prescription in the first month after a beneficiary has a transplant because the costs of supplying immunosuppressives are likely to be higher immediately following a transplant, when the practitioner is adjusting the dose of immunosuppressive drugs. With regard to the comment opposing higher supplying fees for new patients regardless of their transplant date, we agree with the commenter that it would result in inappropriate incentives and are not implementing any such fee. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         Commenters recommended that the supplying fee should account for the different prices paid by pharmacies and physicians, recognizing that these are separate classes of trade that may not have access to comparable pricing. Thus, we should increase the supplying fee associated with providing and overseeing the use of oral anti-cancer drugs. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We do not agree that the supplying fee should vary by product costs. Product costs are paid through the ASP based drug payment system. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         Commenters recommended that we extend the supplying fee to physicians that directly supply covered oral anti-cancer, immunosuppressive and oral anti-emetic drugs to patients, as well as create a dose management and compliance fee for physicians that prescribe oral chemotherapy products. These commenters state that we could use the premise that the MMA does not provide a definition of the word “pharmacy” and we could permit payment of a supplying fee to include a physician acting in the capacity of a pharmacist. Alternatively, commenters suggested that we use its inherent reasonableness authority to extend the supplying fee to physicians. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         Given our current understanding of Congressional intent, we do not believe it would be appropriate to pay a supplying fee to physicians. Moreover, we do not have sufficient data to determine whether our inherent reasonableness authority would apply in this instance. However, we will study these issues further. 
                    </P>
                    <HD SOURCE="HD3">5. Billing Requirements </HD>
                    <P>In the proposed rule, we proposed the following changes to certain billing requirements and clarified policy for other billing requirements in an effort to reduce a pharmacy's costs of supplying covered immunosuppressive and oral chemotherapy drugs to Medicare beneficiaries: </P>
                    <P>
                        • 
                        <E T="03">Original signed order.</E>
                         We clarified Medicare's policy regarding the necessity of an original signed order before the filling of a prescription. According to the Medicare Program Integrity Manual (section 5.1 of Chapter 5), which addresses the ordering requirement for durable medical equipment, prosthetics, orthotics and supplies (DMEPOS), including drugs, most DMEPOS items can be dispensed based on a verbal order from a physician. A written order must be obtained before submitting a claim, but that written order may be faxed, photocopied, electronic, or pen and ink. The order for the drug must specify the name of the drug, the concentration (if applicable), the dosage, and the frequency of administration. The clarification of this requirement should reduce a pharmacy's costs of supplying covered immunosuppressive and oral drugs to Medicare beneficiaries to the extent that pharmacies are currently applying an original signed prescription requirement. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         Commenters recommended that a prescription be filled and billed based solely on a verbal order from a physician and an actual signed written prescription should not be necessary before billing. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         The policy that allows dispensing based on a verbal order but requires a written order for billing applies to all DMEPOS items. This policy balances fraud and abuse concerns with prompt dispensing of DMEPOS items to beneficiaries. We 
                        <PRTPAGE P="66314"/>
                        point out that the written order from the physician can be faxed, photocopied, electronic, or pen and ink. We currently allow pharmacies to accept electronic prescriptions from physicians. 
                    </P>
                    <P>
                        • 
                        <E T="03">Assignment of Benefits Form.</E>
                         We proposed to eliminate use of the Assignment of Benefits form for Part B items and services, including drugs, where Medicare payment can only be made on an assigned basis. For Part B covered oral drugs, this would be a means of reducing a pharmacy's costs of supplying these drugs to Medicare beneficiaries. Currently, pharmacies must obtain a completed Assignment of Benefits form in order to receive payment from Medicare. This requirement increases a pharmacy's cost of supplying covered drugs to Medicare beneficiaries, as other payers do not impose this requirement. Thus, we do not believe that it is necessary for an assignment of benefits form to be filled out for drugs covered under Part B, since payment for them can only be made on an assignment-related basis. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         Some commenters suggested that the Assignment of Benefits form be eliminated for diabetic supplies dispensed by pharmacy suppliers. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         Our proposal to eliminate the Assignment of Benefits form applied to services where Medicare payment can only be made on an assigned basis. That is not the case with diabetic supplies. Thus, we are not eliminating the AOB form for diabetic supplies. 
                    </P>
                    <P>
                        • 
                        <E T="03">DMERC Information Form (DIF).</E>
                         The DIF is a form created by the DMERC Medical Directors that contains information regarding the dates of the beneficiary's transplant and other diagnosis information. This form is a one-time requirement that pharmacies must complete in order to receive payment. Since section 1861(s)(2)(J) of the Act no longer imposes limits on the period of time for coverage of immunosuppressive drugs, we believe that the information on transplant diagnosis can be captured through other means (for example, diagnosis codes on the Part B claim form).
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         Several commenters applauded our efforts to eliminate use of the DIF in an effort to reduce the cost that the billing requirements imposed. These commenters asked that we ensure that this requirement is applied uniformly by all the DMERCs. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We appreciate the support regarding the elimination of the DIF form. Action is being taken to eliminate the DIF form, including accommodating systems issues and providing for notifications. We anticipate resolution of issues to occur soon and elimination would occur next year. 
                    </P>
                    <P>
                        • 
                        <E T="03">Other Billing Issues.</E>
                         We also received other comments regarding other billing issues related to the supplying of immunosuppressive, oral anti-cancer, and oral anti-emetic drugs. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         Commenters suggested that we allow physicians to bill the carrier when oral drugs are provided directly by the physician in his office rather than having the physician bill the DMERC for the oral anti-cancer drug. Others stated that we should allow for billing for pharmaceutical products to be conducted on current electronic platforms, because “batch billing” creates operational and patient care problems, and adds significant participation costs. Commenters also stated that we should eliminate the requirement for a diagnosis code to be present on the prescription; while, at the same time, adopt the usage of the physician's DEA number instead of the UPIN number when submitting claims. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We thank the commenters for identifying these issues. We plan to examine these aspects of billing. 
                    </P>
                    <HD SOURCE="HD3">6. Shipping Time Frame</HD>
                    <P>In the proposed rule, we highlighted the fact that the guidelines regarding the time frame for subsequent deliveries of refills of DMEPOS products had been revised. Effective February 2, 2004, the shipping of refills of DMEPOS products may occur “approximately” on the 25th day of the month in the case of a month's supply. In the proposed rule, we emphasized the word “approximately”; while we indicated that normal ground service shipping would allow delivery in 5 days, if there were circumstances where ground service could not occur in 5 days, the guideline would still be met if the shipment occurs in 6 or 7 days. This change should eliminate the need for suppliers to utilize overnight shipping methods and would permit the shipping of drugs via less expensive ground service.</P>
                    <HD SOURCE="HD2">F. Section 952—Revision to Reassignment Provisions </HD>
                    <P>As discussed in the August 5, 2004 proposed rule, section 1842(b)(6)(A)(ii) of the Act, as amended by section 952 of the MMA, allows, in many circumstances, a physician or NPP to reassign payment for Medicare-covered services, regardless of the site of service, providing there is a contractual arrangement between the physician or NPP and the entity through which the entity submits the bill for those services. Thus, the services may be provided on or off the premises of the entity receiving the reassigned payments. The MMA Conference Agreement states that entities that retain independent contractors may enroll in the Medicare program. The expanded exception created by section 952 of the MMA applies to those situations when an entity seeks to obtain the medical services of a physician or NPP. </P>
                    <P>Section 952 of the MMA states that reassignment is permissible if the contractual arrangement between the entity that submits the bill for the service and the physician or NPP who performs the service meets the program integrity and other safeguards as the Secretary may determine to be appropriate. The Conference Agreement supports appropriate program integrity efforts for entities with independent contractors that bill the Medicare program, including joint and several liability (that is, both the entity accepting reassignment and the physician or NPP providing a service are both liable for any Medicare overpayments). The Conference Agreement also recommends that physicians or NPPs have unrestricted access to the billings submitted on their behalf by entities with which they contract. We incorporated these recommended safeguards in a change to the Medicare Manual, implementing section 952 of the MMA that was published on February 27, 2004. In the August 5, 2004 rule, we proposed to revise § 424.71 and § 424.80 to reflect these safeguards, as well as the expanded exception established by section 952 of the MMA. </P>
                    <P>Section 952 of the MMA revises only the statutory reassignment exceptions relevant to services provided in facilities and clinics (section 1842(b)(6)(A)(ii) of the Act). Section 952 of the MMA does not alter an individual or entity's obligations under any other applicable Medicare statutes or regulations governing billing or claims submission. </P>
                    <P>In addition, physician group practices should be mindful that compliance with the physicians' services exception and the in-office ancillary services exception to the physician self-referral prohibition in section 1877 of the Act requires that a physician or NPP who is engaged by a group practice as an independent contractor may provide “designated health services” to the group practice's patients only in the group's facilities. See the definition of physician in the group at 42 CFR 411.351. </P>
                    <P>
                        We also cautioned that parties must be mindful that contractual arrangements involving reassignment may not be used to camouflage inappropriate fee-splitting arrangements 
                        <PRTPAGE P="66315"/>
                        or payments for referrals. In the August 5, 2004 proposed rule, we solicited comments on potential program vulnerabilities and on possible additional program integrity safeguards to guard against those vulnerabilities. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         We received positive comments for the proposed changes to the reassignment rules from two physician associations and one association representing non-physician practitioners. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We are pleased to receive positive feedback to the changes to the reassignment rules. We believe these changes balance the need to respond to the changing business arrangements in the delivery of health care services with the need to protect the Medicare trust funds from fraudulent and abusive billing practices. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         An association representing emergency medicine physicians and numerous members of that association commented that requiring independent contractor physicians to have unrestricted access to the billings submitted on their behalf is not sufficient to ensure such access. The commenters requested that we revise our regulations to require the entity submitting the bills to provide duplicates of the Medicare remittance notices (which indicate the services billed and the amounts paid for those services) to the independent contractor physicians. Some of the commenters requested that we require independent contractor physicians to receive itemized monthly reports of the claims submitted and remittances received on their behalf. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We believe that requiring independent contractors to have unrestricted access to the billings submitted on their behalf is sufficient to satisfy the independent contractors' need to review the claims information. 
                    </P>
                    <P>We recognize that some independent contractors may not wish to receive copies of all bills submitted on their behalf. It would place an unnecessary burden on entities if we require them to furnish duplicate remittance notices to independent contractors on a routine basis. Similarly, it would place a significant burden on our claims processing systems if we were obligated to provide duplicate remittance notices to those who have reassigned their payments. We note that the method and frequency of obtaining access to billing records is an issue that the independent contractor and the entity to which the independent contractor is reassigning payments can resolve in their written contract. </P>
                    <P>
                        <E T="03">Comment:</E>
                         A commenter asked whether or not the new reassignment exception (which essentially expanded or revised the previous exceptions pertaining to independent contractors), established by section 952 of the MMA, is available when one entity contracts with a second entity, which in turn contracts with a physician or non-physician practitioner to furnish services for the first entity. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We refer to this situation as an indirect contractual arrangement between the independent contractor furnishing the service and the entity doing the billing and receiving payment (excluding billing agents). Thus, the reassignment is between the individual furnishing the service and the entity receiving the reassigned benefits. Indirect contractual arrangements were permissible prior to passage of section 952 of the MMA and remain permissible. The CMS-855-R enrollment form would need to be completed by the entity receiving the reassigned benefits and the person furnishing the service. In accordance with section 952 of the MMA, the contractual arrangement and any program integrity safeguard requirements deemed appropriate by the Secretary are between the independent contractor and the entity receiving the reassigned payments, with the program integrity safeguards applying to both parties. If the parties involved also wish to include the intermediary entity in a similar contract, and apply standards identical or similar to the program integrity safeguards to their arrangement, they have that option; but, it is not required or necessary to comply with the exception to the reassignment prohibition for contractual arrangements. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         Several members of the Congress urged us not to delay the enrollment process of providers or suppliers while implementing section 952 of the MMA. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We do not expect any delays in provider or supplier enrollment to result from implementing the reassignment provisions of this regulation. We are sensitive to the need for an efficient and timely enrollment process. If the new reassignment exception results in the submission of a particularly high volume of claims, or if a Medicare contractor has to process a large number of new enrollment applications, it is possible that delays may occur in some cases. A provider or supplier whose enrollment was delayed must contact the appropriate Medicare contractor's provider or supplier enrollment office to discuss the reasons for the delay. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         A trade association of physician specialists asked that we clarify our definitions of onsite and off-site services. This trade association also requested that we further describe the potential program vulnerabilities that the revised Medicare reassignment exception might create. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We consider onsite services to be services of an independent contractor that are performed in space owned or leased by the entity billing and receiving the reassigned payments. We consider offsite services to be services of an independent contractor that are performed in space that is not owned or leased by the entity billing and receiving the reassigned payments, that is, services performed off the premises. 
                    </P>
                    <P>The Congress originally passed the prohibition on reassignment provision due to experience with fraudulent and abusive billing practices. As we discussed in the preamble to the August 5, 2004 proposed rule, the new reassignment exception for contractual arrangements will potentially permit myriad relationships and financial arrangements. Some of these relationships may have the potential to increase fraudulent and abusive billing practices that the reassignment rules were designed to prevent. We also stated in the proposed rule that the new reassignment exception does not alter an individual's or entity's obligations under existing Medicare statutes and regulations (for example, the physician self-referral prohibition, the anti-kickback statute, purchased diagnostic test rules, incident to rules, etc.). </P>
                    <P>
                        <E T="03">Comment:</E>
                         Several commenters expressed concern over the recent growth of so-called pod, salon, turnkey, mini-mall, or condo labs, especially since section 952 of the MMA appears to liberalize the Medicare reassignment rules. 
                    </P>
                    <P>As we understand the situation, some entities have created a building or a floor of a building that contains a number of cubicles, each of which is equipped with a microscope and other supplies that enable a pathologist to go to a particular cubicle or pod to analyze any tissue sample that is submitted by the group practice that rents pod space on a full-time basis. Apparently, some of the owners of these anatomical laboratories assert that each pod is a centralized location for a laboratory that is owned by a group practice. Other owners assert that each pod serves as an offsite office of a pathologist who works for a group practice as an independent contractor. </P>
                    <P>
                        These entities market their services to specialists in certain disciplines, such as gastroenterology, urology, and dermatology, which rely on a high 
                        <PRTPAGE P="66316"/>
                        volume of anatomic pathology services. The commenters stated that these lab arrangements are subject to excess, waste, and abuse, including, but not limited to: (a) Generation of medically unnecessary biopsies; (b) kickbacks; (c) fee-splitting; and, (d) referrals that would otherwise be prohibited under the physician self-referral statute. 
                    </P>
                    <P>The commenters agree with us that safeguards are necessary to prevent the increased incidence of fraudulent and abusive billing practices resulting from the new reassignment exception for contractual arrangements. To reach the goal of closing any loophole for excess, waste, and abuse opened by the new independent contractor reassignment exception, the commenters provided several suggestions. One commenter recommends that we add language to proposed § 424.80(d) that would prohibit a physician from making a reassignment to another physician, under the independent contractor exception, if the physicians do not practice in substantially the same medical specialty. This limitation would not apply if the entity accepting the assignment is a bona fide multi-specialty physician practice, meaning that it employs (on a W-2 basis) physicians who regularly practice in two or more specialties of medicine. </P>
                    <P>The commenters believe that the regulations need to state more clearly that all requirements of the purchased diagnostic test rules and purchased test interpretation rules need to be met. In other words, the commenters want to prevent the new reassignment exception from applying to services furnished by independent contractor pathologists. </P>
                    <P>These commenters are urging us to review these practices to see if they fail to meet existing obligations under the physician self-referral prohibition or anti-kickback statute. The commenters believe that these business arrangements are exploiting the in-office ancillary services exception and other exceptions to the physician self-referral prohibition. </P>
                    <P>
                        <E T="03">Response:</E>
                         We appreciate comments that specify situations where fraud and abuse may occur and propose solutions to prevent such occurrences. While we decline to incorporate the commenters' suggested regulatory revisions at this time, we share the commenters' concerns. We will be paying close attention to this issue, and may initiate future rulemaking to address arrangements that are fraudulent or abusive. 
                    </P>
                    <P>To respond to commenters' concerns, we are amending the regulations governing reassignment at § 424.80(a) to clarify that nothing in § 424.80 alters an individual or entity's obligations under other Medicare statutes or rules, including, but not limited to, the physician self-referral prohibition (section 1877 of the Act), the anti-kickback statute (section 1128(B)(b)(1) of the Act), the regulations regarding purchased diagnostic tests, and regulations regarding services and supplies provided incident to a physician's services. </P>
                    <P>In response to the concerns expressed by the commenters, we wish to further expand on the fact that section 952 of the MMA did not affect the obligation of an individual or entity to comply with the physician self-referral prohibition (section 1877 of the Act and the corresponding regulations). As stated in the proposed rule, “physician group practices should be mindful that compliance with the in-office ancillary services exception to the physician self-referral prohibition requires that a physician who is engaged by a group practice on an independent contractor basis must provide services to the group practice's patients in the group's facilities. As noted in the Phase I physician self-referral final rule (66 FR 887), “we consider an independent contractor physician to be ‘in the group practice’ if: (1) He or she has a contractual arrangement to provide services to the group's patients in the group practice's facilities; (2) the contract contains compensation terms that are the same as those that apply to group members under section 1877(h)(4)(iv) of the Act or the contract fits in the personal services exception; and, (3) the contract complies with the reassignment rules * * * ’' See also 66 FR 886.” This test is specified at § 411.351 in the definition of physician in the group practice, which contains a premises requirement independent of the reassignment rules. </P>
                    <P>In addition, the use of independent contractors at off-premises locations may impact the ability of a group practice to meet the definition of a group practice at § 411.352 for purposes of complying with section 1877 of the Act. Accordingly, some group practices may need to be careful about the number of physician-patient encounters that independent contractors perform off-premises to ensure that they meet the 75 percent patient-physician encounters test as set forth in § 411.352(h). </P>
                    <P>We will continue to monitor compliance with the reassignment rules and we will analyze the impact of the physician self-referral prohibition on “pod” labs. If we determine that changes to the physician self-referral prohibition are necessary, these changes will be made in a separate rulemaking document. </P>
                    <P>
                        <E T="03">Comment:</E>
                         We received a number of comments and recommendations from three organizations that utilize the services of independent contractor emergency department physicians. One of the three organizations represents management companies that employ independent contractor emergency department physicians. The commenters believe that the changes to the reassignment rules necessitated by section 952 of the MMA should be implemented in a manner that does not impose additional burdens on the Medicare enrollment process. They believe that implementation of the proposed regulations could impede the enrollment process. They expressed concern that amendments to current contracts might be necessary to incorporate the program integrity safeguards included in the proposed regulations. Since they believe requiring contract amendments would be burdensome and costly to hospitals, they are urging us not to require parties to amend their contracts to reflect the program integrity safeguards that we proposed. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We do not believe that implementation of the proposed regulations will impede the enrollment process. Our proposed regulations would not require parties to amend their contracts to reflect the program integrity safeguards. We plan to include the program integrity safeguard requirements on the CMS-855-R enrollment form. The program integrity safeguards will apply to arrangements entered into pursuant to the new reassignment exception for contractual arrangements, regardless of whether the parties reference the safeguards in their contracts. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         Three commenters representing groups that utilize independent contractor emergency physicians strongly oppose our implementation of the two proposed program integrity safeguard requirements: (1) Joint and several liability/responsibility for Medicare overpayments; and (2) unrestricted access to the billings for services provided by independent contractors. The commenters believe that establishing program integrity safeguards is premature and that we should first formally assess the need for such safeguards. These commenters also ask us to clearly define joint and several liability/responsibility. They express concern over our attempt to impose joint and several liability/responsibility on both the contracting entity and practitioner furnishing the services and 
                        <PRTPAGE P="66317"/>
                        note that the CMS-855-R enrollment form certification holds the enrolling provider or supplier responsible for any Medicare overpayments. The commenters argue that we should impose these program integrity safeguards on employer/employee relationships if we are going to impose them on contractual arrangements. The commenters ask how we would monitor compliance with joint and several liability/responsibility. The commenters also have concerns about regulating access to claims submitted by an entity for services furnished by an independent contractor. In their view, this type of requirement should be part of the compliance programs of entities and employers rather than mandated as part of the reassignment rules. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We disagree with the commenters' assertion that it is premature to implement the proposed program integrity safeguards. Section 952 of the MMA specifically authorizes the Secretary to implement program integrity safeguards. Further, in the Conference Report to the MMA, the Congress specifically highlighted the two program integrity safeguards that we have proposed. 
                    </P>
                    <P>Our assessment of the need for program integrity safeguards is based upon prior experience with certain types of entities and their subsidiary billing companies. For example, on April 6, 2000, Lewis Morris, Assistant Inspector General for Legal Affairs, Office of Inspector General (OIG), U.S. Department of Health and Human Services, testified before the House Committee on Commerce, Subcommittee on Oversight and Investigations regarding Medicare and third-party billing companies. Mr. Morris of the OIG detailed the upcoding activities of two firms that provided billing services for entities contracting with emergency department physicians. One firm paid $15 million and the other paid $15.5 million to settle their respective liabilities. Moreover, as we have noted, we have received numerous comments from physicians stating that they have been prevented from seeing the Medicare remittance notices for services they furnished, on penalty of termination. </P>
                    <P>In addition, we understand the commenters' concerns that if the Agency plans to implement the two proposed program integrity safeguards, we should apply these same program integrity safeguards to employees, as well as to independent contractors. Joint and several responsibility/liability and unrestricted access to billings may or may not be appropriate for employees and employers as it is for the parties involved in contractual arrangements. CMS will study this issue further, and if necessary will address it in a separate rulemaking document. </P>
                    <P>We use the words responsibility and liability interchangeably, and in the context of claims filing and payment, they both have the same meaning. We define joint and several liability/responsibility to mean that both the person furnishing a service and the entity billing for that service (and to which payments have been reassigned) can be held liable or responsible for any errors in billing that result in a Medicare overpayment, including, but not limited to, upcoding and billing for services never rendered. </P>
                    <P>We will monitor the program integrity safeguards as we monitor all other program integrity requirements. We also believe that entities and independent contractors will report violations to us, since both may be held responsible for any Medicare overpayments. If an independent contractor is refused access to the billings submitted on his or her behalf, the independent contractor may report this to the appropriate Medicare contractor. </P>
                    <P>
                        <E T="03">Comment:</E>
                         An organization representing entities that use independent contactor emergency department physicians believes if we retain the proposed program integrity requirements, then these requirements should be clarified and included in other reassignment exceptions and in other Medicare conditions of participation. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         It is our goal to have the program integrity requirements identified and included on the appropriate CMS-855-R enrollment form. As we have discussed above, while we will study whether it is appropriate to extend the program integrity safeguards to employer/employee relationships, we do not believe it is necessary to include the program integrity requirements in other reassignment exceptions (or in other Medicare conditions of participation) at this time. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         Three commenters representing organizations that use independent contractor emergency physicians recommend that we revise our definition of entity to specifically identify the types of entities that are listed in the Conference Report to section 952 of the MMA. They believe that our existing definition which defines entity as a person, group or facility enrolled in the Medicare program is ambiguous and inconsistent with Congressional intent. Therefore, they are recommending that we add the language to the definition that specifies that an entity includes but is not limited to, a hospital, clinic, medical group, a physician practice management organization, or a staffing company. One of the commenters opposes stating that entities need to be enrolled in Medicare in the definition of entity because the commenter believes it is not necessary to include such information in the regulations on reassignment. This commenter believes that instructions on enrollment should be addressed in an enrollment regulation. The commenter also states that our current reassignment regulation does not define facility as a hospital or other institution enrolled in the Medicare program. These groups believe that their proposed definition of entity more accurately reflects the language from the Statement of the Managers filed by the MMA Conference Committee and is included in the Conference Report (Conference Agreement). Finally, these groups do not believe that a definition of entity is necessary, since we do not define employer in the reassignment regulations definition section. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We continue to believe that our definition of entity in the proposed rule is appropriate. We believe that defining entity as a person, group, or facility that is enrolled in Medicare encompasses all entities that are allowed to bill and receive payment from Medicare, and does not prevent those entities that were specifically identified in the Conference Report from benefiting from the new contractual arrangement reassignment exception. We will not specifically include a staffing company in the definition of entity because a staffing company cannot enroll in Medicare as a staffing company. Staffing companies can enroll as either a group practice or clinic, depending on how they are licensed or allowed to do business in the state where they are located. We further believe that a definition of entity is necessary to distinguish between entities that are allowed to reassign their right to payment and to receive reassigned payments from entities that are not allowed to reassign their right to payment or to receive reassigned payments (for example, billing agents, entities that provide services under arrangements, and substitute physicians, (for example, locum tenens physicians or physicians working on a reciprocal basis) all of which are not required to enroll in Medicare). 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         Three commenters representing organizations that use independent contractor emergency physicians found our use of the term supplier confusing when denoting the physician or non-physician practitioner 
                        <PRTPAGE P="66318"/>
                        that contracts with an entity and reassigns his or her right to bill and receive payment. Specifically, the commenters found the proposed revision to § 424.80(c) (Prohibition on reassignment of claims by suppliers) confusing because it refers to a hospital or facility as the supplier of services for purposes of the reassignment revision when Medicare already has regulations that separately define provider and supplier. The commenters recommend that we clarify our intent regarding the use of the term supplier. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         In instances of reassignment, the supplier is the person furnishing the service and reassigning his or her right to bill and receive payment to another entity. This is consistent with our definition of supplier in § 400.202. In our proposed revision to § 424.80(c), we state that the employer or entity is considered to be the supplier of the services for subparts C, D, and E of this part, subject to the provisions of paragraph (d) of the section. Once a supplier reassigns his or her right to receive Medicare payments, the entity receiving the reassigned payments essentially takes the place of the supplier. We have revised § 424.80(c) to reflect the new contractual arrangement reassignment exception. The existing § 424.80(c) includes the same formulation and we have simply proposed to replace the words “facility” and “system” with “entity,” because the new exception for payment to an entity under a contractual arrangement now replaces the previous exceptions for payment to a facility or health care delivery system. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         Three commenters that use independent contractor emergency physicians expressed concern about our statement in the preamble to the proposed rule that the new reassignment exception may create fraud and abuse vulnerabilities, which may not become apparent until the program has experience with the range of contractual arrangements permitted by the new reassignment exception. These groups do not believe that the new reassignment exception will result in an increase in violations of the types addressed in the preamble to the proposed rule. The groups also disagree with our statement in the preamble to the proposed rule that contractual arrangements with independent contractor physicians may be used to camouflage inappropriate fee-splitting arrangements or payment for referrals. These groups state that Medicare does not govern fee-splitting arrangements, that policing such arrangements is a matter of State law, and that Medicare reassignment policy has no direct effect on this issue. They question why we have expressed concern over potential violations of the physician self-referral prohibition, because section 952 of the MMA does not affect or otherwise change the obligation of providers and suppliers to comply with the physician self-referral prohibition and its accompanying regulations. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         The Congress originally passed the prohibition on reassignment provision because of increasing fraud and abuse in billing practices. Since the new reassignment exception has expanded the circumstances under which suppliers can reassign their right to receive Medicare payments, we are concerned that the potential exists for an increased incidence of fraud and abuse, which may not become apparent until the program has experience with the range of contractual arrangements permitted by the new reassignment exception. Fee-splitting arrangements may violate the physician self-referral prohibition and the anti-kickback statute. Preventing fraudulent and abusive billing practices continues to be the primary purpose of the reassignment rules, even as they are amended to reflect changing practices in the delivery of health care. 
                    </P>
                    <P>We agree that section 952 of the MMA does not change the obligations of providers and suppliers under the physician self-referral prohibition, and all other Medicare statutes and regulations. We are incorporating this clarification in § 424.80(a). </P>
                    <P>
                        <E T="03">Comment:</E>
                         Three organizations that use independent contractor emergency physicians raised procedural concerns regarding the timing of the final rule, which is effective January 1, 2005. The commenters claim that providers and suppliers do not have time to comply with the new program integrity safeguards. They are asking us to provide providers and suppliers with an additional time frame of at least six months for compliance with the program integrity safeguards, if they are finalized. They recommend that we make the new safeguards applicable to enrollment applications submitted on or after the effective date of the final rule. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We do not believe additional time is necessary for compliance with the program integrity safeguards. Providers and suppliers will not have to amend contracts to include the proposed program integrity requirements. Thus, enrollment applications are not affected by this regulation. The program integrity safeguards will be effective on the effective date of this final rule and these requirements will be applicable to all Medicare providers and suppliers affected by the section 952 change to the reassignment rules. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         One commenter believes that the public comment period for this rule was shortened to 50 days instead of the 60-day comment period required by statute. The proposed rule was published in the 
                        <E T="04">Federal Register</E>
                         on August 5, 2004 and the public comment period ended at 5 p.m. on September 24, 2004. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         While the law requires that we provide a 60-day public comment period and that the notice of proposed rulemaking be published in the 
                        <E T="04">Federal Register</E>
                        , it does not require that the date of 
                        <E T="04">Federal Register</E>
                         publication be the first day of the comment period. The two requirements are independent. We post the proposed rule on our Web site on the date of display of the proposed rule at the Office of the Federal Register, satisfying the requirement for a 60-day comment period. By making the proposed rule available on the CMS Web site (as well as at the Office of the Federal Register), we provided the public with access to not only the proposed rule, but also to all of the supporting files and documents cited in the proposed rule in a manner that can be used for analysis. We note that the computer files posted on the Web site can be used for independent analysis. Therefore, we believe that beginning the comment period for the proposed rule with the display date at the Office of the Federal Register, and posting the proposed rule and data files on the CMS Web site on the display date, fully complies with the statute and provides a far better opportunity for the public to have meaningful input than the past practice under which the comment period began with the publication date in the 
                        <E T="04">Federal Register</E>
                        , a week or longer after the display date and no other data in any other form was furnished. 
                    </P>
                    <HD SOURCE="HD2">G. Section 642—Extension of Coverage of IVIG for the Treatment of Primary Immune Deficiency Diseases in the Home </HD>
                    <P>
                        In the August 5, 2004 proposed rule, we stated that for dates of service beginning on or after January 1, 2004, Medicare would pay for IVIG administered in the home. The benefit is for the drug and not for the items or services related to the administration of the drug when administered in the home, if deemed medically appropriate. The implementing instructions for this benefit were provided in a transmittal released on January 23, 2004. We received several comments regarding this new benefit. The comments and our responses are provided below. 
                        <PRTPAGE P="66319"/>
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         Several commenters expressed concern regarding the lack of coverage for the items and services needed to administer IVIG. These commenters urged us to use our authority to pay for the items that are necessary for the effective use of IVIG. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         The MMA provided coverage for the approved pool plasma derivative for treatment in the home; however, new section 1861(zz) of the Act specifically precludes coverage for the items and services related to the administration of the derivative. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         The commenter stated that on January 23, 2004, we released a transmittal implementing the new IVIG coverage. The transmittal contained the following language: “for coverage of IVIG under this benefit, it is not necessary for the derivative (IVIG) to be administered through a piece of durable medical equipment.” Commenters stated that this language has resulted in the denial of coverage of IVIG for patients because providers are using the rationale that it is medically unnecessary to infuse IVIG through an infusion pump and therefore IVIG is medically unnecessary. The commenters recommended that we issue a new transmittal stating that IVIG is to be covered even when administered through durable medical equipment (DME), as determined necessary by a physician. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         It was not our intention to deny any beneficiary the coverage of IVIG in the home. It appears that the sentence that references the use of DME for the administration of IVIG is both confusing and misleading. Therefore, we will issue a new transmittal removing the apparent DME restriction. 
                    </P>
                    <HD SOURCE="HD2">Result of Evaluation of Comments </HD>
                    <P>We are finalizing the proposed revisions to § 410.10 without alteration. </P>
                    <HD SOURCE="HD2">H. Section 623—Payment for Renal Dialysis Services </HD>
                    <P>Section 623 of the MMA amended section 1881(b) of the Act and directed the Secretary to revise the current renal dialysis composite rate payment system. The MMA included several major provisions that require the development of revised composite payment rates for ESRD facilities. </P>
                    <P>The following is a summary of the proposed revisions to the composite payments rate methodology implementing provisions in section 623 of the MMA that are required to be effective January 1, 2005. </P>
                    <P>• The proposed rule provides for a 1.6 percent increase to the current composite payment rates effective January 1, 2005. </P>
                    <P>• The proposed rule included an add-on to the composite rate for the difference between current payments for separately billable drugs and payments based on a revised drug pricing methodology using acquisition costs. For purposes of this adjustment, in the proposed rule, we defined acquisition costs as the ASP minus 3 percent. We proposed a single adjustment to the composite payment rates for both hospital-based and independent facilities, equal to 11.3 percent. </P>
                    <P>• In the proposed rule, we discussed the reinstatement of the ESRD exceptions process for pediatric facilities as provided in section 623(b) of MMA. The statute defines pediatric ESRD facilities as renal facilities at least 50 percent of whose patients are under age 18. Since April 1, 2004, we have accepted ESRD composite rate exception requests from ESRD facilities that believe they qualify for exceptions as pediatric ESRD facilities. </P>
                    <P>• Section 1881(b)(12)(D) of the Act, added by section 623(d)(1) of the MMA gives the Secretary discretionary authority to revise the current wage indexes and the urban and rural definitions used to develop them. In the proposed rule, we proposed to take no action at this time to revise the current composite rate wage indexes. Because of the potential payment implications of recently revised definitions of urban areas, we believe further study is required. </P>
                    <P>• The proposed rule described the proposed methodology for a case-mix adjustment to a facility's composite payment rate based on the statutorily required limited number of patient characteristics. We used co-morbidity data for all Medicare ESRD patients obtained from the Form CMS-2728, supplemented with co-morbidity information obtained from Medicare claims. We measured the degree of the relationship between specified co-morbidities and ESRD facility per treatment costs, controlling for the effects of other variables, using standard least square regression. The source of the per treatment costs was the Medicare cost report. The result, after all necessary statistical adjustments, was a set of eight case-mix adjustment factors based on age, gender, AIDS, and peripheral vascular disease (PVD). Section 623(d)(1) of the MMA requires that aggregate payments under the case-mix adjusted composite payment system be budget neutral. Therefore, the proposed rule provided an adjustment 0.8390 to be applied to a facility's composite payment rate to account for the effects of the case-mix adjustments. </P>
                    <HD SOURCE="HD2">A. Composite Rate Increase </HD>
                    <P>The current composite payment rates applicable to urban and rural hospital-based and independent ESRD facilities were effective January 1, 2002. Section 623(a)(3) of the MMA requires that the composite rates in effect on December 31, 2004 be increased by 1.6 percent. The updated wage adjusted rates were published in Tables 18 and 19 of the proposed notice. </P>
                    <P>The tables reflected the updated hospital-based and independent facility composite rate of $132.41 and $128.35, respectively, adjusted by the current wage index. The rates shown in the tables do not include any of the basic case-mix adjustments required under section 623 of the MMA. </P>
                    <P>
                        <E T="03">Comment:</E>
                         Although there were no specific comments on the 1.6 percent adjustment, several commenters wanted to emphasize the importance of providing an annual adjustment to the composite rate in order to recognize the increased costs that face renal dialysis facilities. They stated that failure to increase the composite rate on a regular basis has caused dialysis providers to suffer a significant loss of income from their Medicare reimbursement and that dialysis facilities are the only Medicare entities that do not receive a statutorily mandated annual increase in their reimbursement rates. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We do not have the authority to establish an annual update to the composite payment rates. Section 4201(a)(2) of Pub. L. 101-508 effectively froze the methodology for calculation of the rates, including the data and definitions used as of January 1, 1991. Since that time, the Congress has set the composite payment rate for ESRD services furnished to Medicare beneficiaries. As a result, we do not have the authority to update the composite payment rate. 
                    </P>
                    <HD SOURCE="HD2">B. Composite Rate Adjustments To Account for Changes in Pricing of Separately Billable Drugs and Biologicals </HD>
                    <P>Section 623(d) of MMA provides for an add-on to the composite rate for thedifference between current payments for separately billable drugs and payments based on a revised drug pricing methodology using acquisition costs. </P>
                    <P>
                        In the proposed notice we proposed to pay for separately billable ESRD drugs using ASP minus 3 percent based on the average relationship of acquisition costs to average sales prices from the drug manufacturers as outlined in the OIG report. We developed the proposed drug add-on adjustment using the ASP minus 
                        <PRTPAGE P="66320"/>
                        3 percent drug prices. As discussed below, the drug add-on adjustment for this final rule is based on average acquisition costs for the top ten ESRD drugs updated to 2005 and ASP plus 6 percent for the remaining separately billable ESRD drugs. 
                        <E T="03">See</E>
                         section III.E, Payment for Covered Outpatient Drugs and Biologicals, for a discussion of the final payment methodology for ESRD separately billable drugs. 
                    </P>
                    <P>In the proposed notice, we outlined the methodology and data used to develop the proposed drug add-on adjustment to the composite rate of 11.3 percent for both hospital-based and independent ESRD facilities. Since the composite rate payment for hospital-based facilities is higher than the composite rate for independent facilities, the proposed adjustment results in a higher payment rate for hospital-based facilities. The 2005 composite rates (including the 1.6 percent increase) would be $132.41 for hospital-based facilities and $128.35 for independent facilities with the hospital-based facilities' rate higher by $4.06. We found this result consistent with section 1881(b)(7) of the Act, which requires that our payment methods differentiate between hospital-based facilities and others. We also indicated that the proposed methodology for making this drug add-on adjustment to the composite rate is designed to ensure that the aggregate payments to ESRD facilities for separately billable drugs would be budget neutral with what would have been paid absent the MMA provisions. </P>
                    <P>The proposed rule also discussed an alternative approach that produced separate adjustments to the composite rate of 2.7 percent for hospital-based and 12.8 percent for independent facilities. In contrast to a single add-on, separate add-on adjustments would result in a significantly higher composite payment rate for independent facilities than hospital-based facilities, of $8.79 more per treatment. </P>
                    <P>
                        <E T="03">Comment:</E>
                         We received many comments from independent facilities, chain organizations and groups objecting to our proposal to establish a single add-on adjustment to the composite payment rate. Several commenters expressed concern that since hospital-based facilities are paid reasonable cost for their separately billed drugs other than EPO, those facilities should receive an adjustment based only on the spread related to EPO payments. They stated that our proposal to spread the drug savings to all facilities does not comply with the provision in the statute that they believe is intended to hold facilities harmless with respect to their drug payment profit margins. The commenters also contend that since hospital-based facilities already receive about $4.00 per treatment more than independent facilities, they should not share in the drug add-on adjustment for other than their specific EPO usage. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         As we indicated in the proposed rule, we believe that the statutory language supports one uniform drug add-on adjustment to composite payment rates set forth in section 1881(b)(7) of the Act after updating by 1.6 percent. The provision speaks of one “difference between payment amounts” and “acquisition costs * * * as determined by the Inspector General.” It is reasonable to infer that the Congress intended us to compute one “difference” based only on the payment amounts under sections 1842(o) and 1881(b)(11) of the Act. 
                    </P>
                    <P>Although the language of section 1881(b)(7) contemplates differential composite rates for hospital-based facilities and 623(d) contemplates existing composite rates as the starting point for application of the new rate adjustments prescribed under section 1881(b)(12)(A) of the Act, the MMA language does not suggest that these adjustments would be applied differentially across facilities. Otherwise, all of the adjustments, including case-mix and budget neutrality would have to be developed separately based on facility type. </P>
                    <P>We note that the amount of the drug add-on has decreased significantly from the proposed rule as a result of our revised policy of paying for ESRD drugs for 2005. Since the drug payment amounts increased, the amount of the drug add-on to the composite rate decreased. The resulting drug add-on amount is now 8.7 percent. </P>
                    <P>We also note that there is not a significant difference in composite rates for independent facilities under single and separate add-ons. With a single add-on of 8.7 percent, the 2005 composite rate for independent facilities would be $139.52. Under a separate add-on approach, the 2005 composite rate for independent facilities would be $140.93, a difference of $1.41 or about 1 percent before taking other considerations into account. This difference is about 27 percent less than the difference based on the approach and figures in the proposed rule. </P>
                    <P>While a composite rate difference of $1.41 is important, such difference does not take into account two other factors: (1) Since Medicare's 2005 payments for ESRD drugs will be a weighted average of the acquisition costs determined by the Inspector General, the payment amounts for the most utilized ESRD drugs (such as EPO) will be significantly higher than payment based on ASP-3 percent; and (2) Beginning with 2005, Medicare will pay separately for syringes that are currently included in the EPO payments. </P>
                    <P>With separate add-ons, the composite rate for the independent facilities would be $7.33 higher than the composite rate for hospital-based facilities. However, the composite rate for hospital-based facilities would be $10.33 lower under separate add-ons than under a single add-on approach. We believe the current difference in composite rates where the hospital-based rate is about $4.00 higher than the independent facility rate would effectively be preserved with a single add-on and significantly reversed with separate add-ons. </P>
                    <P>Finally, we note that a key purpose of the MMA legislation was to eliminate the cross-subsidization of composite rate payments by drug payments. If the composite rate was inadequate before the MMA provision, it was inadequate for both hospital-based and independent facilities. As such, increasing the composite rate by relatively greater amounts for independent facilities than hospital-based facilities would place the latter facilities at a competitive disadvantage relative to the former facilities. </P>
                    <P>
                        <E T="03">Comment:</E>
                         One comment from a drug manufacturer suggested that in order to preserve high quality care to ESRD patients and prevent cost shifting behavior, we should require a facility to provide the full range of separately reimbursable drugs and biologicals in order to receive the drug add-on adjustment. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We do not believe the statute permits imposing such a requirement as a condition for receiving the add-on adjustment to the composite rate. However, other regulations require that ESRD facilities provide appropriate care to each patient based on a plan of care that would include the administration of medically necessary drugs as prescribed by the patient's dialysis physician. 
                    </P>
                    <HD SOURCE="HD3">1. Growth Factors Used To Update Drug Expenditures and Prices </HD>
                    <P>
                        <E T="03">Comment:</E>
                         One commenter noted that, in the proposed rule, we updated the 2004 ASP drug prices to 2005 prices by using the projected annual growth factor for National Health Expenditures prescription drugs of 3.39 percent. This commenter wanted to know why we did not use the actual growth factors for separately billable drugs that are furnished by ESRD facilities to ESRD 
                        <PRTPAGE P="66321"/>
                        patients. The commenter states that this factor is currently running about 39 percent. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         After consideration of the available price data, as discussed in the section on payment for ESRD separately billable drugs, we have determined that the Producer Price Index (PPI) for prescription preparations is the most appropriate price measure for updating EPO and other separately billable drugs from 2003 to 2005. The PPI for prescription preparations is released monthly by the Bureau of Labor Statistics, and reflects price changes at the wholesale or manufacturer stage. By comparison, the Consumer Price Index (CPI) for prescription drugs reflects price changes at the retail stage. Because EPO and many of the separately billable drugs used by dialysis facilities are purchased directly from the manufacturer, the use of a price index that measures wholesale rather than retail prices is more appropriate. The PPI for prescription drugs is the measure used in the various market baskets that update Medicare payments to hospitals, physicians, and skilled nursing facilities, and home health agencies. In addition, the PPI for prescription drugs was recommended for use in the proposed composite rate market basket detailed in the 2003 Report to the Congress. 
                    </P>
                    <P>Based on historical data through the second quarter of 2004, we used the Global Insight Inc. forecast of the PPI for prescription drugs to determine the update factors for 2004 and 2005. We feel the use of an independent forecast, in this case from Global Insight Inc., is superior to using the NHE projections for drug prices (which is the CPI for prescription drugs) and is consistent with the methodology used in projecting market basket increases for Medicare prospective payment systems. </P>
                    <P>
                        <E T="03">Comment:</E>
                         One comment questioned the 3 percent growth rate that we used in the proposed rule to estimate 2005 Medicare AWP payment amounts for purposes of calculating the drug add-on amount. Specifically, the commenter asked whether the 3 percent figure represented the AWP growth trends for all drugs as opposed to the AWP growth trends for only ESRD separately billable drugs and biologicals. The commenter also asked for clarification of the timeframe used to establish the historical trend. 
                    </P>
                    <P>Several comments also expressed concern that we used a 10-quarter average as an approximation for 2002 expenditures, and as a result, the projected 2005 drug expenditures were understated. These comments strongly recommended that we establish an accurate baseline using actual 2002 expenditures. A study performed for commenters by an industry consultant was cited as confirming that our base year estimate is materially below actual drug spending computed using CMS's 2002 Outpatient Five Percent Standard Analytic File (SAF). Commenters were also concerned that the drug add-on does not reflect the true difference between payments under the current system and acquisition costs described by the OIG. </P>
                    <P>
                        <E T="03">Response:</E>
                         We have taken all these comments into consideration and have re-evaluated our 2005 projection of aggregate ESRD facility drug expenditures. We did not use an average over 10 quarters to determine aggregate drug payments. The 10 quarters of data were used only to establish historical growth trends. However, we determined that our estimates of aggregate drug payment amounts were in fact understated because they did not include deductibles and coinsurance. Since drug payment rates are set at 100 percent of the allowable payment, we incorrectly calculated the aggregate drug payment for 2005. We revised our calculation to ensure that we capture the allowable payment before deductible and coinsurance are removed. In addition, we updated our estimates to incorporate the June 2004 update to the 2003 standard analytical file. The 3 percent growth represents our best estimate of the expected growth rate in AWP prices. In addition, due to numerous coding changes for the various ESRD drugs, we were unable to do direct comparisons for each of the AWP prices from year-to-year. Therefore, we believe the 3 percent inflation factor we used to update the AWP prices is appropriate. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         One comment expressed concern that the projected number of dialysis treatments in 2005 would be overstated if home peritoneal dialysis (PD) treatments for home patients are included because facilities do not bill for non-EPO drugs in that setting. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         Since ESRD facilities also receive composite rate payments for their Method I home patients, the drug add-on would also apply to composite rate payments for those patients. Therefore, it is appropriate for us to count those treatments in projecting the number of dialysis treatments for computation of the drug add-on amount. We did not, however, count treatments attributable to Method II home patients since payment for these patients is made based on reasonable charges as opposed to the composite rate. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         One comment from a patient organization raised concern that the add-on provision would remove any incentives the current payment policy creates for facilities to provide separately billable drugs and biologicals to dialysis patients. This comment suggested that we establish new clinical guidelines or indicators to ensure that dialysis patients receive necessary drugs and biologicals. This commenter also asked whether we have longer term plans to revise payment for dialysis treatment and ancillary services. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We share this commenters concern that changes in payments to dialysis facilities could produce perverse incentives for dialysis facilities to skimp on care to ESRD patients. In order to ensure that patients continue to receive quality care, we are revising the ESRD facility conditions for coverage so that they are more patient-centered and outcome-oriented. We will publish proposed ESRD conditions by the end of 2004. We note that section 623 of MMA also requires us to develop a bundled, case-mix adjusted payment system and report to the Congress by October 1, 2005. This section also requires the establishment of a demonstration to test the revised payment system over a 3-year period beginning January 1, 2006. 
                    </P>
                    <HD SOURCE="HD3">2. Update Methodology for Drug Add-on Adjustment in 2006 </HD>
                    <P>
                        <E T="03">Comment:</E>
                         Several commenters recommended that we publish the methodology that we intend to use to update the drug add-on component of the basic case-mix adjusted payment amounts, beginning in 2006, and that we provide the opportunity for public comment. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We did not propose a mechanism for updating the 2006 payments in this document since this rule addresses payment for 2005. It is our intent to publish a proposed rule in mid-2005 to address payment changes for 2006. The public will be given an opportunity to comment on those proposals at that time. 
                    </P>
                    <HD SOURCE="HD3">3. Computation of Final Drug Add-On Adjustment to the Composite Payment Rate </HD>
                    <P>
                        To develop the final drug add-on adjustment we used historical total aggregate payments for separately billed ESRD drugs for half of 2000 and all of 2001, 2002 and 2003. For EPO, these payments were broken down according to type of ESRD facility (hospital-based versus independent). We also used the 2003 data on dialysis treatments performed by these two types of facilities over the same period. 
                        <PRTPAGE P="66322"/>
                    </P>
                    <HD SOURCE="HD1">I. 2005 Average Acquisition Payment (AAP) Amounts </HD>
                    <P>The OIG report contained 2003 average acquisition costs for the top ten drugs supplied by the four largest dialysis chain organizations and by a sample of those facilities not managed by the four largest chain organizations. According to the OIG report, these ten drugs accounted for about 98 percent of total expenditures for separately billed drugs furnished by ESRD facilities. The report also indicated that payment to the four largest dialysis chains accounted for 73 percent of Medicare drug reimbursement in 2002. Therefore, we weighted the average acquisition costs using a 73-27 split. As discussed earlier, we then updated the 2003 weighted average acquisition costs to arrive at the 2005 AAP amounts by using the PPI for prescription drugs. These factors were 4.81 percent and 3.72 percent for 2004 and 2005, respectively. </P>
                    <GPH SPAN="3" DEEP="249">
                        <GID>ER15NO04.505</GID>
                    </GPH>
                    <HD SOURCE="HD1">II. Estimated 2005 Medicare Payment Amounts Based on 95 Percent of AWP </HD>
                    <P>We estimated what Medicare would pay for ESRD drugs in 2005 if the MMA had not been enacted. We adjusted the first quarter 2004 Medicare payment amounts (95 percent of AWP), based on the prices from the January 2004 Single Drug Pricer, for drugs other than EPO, to estimate 2005 prices by using an estimated AWP growth of 3 percent. As discussed earlier, these growth factors are based on historical trends of AWP pricing over years. We did not increase the price for Epogen since payment was maintained at $10.00 per thousand units prior to MMA. </P>
                    <GPH SPAN="3" DEEP="225">
                        <GID>ER15NO04.506</GID>
                    </GPH>
                    <PRTPAGE P="66323"/>
                    <HD SOURCE="HD1">III. Dialysis Treatments </HD>
                    <P>We updated the number of dialysis treatments based on 2003 data by actuarial projected growth in the number of ESRD beneficiaries. Since Medicare covers a maximum of three treatments per week, utilization growth is limited, and therefore any increase in the number of treatments will be due to enrollment. In 2005, we project there will be a total of 34.8 million treatments performed. </P>
                    <HD SOURCE="HD1">IV. Estimated Drug Spending </HD>
                    <P>We updated the total aggregate 2003 Epogen drug spending for hospital-based and independent facilities using historical trend factors. For 2004 and 2005, we increased the 2003 spending levels by trend factors of 1.0 percent for hospital-based facilities and by 10.0 percent for independent facilities based on historical growth from 2000 to 2003. </P>
                    <P>We also updated the aggregate AWP based spending for separately billed drugs, other than EPO, for independent facilities by using the 10 percent growth factor for Epogen. Since aggregate spending in this category show extremely varied growth in recent history, we could not establish a clear growth trend. For this reason we decided to apply the Epogen growth rate to the other separately billed drugs. Given the problems establishing growth trends for the other drugs, plus the fact the expenditures for Epogen account for about 70 percent of the total spending for the top ten ESRD drugs, we believe this approach to updating all of the separately billed drugs is appropriate. </P>
                    <P>Additionally, we deducted 50 cents for each administration of Epogen from the total Epogen spending for both hospital based and independent facilities, to account for payment for syringes that is currently included in the EPO payments. Payment for syringes used in administering EPO will be made separately beginning January 1, 2005. In 2005, we estimate that the total spending for syringes associated with the administration of Epogen will amount to $1.6 million for hospital-based facilities and $27 million for independent facilities. For 2005, we estimate that the total spending for Epogen provided in hospital-based facilities will be $210 million, and $2.913 billion for drugs provided in independent facilities ($2.003 billion for Epogen and $910 million for other drugs). </P>
                    <HD SOURCE="HD1">V. Add-On Calculation and Budget Neutrality </HD>
                    <P>For each of the ten drugs in the previous tables, we calculated the percent by which 2005 AAP amounts are projected to be different from the payment amounts under the pre-MMA system. For Epogen, this amount is 2 percent. We applied this 2 percent figure to the total aggregate drug payments for Epogen in hospital-based facilities, resulting in a difference of $5 million. </P>
                    <P>Since the top 10 ESRD drugs will be paid at 2005 AAP amounts and the remainder will be paid at ASP plus six percent, we then calculated a weighted average of the percentages by which AAP amounts would be below current Medicare prices, for the top 10 drugs, and the percentage by which ASP plus 6 percent would be below current Medicare payment amounts. For other than the top ten drugs, we do not have detailed data on expenditures for drugs billed by ESRD facilities. Therefore, we computed the percentage by which ASP plus 6 percent is below the estimated 2005 pre-MMA payment amounts for those drugs, using the average of the comparable ASP prices for the top 10 ESRD drugs. This procedure resulted in a weighted average of 13 percent by which the overall revised 2005 drug payment amounts applicable to independent facilities is projected to be less than the 2005 estimated pre-MMA system (that is, 95 percent of AWP). We then applied the 13 percent weighted average to total aggregate drug spending projections for independent facilities, producing a projected difference of $385 million. </P>
                    <P>Combining the 2005 estimates of $5 million and $385 million, for a total of $390 million and then distributing this over a total projected 34.8 million treatments would result in an add-on to the per treatment composite rate of 8.7 percent. We estimate that an 8.7 percent adjustment to the ESRD composite payment rate would be needed to achieve budget neutrality with respect to drug expenditures for ESRD facilities. </P>
                    <HD SOURCE="HD2">A. Patient Characteristic Adjustments </HD>
                    <P>As explained in the proposed rule, the current ESRD composite payment rates are not adjusted for variation in patient characteristics or case-mix. Section 623(d)(1) of the MMA added section 1881(b)(12)(A) of the Act to require that the outpatient dialysis services included in the composite rate be case-mix adjusted. Specifically, the statute requires us to establish a basic case-mix adjusted prospective payment system for dialysis services. Also, the statute requires adjustments under this system for a limited number of patient characteristics. In the proposed notice, we described the development of the methodology for the proposed patient characteristic case-mix adjusters required under the MMA. </P>
                    <P>In summary, we proposed to use a limited number of patient characteristics that explain variation in reported costs for composite rate services, consistent with the legislative requirement. The proposed adjustment factors are as follows: </P>
                    <GPH SPAN="3" DEEP="201">
                        <PRTPAGE P="66324"/>
                        <GID>ER15NO04.507</GID>
                    </GPH>
                    <P>Although the magnitude of some of the patient-specific case-mix adjustments appears to be significant, facility level variation in case-mix is limited because of the overall similarity of the distribution of patients among the eight case-mix classification categories across facility classification groups. </P>
                    <P>We received a significant number of comments regarding the case-mix adjustment factors, which are summarized in this section with our corresponding responses. </P>
                    <HD SOURCE="HD3">1. Sample Data Used To Develop the Basic Case-Mix System </HD>
                    <P>
                        <E T="03">Comment:</E>
                         Comments regarding the sample or universe used to derive the proposed basic case-mix adjustments in the proposed rule expressed concerns about the size of the sample, the number of hospitals and freestanding facilities included, as well as the number of facilities excluded from the data. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We used the database established by our contractor to develop the basic case-mix system in the proposed rule. Facility cost report data were matched to the corresponding facility billing data to insure that the sample reflected the most valid and reliable data available. The specific methodology used to develop the database is discussed in Kidney Epidemiology and Cost Center's (KECC's) Phase I report. The Phase I report entitled: “An Expanded Medicare Outpatient End Stage Renal Disease PPS—Phase I” is available on the University of Michigan Web site: 
                        <E T="03">http://www.sph.umich.edu/kecc.</E>
                         The contractor has been updating the data files for subsequent phases of their research and is beginning to analyze these data for the bundled prospective payment system. The data used for the basic case-mix proposed system were also assessed in terms of consistency. Data from 2000, 2001, and 2002 were examined separately as well as combined to determine if there were consistent trends over the 3-year period. The data were updated to include the latest 2002 data that was available as of September 2004. The updated data reflect an increase of approximately 10 percent in the number of facilities represented in the database. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         Several comments expressed concerns regarding the timeliness of the data used to develop the proposed case-mix measures. These concerns focused on the availability of cost reports for 2002. In the proposed notice we acknowledged we were delayed in obtaining cost reports for 2002 and that the final rule would reflect the most recent data on the number of cost reports available. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         Table 12 indicates the number of dialysis facilities with at least one cost report for 2000 to 2002. This table also reflects the availability of the most recent cost reports data for 2002 and reflects an increase from the proposed rule of an additional 564 cost reports for the independent facilities in 2002. 
                    </P>
                    <GPH SPAN="3" DEEP="119">
                        <GID>ER15NO04.508</GID>
                    </GPH>
                    <P>
                        The availability of cost reporting data may be delayed because of a number of factors including late submissions by facilities and necessary reconciliation and verification of data by fiscal intermediaries prior to submission to our data systems. The comment on delays and availability of data is also related to concerns expressed by other comments regarding the reporting of co-morbid conditions. Several comments addressed potential inconsistencies in 
                        <PRTPAGE P="66325"/>
                        facility reporting of co-morbid conditions, specifically with the impact of the variation of the reporting of AIDs noted in the 2000 data compared to other years. This variation, coupled with the potential incompleteness of the 2002 data, led us to examine options for selecting the time period to be used for determining the case-mix adjustments. 
                    </P>
                    <P>In this final rule, we have decided to use combined data for the 3-year period 2000-2002, to determine the case-mix adjustment factors. The use of combined data enables us to eliminate any impact caused by annual variation in reporting, delays in the availability of administrative files, and overemphasizing the predictive significance of selected variables, because case-mix variables are combined and averaged over a 3-year period, thus representing a more stable database. </P>
                    <P>
                        <E T="03">Comment:</E>
                         Several comments focused on the number of facilities that were excluded from the study sample in the development of the proposed case-mix adjustments. For the proposed regulation, we excluded from our sample facilities where cost report data could not be matched to claims data and vice versa, or where key data elements were missing. In addition we excluded outlier facilities (those with high or low average costs, or high or low proportions of co-morbid conditions.) Data from small facilities (fewer than 20 patients) and those with existing composite rate exceptions were also excluded. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We concurred with the recommendation to reassess the sample. For the final rule, we are including, within the sample, data for facilities with existing exceptions. However, we have continued to exclude data for small facilities, outliers, and facilities with missing or unusable data. Missing data excluded approximately 11 percent of the sample, and not including small facilities or outlier facilities eliminated approximately 9 percent of the study sample. 
                    </P>
                    <P>We did not accept the suggestion that smaller sized facilities were proxies for rural facilities, however, and we will continue to study the rural and urban issue in future research and in updates to the wage index. </P>
                    <P>Overall, including those facilities with exceptions provides a more robust study sample. In this way any effects on the case-mix values due to fluctuations in the data from year to year are greatly diminished. </P>
                    <P>
                        <E T="03">Comment:</E>
                         Several commenters objected that the database used to develop the basic case mix was not available. One commenter indicated that not having the data made it difficult to evaluate the impact of the proposed case-mix variables on specific facilities. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         The database developed for the basic case-mix system is the same database that was developed by the University of Michigan for the ongoing research project to develop a bundled payment system. This database was compiled using our administrative data. We make available for purchase data available in the form of public use files or standard analytic files. Commenters can use the same data files that were used by the University of Michigan to develop the database used. The proposed rule provides the factors necessary to determine impact on individual facilities based on the case-mix within that facility. In addition, we have expanded our discussion of the impact of the case-mix adjustments and have provided a more detailed example to assist facilities in evaluating the impact of the case mix on their specific facilities. 
                    </P>
                    <HD SOURCE="HD3">2. Including Co-Morbid Conditions in the Case-Mix Adjustment </HD>
                    <P>
                        <E T="03">Comment:</E>
                         A number of comments expressed concerns regarding the coding of co-morbid conditions. Some comments acknowledged that limited time has been spent by ESRD facilities in coding multiple conditions. Some stressed that training should be provided to ensure that facilities understand this reporting requirement. One commenter attributed the proposed delay in implementation of the case-mix adjustments to potential difficulties in coding co-morbid conditions and in integrating these coded conditions into the payment. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We considered the commenters concerns regarding incorporating co-morbid conditions and the findings from analyzing more recent data. Although our regression modeling suggests that the inclusion of co-morbidities in the case-mix system would be appropriate, we are concerned that the data available to determine patient level co-morbidities may not accurately reflect diagnoses relevant to the dialysis patient population. Therefore, in this final rule we are not including co-morbidities as case-mix adjustments. As discussed later in this section, we are establishing the case-mix adjustments based on the following variables: age, body mass index (BMI) and body surface area (BSA). More recent analysis of the data and clinical concerns expressed regarding the inclusion of AIDs and selected PVD diagnoses support this decision. However, while co-morbid conditions are not currently part of the basic case-mix system, we encourage all facilities to more thoroughly report and code co-morbid conditions on their claims. This will enable appropriate refinements to the basic case-mix adjustments and also provide a better database from which we can develop case-mix measures for a bundled payment system. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         One commenter representing a chain of ESRD facilities stated that we overstated the prevalence of patients with peripheral vascular disease (PVD). The commenter maintained that overstating the incidence of PVD in the ESRD outpatient population results in an overstatement of the offset for budget neutrality because of the proposed 1.07 case-mix adjuster for PVD patients, thereby decreasing the otherwise applicable composite payment rate prior to case-mix adjustments. The commenter identified 51 diagnoses from the list of PVD diagnosis codes included in the proposed rule that he believed were either not reflective of PVD in ESRD patients, were not usually considered as a cause of PVD in ESRD patients, or were poorly differentiated clinically and could occur even in the absence of PVD. The commenter believed that these 51 diagnoses should be excluded from our list of PVD diagnoses for purposes of determining the case-mix and budget neutrality adjustments to the composite payment rates. Another commenter pointed out that there is substantial clinical disagreement about the definition of PVD and that the ESRD claims data presently do not contain sufficient information to implement the proposed PVD adjustor. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         The selection of specific co-morbid conditions for purposes of adjusting the composite payment rates to reflect the patient characteristics associated with cost differences across facilities is an important issue, and we appreciate the commenter's suggestions. However, we disagree with the recommendation that we exclude certain diagnoses because they are not usually considered a cause of ESRD in patients. We believe that whether a particular co-morbid condition caused the onset of ESRD is irrelevant. The important factor is whether a particular co-morbid condition is associated with facility differences in composite rate costs, regardless of their role in the etiology of ESRD. 
                    </P>
                    <P>
                        We agree with the commenter's suggestion that diagnoses which can occur in the absence of PVD will be excluded for purposes of applying a case mix adjustment based on PVD. In addition, there is apparent disagreement among clinicians as to whether certain 
                        <PRTPAGE P="66326"/>
                        diagnoses are reflective of PVD in ESRD patients, and we will try to achieve as much consensus as possible before proceeding to implement a case mix adjuster which purports to reflect PVD. Accordingly, we are eliminating the case mix adjustment for PVD as set forth in the proposed rule. We point out that further analyses with more restricted sets of diagnostic codes revealed that the omitted codes were still strong predictors of costs. We intend to revisit the issue of appropriate co-morbidity adjustments as we continue our research to develop the bundled ESRD payment system. 
                    </P>
                    <P>We point out that our case mix model that included PVD explained about 35.7 percent of the variation in facility composite rate costs. By comparison, our model using five age groups without co-morbidities explains about 35.6 percent of the cost variations. Although PVD was a statistically significant case mix variable, its contribution to the model's performance overall in explaining facility differences in costs was minimal. While co-morbidity adjustments will be excluded under the basic case mix adjusted composite payment system, accuracy in the reporting of co-morbid conditions on the bills will become increasingly important because of the likelihood that a bundled ESRD payment system will include co-morbidities associated with differences in patient resource consumption. </P>
                    <P>
                        <E T="03">Comment:</E>
                         Two commenters recommended that we exclude AIDS as a co-morbidity warranting case-mix adjustment. These commenters stated that because of State laws requiring that a patient's AIDS status be kept confidential, most facilities do not know whether their patients have AIDS. This does not pose a risk to other patients or caregivers because of the universal precautions which dialysis facilities are required to use in order to prevent exposure and infection. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         Because the claims data contain primarily the patient's primary diagnosis, AIDS is not likely to be recorded as a claims diagnosis for outpatient dialysis patients. Requiring the recording of the AIDS diagnosis on the bills would create powerful incentives for ESRD facilities to circumvent confidentiality restrictions. In those States with AIDS confidentiality requirements, the diagnosis is not likely to be recorded at all. Given the relatively low incidence of AIDS patients in the outpatient dialysis population, the fact that facilities in States with AIDS confidentiality requirements would be potentially disadvantaged if AIDS were included as a payment adjuster, and the fact that the relationship between AIDS and dialysis costs was not stable from year to year, we have decided to eliminate AIDS as a basis for case-mix adjustment to the composite payment rates at the present time. 
                    </P>
                    <HD SOURCE="HD3">3. Case-Mix Adjustment for Gender </HD>
                    <P>
                        <E T="03">Comment:</E>
                         One commenter suggested that we eliminate gender as one of the patient characteristic variables used to case-mix adjust the composite payment rates. The commenter stated that gender was essentially a surrogate for differences in height and weight measures that would yield a superior case-mix adjustment. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         Although height and weight are much better predictors of facility variation in composite rate costs, these data were only available on the Form CMS 2728, not on the bills submitted for payment. Accordingly, we used gender as a surrogate measure in proposing adjustments, because gender is reported on the outpatient bill (for example, UB92 or the equivalent electronic form). However, the National Uniform Billing Committee has approved the use of two new value codes for reporting weight and height (A8—weight in kilograms, A9—height in centimeters) on the billing forms effective January 1, 2005. 
                    </P>
                    <P>The mandatory reporting of height and weight permits the development of case mix measures that reflect both variables, such as BMI and BSA, each of which are superior to weight alone as predictors of resource use. Given the impending availability of height and weight data on the outpatient dialysis bill, we examined the predictive power of weight, BMI, and BSA in lieu of gender based on data reported on the Form 2728 from 2000 through 2002. We found that both BMI and BSA are superior predictors to weight alone and that BSA, coupled with a variable for low BMI, is the best predictor of facility differences in composite rate costs. Accordingly, we have eliminated gender in this final rule as a patient classification variable for purposes of case mix adjustment. Instead we are substituting BSA, and a variable for low BMI, each of which are explained in another section of this final rule. </P>
                    <HD SOURCE="HD3">4. Age Groupings Used in Proposed Case-Mix Adjustment </HD>
                    <P>
                        <E T="03">Comment:</E>
                         Several comments indicated that the proposed age groups were too broad. Some of the comments recommended that we create more age categories for purposes of the case-mix adjustments. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         In the proposed rule we established three age categories for example: less than 65, 65-79, and greater than 79. In reassessing the study sample and the proposed case mix adjusters, we also explored the age categories. We concur with the comments to expand the number of age categories. For the final rule, there will be five age groupings. These are: 18-44, 45-59, 60-69, 70-79, and 80+. Patients under 18 are discussed in the following section on pediatrics. We believe that the revisions to the age groupings more accurately describe the distribution of the patient population and reflect more refined predictors of age for payment purposes. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         One commenter asked what would happens under our proposed adjustment if during the course of a month, an ESRD patient's age changed and they cross the line into another case-mix adjustment factor. For example, on August 15 a 64-year-old ESRD patient turns 65. They questioned how is this situation is handled and is the age used as of the last day of the month. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We believe it is appropriate to handle this situation as it is handled for enrollment. Thus, for a month when the patient has a birthday that puts him or her into another age category, the first of the month would be the effective date of the patient's new age category. 
                    </P>
                    <HD SOURCE="HD3">5. Case-Mix Adjustment for Pediatric Patients </HD>
                    <P>
                        <E T="03">Comment:</E>
                         Several commenters expressed concern over the lack of a case-mix adjustment for pediatric ESRD patients. The commenters stated that although section 623(b) of the MMA provided for an exception process for pediatric ESRD facilities, qualification for a pediatric exception is limited to those facilities where pediatric patients (those under age 18), comprise at least 50 percent of the caseload. The commenters pointed out that ESRD pediatric patients are unusually resource intensive and costly and are widely scattered among facilities, most of which would not qualify as pediatric facilities under the definition set forth in the statute. The commenters recommended that we develop a case-mix adjuster for pediatric ESRD patients using other data sources. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         Using the same regression methodology described in the proposed rule, we attempted to develop a case-mix adjuster for outpatient ESRD patients under age 18. However, based on the approximately 600 Medicare patients for whom bills were available each year from 2000 through 2002, the results were highly variable, statistically 
                        <PRTPAGE P="66327"/>
                        unstable, and therefore inappropriate for development of a case-mix adjuster in accordance with the proposed rule's methodology. However, because of the costliness of pediatric ESRD patients, we believe that an alternative case-mix adjustment is warranted, particularly for those facilities, which do not meet the definition of a pediatric facility under section 623(b) of the MMA. 
                    </P>
                    <P>As the commenter correctly pointed out, some facilities would not qualify for consideration for the pediatric exception provided in the law because their pediatric caseload does not constitute 50 percent of their patients. These facilities may still incur substantial costs for the treatment of pediatric ESRD patients. Pending the development of more refined case-mix adjustments that are more sensitive to individual variation in treatment costs under a fully bundled ESRD PPS, we are providing for a single adjustment to a facility's otherwise applicable composite payment rate, developed based on the methodology described below, for outpatient ESRD pediatric treatments. We want to emphasize that the pediatric adjustment factor resulting from this methodology is intended to be a temporary measure. It will only apply until we can develop an adjustor under the bundled ESRD PPS that is more similar with the case-mix adjustments that would apply to non-pediatric ESRD patients. </P>
                    <P>During the period from November 1, 1993 to the present time, we identified 19 hospital-based and one freestanding ESRD facility, each of which sought and received an atypical services exception based on the higher costs incurred for the treatment of outpatient pediatric patients. For each of these facilities we obtained the number of treatments at the time the exception was submitted and determined the unadjusted composite payment rate that would have applied beginning January 1, 2005 without regard to any exception amount, that is, each facility's unadjusted composite payment rate was inflated to January 1, 2005 to reflect the statutory increases of 1.2 percent effective January 1, 2000, 2.4 percent effective January 1, 2001, and 1.6 percent effective January 1, 2005. </P>
                    <P>We then subtracted the inflated January 1, 2005 unadjusted composite rate from each facility's composite payment rate, including the exception amount granted, to obtain the estimated amount of the exception projected to 2005. This amount was multiplied by the number of treatments previously provided, summed for all 20 facilities, and then divided by the number of treatments for all 20 providers to yield an average atypical services exception amount per treatment. The average exception amount for ESRD facilities that received exceptions due to their pediatric caseload, adjusted to 2005, was $86.79 per treatment. The average unadjusted composite payment rate for these same 20 facilities projected to 2005, similarly weighted by the number of treatments, was $139.32. Thus, the average composite payment rate adjusted to January 1, 2005, including the average exception amount of $86.79, was $139.32 + $86.79 or $226.11. Because the average exception amount was calculated from facilities located in areas with differing wage levels, we converted the average pediatric exception amount to a ratio, $226.11/$139.32 or 1.62. </P>
                    <P>This is the case-mix adjustment factor that will be applied to each facility's composite payment rate per treatment for outpatient maintenance dialysis services furnished to pediatric patients. This includes both in-facility and home dialysis. Applying the adjuster multiplicatively in this manner recognizes the wage index variation in labor costs among urban and rural areas built into the composite rates. Notwithstanding this case-mix adjustment per treatment for ESRD pediatric patients, facilities who otherwise qualify as a pediatric facility under section 623(b) of the MMA will be permitted to seek an exception to this rate if they believe their circumstances warrant a higher payment rate under the atypical services exception provisions set forth in the regulations. We intend the pediatric adjustment factor of 1.62 to be a temporary measure. We anticipate its elimination once the case-mix methodology that will apply in the context of the bundled ESRD PPS is developed. We want the same methodology to apply to both pediatric and non-pediatric ESRD patients. </P>
                    <HD SOURCE="HD3">6. Facility Level Control Variables Used in the Proposed Regression Model </HD>
                    <P>In developing the regression model used to derive the case-mix adjustments, we included variables reflective of facility characteristics. Because facility characteristics do account for differences in facility composite rate costs, we included them in the regression model through the use of facility control variables, so that the patient characteristic case-mix adjusters are not distorted. The facility control variables included the wage index, facility size (based on the annual number of treatments), facility status as hospital-based or freestanding, percent of patients with urea reduction ratios greater than or equal to 65 percent, chain ownership, year of cost report, and percent of pediatric patients treatments. These variables were not used to calculate the basic case-mix adjustment factors. </P>
                    <P>
                        <E T="03">Comment:</E>
                         One comment questioned the inclusion of the proportion of patients with urea reduction ratios (URRs) greater than 65 as a facility control variable in the least squares regression model used to develop the case-mix adjustment factors. The comment maintained that because a patient's URR may be correlated with other co-morbid conditions, the coefficients for the variables tested in the model might be distorted. The comment recommended an evaluation of the degree of association between URR and the main co-morbid conditions to determine the extent of any multicolinearity. The comment further stated that if URR is appropriate as a facility control variable, then other surrogates of dialysis efficiency, such as standardized mortality ratio and proportion of patients with hemoglobin readings above specified target levels, should also be considered as control variables. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We believe that case-mix adjustments to the composite payment rate must be determined by patient and not by facility characteristics. To the extent that facility differences in costs are statistically explained by facility and not patient characteristics, we account for them in the regression model through the use of control variables, so that the potential case-mix adjusters are not distorted. Facility control variables were not used to develop the adjustment factors to the composite payment rates. 
                    </P>
                    <P>For example, chain affiliation, facility size, and status as a hospital-based or freestanding facility were associated with statistically significant differences in facility costs. However, it would be inappropriate to object to the payment rates based on a facility belonging to a particular chain, or based on the number of annual treatments. </P>
                    <P>
                        To test for multicolinearity, that is, to ensure that each co-morbidity tested for inclusion in the regression model was not correlated with other variables, we ran a correlation matrix. The correlation matrix included URR. URR was found not to correlate with any of the co-morbidities tested; in statistical parlance, it was orthogonal. Accordingly, low URR was not a surrogate of co-morbidity. Therefore, we believe it was appropriate to treat URR as a quality of care outcome measure at each facility. The effect of using URR as a facility control variable was to ensure that the case-mix adjustment factors were not distorted for facilities with similar URR outcomes. For example, if 
                        <PRTPAGE P="66328"/>
                        larger patients receive lower doses of dialysis, not controlling for URR could impart a downward bias on the coefficient for patient size. The comment also suggested the use of other variables as facility control variables such as standardized mortality ratio (SMR) and hemoglobin count. Because SMR standardizes or controls for the effect of case mix on the ratio, we would have to ensure consistency in the reporting of specified co-morbidities on the bills in order to ensure the validity of each facility's SMR. That consistency currently does not exist. Facilities are only required to report hematocrit/hemoglobin on the claims available for those patients receiving erythropoeitin (EPO). However, because the proportion of patients receiving EPO is high, the use of hematocrit/hemoglobin as another outcome facility control variable is feasible, but mainly in the context of the bundled payment system. Since the drugs and lab tests associated with anemia management are paid outside the composite payment rate, hematocrit/hemoglobin level would not be appropriate as a control variable applicable to composite rate costs. 
                    </P>
                    <HD SOURCE="HD3">7. Propriety of Case-Mix Adjustment </HD>
                    <P>
                        <E T="03">Comment:</E>
                         Several commenters expressed reservations about our proceeding with the implementation of a case-mix adjustment to the composite payment rates using the methodology set forth in the proposed rule. One commenter cited the May 19, 2004 report prepared by the KECC of the University of Michigan, which pointed out that the proposed case-mix variables collectively explained less than 1 percent of the facility variation in composite rate costs, although the addition of facility control variables increased this proportion to about 33 percent. One commenter stated that the low explanatory power of the proposed case-mix variables indicated that they do not accurately predict cost variation and are flawed. The commenter suggested that we defer applying a case-mix model until the results of the demonstration project mandated under section 623(e) of the MMA are available. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We would have preferred to develop a case-mix adjustment in the context of a bundled outpatient ESRD PPS. In a fully bundled PPS, which section 623(f) of the MMA anticipates, routine and separately billable dialysis related services, drugs, and clinical laboratory tests would be included in the payment bundle. KECC's previous research revealed that, for separately billable services, case-mix explained about 23 percent of the variation in cost across dialysis facilities. (
                        <E T="03">See</E>
                         Hirth, 
                        <E T="03">et al.</E>
                        , Is Case-Mix Adjustment Necessary for an Expanded Dialysis Bundle?, Health Care Financing Review, 2003, 24, pages 77-88). 
                    </P>
                    <P>However, the enactment of Pub. L. No. 108-173 foreclosed the option of deferring implementation of a casemix adjusted composite rate based on a limited number of patient characteristics effective January 1, 2005. We do not believe that the statutory directive set forth in section 623(d) of the MMA permits us to defer the development of a basic case-mix measure, one based on a “limited number of patient characteristics.” </P>
                    <P>We do not agree with the statement that, because the proposed case-mix adjusters collectively account for about 1 percent of the facility variation in composite rate costs, the variables used are fundamentally flawed. In fact, when data is combined over three years, each of the proposed case-mix variables is highly significant statistically, despite the low proportion of facility variation in costs explained. A more important indicator of the importance of the case mix factors identified is the size of the adjustments. If the identified case mix variables did not have a meaningful relationship with costs, the magnitude of the adjustment factors would be insignificant or trivial. They are not. As explained in this final rule, based on our analysis of the comments we received, we have revised the case-mix variables used to adjust the composite payment rates. Our research to develop a statistically robust clinically coherent case-mix measure in the context of the fully bundled ESRD PPS will continue. </P>
                    <HD SOURCE="HD3">8. Alternative Case-Mix Variables </HD>
                    <P>
                        <E T="03">Comment:</E>
                         Several commenters suggested alternative case-mix variables which they believe account for patient differences in resource consumption and would better distinguish facility differences in composite rate costs. The patient characteristics proposed by commenters included quarterly serum albumin values, cancer, limb amputation, gastrointestinal disorders, body mass index, weight, revised age groupings, hypertension, duration of dialysis treatment, and others. The commenters indicated that, based on their clinical judgment, the suggested factors were more likely to be predictors of variability in the cost of care than the proposed AIDS and PVD co-morbidities. A few commenters recommended a delay in the implementation of the case-mix adjusted composite payment rates pending evaluation of the suggested variables. A number of comments indicated that BMI was a significant predictor of cost and recommended that BMI be included in the case-mix adjustment. Another commenter recommended BSA be examined as a potential case-mix predictor. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We appreciate all of the comments we received proposing alternative case-mix variables. We welcome suggestions for case-mix refinement based on sound clinical judgment, especially when analyses including separately billable ESRD services are performed as our research for development of the bundled ESRD payment system progresses. However, we point out, that unless the existence of a suggested co-morbidity or patient characteristic could be determined from either the Form CMS 2728 or claims data which could be linked to a specific ESRD dialysis patient, we were unable to evaluate its potential to predict facility differences in composite rate costs. Furthermore, unless a patient characteristic can be reported on the UB 92 claim form (or the equivalent electronic version), it cannot be used to adjust a facility's composite payment rate. These limitations eliminate for consideration many of the commenters' suggested alternative patient characteristic variables. 
                    </P>
                    <P>Nonetheless, our regression model evaluated 35 patient characteristics including weight, BMI, BSA, seven types of cancer, diabetes, chronic obstructive pulmonary disease, four types of heart disease, and race. Co-morbidities selected for inclusion in the model with significant negative coefficients were removed from subsequent iterations of the stepwise regression model. The inclusion of such co-morbidities would have resulted in reductions in the otherwise applicable composite rate payments. Because we can now require the reporting of height and weight on the claim form beginning January 1, 2005, we have adopted the commenters' suggestions to use either BMI or BSA as a predictor variable. We selected BSA and low BMI because they improve the model's ability to predict the costs of composite rate service compared to using BMI or weight alone. In addition, we have increased the number of age groups from three to five and eliminated gender as a payment variable entirely. </P>
                    <P>
                        As explained later in the “Implementation Date” section, we do not believe it would be appropriate to further delay the implementation of the basic case-mix adjustment. We proposed delaying implementation of the case-mix payments until April 1, 2005 in order to ensure all systems, programming, and other operational requirements are in place. Between publication of this final rule and the 
                        <PRTPAGE P="66329"/>
                        implementation date, we will conduct training programs to ensure that facilities understand both the payment methodology and reporting requirements necessary to ensure appropriate payment to ESRD facilities. 
                    </P>
                    <HD SOURCE="HD3">9. Continuing Research To Develop a More Fully Bundled Case-Mix System </HD>
                    <P>
                        <E T="03">Comment:</E>
                         Several comments requested additional detail regarding the continuing research for the development of a more fully bundled system. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         The research activities for the fully bundled system have focused on updating the database. Research efforts since the passage of MMA have focused on supporting the Congressional mandate for the development of a limited number of case-mix variables. Following the publication of this rule, we anticipate that the emphasis will return to the development of a bundled prospective payment system that includes bundling of drugs, clinical laboratory tests, and other items that are separately billed by such facilities. This research will be reflected in an October 1, 2005 Report to the Congress. 
                    </P>
                    <P>In addition, the MMA requires us to establish the fully case-mix adjusted demonstration which will bundle into the payments both separately billable drugs and biologicals and clinical labs. Both the Report to the Congress and the demonstration will be supported by continuing research. </P>
                    <HD SOURCE="HD3">10. Body Measurements as Case-Mix Adjusters </HD>
                    <P>In the proposed rule, we had discussed the importance of the BMI as a measure of resource consumption related to the composite payment rate. At that time, our analysis indicated that patients with very low or high BMI were more costly to treat. At the time of the publication of the proposed rule, we had no mechanism to obtain indicators for height and weight on the claims form. We had indicated that we would be exploring adding height and weight to the bills. </P>
                    <P>
                        <E T="03">Comment:</E>
                         A number of commenters endorsed the use of low BMI as an appropriate surrogate for the severity of morbid conditions associated with malnourishment in the dialysis population, and some suggested that a BMI below 20.0 kg/m
                        <SU>2</SU>
                         is generally considered in the underweight range. In addition, we also received comments regarding the inclusion of a measure of BSA.
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We concur with the comments to include BMI and BSA as case-mix adjusters reflecting patient characteristics that explain variation in the reported costs for composite rate services. We have obtained approval to collect both height and weight on the bill through the use of two new value codes. ESRD facilities will be required to report height and weight using these value codes, so that payment can be based on the case-mix adjusted composite rate payment system on April 1, 2005.
                    </P>
                    <P>
                        For the implementation of the basic case-mix payments, we are providing an adjustment for low BMI, that is, any patient with a BMI less than 18.5 kg/m
                        <SU>2</SU>
                        . We included this variable because our regression analysis indicated that those patients who are underweight and malnourished consume more resources than other patients. Although we received one comment suggesting defining low BMI as 20 kg/m
                        <SU>2</SU>
                        , we chose the measure of low BMI that is consistent with the CDC and NIH definition for malnourishment. Furthermore, our exploration of alternative BMI thresholds did not improve the model's ability to predict the costs of composite rate services.
                    </P>
                    <P>
                        In addition, we are providing case-mix adjustments based on BSA. Our research into this body measurement indicated that BSA (meters
                        <SU>2</SU>
                        ) is a good predictor of composite rate resource consumption. We examined all of the formulas for BSA. While we found very little differences between the formulas in predictive power, we are adopting the Dubois and Dubois formula for BSA since our literature search revealed that this particular formula was the most widely known and accepted. This formula is: BSA=W
                        <SU>0.425</SU>
                         * H
                        <SU>0.725</SU>
                         * 0.007184 (DuBois D. and DuBois, EF. “A Formula to Estimate the Approximate Surface Area if Height and Weight be Known”: Arch. Int. Med. 1916 17:863-71.), where w and h represent weight in kilograms and height in centimeters, respectively.
                    </P>
                    <P>In addition, we explored a number of options for setting the reference values for the BSA. We examined the distributions for both the midpoint of the BSA and the count of dialysis patients by age, body surface and low BMI. Based on this analysis, we are setting the reference point at a BSA of 1.84 (the average BSA among dialysis patients in 2002). By setting the reference point at the average BSA, the adjusters will reflect the relationship of a specific patient's BSA to the average BSA of all patients. Therefore, some adjusters will be greater than 1.0 and some will be less than 1.0. In this way, we are able to minimize the magnitude of the budget neutrality offset to the composite payment rate.</P>
                    <P>
                        The following presents an example of the method for calculating patient level multipliers that were derived from the coefficients resulting from the regression model that includes control variables, expanded age groups, BSA, and an indicator for low BMI (&lt;18.5 kg/m
                        <SU>2</SU>
                        ). The model excluded small facilities, and outliers.
                    </P>
                    <FP SOURCE="FP-2">Case-mix adjuster = Age factor * low BMI factor * BSA factor</FP>
                    <P>Although we could have selected any increment, we believed an increment of 0,1 provided and appropriate degree of precision of the calculation of the exponent used to compute the BSA case-mix adjustment. The BSA factor is defined as an exponent equal to the value of the patient's BSA minus the reference BSA of 1.84 divided by 0.1. The BSA adjustment factor of 1.037 is then exponentiated based on the calculated BSA factor as 1.037 ((BSA - 1.84)/0.1)</P>
                    <P>
                        <E T="03">For Example:</E>
                         The case-mix adjuster for a 47-year old person who is underweight (BMI&lt;18.5 kg/m
                        <SU>2</SU>
                        ) and has a body surface area of 2.0 m
                        <SU>2</SU>
                         is calculated by using the 1.84 BSA reference point:
                    </P>
                    <FP SOURCE="FP-2">Age Factor = 1.055</FP>
                    <FP SOURCE="FP-2">Low BMI Factor = 1.112</FP>
                    <FP SOURCE="FP-2">
                        BSA Factor = 1.037 ((2.0-1.84)/0.1) = 1.037 
                        <SU>(1.6)</SU>
                         = 1.060
                    </FP>
                    <FP SOURCE="FP-2">Case-Mix Adjuster = 1.055 * 1.112 * 1.06 = 1.244</FP>
                    <P>The resulting case-mix adjustment factor of 1.244 for this patient would be applied to the facility's composite payment rate that is adjusted for area wage index, drug add-on, and budget neutrality.</P>
                    <HD SOURCE="HD3">11. Budget Neutrality for Case-Mix Adjustment</HD>
                    <P>Section 1881(b)(12)(E)(i) of the Act, as added by section 623(d)(1) of the MMA, requires that the basic case-mix adjusted composite rate system be designed to result in the same aggregate amount of expenditure for such services, as estimated by the Secretary, as would have been make for 2005 if that paragraph did not apply. Therefore, the patient characteristics case-mix adjustment required by section 623(d)(1) of the MMA must result in the same aggregate expenditures for 2005 as if these adjustments were not made.</P>
                    <P>
                        In order to account for the payment effect related to the case-mix adjustment, we proposed to standardize the composite rate by dividing by the average case-mix modifier of 1.1919. The proposed budget neutrality adjustment to the composite rate was 0.8390. However, we were not able to simulate case-mix effects at the bill level 
                        <PRTPAGE P="66330"/>
                        because co-morbidities are generally not reported on the ESRD bill. We still intend to refine our case-mix adjustments once we have more complete patient data on the ESRD bill. In this final rule, we have refined our adjustment for budget neutrality related to the case-mix factor. We simulated payment for each ESRD provider by applying a facility-specific case-mix multiplier to the composite rate applicable for that facility. Since the pediatric case-mix adjustment was developed outside the regression model, we simulated payments separately for those treatments. The results of these tow computations were then combined to arrive at the total case-mix adjusted payments. We also simulated payment for each provider as if they did not receive any case-mix adjustments. We then compared the total simulated payments with case-mix adjustment to total simulated payments without case-mix adjustment. The resulting budget neutrality adjustment to the composite rate is 0.9116. 
                    </P>
                    <HD SOURCE="HD2">B. Revised Patient Characteristic Adjustments </HD>
                    <P>The following section discusses in detail the final case-mix adjustments to the ESRD composite rate payment. </P>
                    <P>In summary, based on the comments that we received on the proposed case-mix and additional analyses prepared by our contractor, KECC, in this final rule, we are modifying the proposed case-mix adjustments. We have broadened the number of age groups to include five age categories and added low BMI and BSA as measures. We have also included a specific case-mix adjustment for pediatric patients under age 18. We excluded the proposed categories gender and co-morbid conditions. We will be using a limited number of patient characteristics for the basic case mix system; however, we believe that these adjustments adequately explain variation in the reported costs per treatment for the composite rate services consistent with the legislative requirement. The adjustment factors for the basic case mix are listed in Table 13 below. </P>
                    <GPH SPAN="3" DEEP="237">
                        <GID>ER15NO04.509</GID>
                    </GPH>
                    <P>The following table illustrates the average case-mix adjustment by type of provider based on the 2002 data that was used to develop the adjustment factors. </P>
                    <GPH SPAN="3" DEEP="238">
                        <PRTPAGE P="66331"/>
                        <GID>ER15NO04.510</GID>
                    </GPH>
                    <P>As illustrated in table 14, regardless of the type of provider, the projected average case-mix adjustments for patient characteristics do not vary significantly. </P>
                    <HD SOURCE="HD2">C. Rural Facilities </HD>
                    <P>
                        <E T="03">Comments:</E>
                         Some commenters focused on the potential impact the revised composite rate payment system could have on rural facilities. They were initially concerned that excluding small facilities from the overall sample actually reflected the elimination of rural facilities from the sample. As a means of resolving this issue, they suggested that a rural facility exception be restored. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         The MMA provision for composite rate exceptions limited the availability of exceptions only to pediatric facilities. To the extent that a qualifying pediatric facility is located in a rural area, it would be able to apply for an exception to its composite payment rate. 
                    </P>
                    <HD SOURCE="HD2">D. Dual Eligible Dialysis Population </HD>
                    <P>
                        <E T="03">Comment:</E>
                         One commenter expressed concerns regarding potential impact on the dual eligible population, specifically with respect to coverage of deductibles and coinsurance amounts. Concern was expressed regarding the impact of this proposal on the Medicaid population on a state-by-state basis. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We recognize that this is an important issue for ESRD facilities and can be particularly problematic for chain organizations that own facilities in multiple States. While we cannot direct States for payment for dual eligible beneficiaries, we will take appropriate action to ensure that States are aware of the changes we are implementing so they can take steps to adjust their payments for dual eligible dialysis patients. 
                    </P>
                    <HD SOURCE="HD2">E. Budget Neutrality </HD>
                    <P>Section 623(d)(1) of the MMA added section 1881(b)(12)(E)(i) of the Act, which requires that the basic case-mix adjusted composite rate system be designed to result in the same aggregate amount of expenditure for services, as estimated by the Secretary, as would have been made for 2005 if that paragraph did not apply. Therefore, the drug add-on adjustment and the patient characteristics case-mix adjustment required by section 623(d)(1) of the MMA must result in the same aggregate expenditures for 2005 as if these adjustments were not made. </P>
                    <P>For the proposed drug payment add-on adjustment, we indicated in the proposed rule that the methodology we used to estimate the difference between the current and proposed drug payments was designed so that aggregate payments would be budget neutral. </P>
                    <P>In addition, the proposed rule provided for a budget neutrality adjustment to the composite payment rate of 0.8390 to account for the effects of the proposed case-mix adjustments on aggregate expenditures. </P>
                    <P>
                        <E T="03">Comment:</E>
                         We received a number of comments concerning our application of the budget neutrality provision of section 623 of MMA. Specifically, many comments suggested that we did not comply with Congressional intent that facilities would be held harmless by this provision, that is, that facilities would not receive lower payments then they otherwise would have. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         Section 623 of MMA requires that aggregate payments in 2005 not exceed payments that would otherwise be paid. The budget neutrality provision is to ensure that total aggregate payments from the Medicare trust fund will not increase or decrease as a result of changes in the payment methodology. As with other Medicare payment systems, changes in the payment mechanism will result in the redistribution of Medicare dollars across facilities. There is no provision (nor any implication) in section 623 of the MMA that guarantees that individual facilities would receive the same amount of payment under a case-mix adjusted system as they did previously. 
                    </P>
                    <P>The final budget neutrality adjustment to the ESRD composite payment rate applicable to the case mix adjustments (including the pediatric adjustment) is 0.9116. Also in the proposed rule, the calculation of the drug add-on adjustment was designed to ensure budget neutrality with respect to aggregate drug payments. </P>
                    <HD SOURCE="HD2">F. Geographic Index </HD>
                    <P>
                        <E T="03">Comment:</E>
                         Several comments expressed disappointment that we did not propose revisions to the current outdated wage indexes reflected in the composite payment rates, despite the discretionary authority set forth in section 623(d)(1) of the MMA to replace them. These comments stated that this decision likely would have the greatest impact on facilities located in high cost and high wage areas, where competitive labor market pressures are more 
                        <PRTPAGE P="66332"/>
                        pronounced. Comments generally were in favor of using the most up-to-date information available for developing a revised composite rate wage index. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         The wage index currently used in the composite rates is a blend of two wage index values, one based on hospital wage data from fiscal year 1986 and the other developed from 1980 data from the Bureau of Labor Statistics. The wage index is calculated for each urban and rural area based on 1980 U.S. Census definitions of metropolitan statistical areas (MSAs) and areas outside of MSAs. Restrictions apply to the wage index values used to develop the composite payment rates. Payments to facilities in areas where labor costs fall below 90 percent of the national average, or exceed 130 percent of that average, are not adjusted below the 90 percent or above the 130 percent level. This effectively means that facilities located in areas with wage index values less than 0.90 are paid more than they would receive if we fully adjusted for area wage differences. Conversely, facilities in locales with wage index values greater than 1.30 are paid less than they would receive if we fully adjusted payment for these higher wage levels. 
                    </P>
                    <P>We agree that the current ESRD composite rate wage indexes, and the definitions of the geographic areas on which they are based, need to be updated. On June 6, 2003, OMB issued Bulletin 03-04, which announced new geographic areas based on the 2000 Census. The extent to which we use the new OMB geographic definitions, incorporate them into the various prospective payment systems (PPSs) we administer, and whether we rely on hospital wage and employment data to develop new composite rate wage index values will have the potential to significantly redistribute payments among ESRD facilities. </P>
                    <P>
                        In the August 11, 2004 
                        <E T="04">Federal Register</E>
                         (69 FR 48916), we announced how we were revising the hospital wage index used in connection with inpatient PPS. Although one comment stated that we should adopt the same wage index used in connection with the inpatient PPS, several of the hospital wage index revisions stem from specific provisions of law (for example, geographic reclassification of hospitals) and would not necessarily be appropriate to apply to a revised ESRD wage index for the composite payment rates. Because of the discretion afforded the Secretary in developing a new wage index for ESRD payment purposes, we are carefully assessing the propriety and payment implications of policy options before recommending revisions to the current measure. We will not take action to replace the current composite rate wage index at this time. We point out that, in accordance with section 623(d)(1) of the MMA, any revisions to the wage index ultimately adopted must be phased in over a multiyear period. 
                    </P>
                    <HD SOURCE="HD2">G. Payment Exceptions and the Revised Composite Payment Rate </HD>
                    <HD SOURCE="HD3">1. Application of Statutory Increases to Exception Amounts </HD>
                    <P>
                        <E T="03">Comment:</E>
                         Several comments were critical of our policy of not applying increases to composite rates, mandated by the Congress, to amounts paid under exceptions. The comments maintained that this policy is inequitable, precludes the proper application of inflation updates to costs that we had recognized as appropriate in granting the exception, and over time erodes the value of the exception because of the cumulative impact of an effective “historical freeze.” 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         The commenters are correct that we have only applied the Congressionally mandated statutory increases to the basic wage index adjusted composite payment rates, not to exception payments. For example, a provider which was authorized a $12.00 atypical services exception amount per treatment in addition to its otherwise applicable composite payment rate of $125.00 effective August 12, 2000 would not be entitled to the 2.4 percent increase applicable to composite rate payments on January 1, 2001, because its exception rate of $137.00 exceeded its basic rate of $125.00 increased by 2.4 percent or $128.00. While the commenter believes that our policy of not applying the Congressional mandated increases to exception amounts is unfair, we believe that the policy is consistent with the law. Section 422(a)(2)(C) of SCHIP, enacted December 21, 2000, states as follows in pertinent part:
                    </P>
                    <EXTRACT>
                        <P>Any exception rate under such section in effect on December 31, 2000  * * * shall continue in effect so long as such rate is greater than the composite rate as updated * * *.</P>
                    </EXTRACT>
                    <P>Thus, the statute seems to distinguish between an exception rate and the composite rate, as “updated” by the Congress. The clear implication of the text is that the exception rate is not so updated. Accordingly, we believe that our policy of not applying mandated composite rate increases to exception amounts is consistent with the statute. Moreover, we point out that section 422(a)(2) of SCHIP prohibited the granting of new exceptions and that we are providing facilities the option of either retaining their exception rates, or at any time, electing payment under the case-mix adjusted composite payment rates. We do not believe providers, given this option, will be disadvantaged. </P>
                    <HD SOURCE="HD3">2. Home Dialysis Training Exceptions </HD>
                    <P>
                        <E T="03">Comment:</E>
                         We received comments asking for clarification concerning home dialysis training exceptions since the proposed rule only addressed exceptions in a very general way. They stated that the rule proposes that each facility with an exception rate would compare their exception rate to the new basic case-mix adjusted prospective payment and then decide if it wishes to withdraw the exception rate and be subject to the basic case-mix adjusted composite rate. The commenters stated that this language does not consider a facility that would choose to accept the basic case-mix adjusted prospective payment for its chronic treatments, but continue its exception rates for the training of home patients. The home training exception is the most widely used exception and provides a higher rate for the higher cost of training a patient in fewer than the maximum number of allowed treatments. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We agree and are providing that a home training exception rate may be continued. Facilities with home training exceptions will be able to retain their current exception training rates as well as take advantage of the case-mix adjusted rate for non-training dialysis. 
                    </P>
                    <HD SOURCE="HD3">3. New Exception Window </HD>
                    <P>
                        <E T="03">Comment:</E>
                         One commenter requests that a new “exceptions window” for pediatric facilities be opened in early 2005. It will not be until after this rule is final that its members will be able to determine the exact impact of this new methodology on their operations. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         Section 623(b) of MMA reinstated exceptions for qualifying pediatric facilities defined as facilities with at least 50 percent of their patients under 18 years of age. The current exception window for pediatric facilities closed on September 27, 2004. At this time, future exception windows will be open only for pediatric facilities. The exceptions process is opened each time there is a legislative change in the composite payment rate or when we open the exception window. The fiscal intermediary will notify the ESRD pediatric facilities when a new exception window opens. However, it is our intent to open pediatric exception windows on an annual basis. 
                        <PRTPAGE P="66333"/>
                    </P>
                    <HD SOURCE="HD3">4. Home Dialysis Training Rates </HD>
                    <P>
                        <E T="03">Comment:</E>
                         One commenter asked if the training rate add-on to the composite rate would still be applied. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         Yes, the following rates will apply for self-dialysis or home dialysis training sessions: 
                    </P>
                    <P>• For intermittent peritoneal dialysis (IPD), continuous cycling peritoneal dialysis (CCPD) and hemodialysis training, the facility's case-mix adjusted payment excluding any approved exception rates will be increased by $20 per training session, furnished up to three times per week. </P>
                    <P>• For continuous ambulatory peritoneal dialysis (CAPD), the facility's case-mix adjusted payment excluding any approved exception rates will be increased by $12 per training session, furnished up to three times per week. </P>
                    <P>Based on the example for John Smith in section L (Example of Payment Calculation Under the Case-Mix Adjusted Composite Rate System), the hemodialysis (IPD &amp; CCPD) training rate would be his case-mix adjusted rate of $170.80, increased by the training add-on of $20 for a total training rate of $190.80. For CAPD training, the training rate would be $182.80 ($170.80+$12) </P>
                    <HD SOURCE="HD2">H. Implementation Date </HD>
                    <P>
                        <E T="03">Comment:</E>
                         We received a number of comments supporting our proposed delay in implementing the case-mix portion of the revised composite payment methodology. Many comments maintained that the proposed April 1, 2005 effective date was overly ambitious, and some suggested that a July 1, 2005 implementation date would be more realistic given the need for facility and fiscal intermediary training and education. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         The MMA requires that the basic case-mix adjusted composite payment rates be effective for services beginning January 1, 2005. Despite the statute's specificity, we pointed out in the proposed rule that all of the numerous systems, programming, and operational changes necessary to implement the case-mix adjusted payments cannot be completed in time for a January 1, 2005 implementation date. 
                    </P>
                    <P>As presented in the proposed rule, we considered two options that we believed effectively complied with the statute's January 1, 2005 implementation date. While we stated in the proposed rule that either of these options substantively complies with the January 1, 2005 implementation date requirement of the statute, we rejected both alternatives. </P>
                    <P>The likelihood of payment error, potential disruption of facility payments, and the cost of reprocessing bills militated against either option. We proposed instead an April 1, 2005 implementation date for the basic case-mix adjustments to the composite payment rates, including the budget neutrality reduction. This option avoids the need for reprocessing of bills and applies the budget neutrality adjustment applicable to the case-mix adjustments effective April 1, 2005. Although we agree with the comment that a July 1, 2005 effective date would be ideal in light of the systems and operational changes required to implement the case-mix provisions, we believe that an April 1, 2005 effective date for the case-mix adjustments is feasible, and have decided not to revise that date. We have concluded based on our evaluation of ESRD claims processing systems that the April 1, 2005 implementation date is achievable. As we stated in the proposed rule, the 1.6 percent increase to the composite payment rates and drug add-on will be effective January 1, 2005. </P>
                    <HD SOURCE="HD2">I. Summary of Final Rule Implementing Changes to the ESRD Composite Payment Rate (Section 623 of MMA) </HD>
                    <P>As set forth in this final rule, we will increase the ESRD composite payment rates by 1.6 percent effective January 1, 2005 in accordance with section 623(a) of the MMA. Also, the composite payment rates will be increased January 1, 2005 by 8.7 percent to reflect revisions to the drug pricing methodology for separately billable drugs, as discussed previously in this rule (Composite Rate Adjustments to Account for Changes in Pricing of Separately Billable Drugs and Biologicals). This section explains the development and computation of the revised drug add-on, which differs from the 11.3 percent amount described in the proposed rule, and our response to comments which advocated separate add-on amounts for hospital-based and independent facilities.</P>
                    <P>Despite the discretionary authority set forth in section 623(d)(1) of the MMA to replace the current outdated wage index used in the composite payment rates, we are taking no action to revise the wage index at the present time. A revised wage index will potentially significantly redistribute ESRD payments. We believe that further study is warranted before we revised the current index. Those assessments are presently underway. </P>
                    <P>We have also adopted a revised basic case-mix methodology for adjusting the composite payment rates based on a limited number of patient characteristics, as prescribed in section 623(d) of the MMA. The development and application of the revised case-mix adjusters were previously explained in the “Revised Patient Characteristic Adjustments” section of this final rule. The variables for which adjustments will be applied to each facility's composite payment rate include age, BSA, and low BMI. In response to comments, we eliminated gender in this final rule as a patient classification variable for purposes of case-mix adjustment, substituting BSA and a low BMI variable instead. We have also increased the number of age categories from three to five, and eliminated co-morbidities pending further study. Because height and weight are necessary to compute each patient's BSA and BMI, those measurements, in centimeters and kilograms, respectively, will be required on the UB 92 for outpatient ESRD services furnished on and after January 1, 2005. This final rule also provides for a case-mix adjustment of 1.62 to a facility's composite payment rate for pediatric ESRD patients (that is, under age 18). The methodology used to develop the pediatric case-mix adjustment factor of 1.62 is described in the “Case-Mix Adjustment for Pediatrics Patients” section of this rule. Although the MMA requires that the basic case-mix adjusted composite payment rates be effective for services beginning January 1, 2005, the systems and operational changes necessary to implement them cannot be completed in time for a prospective January 1, 2005 effective date. The case-mix adjustments and the applicable budget neutrality adjustment of 0.9116 will be effective April 1, 2005. </P>
                    <HD SOURCE="HD2">Example of Payment Calculation Under the Case-Mix </HD>
                    <HD SOURCE="HD2">Example 1 </HD>
                    <HD SOURCE="HD3">Adjusted Composite Rate System </HD>
                    <P>The following example presents 2 patients dialyzing at Neighbor Dialysis, an independent ESRD facility located in Baltimore, MD. </P>
                    <HD SOURCE="HD2">Calculation of Basic Composite Rate for Neighbor Dialysis</HD>
                    <FP SOURCE="FP-2">Wage adjusted composite rate for independent facilities in Baltimore, MD: $134.93 </FP>
                    <FP SOURCE="FP-2">Wage adjusted composite rate increased by drug  add-on adjustment $134.93 × 1.087: $146.67</FP>
                    <FP SOURCE="FP-2">Adjusted Facility Composite Rate after budget neutrality adjustment ($146.67 × 0.9116): $133.70</FP>
                    <HD SOURCE="HD2">Patient #1 </HD>
                    <P>
                        John Smith attains age 18 on April 10, 2005 and undergoes hemodialysis. John 
                        <PRTPAGE P="66334"/>
                        weighs 75.5 kg. and is 181.5 cm. in height. Because John Smith attains age 18 April 10, he is considered age 18 for the entire month of April, and would not be classified as a pediatric patient. 
                    </P>
                    <HD SOURCE="HD2">Calculation of Case Mix Adjusted Payment </HD>
                    <P>The BSA and BMI for John Smith will be calculated by the PRICER program used to compute the composite payment for each patient based on the height and weight reported on the UB 92. However, the computations of the BSA and BMI for John Smith are shown below: </P>
                    <FP SOURCE="FP-2">
                        BSA = 0.007184 × (height) 
                        <SU>0.725</SU>
                         × (weight) 
                        <SU>0.425</SU>
                    </FP>
                    <FP SOURCE="FP-2">
                        BSA = 0.007184 × 181.5 
                        <SU>0.725</SU>
                         × 75.5
                        <SU>0.425</SU>
                    </FP>
                    <FP SOURCE="FP-2">BSA = 0.007184 × 43.4196 × 6.2824 = 1.960</FP>
                    <FP SOURCE="FP-2">
                        BMI = weight/height(m) 
                        <SU>2</SU>
                    </FP>
                    <FP SOURCE="FP-2">John Smith is 181.5 cm. in height, which converts to 1.815 meters. </FP>
                    <FP SOURCE="FP-2">
                        BMI = 75.5/1.815 
                        <SU>2</SU>
                         = 22.919
                    </FP>
                    <P>
                        The case mix adjustment factor for John Smith, an 18 year old whose BMI exceeds 18.5 kg/m
                        <SU>2</SU>
                         and has a BSA of 1.960 is calculated as follows:
                    </P>
                    <FP SOURCE="FP-2">Age adjustment factor (age 18-44) 1.223 </FP>
                    <FP SOURCE="FP-2">
                        BMI adjustment factor (BMI ≥ 18.5 kg/m
                        <SU>2</SU>
                        ) 1.000
                    </FP>
                    <FP SOURCE="FP-2">
                        BSA adjustment factor (1.037
                        <E T="51">1.960-1.84/0.1</E>
                        ) 1.0446
                    </FP>
                    <FP SOURCE="FP-2">Case mix adjustment factor (1.223 × 1.000 × 1.0446) 1.2775 </FP>
                    <FP SOURCE="FP-2">Basic case mix adjusted composite payment ($133.70 × 1.2775) $170.80 </FP>
                    <HD SOURCE="HD2">Patient 2 </HD>
                    <P>Jane Doe is a 82 year old malnourished patient who undergoes hemodialysis. Jane is 158.0 cm. in height. </P>
                    <HD SOURCE="HD2">Calculation of Case Mix Adjusted Payment </HD>
                    <P>The BSA and BMI for Jane Doe, which will be automatically computed by the PRICER program, are calculated as follows:</P>
                    <FP SOURCE="FP-2">
                        BSA = 0.007184 × (height) 
                        <SU>0.725</SU>
                         × (weight) 
                        <SU>0.425</SU>
                    </FP>
                    <FP SOURCE="FP-2">
                        BSA = 0.007184 × 158.0 
                        <SU>0.725</SU>
                         × 31.25 
                        <SU>0.425</SU>
                    </FP>
                    <FP SOURCE="FP-2">BSA = 0.007184 × 39.2669 × 4.3183 = 1.2182 </FP>
                    <FP SOURCE="FP-2">
                        BMI = weight/height(m) 
                        <SU>2</SU>
                    </FP>
                    <FP SOURCE="FP-2">Jane Doe is 158 cm. in height, which converts to 1.580 meters. </FP>
                    <FP SOURCE="FP-2">
                        BMI = 31.25/1.580 
                        <SU>2</SU>
                         = 12.5180
                    </FP>
                    <P>
                        The case mix adjustment factor for Jane Doe, an 82 year old whose BMI is less than 18.5 kg/m
                        <SU>2</SU>
                         and has a BSA of 1.2182, is calculated as follows: 
                    </P>
                    <FP SOURCE="FP-2">Age adjustment factor (age 80+) 1.174 </FP>
                    <FP SOURCE="FP-2">
                        BMI adjustment factor (BMI ≤ 18.5 kg./m
                        <SU>2</SU>
                        ) 1.112 
                    </FP>
                    <FP SOURCE="FP-2">
                        BSA adjustment factor (1.037 
                        <E T="51">1.2182-1.84/0.1</E>
                        ) 0.7978 
                    </FP>
                    <FP SOURCE="FP-2">Case-mix adjustment factor (1.174 × 1.112 × 0.7978) 1.0415 </FP>
                    <FP SOURCE="FP-2">Basic case mix adjusted composite payment ($133.70 × 1.0415) $139.24 </FP>
                    <HD SOURCE="HD2">Example 2 </HD>
                    <P>Linda Jones is age 16 and undergoes peritoneal dialysis at Community Hospital, a hospital-based facility in New York City. Linda weighs 35 kg and is 160.0 cm in height. The basic composite rate for Linda Jones is calculated as follows:</P>
                    <FP SOURCE="FP-2">Wage adjusted composite rate for hospital-based facilities in New York, New York: $146.35</FP>
                    <FP SOURCE="FP-2">Wage adjusted composite rate increased by drug adjustment factor ($146.35 × 1.087): $159.08</FP>
                    <FP SOURCE="FP-2">Adjusted Facility Composite Rate after budget neutrality adjustment ($159.08 × 0.9116) $145.02</FP>
                    <P>Because Linda is a pediatric ESRD patient, the automatic pediatric adjustment factor of 1.62 applies. Neither the age, BMI, nor BSA adjustments are applicable because Linda is less than age 18.</P>
                    <FP SOURCE="FP-2">Pediatric adjusted composite rate ($145.02 × 1.62) $234.93</FP>
                    <P>If Community Hospital were entitled to a composite rate exception, then the provider could elect to retain its exception rate in lieu of receiving the otherwise applicable pediatric payment rate of $234.93. </P>
                    <HD SOURCE="HD2">Impact Analysis </HD>
                    <P>
                        <E T="03">Comment:</E>
                         One commenter observed that the budgetary impact on the Medicare program of proposed section 623 changes (impact table) generally indicates an “overall” neutral or modest reimbursement increase for all types of dialysis facilities (independent and rural, for profit and non-profit, urban and rural). This commenter requested data that indicate the number of dialysis facilities that are operating at a loss in the U.S., by corresponding facility characteristics shown in the impact table. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         The purpose of the impact table is to simulate what ESRD facilities will receive in payments under the MMA section 623 changes compared to what ESRD facilities would receive without any changes to the current composite payment rates. We do not have data to determine whether or not a facility may operate at a loss under MMA section 623. 
                    </P>
                    <HD SOURCE="HD2">J. Section 731—Coverage of Routine Costs for Category A Clinical Trials </HD>
                    <P>Before the enactment of the MMA, Medicare did not cover services related to a noncovered Category A device. The MMA authorizes Medicare to cover the routine costs associated with certain Category A clinical trials for services furnished on or after January 1, 2005. For a trial to qualify for payment, it must meet certain criteria to ensure that the trial conforms to appropriate scientific and ethical standards. In addition, the MMA established additional criteria for trials initiated before January 1, 2010 to ensure that the devices involved in these trials are intended for use in the diagnosis, monitoring, or treatment of an immediately life-threatening disease or condition. Seven commenters were in favor of this provision. Of them, four had additional comments. One commenter was against the provision. </P>
                    <P>
                        <E T="03">Comment:</E>
                         One commenter stated that this provision would result in money being taken away from the pool of money for physician payments of non-experimental procedures. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We considered this issue in determining the SGR for 2005. Since we have made a regulatory change to allow for coverage of routine costs associated with Category A clinical trials, we are required by statute to reflect any increased costs of this policy in the 2005 SGR. At this time, we are estimating that the costs associated with coverage of routine costs of Category A clinical trials will increase Medicare spending for physicians' services by less than 0.1 percent. However, we are reviewing this issue and we will adjust our estimates once we have actual spending data for 2005. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         One commenter specifically requested that we define routine costs. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We discuss and define routine costs in section 310.1 of the Medicare National Coverage Determination Manual (pub 100.3). We will take this comment into consideration if we decide to revise section 310.1 in the future. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         Two commenters recommended that we adopt a definition of “immediately life-threatening” that would allow contractors some level of flexibility when they apply this criteria to evaluate trials. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We will consider the importance of some level of flexibility in defining “immediately life-threatening.” Although we are not defining this term in our regulation, we intend to provide guidance through implementing instructions. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         Another commenter suggested that contractors determine in advance if trials satisfy the immediately life threatening requirement. 
                        <PRTPAGE P="66335"/>
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We are considering implementation requirements and will take this suggestion under advisement. 
                    </P>
                    <HD SOURCE="HD2">Result of Evaluation of Comments </HD>
                    <P>We are finalizing the changes to § 405.207 as proposed. </P>
                    <HD SOURCE="HD2">K. Section 629—Part B Deductible </HD>
                    <P>Section 629 of the MMA provides for regular updates to the Medicare Part B deductible in consideration of inflationary changes in the nation's economy. Since 1991, the Medicare Part B deductible has been $100 per year. The MMA stipulates that the Medicare Part B deductible will be $110 for calendar year 2005, and, for a subsequent year, the deductible will be the previous year's deductible increased by the annual percentage increase in the monthly actuarial rate under section 1839(a)(1) of the Act, ending with that subsequent year (rounded to the nearest dollar). Section 1839(a)(1) of the Act requires the Secretary of Health and Human Services to calculate the monthly actuarial rate for Medicare enrollees age 65 and over. </P>
                    <P>We proposed to update § 410.160(f), “Amount of the Part B annual deductible,” to conform to the MMA and to reflect that the Medicare Part B deductible is $100 for calendar years 1991 through 2004. </P>
                    <P>
                        <E T="03">Comment:</E>
                         Commenters stated that they understand that we are following the statute in implementing this provision, but encouraged us to educate Medicare beneficiaries regarding this change.
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We agree that it is important to educate beneficiaries about the deductible, as well as the other provisions of the MMA, such as the new screening benefits, and we will be using publications such as the “Medicare and You Handbook” for this purpose. 
                    </P>
                    <HD SOURCE="HD2">Result of Evaluation of Comments </HD>
                    <P>We are finalizing the proposed changes to § 410.160(f). </P>
                    <HD SOURCE="HD2">L. Section 512—Hospice Consultation </HD>
                    <HD SOURCE="HD3">1. Coverage of Hospice Consultation Services </HD>
                    <P>As discussed in the proposed rule published August 5, 2004, effective January 1, 2005, section 512 of the MMA provides for payment to a hospice for specified services furnished by a physician who is either the medical director of, or an employee of, a hospice agency. Payment would be made on behalf of a beneficiary who is terminally ill (which is defined as having a prognosis of 6 months or less if the disease or illness runs its normal course), has not made a hospice election, and has not previously received the pre-election hospice services specified in section 1812(a)(1)(5) of the Act as added by section 512 of the MMA. These services comprise an evaluation of an individual's need for pain and symptom management, counseling the individual regarding hospice and other care options, and may include advising the individual regarding advanced care planning. </P>
                    <P>We believe that most individuals will seek this type of service from their own physicians. Thus, we do not expect that the services of a hospice physician would be necessary for all individuals who elect hospice. However, a beneficiary, or his or her physician, may seek the expertise of a hospice medical director or physician employee of a hospice to assure that a beneficiary's end-of-life options for care and pain management are discussed and evaluated. </P>
                    <P>Currently, beneficiaries are able to receive this evaluation, pain management, counseling, and advice through other Medicare benefits. For example, physicians who determine the beneficiary's terminal diagnoses can provide for these E/M services as well as for pain and symptom management under the physician fee schedule. Beneficiaries may also obtain assistance with decisions pertaining to end-of-life issues through discharge planning by social workers, case managers, and other health care professionals. To the extent that beneficiaries have already received Medicare-covered evaluation and counseling for end-of-life care, the hospice evaluation and counseling would seem duplicative. We plan to monitor data regarding these services to assess whether Medicare is paying for duplicative services. </P>
                    <P>In the proposed rule, we proposed to cover the services described above for a terminally ill beneficiary when the services are requested by a beneficiary or the beneficiary's physician. The service would, in accordance with the statute, be available on a one-time basis to a beneficiary who has not elected or previously used the hospice benefit, but who might benefit from evaluation and counseling with a hospice physician regarding the beneficiary's decision-making process or to provide recommendations for pain and symptom management. The beneficiary or his or her physician decides to obtain this service from the hospice medical director or physician employee. Thus, the evaluation and counseling service may not be initiated by the hospice, that is, the entity receiving payment for the service. </P>
                    <P>The statute specifies that payment be made to the hospice when the physician providing the service is an employee physician or medical director of a hospice. Therefore, other hospice personnel, such as nurse practitioners, nurses, or social workers, cannot furnish the service. The statute requires that the physician be employed by a hospice; therefore, the service cannot be furnished by a physician under contractual arrangements with the hospice or by the beneficiary's physician, if that physician is not an employee of the hospice. Moreover, if the beneficiary's physician is also the medical director or physician employee of a hospice, that physician already possesses the expertise necessary to furnish end-of-life evaluation, management, and counseling services and is providing these services to the beneficiary and receiving payment for these services under the physician fee schedule through the use of E/M codes. </P>
                    <P>In the event that the individual's physician initiates the request for services of the hospice medical director or physician, we indicated in the proposed rule that we would expect that appropriate documentation guidelines would be followed. The request or referral would be in writing, and the hospice medical director or employee physician would be expected to provide a written note on the patient's medical chart. The hospice employee physician providing these services would be required to maintain a written record of this service. If the beneficiary initiates the services, we would expect that the hospice agency would maintain a written record of the service and that communication between the hospice medical director or physician and the beneficiary's physician would occur, with the beneficiary's permission, to the extent necessary to ensure continuity of care. </P>
                    <P>We proposed to add new § 418.205 and § 418.304(d) to implement section 512 of the MMA. </P>
                    <P>
                        <E T="03">Comment:</E>
                         Several commenters requested that this provision be extended to contracted physicians and nurse practitioners. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         Section 1812(a)(5) of the Act explicitly indicates that a physician employed by a hospice agency must provide the services under this provision. We recognize that contractual relationships are permitted by hospice agencies for medical director and physicians' services under the hospice benefit as described in section 1861(dd) of the Act. However, the plain language of section 1812(a)(5) provides only for employees of the hospice to furnish the service. 
                        <PRTPAGE P="66336"/>
                    </P>
                    <P>Section 1812(a)(5) of the Act also requires that this service be provided by a physician as defined in section 1861(r)(1) of the Act. While nurse practitioners may serve as attending physicians for beneficiaries who have elected the hospice benefit, this provision does not permit non-physicians to provide this pre-hospice service. </P>
                    <P>
                        <E T="03">Comment:</E>
                         We received several comments that supported this provision as beneficial for end-of-life care. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We believe that this provision supports and supplements options available to beneficiaries as they make end-of-life decisions when the individual's health care provider and community resources are not able to provide the expertise and information. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         We received a comment suggesting that the certification of a terminal illness, with a 6-month prognosis if the disease runs its normal course, be eliminated and that this service should be available to any individual deemed to be terminal. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         Section 1812(a)(5) of the Act explicitly indicates that this one-time service is available to Medicare beneficiaries who are terminally ill and have not previously elected the hospice benefit. Section 1861(dd)(3)(A) of the Act defines the phrase “terminally ill” as denoting a medical prognosis that the individual's life expectancy is 6 months or less. Since section 1812(a)(5) of the Act specifies that the beneficiary must have a terminal illness, which includes the 6-month prognosis, we have no authority to eliminate this definition. 
                    </P>
                    <P>Since the benefit is a pre-hospice one, we have not required that a certification be completed before this service is provided. Nonetheless, in the judgment of the individual's physician, the individual must be terminally ill, that is, having a 6-month or less life expectancy if the disease or illness runs its normal course. </P>
                    <HD SOURCE="HD3">2. Payment for Hospice Consultation Services </HD>
                    <P>
                        Section 512(b) of the MMA amends section 1814(i) of the Act and establishes payment for this service at an amount equal to an amount established for an office or other outpatient visit for E/M associated with presenting problems of moderate severity and requiring medical decision-making of low complexity under the physician fee schedule, other than the portion of such amount attributable to the practice expense component. No existing CPT or HCPCS code specifically represents these services. We proposed establishing a new HCPCS code, G0337 (proposed as G0xx4) 
                        <E T="03">Hospice—evaluation and counseling services, pre-election.</E>
                         The hospice would use this new HCPCS code to submit claims to the Regional Home Health Intermediary (RHHI) for payment for this service. Utilization of the code would allow us to provide payment for the service, as well as enable us to monitor the frequency with which the code is used and assess its appropriate use. Payments by hospices to physicians or others in a position to refer patients for services furnished under this provision may implicate the Federal anti-kickback statute. 
                    </P>
                    <P>In accordance with the statute, we proposed that the payment amount for this service would be based on the work and malpractice expense RVUs for CPT code 99203 multiplied by the CF (1.34 Work RVU + 0.10 Malpractice RVU) * (CF). The CPT code for an office or outpatient visit for the E/M of a new patient represents a detailed history, detailed examination and medical decision making of low complexity. We believe that this E/M service is quite similar to the components of the new service provided by a medical director or physician employed by the hospice agency. Assuming that there are no changes in RVUs for CPT code 99203, and that the CY 2005 update to the physician fee schedule is the 1.5 percent specified in the MMA, the national payment amount for this service would be $54.57 for this service (1.44 * $37.8975). </P>
                    <P>
                        <E T="03">Comment:</E>
                         We received several comments indicating that CPT Code 99203, a mid-level office visit with a new patient, does not accurately reflect the complexity associated with the hospice consultation. One commenter suggested using CPT code 99205. In addition, commenters stated that payment for this benefit should reflect the length and intensity of each consultation. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         Section 1814(i)(4) of the Act explicitly states that the payment for this service be equal to an amount established for an office or outpatient visit with presenting problems of moderate severity and requiring low complexity medical decision-making. We believe that CPT code 99203, rather than CPT code 99205, most closely conforms to the statutory language. However, in order to establish a payment rate that excludes the practice expense component and to ensure that we pay for the service only once, we established a G code. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         We received one comment that indicated that existing consultation codes coupled with a place of service should be used. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We appreciate the concern about introducing another code into a complex system of codes. While the title of the provision indicates that this is a consultative service, we believe that, unlike other consultations, beneficiaries are able to seek this service without a referral. Moreover, we need to be able to distinguish this service so that we can ensure that it is furnished only once to an individual. In addition, existing E&amp;M codes are billed by physicians. This provision is billed by the hospice agency and is not a result of reassignment of payment by a physician to a hospice agency. Finally, the G code will allow us to track utilization of this new benefit.
                    </P>
                    <HD SOURCE="HD2">Result of Evaluation of Comments</HD>
                    <P>
                        We are adopting our proposed policy and revising the regulations at § 418.205 and § 418.304(d). We are also finalizing our proposal to pay for this service using a G code (G0337) 
                        <E T="03">Hospice—evaluation and counseling services, pre-election,</E>
                         with the payment based on the work and malpractice expense RVUs for CPT code 99203.
                    </P>
                    <HD SOURCE="HD2">M. Section 302—Clinical Conditions for Coverage of Durable Medical Equipment (DME)</HD>
                    <P>
                        Section 1832(a)(1)(E) of the Act, as added by section 302(a)(2) of the MMA, requires the Secretary to establish clinical conditions of coverage standards for items of DME. The statute requires the Secretary to establish types or classes of covered items that require a face-to-face examination of the individual by a physician or specified practitioner. Due to the timeframe and the extensive number of public comments received, we will implement this provision at a later date. We will address all public comments in a future 
                        <E T="04">Federal Register</E>
                         document.
                    </P>
                    <HD SOURCE="HD2">N. Section 614—Payment for Certain Mammography Services</HD>
                    <P>Medicare covers an annual screening mammogram for all beneficiaries who are women age 40 and older and one baseline mammogram for beneficiaries who are women age 35 through 39. Medicare also covers medically necessary diagnostic mammograms. Payment for screening mammography, regardless of setting, is paid under the physician fee schedule, but diagnostic mammography performed in the hospital outpatient department is currently paid under the hospital outpatient prospective payment system (OPPS).</P>
                    <P>
                        As stated in the August 5, 2004 proposed rule, section 614 of the MMA amended section 1833(t)(1)(B)(iv) of the 
                        <PRTPAGE P="66337"/>
                        Act to exclude payment for screening and diagnostic mammograms from the OPPS. Beginning January 1, 2005, we will pay for diagnostic mammograms under the OPPS based on the payments established under the physician fee schedule. Thus, both diagnostic and screening mammography services provided in the OPPS setting will now be paid based on the physician fee schedule.
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         Commenters expressed support for this proposed change in payment and believe it will assist in ensuring that these services are available to women at risk for breast cancer.
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We agree that it is important to ensure access to these services. Additional discussion of the MMA provision can also be found in the OPPS final rule, “Medicare Program; Changes to the Hospital Outpatient Prospective Payment System and CY 2005 Payment Rates'' currently under development.
                    </P>
                    <HD SOURCE="HD2">O. Section 305—Payment for Inhalation Drugs</HD>
                    <P>The August 5, 2004 proposed rule contained the ASP plus 6 percent payment amounts based on data received from manufacturers' ASP for the first quarter of 2004 for albuterol sulphate and ipratropium bromide. We indicated that such payment amounts were not the payment rates for 2005 and specified that Medicare payment rates for the first quarter of 2005 would be based on data submitted by manufacturers from the third quarter of 2004.</P>
                    <P>We proposed to establish a separate dispensing fee for inhalation drugs. We noted that Medicare currently pays a monthly dispensing fee of $5 for each inhalation drug used in a nebulizer. We requested information about an appropriate dispensing fee amount.</P>
                    <P>We also proposed to make several changes related to billing for inhalation drugs. We proposed to allow a prescription for inhalation drugs written by a physician and filled by a pharmacy to be increased from 30-day to a 90-day period. We indicated that we had recently revised the guidelines regarding the time frame for delivery of refills of DMEPOS products to occur no sooner than “approximately five days” prior to the end of usage for the current product. We emphasized the word “approximately” in this time frame. The change allows shipping of inhalation drug refills on “approximately” the 25th day of the month in the case of a 30-day supply and on “approximately” the 85th day in the case of a 90-day supply. We indicated our belief that such revision eliminates the need for suppliers to use overnight shipping of inhalation drugs and allows shipping of inhalation drugs by less expensive ground service. </P>
                    <P>We also clarified the ordering requirements for DMEPOS items, including drugs. Drugs, including, inhalation drugs, can be dispensed with a verbal physician order and without a written prescription. Although a written prescription must be obtained before submitting a claim, we reiterated that we allowed photocopied, electronic, or pen and ink prescriptions. We pointed out the recent revision to the Program Integrity Manual of acceptable proof of delivery requirements for DMEPOS items. Finally, we proposed to eliminate the requirement that pharmacies have a signed Assignment of Benefits (AOB) form from a beneficiary in order for Medicare to make a payment. Our proposal would eliminate a billing requirement for all drugs, including inhalation drugs and other items where Medicare payment is only made on an assigned basis. </P>
                    <P>
                        <E T="03">Comment:</E>
                         A number of commenters, particularly retail pharmacies, indicated that they are not able to obtain albuterol sulfate at the $0.04 per milligram and ipratropium bromide at the $0.30 per milligram rates specified in the proposed rule based on manufacturer submissions of data for the first quarter of 2004. A large company indicated that the ASPs stated in the proposed rule for albuterol sulfate and ipratropium bromide were extremely close to its own acquisition costs and inferred that the payment amount would be below smaller providers' purchase prices. A commenter questioned the suggestion in the proposed rule that because albuterol sulfate and ipratropium bromide are generic drugs with multiple manufacturers a pharmacy might be able to obtain them at a price below the average. The commenter suggested that this is highly speculative because we have not yet received the information from manufacturers to set the ASP for the first quarter of 2005. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         The ASP plus 6 percent prices for drugs in the proposed rule were calculated based on manufacturer submissions of data covering the first quarter of 2004. We indicated that such ASP plus 6 percent figures were not actual payment rates for the first quarter of 2005. ASP data submitted by manufacturers for the second quarter of 2004 show some significant changes for inhalation drugs. The data show that the ASP plus 6 percent would be $0.05 per milligram for albuterol sulfate, a 25 percent increase, and $0.45 per milligram for ipratropium bromide, a 50 percent increase. We also note that in its recent study, “Medicare: Appropriate Dispensing Fee Needed for Suppliers of Inhalation Therapy Drugs” (GAO-05-72), the GAO found that acquisition costs of inhalation drugs varied widely. The GAO found that acquisition costs of albuterol sulfate ranged from $0.04 to $0.08 and ipratropium bromide ranged from $0.23 to $0.64. Based on the submission of manufacturer's average sales price data for the second quarter of 2004, Medicare's payment rates for ipratropium bromide and albuterol sulfate are within the acquisition cost range found by the GAO. The GAO also found that acquisition cost was not necessarily related to the size of the supplier. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         One commenter suggested that we should consider delaying the implementation of cuts in Medicare reimbursement for inhalation drugs until 2006. The commenter suggested that a delay would ensure that physicians and beneficiaries have a range of options available for managing respiratory diseases. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We do not believe that we can delay the implementation of the ASP payment system until 2006 because the MMA provides for the implementation of the ASP payment system in 2005. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         Commenters strongly supported our proposal to pay a separate dispensing fee for inhalation drugs, but we received varied comments on the scope of services appropriately included in a dispensing fee. Commenters indicated that an appropriate dispensing fee is necessary because the costs associated with dispensing these drugs typically exceed ASP plus six percent. Without adequate compensation, commenters argued that Medicare beneficiary access to inhalation drugs would be harmed. Commenters referenced an August 2004 report prepared for the American Association of Homecare (AAH) by a consultant that surveyed 109 homecare pharmacies between the end of May and the middle of July 2004. Commenters cited survey results from the report suggesting that 89 percent of suppliers would discontinue providing inhalation drugs to Medicare beneficiaries in the absence of adequate compensation. One commenter believes it is reasonable to expect that reducing Medicare payment for inhalation drugs will trigger an increase in emergency room visits, doctor visits, and hospital admissions. Other commenters suggested a dispensing fee that is too low would result in a concentrated market, thereby adversely affecting beneficiary choice and access. 
                        <PRTPAGE P="66338"/>
                    </P>
                    <P>The AAH study indicated that in order to maintain 2004 levels of service to Medicare beneficiaries and provide an operating margin of 7 percent, Medicare would have to pay an additional payment of $68.10 per service encounter. This figure includes an average of the costs reported as being incurred during the first quarter of 2004 for the pharmacies that responded to the AAH survey. The study defined a service encounter as each instance one or more billing codes were submitted to Medicare for payment. The study reported that the typical Medicare beneficiary has 8.8 service encounters each year, or one service encounter every 42 days. Most commenters who cited the AAH study supported a fee of $68.10 per service encounter. </P>
                    <P>Commenters also cited another AAH report, dated September 2001 (and updated to 2003) from a different consultant, who surveyed a sample of 19 homecare pharmacies and found that drug acquisition costs accounted for 26 percent of costs incurred by homecare pharmacies. Facility, labor, delivery, patient care and education, billing and collection costs and other direct costs were found to account for 46 percent; indirect costs such as management information systems, regulatory compliance programs, professional liability insurance and field and corporate administration was 25 percent; and bad debt was 3 percent. The study concluded that homecare pharmacies generated after-tax returns of 9.2 percent. </P>
                    <P>A retail pharmacy commented that a dispensing fee five to six times the current dispensing fee of $5 is necessary to cover its costs. Another retail pharmacy indicated that a dispensing fee of $25 would be an adequate dispensing fee, including the additional costs of processing Medicare claims and instructing the patient on using the drugs, and would be profitable for it. </P>
                    <P>A manufacturer urged CMS to conduct a study of the appropriate pharmacy activities and their costs in calculating a dispensing fee. The commenter believes such a study would yield a more accurate amount than data and information provided as part of comments to proposed rules does. One inhalation company indicated that the costs of rent, delivery and salary had recently increased by specific percentages. Several commenters opposed the inclusion in the dispensing fee of a transitional payment. Another commenter strongly urged establishing a dispensing fee that include an appropriate transitional payment, given the significant payment reductions scheduled to begin in 2005. </P>
                    <P>On the scope of services, commenters indicated that various services involved with dispensing inhalation drugs to Medicare beneficiaries such as: (i) Training beneficiaries and caregivers on proper use of drugs with nebulizers; (ii) establishing and revising a plan of care and coordinating care; (iii) providing in-home visits; (iv) providing 24-hours/7-days a week on-call personnel; (v) contacting physicians and beneficiaries regarding dispensing of inhalation drugs; (vi) providing follow-up contact with beneficiaries, including compliance monitoring and refill calls. Commenters indicated that they felt CMS has the authority to pay for costs associated with delivering inhalation drugs under the durable medical equipment (DME) benefit. </P>
                    <P>An association representing pharmacists recommended an expansion of Part B to include compensation for therapy management services furnished by pharmacists. An association representing respiratory therapists recommended a separate payment for beneficiary training by practitioners with documented evidence of education, clinical training and competency testing, such as respiratory therapists. A company suggested that we establish a basic dispensing fee and separately reimbursable codes for those who provide additional services, reflecting the range of management services involved with inhalation drugs. Another association acknowledged that although limited peer reviewed studies exist on the role of homecare providers and the respiratory practitioners in furnishing care to COPD patients, significant anecdotal data and a consensus within the pulmonary medicine and respiratory therapy professional communities support the role and contribution of home respiratory care providers. Several commenters indicated that training a beneficiary on using a nebulizer should also be reimbursed. However, they pointed out that training cannot be done by the physician or physician's staff because many physicians do not have a nebulizer on which to train the beneficiary and the Medicare payment is not sufficient to cover the physician's staff time. </P>
                    <P>
                        <E T="03">Response:</E>
                         We appreciate the support for our proposal to establish a dispensing fee as well as the information about the levels and components of such a fee. 
                    </P>
                    <P>The October 12, 2004 GAO report is based on a survey of 12 companies representing 42 percent of the inhalation therapy market. The GAO found wide variation in suppliers' monthly costs associated with dispensing inhalation drugs. In addition, the GAO found that large suppliers do not necessarily have lower costs and do not necessarily realize economies in costs associated with dispensing inhalation therapy drugs. The GAO indicated that the wide range is due in part to the range of services offered by suppliers and that some costs incurred by suppliers may not be necessary to dispense inhalation drugs, for example marketing, overnight shipping, and 24-hour hotlines for beneficiary questions. The GAO report indicates that the range of costs suppliers are incurring is a good starting point for a dispensing fee amount, but that the appropriate dispensing fee Medicare pays must take into account how excess payments affect the costs. </P>
                    <P>We note the extreme variation that the GAO found in the costs of dispensing nebulized drugs to Medicare beneficiaries: GAO found that per patient monthly costs of dispensing these medications ranged from a low of $7 to a high of $204 in 2003. Because it appears that the GAO survey and the 2004 AAH survey may have included different costs and services, further research is needed to understand these differences. In addition to the GAO and AAH studies, we note the wide range of comments indicating what services a dispensing fee should cover. We believe that before a determination can be made as to an appropriate dispensing fee for inhalation drugs after 2005, we need to more fully understand the components of and the reasons behind the current variability in the costs of furnishing of these drugs and the services being provided. We intend to work with the AAH, others concerned with inhalation therapy and our partners in the Department of Health and Human Services to explore these issues more fully. </P>
                    <P>
                        In the interim, for 2005, we are establishing a $57 monthly fee and an $80 90-day fee for furnishing inhalation drugs using data in the AAH study and the GAO report. We established the monthly fee based on the weighted average of the costs for new and established patients from the 2004 AAH study after excluding sales and marketing, bad debt, and an explicit profit margin. Because the AAH study did not establish a fee for the 90-day period, we applied the methodology used in the GAO report to the data in the AAH study to calculate the 2005 90-day fee. Accordingly, we assumed that direct costs associated with a monthly fee are similar to the direct costs associated with the 90-day fee and then we tripled the indirect costs. We intend to further examine the conversion of per 
                        <PRTPAGE P="66339"/>
                        encounter costs as reported in the AAH study to comparable monthly and 90-day cost figures. 
                    </P>
                    <P>We note that although the AAH study contained costs related to services that may be of potential benefit to our beneficiaries, and many commenters indicated that we should provide payment for these and the other services described above, we are concerned that these services may be outside the scope of a dispensing fee. We are continuing to study these services and associated cost categories as the new payment systems are implemented and we gain experience with them. We intend to revisit this issue and proceed through notice and comment rulemaking in order to establish an appropriate dispensing fee for 2006. </P>
                    <P>
                        <E T="03">Comment:</E>
                         A commenter suggested that the dispensing fee be established on a per dose basis. It was argued that this would provide Medicare with protection against pharmacies dispensing partial shipments or shipments more frequently than 30 or 90 days in order to increase the number of dispensing fees. We received comments in support of a need-based dispensing fee to accommodate additional drugs when beneficiaries suffer from disease flare-ups. We also received comments indicating that beneficiary's prescriptions change, often during the first month. Other commenters cited the AAH study, which calculated different costs associated with dispensing inhalation drugs for new patients and established patient. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         The dispensing fee we are establishing covers all drugs shipped to a beneficiary during a month (or 90-day period) regardless of the number of times a supplier ships inhalation drugs to a beneficiary. If a supplier does not supply the prescription in full, it is the supplier's responsibility to fill and deliver the remainder of the prescription, but Medicare will not pay additional monthly dispensing fees. We will monitor the issue about partial shipments and potentially erroneous billing for multiple monthly dispensing fees. We also are concerned that a per-dose dispensing fee could provide an incentive to supply more drugs. 
                    </P>
                    <P>The 2005 fee is an average across all beneficiaries, new and established, and covers additional drugs shipped during a month if a beneficiary's prescription changes. We will study the issue further of different dispensing fees for new and established beneficiaries and the frequency that additional drugs are shipped for prescription changes. </P>
                    <P>
                        <E T="03">Comment:</E>
                         A manufacturer recognized that compounded products can be covered under certain circumstances and that compounding could be included appropriately in a dispensing fee. Another manufacturer expressed concern about including compounding in the activities that a dispensing fee covers. A suggestion was made that a HCPCS modifier be used for inhalation drugs that are compounded. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         The costs of compounding are included in the AAH study but are not separately identified in the direct cost line items. Because the 2005 fee is based on the AAH study, we need to avoid duplicate payment. With compounding bundled into the fee for 2005, we have concerns about paying separately for compounding in 2005. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         A commenter recommended that we address compounding circumstances that might be inconsistent with FDA's policy prohibiting pharmacy compounding of two or more separate FDA-approved products when a combination product approved by the FDA is commercially available and compounding that might be done without the necessary controls to ensure drug product sterility and potency. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         The fact that we consider compounding to be included in the 2005 fee to furnish inhalation drugs does not in any way support practices that are inconsistent with FDA guidelines. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         The commenter also suggested that we consider creating a HCPCS modifier for drugs that a prescribing physician intends to be compounded but which a pharmacy dispenses separately in non-compounded form. The commenter believes that such a modifier would help discourage pharmacies from leaving the responsibility for compounding to the beneficiary who would be combining the drugs in non-sterile, uncontrolled conditions. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We understand the commenter's concerns and will study this issue. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         We received comments suggesting that the actual savings attributable to MMA section 305 may be both higher and lower than the November 20, 2003 Congressional Budget Office (CBO) estimate for MMA section 305. One company suggested that the actual savings could be less than estimated by CBO because the ASP model potentially motivates drug manufacturers to increase drug costs, which will be directly passed on to the government. Other commenters cited two different estimates from the AAH report. Using one calculation, the commenters argued that a dispensing fee of $68.10 per encounter would still enable Medicare to achieve savings of $350 million per year or more than $4 billion over 10 years. Using another calculation, the commenters argued that the savings would be $7 billion over the 10-year budget-scoring window. The commenters indicated that the $4 billion savings figure was comparable to the initial projections made by the Congressional Budget Office (CBO) in 2003 and the $7 billion figure was in excess of the CBO estimated savings. Commenters cited these figures to argue that establishment of a per service encounter fee of $68.10 would set the payment at the level originally envisioned by Congress. Another commenter suggested that a dispensing fee of $0.85 per 2.5 mg dose for albuterol sulfate and $0.97 per dose for a blended mix of other inhalation drugs including ipratropium bromide would be consistent with what they believe are the 17.7 percent savings assumed by CBO. One commenter indicated that CBO underestimated the savings from section 305. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         MMA specifically requires the use of the ASP methodology to establish more appropriate payment rates for drugs. MMA explicitly requires the establishment of a supplying fee for Part B covered oral drugs as determined to be appropriate by the Secretary. MMA also explicitly requires establishment of a furnishing fee for blood clotting factors. However, MMA does not specify a particular dispensing fee amount for inhalation drugs, nor does MMA specify a method to determine a dispensing fee for inhalation drugs. Accordingly, CMS used existing authority to propose in the NPRM that an appropriate dispensing fee be established. Because MMA did not require a specific method or amount for a dispensing fee for inhalation drugs, we find the arguments unpersuasive that a dispensing fee of a particular amount was envisioned by Congress or consistent with Congressional intent as reflected in a CBO estimate. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         We received comments that supported and opposed the use of 90-day prescriptions. One commenter supporting the proposed change indicated that most beneficiaries who receive nebulized medications suffer from chronic lung diseases and will require medication to manage their disease for prolonged periods. The commenter indicated that allowing a prescription for 90-days would reduce paperwork and redundant effort for beneficiaries, physicians and DME suppliers. A commenter indicated that there would be modest savings in dispensing, billing and shipping costs with allowance of a 90-day supply of 
                        <PRTPAGE P="66340"/>
                        refills. One company suggested savings of 12.5 percent, most notably in shipping. Commenters opposing 90-day prescriptions gave various reasons, including that beneficiaries may experience side effects and change prescriptions within the first month and a certain percent of beneficiaries die each month resulting in non-returnable product. In addition, some argued that pharmacy savings for a 90-day shipment would not be significant because shipping costs account for only an estimated 16 percent of supplier's non-acquisition costs associated with providing inhalation drugs. Another company argued that a 90-day shipment would substantially increase provider's expenses for boxes and shipping. Some commenters agreed that certain chronic use medications should be provided in larger quantities, but urged caution due to the practices of some suppliers who automatically ship additional product without knowing whether the patient's current supply is exhausted. Some comments suggested that a 60-day supply might be more cost-effective in the long-term because there would be a reduced risk that large quantities of medications might be wasted. Another commenter suggested that the policy be defined to cover only drugs that are proven to be stable for at least 90 days following dispensing. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         As we indicated in the proposed rule, we believe that reasonableness should govern filling a monthly vs. 90-day prescription depending on the circumstances of the beneficiary. We agree with the commenter that the initial prescription for a new patient should be written for a 30-day period because of the potential for adverse reactions or changes in the treatment regimen. We would expect prescriptions for new patients to be for 30-day periods. In addition, we believe that it is reasonable for physicians to write a 30-day prescription for those beneficiaries who they believe are less stable. Similarly, we believe that refill prescriptions for 90-day periods are reasonable, particularly for stable beneficiaries. Although the Medicare program would achieve savings from the appropriate use of 30-day and 90-day prescriptions, we believe that given the comments it would be prudent for us to monitor the 90-day supply issue. Section 4.26.1, the Proof of Delivery Methods section of the Program Integrity Manual, instructs that suppliers of DMEPOS product refills contact the beneficiary prior to dispensing the refill to ensure that the refilled item is necessary and confirm any changes or modifications to the order. Suppliers who ship either a 30-day or 90-day supply of inhalation drugs without knowing the beneficiary's current supply is exhausted would be in violation of this policy. The 90-day period should not be of concern for inhalation drugs because most of these drugs are stable for at least 90-days and thus can be dispensed for such period. We would revisit this issue if additional inhalation drugs that are unstable after 90-days become available. 
                    </P>
                    <P>Because we received limited data on costs of furnishing a 90-day supply, it is more difficult to determine a 2005 fee for furnishing a 90-day supply of inhalation drugs. However, given that this is an optional payment arrangement for beneficiaries whose course of treatment has stabilized to the point that the required dosage can be predicted with a reasonable degree of certainty over a 90-day period, we believe that it is important to establish a 90-day fee. As described earlier, we are establishing a 90-day fee for furnishing inhalation drugs by applying the methodology from the GAO report to the data in the AAH study. We assumed all of the direct costs associated with a monthly fee are similar to the direct costs associated with a 90-day fee and we tripled the indirect costs. We plan to study this issue further. </P>
                    <P>
                        <E T="03">Comment:</E>
                         Many commenters acknowledged that most DMEPOS items, including drugs, can be dispensed based on verbal orders. Several commenters objected to the requirement that a written order from the physician still must be obtained before billing. They suggested that we revise policy so that a prescription could be both filled and billed based solely on a verbal order from a physician. They pointed out that the requirement that a pharmacy still obtain a written order for a prescription in order to be able to bill Medicare creates a significant administrative burden for a pharmacy because it often requires persistent follow-up with a physician. Another commenter suggested that we consider accepting electronic transmissions of prescriptions, for example, e-scripts. Another commenter requested clarification of the rule for dispensing based on a verbal order for inhalation drugs and the proposed requirement that an order for an item of DMEPOS be signed and dated within 30 days of a face-to-face examination of a beneficiary. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         The policy that allows dispensing based on a verbal order but requires a written order for billing applies to all DMEPOS items. This policy balances fraud and abuse concerns with prompt dispensing of DMEPOS items to beneficiaries. Written orders from the physician can be faxed, photocopied, or provided via electronic or pen and ink forms. In accordance with current policy, pharmacies may accept electronic prescriptions from physicians. 
                    </P>
                    <P>Beneficiaries receiving inhalation drugs are having face-to-face exams routinely and generally do not need additional visits to re-order their drugs. A single face-to-face exam is generally sufficient for items ordered, that is, we would not require a separate face-to-face exam for the nebulizer and for the inhalation drugs. We assume that physicians would order them at the same time because they are used together. </P>
                    <P>
                        <E T="03">Comment:</E>
                         One commenter supported the revision made earlier this year that provides flexibility regarding the timeframe for refilling Medicare prescriptions. The commenter noted that most third party plans allow pharmacies to refill prescriptions within five days of the end of usage for the previous prescription quantity dispensed. Another commenter recommended that the time frame for subsequent deliveries be expanded beyond five days. The commenter indicated that they believe a five-day time frame is too short a period for ground service and would not eliminate the need for overnight shipping. This is based on the commenter's experience that beneficiaries do not respond to calls to confirm that they need additional supply until the beneficiary has only a few days' supply left. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         As we indicated in the proposed rule, the revised time frame for delivery of refills of DMEPOS products provides for refills to occur no sooner than “approximately five days prior to the end of the usage for the current product.” In the proposed rule we emphasized the word “approximately.” While we believe that normal ground service would allow delivery in five days, if there were circumstances where ground service could not occur in five days, the guideline would still be met if the shipment occurs in six or seven days. As another commenter noted, the five-day standard is consistent with the time frame for shipping used by most third party plans. Given the consistency with private sector plans, because the requirement applies to all DMEPOS product refills, and because the standard is not a firm five-day limit, we do not believe that it is necessary to lengthen the standard. We will study further the ability of a supplier to contact beneficiaries for refills compared with its ability to provide 
                        <PRTPAGE P="66341"/>
                        beneficiary and caregiver training on a monthly basis. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         One commenter indicated that the DMERCs have not consistently implemented the revised proof of delivery provisions but that they are engaged in dialogue with CMS and the DMERCs to clarify the requirements and standardize their interpretation across the four DMERCs. Other commenters suggested that the proof of delivery requirement be eliminated. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We encourage dialogue to ensure consistent understanding and application of the proof of delivery requirements. The proof of delivery requirements have recently undergone an extensive review and revision and, based on the need to prevent fraud and abuse, we see a need to continue them. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         Those commenters who addressed our proposed elimination of the Assignment of Benefits (AOB) form for items and services, including drugs, where assignment is required by statute, supported our proposed change. Commenters agreed that obtaining an AOB in each instance is redundant because the supplier is required by statute to accept the assignment. Some commenters suggested that a onetime AOB be obtained from the beneficiary that will be valid for every DMEPOS item he or she receives during the period of his or her medical necessity. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We appreciate the support for our proposal. As discussed in section IV of this final rule, we are adopting our proposal to eliminate the requirement for AOB form for items and services, including drugs, where assignment is required by statute. We do not agree with the suggestion to allow for a one-time AOB form to cover items and services provided in the future because there could be fraud and abuse issues. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         We received conflicting comments about the impact of the changes and clarifications relating to billing requirements on the costs of dispensing inhalation drugs. 
                    </P>
                    <P>Commenters differed on the impact of the revisions to the proof of delivery requirements that we pointed out in the proposed rule that went into effect in early 2004. One company that currently uses automated systems indicated that the revision to the proof of delivery requirements would not generate savings for them. Commenters indicated that the DMERCs have not consistently implemented the changes, and that consequently there has not been significant administrative relief and subsequent savings. </P>
                    <P>We received conflicting comments about the impact of the revised time frame for shipping guidelines. While one commenter indicated that savings had already been achieved because the provision had already been implemented, another commenter indicated that the revision would have negligible effect because the commenter would not change its existing business practice of using overnight shipping. </P>
                    <P>One commenter said it had already adopted the provision of prescriptions being filled by verbal order, followed up by a written order for the claim submission and that these changes did not generate any additional savings for the commenter. Some suggested that the elimination of the AOB form for drugs would have limited savings because some suppliers currently obtain the AOB form at the same time that they obtain other forms that would be continued. Retail pharmacies agreed that elimination of the AOB form and verbal prescription order would reduce their paperwork. However, inhalation companies did not agree. </P>
                    <P>
                        <E T="03">Response:</E>
                         We understand the commenters concerns and will study the impact of these billing changes on the different suppliers' costs as the new payment system is implemented. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         Several commenters suggested that we review and consider changing several aspects of billing that might have cost-savings potential for suppliers of drugs. Several commenters indicated that Medicare's lack of on-line adjudication represented a significant cost and burden to them. One retail pharmacy commented that pharmacies face higher than normal rejection rate on claims because Medicare claims are not processed on-line, resulting in higher administrative costs. Others commented that pharmacies that dispense Medicare prescriptions must obtain documentation that is typically provided by the physician. For example, one company indicated that suppliers are held responsible for the appropriate medical necessity documentation in the patient's medical record but that the supplier has no control over physician records. Some suggested that we consider eliminating the requirement that a diagnosis code be required on the prescription. One pharmacy commented that pharmacies should not be expected to verify that the physician has in fact performed a face-to-face exam for the purpose of treating and evaluating the patient's medical condition or whether the physician has created appropriate documents in his records. Rather, the pharmacy believes that this responsibility should be left to the physician, and the creation of a prescription should be all that is needed to verify that the physician has complied with all Medicare requirements. A commenter noted that Medicare requires that suppliers submit claims with the physician's Unique Physician Identification Number (UPIN) while most third party plans require the physician's DEA number and suggested that we consider adopting usage of the physician's DEA number instead of UPIN. A pharmacy commented that dispensing units are different than current National Council for Prescription Drug Programs (NCPDP) standards; Medicare reimburses products based on a per mg price while the NCPDP standard suggests reimbursement on a per ml price. The pharmacy indicated that this makes it more difficult for the pharmacy to calculate proper reimbursement for these Medicare claims. Other commenters suggested that the Medicare enrollment and reenrollment process for suppliers be significantly streamlined. A retail pharmacy indicated that Medicare requires pharmacy suppliers to submit extensive and often duplicative pharmacy-specific paperwork that is more voluminous than any other third party plan in which retail pharmacies participate. One inhalation company suggested certain aspects of billing such as the requirement that the supplier query the physician and beneficiary to find out if the beneficiary had already received a same or similar item from another supplier. The company also identified what it claimed are several other labor-intensive, costly aspects of Medicare billing including electronic claims filing requirements; information system programming and testing; paperwork and new business procedures required to be compliant with HIPAA; Medicare and secondary insurance benefits verification and qualification; responding to significantly increased pre-payment audit activities; administering the Patient Financial Hardship Waiver prior to billing deductible and coinsurance amounts; billing and writing off beneficiary cost-sharing as bad debts; and differing DMERC policies concerning documentation needed to support home inhalation therapies. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We thank the commenters for identifying these items. We plan to examine these aspects of billing. To the extent that there are different interpretations or applications of national policy by DMERCs, our goal is increased standardization. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         A comment from a group focused on respiratory care indicated that there may be over utilization of albuterol sulfate. The comment indicated that a large amount of scientific evidence concludes that high albuterol sulfate use is indicative of 
                        <PRTPAGE P="66342"/>
                        poor overall disease management. The commenter further indicated that Medicare's costs related to the use of albuterol sulfate may result from the fact that alternative drug treatment regimes are not adequately considered in the management of the patient's disease. The commenter urged us to examine the underlying causes of high utilization rates of albuterol sulfate. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         Our goal is to ensure that Medicare beneficiaries have access to the appropriate drugs to treat their diseases. We believe that the availability of discounts through the Medicare drug card and the implementation of the Part D drug benefit beginning in 2006 promote treatment decisions being made based on the best clinical evidence, rather than being influenced by differential coverage. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         We received many comments addressing the issue of nebulizers versus metered dose inhalers (MDIs). Most commenters questioned whether a significant shift of Medicare beneficiaries to MDIs would occur when MDIs are covered in the Part D drug benefit beginning in 2006. We received many comments, studies and literature reviews on nebulizers and MDIs. Some commenters identified the specific disadvantages of MDIs and holding chambers or spacers. Some commenters questioned the conclusion of the literature review mentioned in the proposed rule that nebulizers are not clinically superior in delivering inhalation drugs than MDIs and the commenters asserted that the two are not fully substitutes. Some commenters quantified the costs to beneficiaries of nebulizers and MDIs. One commenter pointed out that MDIs would increase in 2006 based on the ban of the propellent chlorofluorocarbon. Another commenter questioned the point in the proposed rule that MDIs are more portable than nebulizers since advances in nebulizer technology have included additional portability. The commenter noted that since Medicare covers only one standard nebulizer, many of their patients have purchased portable nebulizers on an out-of-pocket basis to use as a second device while outside of their home. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         A number of drugs are available to treat the persons with asthma or who develop COPD. These include drugs, often inhaled, that expand the bronchial tubes and allow the patient to breathe more freely. Depending on the needs of the individual patient, these medications can be delivered using nebulizers or MDIs. Although nebulizers have long been covered under Medicare Part B, the MMA expanded access to MDIs beginning in 2006 through the new Medicare Part D drug benefit. While two meta-analyses cited by one commenter are consistent with the literature review mentioned in the proposed rule that found a lack of overall clinical superiority of MDIs over nebulizers, we recognize that even after coverage of MDIs begins in the Part D drug benefit in 2006, due to their particular circumstances, many beneficiaries will require the use of nebulizers and that nebulizers will continue to play an important role in inhalation therapy. Part B does not currently cover MDIs and we will gain experience with the costs of MDIs as the Part D drug benefit is implemented. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         Comments were received from respiratory drug distributors and homecare providers addressing drugs that are supplied from the manufacturer in more than one form. One company suggested that since inhalation drugs are provided by the manufacturer in two forms, a premixed solution or as a powder (or other concentrate) that is diluted by the pharmacist, the ASP should be calculated separately for each of these two forms in order to reflect the different acquisition costs to the pharmacy for the different forms. The company suggested use of a modifier for the J-code to distinguish between these two forms for reimbursement purposes. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We disagree. Consistent with the statute, the ASP is calculated by the HCPCS codes rather than the NDC code. This allows flexibility in appropriate drug delivery. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         We received letters from individual beneficiaries and their family members indicating that the beneficiary has tried MDIs unsuccessfully and that inhalation drugs administered through a nebulizer were a successful treatment. They asked us not to assume that everyone on a nebulizer could be switched to inhalers and asked that we allow inhalation medications administered through nebulizers to remain funded by Medicare. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We recognize that nebulizers are required by many beneficiaries due to their particular health circumstances. We did not propose to eliminate Medicare funding for inhalation medications administered through nebulizers. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         Several commenters questioned why there should be public funding for COPD treatments for persons who chose to smoke cigarettes. The commenters indicate that it may be too harsh a policy to cease all reimbursement for COPD treatments, but they suggested two alternatives: (1) No individual who currently smokes should receive any Medicare benefit for the treatment of any respiratory condition, and (2) Any individual who historically smoked heavily and receives treatment for respiratory disorders should face an annual deductible equal to the cost of smoking a pack of cigarettes a day. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         As we indicated in the proposed rule, smoking has been linked to a large number of health problems and is the leading cause of cancer and pulmonary disease. The Department of Health and Human Services (HHS) has been actively encouraging Americans to quit smoking through its smoking cessation initiatives. Americans who quit smoking will enjoy longer, healthier lives and avoid diseases such as COPD. However, the Medicare law does not limit benefits to persons who do not currently smoke, nor does the Medicare law impose a deductible that is different for smokers and non-smokers. This regulation implements the law as it is currently written. 
                    </P>
                    <HD SOURCE="HD2">Result of Evaluation of Comments </HD>
                    <P>In the proposed rule, we requested comments on the appropriate separate dispensing fee for inhalation drugs used in a nebulizer. In this final rule we are establishing 2005 fees of $57.00 for furnishing a 30-day prescription and $80.00 for furnishing a 90-day prescription for inhalation drugs. This fee would be paid in addition to the Medicare payment amount for the drug. </P>
                    <P>As discussed in section IV, we are finalizing our proposal to eliminate the Assignment of Benefits (AOB) form for items and services, including drugs, where assignment is required by statute. We reiterate language in the recently updated guidelines for DMEPOS refills, emphasizing the word “approximately”. This allows for refill prescriptions to be shipped by ground service on “approximately” the 25th or 85th day of the respective prescription period. In addition, we clarified the ordering requirements for DMEPOS items, including drugs, which can be dispensed with just a verbal physician order. </P>
                    <HD SOURCE="HD2">P. Section 706—Coverage of Religious Nonmedical Health Care Institution Services Furnished in the Home </HD>
                    <HD SOURCE="HD3">1. Background </HD>
                    <P>
                        Section 706(a) of the MMA amended section 1821(a) of the Act by adding home health services to the list of services furnished to an individual by a religious nonmedical health care institution (RNHCI). Section 706(b) added section 1861(aaa) to the Act to expand the term “home health agency” (HHA) to include a RNHCI. However, 
                        <PRTPAGE P="66343"/>
                        this expansion is limited to RNHCI items (specified durable medical equipment) and services furnished in the beneficiary's home when the items and services are comparable to those provided by a HHA that is not a RNHCI. Moreover, payment may not be in excess of $700,000 per calendar year, and may not be made after December 31, 2006. Accordingly, we are implementing changes to the RNHCI regulation to include services furnished in the home that result from the enactment of the MMA and that are becoming effective January 1, 2005. 
                    </P>
                    <P>The new time-limited home health services benefit will be referred to as “home benefit” or “home services” throughout this rule. The RNHCI home benefit may only be provided to an eligible beneficiary who is confined to the home for health reasons and who has a condition that makes the beneficiary eligible to receive services under Medicare home health. Additionally, the beneficiary must have an effective RNHCI election and receive his or her home services from the RNHCI. The home benefit is not a substitute for hospice care. As in the original RNHCI benefit, Medicare will pay only for nonmedical services in the home, but not for those religious items or services provided by the RNHCI. Additionally, RNHCI home service patients who have a documented need for a specified DME item can obtain that item with the applicable deductible and coinsurance. </P>
                    <HD SOURCE="HD3">2. Legislative History </HD>
                    <P>
                        In 1965, payments to Christian Science sanatoria (inpatient nonmedical care facilities for bedfast patients) were included in the initial provisions of Medicare under title XVIII of the Act. In 1996, in 
                        <E T="03">Children's Healthcare Is a Legal Duty, Inc.</E>
                         v. 
                        <E T="03">Vladeck,</E>
                         938 F. Supp. 1466 (D. Minn. 1996) (“
                        <E T="03">CHILD I</E>
                        ”), a Federal district court held that some of the provisions pertaining to Christian Science sanatoria were unconstitutional on the grounds that they were sect specific, in violation of the Establishment Clause of the U.S. Constitution. 
                    </P>
                    <P>Section 4454 of the BBA amended section 1861(a)(1) of the Act, deleting Christian Science sanatoria from the Act and creating instead the RNHCI benefit to provide Medicare Part A and Medicaid access for all religious groups whose belief structure does not include medical intervention. We note that, in the Conference Report to the BBA (H.R. Conference Report, No. 105-217, at 768 (1997)), the Congress specified that the RNHCI provisions were a sect-neutral accommodation available to any person who is relying on a religious method of healing and for whom the acceptance of medical health services would be inconsistent with his or her religious beliefs. Further, the Congressional conferees were convinced that the RNHCI provisions fully responded to and satisfied the constitutional concerns that had been addressed by the district court in CHILD I. </P>
                    <P>Besides adding the new RNHCI benefit, section 4454 of the BBA also added sections 1861(ss) and 1821 to the Act. Section 1861(ss) sets forth: </P>
                    <P>• The ten requirements that a provider must meet in order to be considered a RNHCI; </P>
                    <P>• Parameters for oversight and monitoring; </P>
                    <P>• Authority for Federal review of items and services provided for excessive or fraudulent claims; and </P>
                    <P>• Parameters for ownership/affiliations. </P>
                    <P>As in the past, the new provisions do not mention the use of a religious counselor or practitioner; we consider that to be the responsibility of the patient. </P>
                    <P>Section 1821 of the Act provides for conditions for coverage of RNHCI services including: </P>
                    <P>• The election, revocation, and limitations of the RNHCI benefit (section 1821(b)); </P>
                    <P>• The monitoring and safeguarding against expenditures (section 1821(c)); and </P>
                    <P>• The sunset provisions for the RHNCI benefit (section 1821(d)). </P>
                    <P>Section 1821(a) of the Act, as amended by the MMA, provides for Part A payment for inpatient hospital services, post-hospital extended care services, or home health services furnished to a beneficiary in, or by, a RNHCI only when the beneficiary has: </P>
                    <P>• A valid election for the RNHCI benefit in effect; and </P>
                    <P>• A condition that would qualify for inpatient hospital, extended care services, or home health if the beneficiary were an inpatient or resident in a hospital or skilled nursing facility, or was a patient residing at home under the care of a HHA that was not a RNHCI. </P>
                    <P>The election of the RNHCI benefit becomes effective immediately after execution and remains in effect for a lifetime or until revoked. As described in section 1821(b) of the Act, the election is a written statement signed by the beneficiary or the beneficiary's legal representative which states that: </P>
                    <P>• The individual is conscientiously opposed to the acceptance of nonexcepted medical treatment; </P>
                    <P>• The individual's acceptance of that nonexcepted treatment would be inconsistent with the individual's sincere religious beliefs; and </P>
                    <P>• The individual's receipt of nonexcepted medical care constitutes a revocation of the election. </P>
                    <P>The RNHCI election may be revoked by voluntarily notifying the Secretary in writing of the revocation or the election may be revoked by simply receiving nonexcepted medical care for which payment is sought under Medicare. Once a RNHCI election is revoked twice, the next election may not take place until a date that is at least one year from the date of the most recent revocation. Any election thereafter does not become effective before a date that is at least five years after the date of the previous revocation. The receipt of excepted medical care does not result in a revocation of the election. As stated in § 403.702 of the regulations, the following definitions apply—</P>
                    <P>
                        • 
                        <E T="03">Excepted medical care or treatment</E>
                         for purposes of the RNHCI benefit is defined as medical care or treatment (including medical or other health care services) received involuntarily (for example, following an accident), or required by any level of government (for example, immunizations). 
                    </P>
                    <P>
                        • 
                        <E T="03">Nonexcepted medical care or treatment</E>
                         refers to all medical care or treatment that is not defined as excepted medical care or treatment. The beneficiary always retains the right to receive medical care under Medicare based on his or her level of coverage (for example, Part A, Parts A and B). However, using nonexcepted care will result in the revocation of the RNHCI election. 
                    </P>
                    <P>
                        On November 30, 1999, we published the RNHCI interim final rule with comment period in the 
                        <E T="04">Federal Register</E>
                         (64 FR 67028), effective on January 31, 2000. The final RNHCI regulations were published on November 28, 2003 (68 FR 66710). There are currently 16 RNHCIs in the United States: Three in California; two each in Florida and Ohio; and one each in: Colorado, Illinois, Indiana, Massachusetts, New York, Texas, Virginia, Washington, and Wisconsin. 
                    </P>
                    <HD SOURCE="HD3">3. Summary of Section 706 of the MMA </HD>
                    <P>Section 706 of the MMA amended the Act to extend Medicare coverage of RNHCI items and services to the RNHCI beneficiary's home when the items and services are comparable to those provided by a HHA that is not a RNHCI. </P>
                    <P>
                        Specifically, section 706(a) of the MMA amended section 1821(a) of the Act by adding home health services to the list of services furnished to an individual by a RNHCI. Section 706(b) of the MMA added section 1861(aaa) to the Act to expand the term “home 
                        <PRTPAGE P="66344"/>
                        health agency” to include a RNHCI as defined in section 1861(ss)(1) of the Act, but only for items and services that are ordinarily furnished by a RNHCI to individuals in their homes, and that are comparable to items and services furnished to individuals by a HHA that is not a RNHCI. Section 1861(aaa)(2)(A) of the Act states that, subject to section 1861(aaa)(2)(B), payment may be made for services provided by a RNHCI only to the extent and under the conditions, limitations, and requirements that are in regulations consistent with section 1821 of the Act. Section 1861(aaa)(2)(B) states that payment may not be made for RNHCI home services under section 1861(aaa)(2)(A) of the Act in excess of $700,000 per calendar year, or after December 31, 2006. 
                    </P>
                    <P>This interim final rule amends the existing RNHCI regulations in Subpart G to implement section 706 of the MMA. </P>
                    <HD SOURCE="HD3">4. Discussion </HD>
                    <HD SOURCE="HD2">a. Implementation of Section 706 of the MMA </HD>
                    <P>As stated above, section 706 of the MMA added section 1861(aaa)(1) to the Act to expand the term “home health agency” to include a RNHCI, as defined in section 1861(ss)(1) of the Act, but only for items and services that are ordinarily furnished by that institution to individuals in their homes, and that are comparable to items and services furnished by a HHA that is not a RNHCI. This posed a number of implementation challenges as a RNHCI does not conform to the statutory definition or requirements of a HHA in section 1861(m) of the Act, which is based on a medical model. Some of these challenges result from the fact that— </P>
                    <P>• RNHCIs were established to accommodate those religious groups that do not believe in the use of physicians to direct or supervise health care; and </P>
                    <P>• RNHCI nursing does not correspond to the statutory or regulatory parameters established by Medicare for “skilled care” in the home setting. </P>
                    <P>In addition, the RNHCI payment methodology does not readily lend itself to payment to the RNHCI for items and services under the RNHCI home benefit. Therefore, in an effort to implement the intent of the amendment, we will generally use the definition and requirements for a RNHCI, rather than a HHA (with some exceptions), in order to extend RNHCI services into the home environment. However, in order to aid in determining comparability, we are also utilizing, when appropriate, some of the home health requirements set forth in section 1861(m) of the Act. </P>
                    <P>The presence of physician orders and oversight is a keystone in the operational viability of a HHA and nonexistent in the RNHCI, where the religious practitioner (noncovered by Medicare) is the primary focal person in establishing the course for the religious method of healing. In addition, the RNHCI nurse further assists the patient in navigating the course established for the religious method of healing. To address the need for oversight for the RNHCI home benefit as with the current inpatient RNHCI benefit, we are implementing section 706 of the MMA by continuing to require that the RNHCI utilization review committee review the need for care (expanded now to include both admission to the home benefit and continued care in the home setting), and to oversee the utilization of items and services in the time-limited home benefit. The utilization review committee, however, cannot act in place of a physician in ordering items and services other than those designated specifically for the purpose of this time-limited RNHCI home benefit. A claim from any other individual or provider attempting to seek Medicare payment for non-designated RHNCI home benefit items and services without a physician order will be disallowed. </P>
                    <P>We also recognize that implementing section 706 is particularly challenging in light of the fact that no sophisticated physical treatments or procedures are provided in RNHCIs, while conventional medical care becomes more technical every year, making the care delivered by HHA personnel increasingly complex. The major challenge was determining comparability between home health services for HHAs defined in part 409 subpart E, and RNHCI services which are nonmedical in nature. </P>
                    <P>Medicare pays for supportive care or dependent services under the home health benefit only when under the orders and direction of a licensed physician if there is a medical need for skilled health care by a registered nurse, physical therapist, speech-language therapist, occupational therapist, or medical social worker. Under the Medicare home health benefit, when there is no longer a need for the “skilled” health care services, the supportive dependent services no longer qualify for payment. Based on section 1861(m) of the Act, we believe that Medicare home health care benefits are skilled-care oriented. These benefits were not designed to provide coverage for care related to help with activities of daily living unless the patient requires skilled nursing care or physical or speech therapy. The RNHCI nurse may be skilled in ministering to a beneficiary's religious needs (not covered by Medicare), but does not have the training or nursing skill sets required of credentialed/licensed health care professionals (for example, a registered nurse). While the RNHCI nurse may provide supportive care, that care is focused primarily on religious healing and meeting basic beneficiary needs for assistance with activities of daily living (for example, bathing, toileting, dressing, ambulation), as part of creating an environment for religious healing. The care provided by a RNHCI nurse is not at the level of either a registered nurse or a licensed practical nurse. The physical care provided by a RNHCI nurse is at a level that could be considered as supportive, but is decidedly not skilled nursing care as that term is understood under the Medicare home health program. </P>
                    <P>In the search for comparability of services, we considered the requirements and functions of the home health aide contained in sections 1861(m) and 1891(a)(3)(A) of the Act and in the regulations at 42 CFR 484.36. We performed a parallel review of the activities and skills utilized by home health aides and RNHCI nurses to determine comparability at an operational level. We determined that both the RNHCI nurse and the home health aide perform the following basic tasks— </P>
                    <P>• Assisting with activities of daily living (ADLs) that include: ambulation, bed-to-chair transfer, and assisting with range of motion exercises; bathing, shampoo, nail care, and dressing; feeding and nutrition; and toileting; </P>
                    <P>• Performing light housekeeping, incident to visit; and </P>
                    <P>• Documenting the visit. </P>
                    <P>However, the home health aide is also responsible for— </P>
                    <P>• Care of catheters and drainage equipment; </P>
                    <P>• Checking oxygen and other respiratory equipment; </P>
                    <P>• Communicating with nurse or other skilled team members;* </P>
                    <P>• Assisting with exercises as ordered by PT, OT or speech language therapist; </P>
                    <P>• Observation and reporting of existing medical conditions;* </P>
                    <P>• Recognizing and responding to emergency situations (including CPR); </P>
                    <P>• Routine care of prosthetics and orthotics; </P>
                    <P>• Taking and reporting vital signs;* </P>
                    <P>• Using basic infection control procedures;* and </P>
                    <P>• Care of wound/stoma dressings. </P>
                    <P>
                        The home health aide during a home visit will usually perform at least three of the four skills marked with an 
                        <PRTPAGE P="66345"/>
                        asterisk (*) from the ten skills listed. The remaining areas of responsibility are carried out as indicated by the patient's needs and the patient's care plan. 
                    </P>
                    <P>
                        In analyzing the outcomes of the home health aide/RNHCI nurse review, we found that both groups engaged in the comparable tasks of assisting with activities of daily living, performing light housekeeping (incident to visit), and documenting the visit. Therefore, we will pay for the performance of these tasks by a RNHCI nurse in the home under the home benefit established by section 706 of the MMA. However, in reviewing for comparability of these services, we also found that the Medicare requirements for a home health aide exceed the preparation and skills of the RNHCI nurse for furnishing physical care. The home health aide performs activities that support the patient's prescribed medical therapeutic regimen and contribute to the Outcome and Assessment Information Set (OASIS) data collection effort. Moreover, we assumed that a significant portion of each RNHCI nurse visit is focused on religious activity (noncovered by Medicare). However, in spite of the difference in skill levels and the incorporation of non-covered religious activity into a visit, Medicare payment for the RNHCI home benefit is based on a fixed payment per visit, rather than on a total number of hours or number of caregivers involved. Unlike the home health benefit, the RNHCI benefit does not involve multiple levels of covered caregivers. Under the home health PPS only the 
                        <E T="03">low utilization payment adjustment</E>
                         (LUPA) rate provides for payment for individual home health visits. Due to the uniqueness of the RNHCI and RNHCI nurses in the Medicare program, we have developed a payment rate that is a percentage of the PPS LUPA rate for home health aide visits provided under the home health PPS, which we believe adequately represents the percentage of comparable tasks performed by the RNHCI nurse. Only a visit by a RNHCI nurse to a home is payable by Medicare. The cost for the religious portion of the visit continues to be the responsibility of the individual patient or the specific RNHCI. 
                    </P>
                    <P>Another challenge was posed by the provision of DME items for RNHCI patients in the home, since all DME is covered for Medicare payment only when ordered by a physician. That physician order may provide the RNHCI patient with the desired DME item, but will also revoke the patient's election for RNHCI care. We addressed the issue of DME by reviewing those items that are routinely found in a RNHCI that are comparable to those used by a HHA that is not a RNHCI. This resulted in a list of DME items that one could normally buy or rent off the shelf from a community pharmacy or health care supply store. For purposes of this time-limited benefit, we are permitting the RNHCI nurse to order from this list of designated items under the oversight of the RNHCI utilization review committee. A listing of these items is provided in Table 15 below. </P>
                    <BILCOD>BILLING CODE 4120-01-P</BILCOD>
                    <GPH SPAN="3" DEEP="609">
                        <PRTPAGE P="66346"/>
                        <GID>ER15NO04.511</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="82">
                        <PRTPAGE P="66347"/>
                        <GID>ER15NO04.512</GID>
                    </GPH>
                    <BILCOD>BILLING CODE 4120-01-C</BILCOD>
                    <P>We will provide the specifics for implementing the DME items and payment under this time-limited benefit in later Medicare program instructions. </P>
                    <P>Under section 1861(aaa)(2)(B) of the Act, payments for the RNHCI home benefit may not be made that exceed $700,000 per calendar year, and not after December 31, 2006. Under the RNHCI home benefit, Medicare will pay only for nonmedical health services in the home, as well as for those DME items included in Table 15 of this preamble. Medicare will not pay for religious items or services provided by the RNHCI. We have developed a special billing system for those RNHCI providers offering the home benefit to monitor expenditures on home services and items for purposes of staying within the statutory calendar year expenditure limit. </P>
                    <HD SOURCE="HD3">5. RNHCI Regulatory Provisions—RNHCI Medicare Benefits, Conditions of Participation, and Payment </HD>
                    <P>As noted previously, to implement section 706 of the MMA, we reviewed the requirements for both HHAs and RNHCIs to identify the most feasible approach. Accordingly, we have made the following changes to the RNHCI regulations:</P>
                    <HD SOURCE="HD2">a. Basis and Purpose of Religious Non-Medical Health Care Institutions Providing Home Services—§ 403.764 </HD>
                    <P>We added § 403.764 to set forth the basis and purpose of the RNHCI home benefit. Specifically, we added subsection (a) to include a reference to section 1861(aaa) of the Act to the general RNHCI authority noted in § 403.700 and a description of the provisions of section 1861(aaa). We also added subsection (b) to describe the home benefit, the statutory annual fiscal limitation, and the sunset provision.</P>
                    <HD SOURCE="HD2">b. Definitions and Terms—§ 403.702 </HD>
                    <P>We made no changes to the regulation.</P>
                    <HD SOURCE="HD2">c. Conditions for Coverage—§ 403.720 </HD>
                    <P>We made no changes to the regulation. </P>
                    <P>We wish to emphasize that the RNHCI home benefit is an option available to each RNHCI, and the facility is not required to offer this service to either gain or maintain RNHCI status. </P>
                    <P>The RNHCI home benefit is not to be confused with hospice care that may involve more frequent visits and can involve institutional services. If, for some reason, the RNHCI home-serviced patient requires more than what is provided under the RNHCI home benefit, RNHCI or other institutional services may be required.</P>
                    <HD SOURCE="HD2">d. Valid Election Requirements—§ 403.724 </HD>
                    <P>We made no changes to the regulation because no modification or clarification to this requirement is needed to implement the RNHCI home benefit. Section 1821(b) of the Act addresses the issues involved in beneficiary election of RNHCI services.</P>
                    <HD SOURCE="HD2">e. Conditions of Participation—§ 403.730 through § 403.746 </HD>
                    <P>We have not changed the following conditions of participation, as they do not require any modification or clarification for implementing the RNHCI home benefit: </P>
                    <P>• Patient Rights (§ 403.730) </P>
                    <P>• Quality Assessment and Performance Improvement (§ 403.732) </P>
                    <P>• Administration (§ 403.738) </P>
                    <P>• Staffing (§ 403.740) </P>
                    <P>We have not changed the following conditions of participation, as they are specific to institutions and are not applicable to the implementation of the RNHCI home benefit: </P>
                    <P>• Food Services (§ 403.734) </P>
                    <P>• Discharge Planning (§ 403.736) </P>
                    <P>• Physical Environment (§ 403.742) </P>
                    <P>• Life Safety From Fire (§ 403.744) </P>
                    <P>The following condition of participation requires the addition of a new standard to reflect the additional responsibility necessary for implementing the RNHCI home benefit: </P>
                    <P>• Utilization Review (§ 403.746) </P>
                    <P>As explained previously, the utilization review committee will review the need for care and oversee the utilization of items and services for the RNHCI home benefit. Accordingly, § 403.746 will be revised to reflect the additional responsibility necessary for implementing the RNHCI home benefit. Specifically, § 403.746 will be modified to add a new subsection (c) to read as follows: </P>
                    <P>
                        (c) 
                        <E T="03">Standard: Utilization review committee role in RNHCI home services.</E>
                         In addition to the requirements in (b), the utilization review committee is responsible for the admission and continued care review (at least every 30 days) of each patient in the RNHCI home services program. The utilization review committee is responsible for oversight and monitoring of the home services program, including the purchase and utilization of designated durable medical equipment (DME) items for beneficiaries in the program. 
                    </P>
                    <P>We again note that under the RNHCI home benefit, one of the tasks of the RNHCI nurse is to order from a selected group of DME items that meet the documented needs presented by a patient, if that need is presented by the patient. The utilization review committee will provide oversight for the DME orders and utilization of the items. The utilization review committee cannot act as a physician in ordering DME items other than those items designated specifically for the purpose of this time limited RNHCI benefit. A claim from any other individual or provider attempting to seek Medicare payment for non-designated RNHCI home benefit DME items without a physician order will be disallowed. </P>
                    <P>In implementing section 706 of the MMA, we have also revised the regulations to add the following provisions: </P>
                    <HD SOURCE="HD2">a. Requirements for Coverage and Payment of RNHCI Home Services (§ 403.766) </HD>
                    <P>
                        The RNHCI home benefit is an option available to each RNHCI, but it is not a service that the facility must offer to gain or maintain RNHCI status. With the exception of limited DME items, we have determined that services that RNHCI nurses provide are generally covered for Medicare payment under the time limited RNHCI home benefit as these services (for example, assistance with ADLs, light housekeeping incident to the visit, and documentation of the visit), are comparable to the services of home health aides in HHAs that are not RNHCIs. 
                        <PRTPAGE P="66348"/>
                    </P>
                    <P>
                        To reflect the requirements of this limited benefit, we are adding a new section 403.766. Specifically, in § 403.766(a), we are requiring the RNHCI provider to submit a notice of intent if it is interested in providing RNHCI home services. This will help us facilitate the implementation of the RNHCI home benefit by letting us focus our efforts on those providers interested in providing this new benefit. The RNHCI provider is also responsible for providing RNHCI home services to eligible beneficiaries. We are imposing this requirement because we believe the RNHCI provider itself is responsible for providing the RNHCI home services, directly or under arrangement, to the eligible beneficiary. This means that the beneficiary cannot contract directly with a supplier or RNHCI nurse, but that the RNHCI provider itself is responsible for provision of the RNHCI home benefit services. This requirement conforms to the “under arrangement” requirement that home health agencies generally have to comply with to receive payment under the home health prospective payment system (
                        <E T="03">see</E>
                         § 409.100(a)(2)). Furthermore, because the RNHCI is not a supplier, we are explicitly requiring the RNHCI provider to make arrangements for suppliers to furnish the designated RNHCI home benefit DME items. Likewise, the RNHCI provider will have to arrange for the RNHCI nursing services. While the RNHCI regulations currently require the RNHCI provider to have a utilization review plan and committee in place, we believe it would be prudent in the RNHCI home benefit regulation to explicitly require the RNHCI home benefit provider to have a utilization review committee that assumes the additional responsibility for the oversight and monitoring of the items and RNHCI nursing services provided under the home benefit. Lastly, because the RNHCI home benefit does not supersede or otherwise replace the existing RNHCI benefit, the provider will continue to have to meet all the existing applicable RNHCI regulatory requirements in subpart G of part 403. 
                    </P>
                    <P>We will also define an “eligible beneficiary” for the RNHCI home benefit in § 403.766(b). First, the beneficiary must elect to receive RNHCI services. Clearly, the RNHCI home benefit can only be provided to a beneficiary who has elected RNHCI services. Second, we believe that the purpose of providing a home benefit by a RNHCI provider was not to expand the basic eligibility criteria for receiving home health services. In fact, section 1821(a) of the Act, as amended by the MMA, now states that payment for RNHCI home services be made only if the individual has an election in effect and has a condition such that the individual would otherwise qualify for Medicare home health services. Specifically, this means that the individual must be confined to the home, as defined in section 1814(a) of the Aft and have a condition that would make him or her eligible to receive Medicare home health services. Third, much like the requirement that the RNHCI provider is responsible for providing RNHCI home services directly or under arrangement to the beneficiary, the beneficiary can only receive RNHCI home services through the RNHCI. The purpose of this requirement is to provide Medicare payment for the RNHCI home benefit only to beneficiaries who receive these services through the RNHCI. This requirement is consistent with section 1821(a) of the Act, as amended, which provides Medicare payment for home services furnished an individual by a RNHCI. We note that under the home health benefit beneficiaries are responsible for the deductible and coinsurance for DME furnished as a home health services. We see no reason to modify that requirement for beneficiaries receiving RNHCI home services. As this is a new benefit for RNHCI beneficiaries, we wish to make it clear that they are responsible for deductible and coinsurance for the designated RNHCI home benefit DME items in the same manner as Medicare beneficiaries receiving DME under the home health benefit. </P>
                    <HD SOURCE="HD2">b. Excluded Services (§ 403.768) </HD>
                    <P>Under the home health benefit, certain items and services are excluded under the benefit. The RNHCI home benefit will exclude the same items and services, which are: </P>
                    <P>• Drugs and biologicals; </P>
                    <P>• Transportation; </P>
                    <P>• Services that would not be covered as inpatient services; </P>
                    <P>• Housekeeping services; </P>
                    <P>• Services covered under the ESRD program; </P>
                    <P>• Prosthetic devices; and </P>
                    <P>• Medical social services provided to family members. </P>
                    <P>Accordingly, we are adding a new § 403.768 to reflect the services excluded under the RNHCI home benefit. </P>
                    <P>In addition, we note that the statute does not provide for the provision of the RNHCI home benefit in a home health agency that is not a RNHCI, and we will provide for this exclusion in the regulation. We wish to reiterate that items and services not provided by a RNHCI but instead provided by a supplier or RNHCI nurse not under arrangement with the RNHCI are not included under the RNHCI home benefit. The regulation will also note this exclusion.</P>
                    <HD SOURCE="HD2">c. Payment for RNHCI Home Services (§ 403.770) </HD>
                    <P>As discussed above, providing home services in the RNHCI environment incorporates many of the same components of the provision of home health aide services under the Medicare home health benefit. Because this is a new benefit not contemplated under the original RNHCI legislation, an appropriate payment methodology needed to be developed. As explained previously, we believe that an appropriate proxy for the cost of providing RNHCI home services can be found in the low utilization payment amount for home health aide visits under the Medicare home health PPS. Generally, Medicare home health services are reimbursed a prospectively set payment amount for a 60-day episode of care, adjusted for case mix. This 60-day episode payment includes costs for non-routine medical supplies, as well as costs for the six major home health disciplines, including home health aide services. The home health episode payment rate does not include reimbursement for durable medical equipment, which is paid through a separate DME fee schedule. The home health PPS rates were required to be budget neutral to what would have been expended under the reasonable cost system. The 60-day episode rate is updated annually by some percentage of the home health market basket, as dictated by law, and is adjusted by the hospital wage index to account for geographic variations in labor costs. </P>
                    <P>
                        Medicare home health services may also be paid on a visit basis if the home health episode has four or fewer visits. Medicare pays on the basis of a national per-visit amount by discipline, referred to as low utilization payment adjustment (LUPA), adjusted for case mix. As mentioned previously, the LUPA rate for home health aide services is a very close approximation of the cost of providing home services in the RNHCI environment. However, due to the difference in skill levels and the incorporation of RNHCI religious activities that are not covered by Medicare, payment for the RNHCI home benefit is set at 80 percent of the per visit rate for a home health aide visit under the Medicare home health benefit. 
                        <PRTPAGE P="66349"/>
                    </P>
                    <P>
                        The policies and rationale governing LUPA payments under the Medicare home health benefit are described in the July 3, 2000 HH PPS final rule (65 FR 41127). Generally, low utilization episodes are paid at a standardized average per visit amount, adjusted for geographic differences in wages, which will be the basis of calculating payment under the RNHCI home benefit program. These amounts are updated annually by the home health market basket percentage as dictated by statute and are being used for the RNHCI home benefit. For CY 2005, the Medicare HHA PPS rates were updated by the home health market basket minus 0.8 percent. The HHA PPS LUPA amount for CY 2005 is $44.76 for a home health aide visit, as published in the 
                        <E T="04">Federal Register</E>
                         October 23, 2004 (69 FR 62124). Because we believe the intent is to provide comparable home health services to a beneficiary at home provided by a RNHCI, we believe it is similarly necessary to develop a payment methodology to reflect the provision of these comparable services. As previously mentioned, we have determined that the LUPA payment, as calculated under the home health PPS and adjusted for geographic differences in wages is an appropriate payment methodology for the RNHCI home benefit. We further note that as the LUPA will be updated by the applicable market basket percentage under the home health PPS, we will also adopt the updated LUPA payment for CY 2006 as the basis of payment for the RNHCI home benefit in CY 2006. An update of the HHA payment rates is published annually in the 
                        <E T="04">Federal Register</E>
                        , with CY 2006 updated figures available in Fall 2005. As mentioned above, the beneficiary receiving the RNHCI home benefit will be responsible for deductible and coinsurance for the designated RNHCI home benefit DME items. The regulation will indicate that payment for DME as a RNHCI home item is made less the deductible and coinsurance amount. 
                    </P>
                    <P>In view of the small size and low volume of most RNHCIs, we will use a 30-day cycle for the submission of RNHCI home benefit claims. Unlike standard HHAs that use a 60-day cycle, the RNHCI will use a 30-day cycle for both payment request and as a minimum for continued care home benefit review by the utilization review committee. Specific instructions on the processing of RNHCI home benefit payments will be issued in separate Medicare instructions. </P>
                    <P>Example of LUPA Payment Adapted for RNHCI Home Benefit Payment:</P>
                    <P>A RNHCI in Baltimore, Maryland is providing the RNHCI home benefit to a patient with a RNHCI election. The RNHCI has provided 12 visits within a 30-day cycle. The RNHCI would determine the payment for the home benefit visits as follows:</P>
                    <BILCOD>BILLING CODE 4120-01-P</BILCOD>
                    <GPH SPAN="3" DEEP="630">
                        <PRTPAGE P="66350"/>
                        <GID>ER15NO04.513</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="190">
                        <PRTPAGE P="66351"/>
                        <GID>ER15NO04.514</GID>
                    </GPH>
                    <BILCOD>BILLING CODE 4120-01-C</BILCOD>
                    <HD SOURCE="HD1">IV. Other Issues </HD>
                    <HD SOURCE="HD2">A. Provisions Related to Therapy Services </HD>
                    <HD SOURCE="HD3">1. Outpatient Therapy Services Performed “Incident To” Physicians' Services </HD>
                    <P>Section 1862(a)(20) of the Act permits payment for therapy services furnished incident to a physician's professional services only if the practitioner meets the standards and conditions that would apply to the therapy services if they were furnished by a therapist, with the exception of any licensing requirement. We proposed to amend the regulations at § 410.26, § 410.59, § 410.60, and § 410.62 to reflect the statutory prohibition on payment for “therapy” services of individuals who do not meet the existing qualification and training standards for therapists (with the exception of licensure) as these standards are set out in § 484.4. </P>
                    <P>As discussed in the August 5, 2004 proposed rule, section 1862(a)(20) of the Act refers only to PT, OT, and SLP services and not to any other type of therapy or service. This section applies to covered services of the type described in sections 1861(p), 1861(g) and 1861(ll) of the Act; it does not, for example, apply to therapy provided by qualified clinical psychologists. This section also does not apply to services that are not covered either as therapy or as E/M services provided incident to a physician or NPP, such as recreational therapy, relaxation therapy, athletic training, exercise physiology, kinesiology, or massage therapy services. </P>
                    <P>In the following discussion, the phrase “therapy services” means only PT, OT, and SLP. Also, “therapist” means only a physical therapist, occupational therapist, and speech-language pathologist. </P>
                    <P>Section 1861(s)(2)(K) of the Act permits certain NPPs, specifically PAs, NPs, and CNSs, to function as physicians for the purposes of furnishing therapy services which they are legally authorized to perform by the State in which the services are performed. Therefore, in our responses to comments in the following discussion, the statements concerning therapy services that apply to physicians also apply to PAs, NPs, and CNSs. </P>
                    <P>We received many comments on this proposal from professionals and associations for audiologists, speech-language pathologists, physical therapists, occupational therapists, long term care facilities, kinesiotherapists, massage therapists, athletic trainers, nurses, and physicians such as physiatrists, neurologists, podiatrists, chiropractors, osteopaths, medical groups, and family practitioners. </P>
                    <P>The proposal describes covered Medicare services and is not intended to affect the policies of other insurers who may cover services that Medicare does not, for example, therapy services performed by massage therapists or athletic trainers. </P>
                    <P>
                        <E T="03">Comment:</E>
                         Several associations believe that this proposal is based on an incorrect interpretation of the intent of section 1862(a)(20) of the Act. Some claim that the proposed clarification is prohibited by the statute. They note the lack of any elaboration upon the Congress' intent in the Conference Report accompanying section 4541(b) of the BBA, but suggest the provision was based on a 1994 OIG report, “Physical Therapy in Physicians' Offices” (OEI-02-90-00590, March 1994). In the view of some commenters, the intended effect of section 1862(a)(20) of the Act was to apply to incident to therapy services the standards and conditions related to treatment plans, the need for goals, and the requirement that therapy is to be restorative. This position is based on the fact that these standards were the focus of the 1994 OIG report. The commenters point out that the report did not compare therapist services to services furnished by nontherapists in a physician’s office, but it only compared the services billed by therapists to those billed by physicians. 
                    </P>
                    <P>Commenters argued that the plain meaning of section 1862(a)(20) of the Act indicates that incident to services are not necessarily furnished by therapists. They point to the parenthetical exclusion of licensure requirements in the statutory language as evidence that the Congress did not intend to apply the personnel requirements applicable to therapists in private practice to incident to therapy services. Some commenters believe this exclusion was intended to preserve the right of physicians to supervise auxiliary personnel that were not licensed as therapists. They suggest that we are creating a de facto licensure requirement. </P>
                    <P>
                        Comments from the two members of the Congress who introduced the act that resulted in section 1862(a)(20) of the Act support the proposed rule, stating that the proposed clarification meets the intent of the law when it was passed by the Congress in 1997. These commenters confirm that the legislation was based in part on the 1994 OIG report and the intent was to establish “a consistent standard for the delivery for PT services to ensure quality patient care.” Two additional comments were received from the Congress in support of the proposal. 
                        <PRTPAGE P="66352"/>
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         Our interpretation is based on the plain language of the law: no payment may be made for incident to therapy services “that do not meet the standards and conditions (other than any licensing requirement specified by the Secretary) under the second sentence of section 1861(p) * * * ” 
                    </P>
                    <P>The second sentence of section 1861(p) of the Act reads as follows: </P>
                    <EXTRACT>
                        <P>“The term ‘outpatient physical therapy services’ also includes PT services furnished an individual by a physical therapist (in his office or in such individual's home) who meets licensing and other standards prescribed by the Secretary in regulations, otherwise than under an arrangement with and under the supervision of a provider of services, clinic, rehabilitation agency, or public health agency, if the furnishing of such services meets such conditions relating to health and safety as the Secretary may find necessary.” </P>
                    </EXTRACT>
                    <P>It is evident then, that the standards and conditions referenced in section 1862(a)(20) of the Act encompass qualifications of the individual providing the therapy. Consequently, we disagree with those commenters who suggest that it was not the intent of section 1862(a)(20) of the Act to apply the personnel qualifications of the second sentence of section 1861(p) of the Act to therapy provided incident to a physician's service. We believe our interpretation of the law is further supported by the comment received from the Congress members who sponsored the original bill that became section 1862(a)(20) of the Act. </P>
                    <P>According to the proposed requirements, a person who is trained in therapy, but has not completed the further requirements of therapy licensure, may provide services incident to a physician's services. These individuals are not therapists, since they are not licensed, but they are qualified personnel who may, under direct supervision, provide therapy services incident to a physician. </P>
                    <P>A physician may utilize supervised unlicensed staff and may bill for a covered therapy service incident to the physician's service if it is provided according to Medicare policies, including coverage and incident to policies. </P>
                    <P>
                        <E T="03">Comment:</E>
                         Commenters also note that qualifications at § 484.4 are in the home health agency section of the regulations, while the second sentence of section 1861(p) of the Act (referenced by section 1862(a)(20) of the Act) does not apply to therapy provided in home health agencies. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         The statute specifies therapy services provided incident to a physician must meet the standards and conditions that would apply to a therapist, except licensure. For the history of the qualifications for the private practice setting, please see the discussion in this rule as described below in section IV.A.2, “Qualification Standards and Supervision Requirements in Therapy Private Practice Settings.” We proposed to apply to all settings the qualifications in § 484.4 because they are standards that currently apply to therapists in provider settings. It is our intent to make therapist qualifications consistent in all settings (unless otherwise required by statute). Therefore, unless a person meets the standards in § 484.4, except licensure, their services may not be billed as therapy services incident to a physician's service, regardless of any other training, other licensure or certification or other experience they may have. For example, the services of chiropractors or athletic trainers who do not meet the requirements in § 484.4 except licensure, cannot be billed as therapy services incident to a physician's service. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         Several associations indicated that we are changing our interpretation of the statute. They assumed any instruction relevant to the law was made in 1998 through Transmittal 1606. That transmittal provided guidance for therapy services, but did not address the qualification of the people who furnish therapy incident to physician services. It was also suggested that we delay implementation to allow further study and comment from interested parties. The AMA urged us to withdraw proposed changes and reissue a later proposal after consulting with all affected physician and other health professional organizations. 
                    </P>
                    <P>Also, the commenters note that the Administrative Procedure Act (APA) requires that we characterize this as a change rather than a clarification. </P>
                    <P>
                        <E T="03">Response:</E>
                         In the past, we did not discuss the plain language of the law ecause we did not believe it needed extensive clarification. However, it has become clear to us that contractors have varied in their policies. 
                    </P>
                    <P>Some contractors created local policies that paid only for services provided by licensed therapists in all settings including incident to a physician's service. Others had no policies that assured the qualifications of personnel furnishing services billed as therapy services incident to a physician. </P>
                    <P>
                        Study of the utilization of therapy services, internal discussions with contractors and medical review of claims for the purpose of error rate analysis all suggested that the services being performed in the offices of physicians did not consistently meet the standards and conditions we applied to therapy services in private practice or in provider settings. Problems associated with an imprecise definition of therapy services were discussed at length in Section 4.1 of the “Study and Report on Outpatient Therapy Utilization” (the DynCorp utilization study) found at 
                        <E T="03">http://www.cms.hhs.gov/medlearn/therapy.</E>
                         Review of medical records following this report reinforced the personnel qualification problem. 
                    </P>
                    <P>
                        In Pub. 100-04, the Medicare Claims Processing Manual at chapter 5, section 20, there is a list of codes that represent services that are always therapy services (available online at 
                        <E T="03">http://www.cms.hhs.gov/manuals/104_claims/clm104c05.pdf).</E>
                         Whenever these codes are billed, they must have a modifier that identifies the type of therapy (PT, OT, or SLP) and the services provided must meet the standards and conditions that apply to outpatient therapy services. In the medical review of therapy claims, there were frequent observations of “always therapy” services performed by persons other than therapists, which were billed inappropriately as therapy. 
                    </P>
                    <P>Since the qualifications of therapists and therapy services continued to be problematic, we chose to raise the subject of therapist qualifications last year. Last year's comments made it clear that there is widespread use of nontherapists, particularly athletic trainers, in the offices of physicians and those services are being billed as therapy services. The volume of similar comments this year made it evident to us that the clarification was needed. </P>
                    <P>We characterize this statement as a clarification because it merely restates the law. Moreover, we announced our clarification in the proposed rule, and it has been subject to comment in last year's proposed rule and again this year. So, assuming that it did change policy, its promulgation meets the requirements of the APA. </P>
                    <P>In addition, we note that we continue to pay only for covered services whether they are therapy or other services. Coverage rules in the Program Integrity Manual, chapter 13.5.1, require, for example, that the service be safe, effective, in accordance with accepted standards of medical practice, and furnished by qualified personnel. </P>
                    <P>
                        We recognize there has been inconsistent application of this statutory requirement. Therefore, in order to allow sufficient time for physicians to adjust their practices, and to avoid disrupting ongoing therapy in affected practices, we will delay implementation 
                        <PRTPAGE P="66353"/>
                        until manual instructions are published. We anticipate publication of manual instructions on or after March 1, 2005. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         Many commenters offered the opinion that restricting payment for therapy services to those performed by therapists would reduce access and quality of care and increase costs. They noted that it is more convenient for therapy to be available in a physician's office than at another site. Also, there was concern that therapists may not work in rural areas, especially because there is a shortage of qualified therapists. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         The statute requires that those who provide therapy services meet therapy standards. It provides an exception for licensure in an incident to setting, but it does not provide an exception for rural areas. Since recent changes allow physical and occupational therapists that are enrolled in Medicare to work for physicians, there is no legal impediment to physicians being able to provide therapy services in their offices without the use of nontherapists. The Department of Labor Bulletin 2572, titled “Occupational Projections and Training Data 2004-05 Edition”, suggests no shortage of therapists. 
                    </P>
                    <P>Nor do we find evidence to suggest the quality of care will be decreased by the use of personnel trained in therapy services as opposed to those trained in other disciplines. The cost of therapy services to Medicare will not be changed by the use of appropriately trained personnel. </P>
                    <P>
                        <E T="03">Comment:</E>
                         Many comments from physical therapists and PT associations agreed in principle with consistently defining the qualifications for therapists in all settings. They point out that, although the statute allows unlicensed people to provide therapy services incident to the services of a physician, the purpose of licensure is to assure that services are safely and effectively furnished by professionals who have demonstrated the necessary knowledge and skills. The statute permits the use of therapists who have not met licensing requirements and those whose licenses were revoked due to malpractice or fraud. The supervision requirement that the physician be present somewhere in the suite, but not in line of sight, is insufficient to assure the safety and quality of service provided by unlicensed staff. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         Although the law permits unlicensed individuals to provide services incident to the services of a physician, we believe physicians will be motivated to screen employees to weed out sanctioned or incompetent people who have training in therapy since physicians would be liable for the actions of an incompetent employee. We require direct supervision of the employee by the physician as a minimum standard, but a physician will provide whatever guidance and supervision is required to assure the safety, effectiveness and quality of the service. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         Many comments were received from individuals such as athletic trainers, kinesiotherapists, massage therapists and chiropractors describing their training as equal or superior to therapists' and suggesting that they provide care similar to therapists. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         The statute allows Medicare to pay only for PT, OT and SLP services. Comments from therapists and nontherapists agreed that their training and licensure is unique to their professions, and they are separately trained and licensed for those unique professions. It is clear that many nontherapist health care practitioners are well-trained professionals dedicated to the provision of quality treatment for their patients. However, their training is not in PT, OT, or SLP, but in the other disciplines for which they are licensed or accredited. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         A number of physicians and associations for physicians wrote to tell us that they believe it is their right and within their authority to decide who can provide effective therapy services in their offices. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         The statute requires Medicare to pay only for services that meet the standards and conditions, except licensure, that apply to therapists. It is the right and responsibility of a physician to recommend services for patients that in the physician's judgment are needed and effective. Medicare, however, need not pay for all services that a physician recommends. We are required to pay for services that are covered in the statute and to deny payment for services that are not covered, even if the physician considers those services necessary and effective. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         Some physicians wrote to tell us they are currently billing Medicare for therapy services when athletic trainers perform services in their offices. Several commenters asked what services may be billed to Medicare when provided by auxiliary staff who are qualified as athletic trainers, or who have certification in fields other than therapy. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         While some carriers may have paid claims for incident to therapy services furnished by individuals without therapy training, we have never had a policy that permits athletic trainers or any other staff who do not have training in PT to provide services that are billed as PT services. Carrier payment for a service is not conclusive evidence that the service was appropriately rendered. Billing with a code that does not accurately represent the service provided is inappropriate. If identified by carrier medical review, these claims must be denied, and further development of the claim may be indicated to determine if there was intent to bill improperly. 
                    </P>
                    <P>Medicare defines PT, OT and SLP as services that require the skills of a physical therapist, occupational therapist or speech-language pathologist. Therapy codes are priced based on the salaries and expenses of therapists and we expect that therapy claims are made for services of therapists (or, for incident to services by someone with their training, except for licensure). </P>
                    <P>When a service is not a covered service, it is inappropriate to bill Medicare for that service as a service incident to a physician, or as an E/M service. For example, if a service is appropriately described as acupuncture or athletic training or massage therapy, Medicare will not pay for that service because it is not covered. </P>
                    <P>A physician may not bill Medicare for a service that is on the list of “always therapy” services (see Pub. 100-04, the Medicare Benefit Policy Manual, chapter 5, section 20) if the service was done by staff that is not qualified to provide a skilled therapy service, because that is not a covered therapy service. The “always therapy” codes always require a modifier to describe whether the service was PT, OT or SLP. </P>
                    <P>
                        There are covered services that other staff, such as athletic trainers, may perform with other training, however, these are not therapy services. Other codes on the therapy list are “sometimes therapy” services and require modifiers only when they are therapy services rather than physician services. For example, a physician may apply a surface neurostimulator (CPT 64550) as an isolated service, outside of a therapy plan of care and appropriately bill the code without a therapy modifier. That service is not a therapy service. If that physician supervises auxiliary personnel in the provision of that same nontherapy service, the auxiliary personnel does not have to be qualified as a therapist because the service rendered is not therapy. In any case, when Medicare is billed for a service, the person providing the service must be qualified to provide the service, as determined by the contractor in accordance with coverage requirements 
                        <PRTPAGE P="66354"/>
                        in Pub. 100-08, the Medicare Program Integrity Manual, chapter 13.5.1. However, if a therapist provides the service under any circumstance, or if either the physician or qualified personnel provides the service as part of a therapy plan of care, it is a therapy service and it requires a modifier. In cases where there is doubt, the contractor will determine whether the service is therapy or is not therapy. 
                    </P>
                    <P>Further information about services that may be completed by non-therapists will be available in implementing instructions. </P>
                    <P>
                        <E T="03">Comment:</E>
                         The American Chiropractic Association commented that doctors of chiropractory are authorized to perform PT services in all but two States, Michigan and Washington. They request that we note that fact in our commentary and in the regulation. They note that Doctors of Chiropractic are included in the definition of “physician” and they propose language in addition to that in § 484.4 to define the qualifications of chiropractors, in order to recognize the State-authorized practice privileges of Doctors of Chiropractic. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         Chiropractors may bill services to Medicare as physicians, but only for the purposes of providing manipulation of the spine for the correction of a subluxation, which is a chiropractor service, and not a therapy service. For these manipulation services, chiropractors may directly 
                        <E T="03">supervise</E>
                         employees who provide incident to services. However, as Medicare physicians, chiropractors are not authorized to 
                        <E T="03">order</E>
                         therapy services or to perform any other services. To qualify to provide therapy services incident to a physician, chiropractors must meet all of the criteria set forth at § 484.4 except licensure. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         Several associations and some individuals commented that we are creating a monopoly for therapists to provide therapy services and unnecessarily restricting other professions from providing therapy services. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We are bound by the statutory authority given to us in section 1832 of the Act to pay only for services for which there are benefits enumerated in the statute. PT, OT and SLP have benefits in section 1861 of the Act. Therefore, Medicare pays only for those services. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         Several commenters noted that some NPPs, specifically PAs, NPs, and CNSs, may perform therapy services billable under Medicare as therapy services if their State scope of practice allows. The commenters question whether those NPPs may also perform therapy services incident to a physician or NPP. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         Medicare does not impose therapy training requirements on physicians whose State scope of practice allows them to perform therapy services. Section 1861(s)(2)(K) of the Act permits PAs, NPs, and CNSs, to furnish services which would be physicians' services, that is, to function as physicians for purposes of furnishing services, including therapy services, which they are legally authorized to perform by the State in which the services are performed. Therefore, this final rule has been modified to reflect that in States that authorize physicians, PAs, NPs, and CNSs to provide one or more of the therapy services (PT, OT, or SLP services), those NPPs may provide the services incident to the services of a physician or NPP under the same conditions as physicians, that is, without meeting the training requirements applicable to therapists. 
                    </P>
                    <HD SOURCE="HD2">Results of Evaluation of Comments </HD>
                    <P>To the extent that this policy is different from current manual text, we proposed this rule and received comments. We are finalizing the proposal in this final rule with the changes noted above in accordance with the APA. We will implement this regulation through manual guidance on or after March 1, 2005. </P>
                    <HD SOURCE="HD3">2. Qualification Standards and Supervision Requirements in Therapy Private Practice Settings </HD>
                    <P>Sections 1861(g) and (p) of the Act include services furnished to individuals by physical and occupational therapists meeting licensing and other standards prescribed by the Secretary if the services meet the necessary conditions for health and safety. These services include those furnished in the therapist's office or the individual's home. By regulation, we have defined therapists under this provision as physical or occupational therapists in private practice (PTPPs and OTPPs). </P>
                    <P>Under Medicare Part B, outpatient therapy services, including physical and occupational therapy services, are generally covered when reasonable and necessary and when provided by physical and occupational therapists meeting the qualifications set forth at § 484.4. Services provided by qualified therapy assistants, including physical therapist assistants (PTAs) and occupational therapy assistants (OTAs), may also be covered by Medicare when furnished under the level of supervision by the therapist that is required for the setting in which the services are provided (institutions and private practice therapist offices). For PTPPs and OTPPs, the regulations now specify only that the PT or OT meet State licensure or certification standards; the regulations and do not currently refer to the professional qualification requirements at § 484.4. </P>
                    <P>Since 1999, when therapy services are provided by PTAs and OTAs in the private practice of a PT or OT, the services must be personally supervised by the PTPP or OTPP. In response to a requirement to report to the Congress on State standards for supervision of PTAs, we contracted with the Urban Institute. The Urban Institute found that no State has the strict, full-time personal supervision requirement, for any setting, that Medicare places on PTAs in PTPPs. (The report examined only PTAs, who are more heavily regulated by the States than OTAs). </P>
                    <P>To provide a consistent therapy assistant supervision policy, we proposed to revise the regulations at § 410.59 and § 410.60 to require direct supervision of PTAs and OTAs when PTs or OTs provide therapy services in private practice. We also specifically solicited comments regarding the proposed PTA supervision policy, and whether or not it would have implications for the quality of services provided, or for Medicare spending, either through increased capacity to provide these services, or, in the event that the Congress again extends the moratorium on the implementation of the limits on Medicare reimbursement for therapy services imposed by the BBA of 1997. </P>
                    <P>In addition, as discussed in the August 5, 2004 proposed rule, the current OTPP or PTPP regulations at § 410.59(c) and § 410.60(c) do not reference qualification requirements for therapy assistants or other staff working for PTs and OTs in private practices. In order to create consistent requirements for therapists and for therapy assistants, we proposed to restore the qualifications by adding the cross-reference to the qualifications at § 484.4 for privately practicing therapists and their therapy assistants at § 410.59 and § 410.60. </P>
                    <P>
                        <E T="03">Comment:</E>
                         Commenters representing therapy organizations, as well as individual providers, were supportive of our proposal to revise the regulations at § 410.59 and § 410.60 to require direct, rather than personal, supervision of PTAs and OTAs when therapy services are provided by PTs or OTs in private practice.
                    </P>
                    <FP>
                        (We use the 3 supervision levels defined at § 410.32, personal, direct, and 
                        <PRTPAGE P="66355"/>
                        general, to describe the supervision requirements for various Medicare services and settings.) 
                    </FP>
                    <P>Many commenters also stated that this is consistent with the Medicare requirements in other provider settings, such as hospitals, HHAs and rehabilitation agencies and is also consistent with the Medicare requirements for therapists in private practice that were in place prior to 1999. Commenters also believe that this will assist in ensuring access to therapy services and in protecting patient privacy. </P>
                    <P>
                        <E T="03">Response:</E>
                         Requiring direct supervision of therapy assistants in PT and OT private practice settings is consistent with the supervision requirements that PTs and OTs in independent practice were required to meet, prior to 1999, at § 410.59(c) and § 410.60(c). This direct supervision requirement in PT and OT private practices requiring the therapist to be on site or “in the office suite” differs from our therapy assistant supervision requirements in institutional settings (for example, outpatient hospital departments, HHAs, and rehabilitation agencies). In those settings, PTs and OTs may provide general supervision of therapy assistants without being on-site. 
                    </P>
                    <P>We agree that changing the level of supervision of therapy assistants from personal to direct will help to improve access to medically necessary services. </P>
                    <P>
                        <E T="03">Comment:</E>
                         A few commenters stated they believe permitting general supervision, rather than direct, is more consistent with State therapy supervision requirements. While State requirements vary, this variation may be due to the fact that PTAs are not licensed in some States. Other commenters stated that therapy assistants are qualified to provide services without having therapists in-the-room to provide personal supervision. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         A review of State practice acts revealed that Medicare's personal in-the-room supervision requirement for therapy assistants in PT and OT private practices was more stringent than any State supervision requirement for any setting. The Urban Institute report also found that most States permit a supervision level similar to our general supervision requirement for institutional settings. However, we believe that services delivered by therapy assistants in private practices require a higher level of therapist supervision than those provided in institutional settings where stringent standards for Medicare participation are enforced through State survey and certification programs, rather than the simplified carrier enrollment process for the PT or OT private practice offices. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         One commenter stated that only licensed therapists should be allowed to provide and bill for therapy and another commenter demanded that therapy services only be reimbursed when provided by a therapist, not any other professional, including nurses, PAs, or chiropractors, and not by therapy assistants. They suggested that without this requirement there would be program abuses. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We concur with the therapy associations and the overwhelming majority of commenters that therapy assistants are qualified by their training and education to provide services without the personal in-the-room supervision in the private practice setting. This does not mean, however, that therapy assistants may bill for the services they provide. Under the law, only PTs and OTs in private practice may bill Medicare for the therapy services provided by PTAs and OTAs. These therapists enroll in the Medicare program and receive a provider identification number (PIN) in order to file claims for the therapy services provided as a PTPP or OTPP. Institutional therapy providers bill Medicare on behalf of the PTs, OTs, and speech language pathologists who provide therapy services in these settings. 
                    </P>
                    <P>Other professionals, including nurses, athletic trainers, and chiropractors do not meet the statutory requirements for therapists in section 1861(p) of the Act and as implemented at § 484.4. We proposed to amend the regulations at § 410.59 and § 410.60 to specify that only individuals meeting the qualification standards and training consistent with § 484.4 may bill and receive Medicare payment for therapy services. In addition, a State license or certification in PT or OT will continue to be required for therapist providing services as PTPPs or OTPPs. </P>
                    <P>When PAs, NPs, or CNSs are authorized by their State practice acts to provide physical or occupational therapy services, and these NPPs are acting within their capacity to provide physician services under section 1861(s)(2)(K) of the Act, their services are considered therapy services.</P>
                    <P>
                        <E T="03">Comment:</E>
                         One commenter stated that allowing lesser trained individuals such as therapist assistants to provide services if a therapist supervises, but prohibiting physicians from delegating performance of these services to doctors of chiropractic inappropriately gives therapists more authority than physicians. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         Medicare law recognizes chiropractors as physicians, but only for the limited purpose of providing manipulation of the spine for the correction of a subluxation. In order to qualify as a PT or OT for Medicare purposes, chiropractors would need to meet all of the criteria set forth at § 484.4. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         In response to our request for information on the impact of this proposed change on the quality of services and Medicare spending, several individuals stated that the proposed change would not affect the way therapists practice, since they are fully accountable for services provided under their direction and, therefore, the change would not diminish the quality of services. Furthermore, commenters believe the change would also allow the appropriate and efficient utilization of therapist assistants because the in-the-room supervision unnecessarily drives up the cost of health care without providing additional consumer protection. 
                    </P>
                    <P>The American Physical Therapy Association (APTA) anticipates there will be little, if any, increase in spending as a result of this policy and believes that any increases would be due to improving access to medically necessary outpatient therapy services provided by qualified practitioners. For spending implications, the APTA believes it is highly unlikely that physical therapists would significantly alter their staffing patterns and thereby increase spending as a result of this change in policy. The majority of States have laws that establish limits on the number of PTAs that a PT can supervise (referred to as “supervision ratios”). For example, a large number of States have a supervision ratio of one PT to two PTAs. There are also a limited number of PTAs whom PTs could supervise, and APTA does not anticipate substantial growth in the number of PTAs in the foreseeable future. To the contrary, the number of PTA education programs is declining. </P>
                    <P>Furthermore, services of PTs in private practice comprise a relatively small percentage of services billed under the Medicare program. Therefore, the overall financial impact of any change in the supervision requirement in this setting would be minimal. </P>
                    <P>
                        <E T="03">Response:</E>
                         We appreciate the information provided by the commenters. Other opportunities already exist for therapists to provide services under Medicare in rehabilitation agencies and CORFs where the therapy assistant supervision level is general. Therapists opting to utilize therapy assistants might be more 
                        <PRTPAGE P="66356"/>
                        likely to own a rehabilitation facility where the physical or occupational therapy assistant supervision level is general, rather than a private practice office where the therapist is required to be on-site to supervise services of the therapy assistant. The Urban Institute Report confirmed the limited number of therapy assistants available to be hired and found that workforce and distribution percentages of PTs and PTAs parallel each other, with nearly 25 percent of PTAs employed by PTPPs. We believe that the State supervision requirements and the limited number of PTAs are likely to limit the financial implications of this change. We plan to monitor this area to determine whether volume changes occur and, if so, in what settings they occur. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         Commenters supported our proposal to revise § 410.59 and § 410.60 to cross-reference the qualifications at § 484.4 for privately practicing therapists and their therapy assistants. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We appreciate the numerous letters of support for this proposal, including the national and State-level therapy organizations, other professional organizations, and many therapists and therapy assistants. 
                    </P>
                    <HD SOURCE="HD2">Result of Evaluation of Comments</HD>
                    <P>We will finalize the proposed revisions to § 410.59 and § 410.60 to require direct supervision of PTAs and OTAs when therapy services are provided by PTs or OTs in private practice and also to cross-reference the qualifications at § 484.4 for privately practicing therapists and their therapy assistants. </P>
                    <HD SOURCE="HD3">3. Other Technical Revisions </HD>
                    <P>We proposed technical corrections to § 410.62 to refer consistently to SLP (currently the terms “speech pathology” and “speech-language pathology” are used interchangeably) and proposed revisions to § 410.62(a)(2)(iii) to appropriately reference § 410.61 (the current reference is to § 410.63). </P>
                    <P>We also proposed removing subpart D, Conditions for Coverage: Outpatient Physical Therapy Services Furnished by Physical Therapists, from part 486. Our November 1998 rule (63 FR 58868) discussed replacing this subpart with a simplified carrier enrollment process for physical or occupational therapists in private practice; however, the conforming regulatory change to remove subpart D was never made. </P>
                    <P>In addition, we proposed a technical change at § 484.4 to correct the title “physical therapy assistant” to “physical therapist assistant” and proposed amending § 410.59(e) and § 410.60(e) to include a reference to the 2-year moratorium on the therapy caps established by section 624 of the MMA. </P>
                    <P>
                        <E T="03">Comment:</E>
                         Commenters representing therapy specialty organizations supported these changes. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We will finalize these changes as proposed. 
                    </P>
                    <HD SOURCE="HD2">Result of Evaluation of Comments </HD>
                    <P>We are finalizing the changes as proposed. </P>
                    <HD SOURCE="HD2">B. Low Osmolar Contrast Media </HD>
                    <P>High osmolar and low osmolar contrast media (LOCM) are used to enhance the images produced by various types of diagnostic radiological procedures. When the Medicare physician fee schedule was established, findings of studies of patients receiving both types of contrast media had been published, and the ACR had adopted criteria for the use of LOCM. At that time, we determined that the older, less expensive high osmolar contrast media (HOCM) could be used safely in a large percentage of the Medicare population. However, we also decided that separate payment for LOCM may be made for patients with certain medical characteristics. We adopted the ACR criteria, with some modification, as the basis for a policy that separate payments are made for the use of LOCM in radiological procedures for patients meeting certain criteria. These criteria were established at § 414.38. Under these conditions, we pay for LOCM, utilizing HCPCS codes A4644 through A4646. </P>
                    <P>In the August 5, 2004 rule, we proposed to revise the regulations at § 414.38 to eliminate the restrictive criteria for the payment of LOCM. This proposal would make Medicare payment for LOCM consistent across settings since, under the OPPS, there is no longer a payment difference between LOCM and other contrast materials. </P>
                    <P>We also proposed that, effective January 1, 2005, payment for LOCM would be made on the basis of the ASP plus six percent in accordance with the standard methodology for drug pricing established by the MMA. However, because the technical portions of radiology services are currently valued in the nonphysician work pool and the CPEP inputs for these services are not used in calculating payment, we also indicated we would continue to reduce payment for LOCM by eight percent to avoid any duplicate payment for contrast media. </P>
                    <P>
                        <E T="03">Comment:</E>
                         Commenters representing radiology, interventional radiology, and imaging contrast manufacturers were supportive of this proposed change; however, our payment methodology of ASP plus six percent minus eight percent was questioned. Two commenters also believe that the implementation date for the application of ASP methodology should be changed from January 1, 2005. One requested an effective date of April 1, 2005 and the other requested an effective date of January 1, 2006. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We appreciate the commenters' support for this change. We stated in the proposed rule that effective January 1, 2005, payment for LOCM would be made on the basis of the ASP plus six percent. However, there is an October 30, 2004 deadline for submission of the ASP data used for the January 1, 2005 payment, and this date occurred prior to our finalizing the proposed payment methodology for LOCM. Therefore, the ASP payment methodology for LOCM will be made effective April 1, 2005. Manufacturers of LOCM will be required to submit their fourth quarter 2004 (4Q04) ASP information to us on or before January 30, 2005. Subsequent data must be submitted within 30 days after the end of each calendar quarter. The 4Q04 data will be used to determine the April 1, 2005 ASP plus six percent payment limits. Further information on the specific format of the data submission and the address to which the information can be sent is found on the CMS ASP Web site, specifically at 
                        <E T="03">http://www.cms.hhs.gov/providers/drugs/asp.asp.</E>
                    </P>
                    <P>Our policy to reduce payment for LOCM by 8 percent stems from the fact that the technical component RVUs for these procedures took into account the use of (and expenses for) HOCM in the (see the November 25, 1991 final rule (56 FR 59502)). However, since that time, the price differential between HOCM and LOCM has declined. In addition, upon further review, we are not able to determine accurately the degree of duplicate payment that might occur when both the imaging procedure and LOCM are billed. Therefore, we are not applying the eight percent reduction to the LOCM payment as proposed. The payment for LOCM will be consistent with the payment rate for the majority of drugs administered by physicians. </P>
                    <P>
                        <E T="03">Comment:</E>
                         One contrast agent industry association suggested that we issue additional codes for the reporting of contrast media. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         For 2005, we are continuing to use the current three HCPCS codes in the reporting of low osmolar contrast agents. However, we are exploring the possibility of additional codes to accurately capture the cost differences among all contrast agents as well as the differing clinical 
                        <PRTPAGE P="66357"/>
                        uses, concentration, and dose administrations. We welcome input from the medical community and the manufacturers of contrast media on this issue. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         A commenter suggested that we use a model to capture volume and concentration variances of LOCM. In this model, ASP would be calculated as ASP = Total Sales/Total Volume. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         This suggested methodology does not take into account the weighted average for each national drug code (NDC) within a HCPCS code that must be used to derive an appropriate ASP code price. 
                    </P>
                    <HD SOURCE="HD2">Result of Evaluation of Comments </HD>
                    <P>We are revising the regulations at § 414.38 to eliminate the criteria for the payment of LOCM. In addition, effective April 1, 2005, payment for LOCM will be made on the basis of the ASP plus six percent. </P>
                    <HD SOURCE="HD2">C. Payments for Physicians and Practitioners Managing Patients on Dialysis </HD>
                    <HD SOURCE="HD3">1. ESRD-Related Services Provided to Patients in Observation Settings </HD>
                    <P>
                        In response to comments received on billing procedures for physicians and practitioners managing patients on dialysis when the dialysis patient is hospitalized during the month, we stated in the November 7, 2003 
                        <E T="04">Federal Register</E>
                         (68 FR 63220) that ESRD-related visits furnished to patients in observation status would not be counted as visits under the MCP but would be paid separately. Prior to this, long-standing Medicare policy had included ESRD-related visits furnished in the observation setting within the MCP. However, upon further review of this issue, in the proposed rule published August 5, 2004, we proposed a revision to this policy and stated that ESRD-related visits provided to patients by the MCP physician in an observation setting would be counted as visits for purposes of billing the MCP codes. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         Several commenters expressed support for allowing ESRD-related visits provided to patients by the MCP physician in the observation setting to be counted for purposes of billing the MCP codes. However, Kidney Care Partners (KCP) and the Renal Physicians Association (RPA) requested clarification as to how a physician or practitioner who is not part of the MCP practice team should bill for visits furnished in the hospital observation setting. The RPA suggested that a hemodialysis procedure with single physician evaluation as described by CPT code 90935 be used. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         Physicians or practitioners who are not part of the MCP practice team but who furnish a visit to an ESRD beneficiary in the observation setting can bill the appropriate observation codes that accurately describe the service (CPT codes 99217 through 99220). A hemodialysis procedure with single physician visit as described by CPT code 90935 will only be used when the beneficiary is an inpatient or for outpatient dialysis services for a non-ESRD patient. 
                    </P>
                    <HD SOURCE="HD3">2. Payment for Outpatient ESRD-Related Services for Partial Month Scenarios </HD>
                    <P>Since changing our payments for physicians and practitioners managing patients on dialysis, we have received a number of comments from the nephrology community requesting guidance on billing for outpatient ESRD-related services provided to transient patients and in partial month scenarios (for example, when the patient is hospitalized during the month or receives a kidney transplant). To address this issue, we proposed to change the description of the G codes for ESRD-related home dialysis services, less than full month, as identified by G0324 through G0327. The new descriptor would include other partial month scenarios, in addition to patients dialyzing at home. The proposed descriptors for G0324 through G0327 are as follows: </P>
                    <P>• G0324, End stage renal disease (ESRD) related services for dialysis less than a full month of service, per day; for patients under two years of age; </P>
                    <P>• G0325, End stage renal disease (ESRD) related services for dialysis less than a full month of service, per day; for patients between two and eleven years of age; </P>
                    <P>• G0326, End stage renal disease (ESRD) related services for dialysis less than a full month of service, per day, for patients between twelve and nineteen years of age. </P>
                    <P>• G0327, End stage renal disease (ESRD) related services for dialysis less than a full month of service, per day, for patients twenty years of age and over. </P>
                    <P>In the August 5, 2004 proposed rule, we stated that these G codes would provide a consistent way to bill for outpatient ESRD-related services provided under the following circumstances: </P>
                    <P>• Transient patients—Patients traveling away from home (less than full month); </P>
                    <P>• Home Dialysis Patients (less than full month); </P>
                    <P>• Partial month where there were one or more face-to-face visits without the comprehensive visit and either the patient was hospitalized before a complete assessment was furnished, dialysis stopped due to death, or the patient had received a kidney transplant. </P>
                    <P>However, we noted that this proposed change to the descriptions of G0324 through G0327 was intended to accommodate unusual circumstances when the outpatient ESRD-related services would not be paid for under the MCP and that use of the codes would be limited to the circumstances listed above. Physicians who have an on-going formal agreement with the MCP physician to provide cursory visits during the month (for example “rounding physicians”) could not use the per diem codes. </P>
                    <HD SOURCE="HD2">Clarification on Billing for Transient Patients </HD>
                    <P>In the August 5, 2004 proposed rule, we stated that, for transient patients who are away from their home dialysis site and at another site for fewer than 30 consecutive days, the revised per diem G codes (G0324 through G0327) would be billed by the physician or practitioner responsible for the transient patient's ESRD-related care. Only the physician or practitioner responsible for the traveling ESRD patient's care would be permitted to bill for ESRD-related services using the per diem G codes (G0324 through G0327). </P>
                    <P>If the transient patient is under the care of a physician or practitioner other than his or her regular MCP physician for a complete month, the physician or practitioner responsible for the transient patient's ESRD-related care would not be able to bill using the per diem codes. We also solicited comments on when a patient will be considered transient. </P>
                    <P>
                        <E T="03">Comment:</E>
                         Several commenters, including the ASN, KCP, and the RPA, supported our proposed change to the description of HCPCS codes G0324-G0327 (per diem codes). The KCP believed that this change would provide a consistent billing method when the patient is transient, furnished home dialysis (less than full month), and for other partial month scenarios when the patient is hospitalized, has a transplant or when the patient expires. Additionally, several commenters praised us for our willingness to work with the renal community to address the multitude of issues surrounding the way physicians and practitioners are paid for managing patients on dialysis. 
                    </P>
                    <P>
                        However, the RPA and KCP suggested that, in addition to the situations described in the proposed rule, the per diem codes as described by G0324 through G0327 should be used to bill whenever one or more visits occurred 
                        <PRTPAGE P="66358"/>
                        during the month regardless of whether the complete monthly assessment was furnished. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         As explained in the proposed rule, we believe the per diem codes will only be used for unusual circumstances where the ongoing management of an ESRD patient would not be paid through the MCP. As discussed earlier, we proposed to allow the per diem codes only in specific circumstances. However, after further review of this issue, we believe that it would also be appropriate to use the per diem codes when the beneficiary's MCP practitioner changes permanently during the month. For example, the ESRD beneficiary moves from one State to another and a new MCP physician or practitioner has the ongoing responsibility for the E/M of the patient's ESRD-related care who is not part of the same group practice as an employee of the previous MCP physician. We addressed this issue in a recent instruction published on September 17, 2004 (CR 3414 “Payment for Outpatient ESRD-Related Services”, Transmittal 300). For more information on this instruction please visit our Web site at 
                        <E T="03">http://www.cms.hhs.gov/manuals/</E>
                         and select 2004 transmittals under the program transmittals link. 
                    </P>
                    <P>However, we will not permit the use of per diem codes (HCPCS codes G0324 through G0327) for all instances when the MCP physician or practitioner furnishes at least one visit during the month without regard to the status of a complete monthly assessment of the patient. We are concerned that permitting the per diem codes to be used in this manner may undermine the MCP. For example, the ESRD MCP includes various physician and practitioner services such as the establishment of a dialyzing cycle, outpatient E/M of the dialysis visit(s), telephone calls, patient management as well as clinically appropriate physician or practitioner visit(s) during the month. At least one of the visits must include a clinical examination of the vascular access site furnished face-to-face by a physician, CNS, NP or PA. When a practitioner bills for the MCP, the medical record must document that all of these services are furnished. By using the per diem codes in the manner suggested by the commenter, it would not be necessary for the practitioner to provide a complete monthly assessment of the ESRD beneficiary to receive payment for the ongoing management of patients on dialysis. </P>
                    <P>
                        <E T="03">Comment:</E>
                         With regard to the ESRD-related services for home dialysis patients, less than full month, one healthcare corporation believes that the proposed coding changes continue to penalize nephrologists for prescribing home therapy because a per diem (pro-rated) payment is made when a hospitalization occurs. The commenter believes that this policy results in an inequity as compared to a physician providing 2-3 visits per month for center-based dialysis patients. Additionally, the commenter argues that the pro-rated methodology used for home dialysis patients (partial month) is inconsistent with how we pay the MCP physician for patients undergoing dialysis treatments in a dialysis facility. 
                    </P>
                    <P>The commenter believes that we should increase the payment for ESRD-related services for home dialysis patients to a level that is at least as high as the ESRD-related services (for full month) with 4 or more visits per month. The commenter contends that raising the payment amount for home-based dialysis patients would result in revenue opportunities similar to those available in the center-based scenario and would provide a greater incentive for home dialysis treatment. </P>
                    <P>
                        <E T="03">Response:</E>
                         We do not agree with the commenter's statement that an inconsistency exists in the way we pay the MCP physician for managing a home dialysis patient (less than full month) and center dialysis patient (less than full month). 
                    </P>
                    <P>Our proposed change to the description of HCPCS codes G0324 through G0327 would apply to dialysis patients who receive dialysis in a dialysis center or other facility during the month as well as to home dialysis patients. For example, if a center dialysis patient is hospitalized during the month, has a transplant, or expires before a complete assessment is furnished (including a face-to-face examination of the vascular access site), the MCP physician would use the per diem rate to bill for ESRD-related care. When either a home dialysis patient or a patient who receives dialysis in a dialysis facility is hospitalized, the MCP physician or practitioner may bill for inpatient hemodialysis visits as appropriate (for example CPT codes 90935 and 90937). </P>
                    <P>Additionally, we believe the current payment level for physicians managing patients on home dialysis for a full month already provides an incentive for an increased use of home dialysis. For instance, payment for the monthly management of home dialysis patients is made at the same rate as the MCP with 2 to 3 visits. However, a monthly visit is not required as a condition of payment for physicians and practitioners managing home dialysis patients. Essentially, a physician or practitioner managing ESRD patients who receive dialysis in a dialysis facility would be required to furnish 2 to 3 face-to-face visits in order to receive the same level of payment as he or she would have received for managing a home dialysis patient. We do not believe it would be appropriate to pay physicians managing home dialysis patients at the highest MCP amount when no visits are required as a condition of payment. </P>
                    <HD SOURCE="HD2">Definition of a “Transient Patient” </HD>
                    <P>
                        <E T="03">Comment:</E>
                         The RPA and KCP believe that it would be more appropriate to refer to these patients as “visiting patients”. The RPA suggested that a “visiting patient” be defined as a “patient receiving dialysis or renal-related care whose care is temporarily supervised (for less than one month's time) by a physician who is not a member of the practice that usually charges under the MCP or G codes”. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We believe the term “transient patients” better describes a beneficiary who is away from his or her home dialysis site for less than a full month. 
                    </P>
                    <HD SOURCE="HD2">General Comments on Our Changes in Payments for Physicians and Practitioners Managing Patients on Dialysis </HD>
                    <P>
                        <E T="03">Comment:</E>
                         One commenter requested clarification as to how ESRD-related visits furnished to beneficiaries residing in a skilled nursing facility (SNF) adjacent to a hospital should be handled. The commenter explained that his SNF patients with ESRD usually receive dialysis treatments in an independent dialysis facility connected to a hospital's SNF. However, in cases when the patient is “too ill” to be transported to the independent dialysis facility, the dialysis treatment occurs in the inpatient dialysis treatment area (but the patient is not admitted to the hospital as an inpatient). The commenter noted that ESRD-related visits may be furnished while the patient is dialyzing or at the SNF when the patient is not dialyzing. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         Although we have not issued specific instructions on this issue, we believe that ESRD-related visits furnished to SNF residents are similar to other ongoing management services under the MCP. As such, ESRD-related visits furnished to patients residing in a SNF will be counted for purposes of billing the MCP codes. However, if the beneficiary is admitted to the hospital as an inpatient, the appropriate inpatient visit code will be used, for example, CPT code 90935. 
                        <PRTPAGE P="66359"/>
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         With regard to our revisions to the MCP (as published in the CY 2004 final rule), the American Association of Kidney Patients (AAKP) questioned if we have any current data on or future plans to study whether access to nephrologists or the quality of medical care for ESRD patients has been improved or impaired. Additionally, AAKP questioned whether we have any plans to develop additional proposals (beyond the telehealth proposal) to address access needs in rural and other underserved areas. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         In evaluating the MCP, we will be looking for trends in hospitalization rates and resource utilization for ESRD patients. Moreover, we understand the challenges nephrologists face in visiting all patients on dialysis. To that end, we believe that our policy to allow clinical nurse specialists, nurse practitioners and physician assistants to furnish visits under the MCP, along with our addition of specific ESRD-related services to the list of Medicare telehealth services, will help ameliorate access issues. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         The RPA and the ASN continued to express concerns with the changes made in the CY 2004 final rule to the way physicians are paid for managing patients on dialysis. The RPA strongly believes that many of the underlying principles of the new HCPCS codes for managing ESRD patients need to be changed. The RPA cited the impact on rural providers, the lack of gradation in payment amounts between furnishing 2 and furnishing 3 visits per month, and the premise that more visits will equate to better quality of care as major shortcomings of the new ESRD MCP. 
                    </P>
                    <P>The RPA and ASN emphasized their belief that more physician and practitioner visits per month does not correlate to efforts to improve the quality of care for ESRD patients. RPA contends that a stratified MCP system based on the number of monthly physician and practitioner visits is unnecessarily complicated and believes that the vast majority of nephrologists provided appropriate ESRD-related care under the previous MCP. To that end, the RPA urged us to implement a simpler system based on a minimum number of patient visits and a new documentation requirement for the services provided under the MCP. </P>
                    <P>
                        <E T="03">Response:</E>
                         We appreciate the commenters' suggestions and will consider these comments as we continue to refine how we pay for physicians and practitioners managing patients on dialysis. 
                    </P>
                    <HD SOURCE="HD2">Results of Evaluation of Comments </HD>
                    <P>ESRD-related visits provided to patients by the MCP physician or practitioner in an observation setting will be counted as visits for purposes of billing the MCP codes. </P>
                    <P>Moreover, we will change the description of the G codes for ESRD-related home dialysis services, less than full month, as identified by G0324 through G0327. The new descriptor will include other partial month scenarios, in addition to patients dialyzing at home. The descriptors for G0324 through G0327 will be as follows: </P>
                    <P>• G0324: End stage renal disease (ESRD) related services for dialysis less than a full month of service, per day; for patients under two years of age. </P>
                    <P>• G0325: End stage renal disease (ESRD) related services for dialysis less than a full month of service, per day; for patients between two and eleven years of age. </P>
                    <P>• G0326: End stage renal disease (ESRD) related services for dialysis less than a full month of service, per day; for patients between twelve and nineteen years of age. </P>
                    <P>• G0327: End stage renal disease (ESRD) related services for dialysis less than a full month of service, per day; for patients twenty years of age and over. </P>
                    <P>The revised per diem ESRD-related services G codes will be used for outpatient ESRD-related services provided in the following scenarios: </P>
                    <P>• Transient patients—Patients traveling away from home (less than full month); </P>
                    <P>• Home dialysis patients (less than full month); </P>
                    <P>• Partial month where one or more face-to-face visits without the comprehensive visit and either the patient was hospitalized before a complete assessment was furnished, dialysis stopped due to death, or the patient had a transplant. </P>
                    <P>• Patients who have a permanent change in their MCP physician during the month. </P>
                    <HD SOURCE="HD2">D. Technical Revision—§ 411.404 </HD>
                    <P>In § 411.404, Medicare noncoverage of all obesity-related services is used as an example. Since we are currently revising this coverage policy, we proposed to omit this example. </P>
                    <P>Commenters were supportive of this proposed change and we are finalizing it as proposed. </P>
                    <HD SOURCE="HD2">E. Diagnostic Psychological Tests </HD>
                    <P>All diagnostic tests covered under section 1861(s)(3) of the Act and payable under the physician fee schedule must be furnished under the appropriate level of supervision by a physician as defined in section 1861(r) of the Act. Section 410.32(b)(2)(iii) states an exception to these physician supervision requirements for clinical psychologists and independently practicing psychologists (who are not clinical psychologists) which allows them to personally perform diagnostic psychological testing services without physician supervision. However, diagnostic psychological tests performed by anyone other than a clinical psychologist or an independently practicing psychologist must be provided under the general supervision of a physician as defined in section 1861(r) of the Act. Accordingly, clinical psychologists and independently practicing psychologists have not been permitted to supervise others in the administration of diagnostic psychological tests. </P>
                    <P>As discussed in the August 5, 2004 proposed rule, we were asked to re-evaluate our regulations regarding clinical psychologists' supervision of diagnostic psychological tests, and additional information concerning provision of these services was also supplied. Based upon our review of this issue, we determined that clinical psychologists possess knowledge sufficient to direct test selection and interpret test data. Therefore, we proposed to change the requirements at § 410.32(b)(2)(iii) to permit clinical psychologists to supervise the performance of diagnostic psychological and neuropsychological testing services. </P>
                    <P>
                        <E T="03">Comment:</E>
                         Two specialty societies representing psychologists and many individual commenters were in support of the change. One major association representing psychiatrists and a few individual commenters opposed the proposal. According to the association, expanding the supervision requirements will not lessen the burden on physicians and healthcare facilities within rural areas. In addition, this association asked that we provide data showing that the change to the supervision requirements will reduce the burden on physicians and health care facilities, and that access will be improved in rural areas. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We appreciate the positive comments in support of this proposal. 
                    </P>
                    <P>
                        In response to the request for evidence that this change will reduce burden and improve access, we would first note that our primary reason for proposing this change was that we believe clinical psychologists possess the core knowledge to sufficiently supervise the administration of these tests. By enabling them to do so, this change will allow greater flexibility in their practices. 
                        <PRTPAGE P="66360"/>
                    </P>
                    <P>With regard to improved access in rural areas, we noted previously in this rule that we recognize mental health HPSAs for incentive payments for psychiatrists. Accordingly, we believe that the expansion of the supervision requirements will help improve access in these areas. </P>
                    <HD SOURCE="HD2">Result of Evaluation of Comments </HD>
                    <P>As proposed, we are revising § 410.32(b)(2)(iii) to permit clinical psychologists to supervise the performance of diagnostic psychological and neuropsychological testing services. </P>
                    <HD SOURCE="HD2">F. Care Plan Oversight </HD>
                    <P>Care Plan Oversight (CPO) refers to the supervision of patients receiving Medicare-covered home health or hospice services requiring complex multidisciplinary care modalities, including regular development and review of plans of care. In the August 5, 2004 rule, we proposed to revise § 414.39 to clarify that NPPs can perform home health CPO; however, they cannot certify a patient for home health services and sign the plan of care. We also proposed the conditions under which NPP services may be billed for CPO and explained that the proposed conditions are meant to ensure that the NPP has seen and examined the patient and that the appropriate and established relationship exists between the physician who certifies the patient for home health services and the NPP who will provide the home health CPO. </P>
                    <P>
                        <E T="03">Comment:</E>
                         Several commenters support the proposed revision and conditions of coverage. They support the integrated practice arrangements required by proposed § 414.39(c)(2)(iii). They believe the proposed conditions ensure appropriate, ongoing supervision of both the patient's condition and the NPP. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We appreciate the commenters' support for this proposal. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         We received a comment from an association representing home care physicians requesting that we include PAs in the clarification because PAs increasingly play the same role as NPs in home health care and bill under the same house call codes. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We agree with the commenter that we include PAs in the clarification. The definition of NPPs in proposed § 414.39(a) includes NPs, CNSs, and PAs. However, we also note that PAs cannot bill directly for their own services. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         We received a comment requesting that we clearly state the definition of the appropriate relationship between the physician and the NPP. The commenter requested that we cross-reference applicable State standards because the meaning of collaboration varies across States and some States require employment relationships. Also, the commenter recommended that we require a written agreement regarding the responsibilities for managing care when the NP or PA is not from the same organization as the physician who has certified the skilled home care services. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We agree that State laws or regulations governing collaborative relationships, where applicable, would be useful in this regard. In the absence of State laws or regulations, NPs and CNSs will be required to document their scope of practice and indicate the relationships they have with physicians to handle issues outside their scope of practice. If the NPP is a PA, the physician signing the plan of care also must be the physician who provides general supervision of PA services for the practice. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         We received a comment requesting that this clarification be made retroactive to at least FY 2000 to allow denied claims to be resubmitted. The commenter stated that many claims for CPO services by NPs were denied over the past several years, despite CMS and legislative intent to have these claims reimbursed. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We clarified in the November 1, 2000 final rule (65 FR 65407) that CPO services of NPPs, practicing within the scope of State law applicable to their services, could be paid under Medicare. However, our policy has also been that the physician who bills for CPO must be the same physician who signs the plan of care. 
                    </P>
                    <P>Appeal rights are available for these claims for CPO services provided by NPPs in HHAs if the appeal is requested within 120 days of the date of the claim denial. If appeal rights have expired, the physician or supplier may request a reopening for any reason within 12 months of the date of the notice of initial determination. After the 12-month period, but within 4 years from the date of the initial determination, a reopening may be requested for good cause. The decision on whether to reopen a claim at the request of the physician or supplier is at the discretion of the Medicare contractor. </P>
                    <P>
                        <E T="03">Comment:</E>
                         We received comments noting that this clarification does not allow NPs, CNSs, or PAs to certify a patient for home health care services or to sign the plan of care. The commenters noted that certification by NPPs is not currently permitted under the statute. One of the commenters recommended that we revise the rules on certification and recertification to allow NPs, CNSs, or PAs to perform them. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         The commenters are correct that the statute (sections 1814(a)(2)(C) and 1835(a)(2)(A) of the Act) requires a physician to certify a patient for home health care services or to sign the plan of care. Therefore, the issue of whether to allow NPs, CNSs, or PAs to certify a patient for home health care services or to sign the plan of care is not within the purview of this rule. 
                    </P>
                    <HD SOURCE="HD2">Result of Evaluations of Comments </HD>
                    <P>We are adopting the proposed changes to § 414.39 that clarify that NPPs can provide care plan oversight for beneficiaries who receive home health services. </P>
                    <HD SOURCE="HD2">G. Assignment of Medicare Claims—Payment to the Supplier </HD>
                    <P>The current regulation requires the beneficiary (or the person authorized to request payment on the beneficiary's behalf) to assign a claim to the supplier for an assignment to be effective. However, over time, the Act was amended in various sections to require that Medicare payment for certain services would only be made on an assigned basis regardless of whether or not the beneficiary actually assigns the claim to the supplier. In these instances, the current requirement in § 424.55(a), which specifies that the beneficiary assign the claim to the supplier, is now unnecessary. Therefore, we proposed to create an exception to the general rule in § 424.55(a). New § 424.55(c) would eliminate the requirement that beneficiaries assign claims to suppliers in situations when payment under the Act can only be made on an assignment-related basis or when payment is for services furnished by a participating physician or supplier. </P>
                    <P>
                        <E T="03">Comment:</E>
                         The ACLA supports the proposal and agrees that this new exception to the requirement for beneficiaries to assign benefits in situations where benefits can, by statute, only be paid on an assigned basis will reduce the paperwork burden on beneficiaries and suppliers. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We agree that the proposed regulation will reduce the paperwork burden on beneficiaries and suppliers and we are finalizing the revisions as proposed. 
                    </P>
                    <HD SOURCE="HD2">Result of Evaluation of Comments </HD>
                    <P>We are finalizing § 424.55(c) as proposed. </P>
                    <HD SOURCE="HD2">H. Additional Issues Raised by Commenters</HD>
                    <P>
                        <E T="03">Comment:</E>
                         Two specialty societies representing plastic surgeons and 
                        <PRTPAGE P="66361"/>
                        podiatrists, as well as the RUC, recommended that the global period for CPT 15342, Application of bilaminate skin substitute/neodermis; 25 sq cm, be changed from a 10-day global period to a 0-day global period. The commenters stated that the plastic surgeons generally perform this procedure on more severely injured patients, such as burn patients, who are often seen in the inpatient setting. The podiatrists, on the other hand, typically treat patients with diabetic foot ulcers in the outpatient setting. Therefore, the commenters contend that though the work required to perform the procedure is the same for both specialties, the post-surgical work and time are not and the change in the global period would allow both scenarios to be paid appropriately. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We understand that this code can represent differing scenarios. However, while podiatrists perform approximately 45 percent of the procedures and general surgeons 17 percent, plastic surgeons perform only 7 percent. In addition, only 9 percent are performed in the inpatient hospital setting. Our general approach and the one adopted by the RUC for valuing all services is to base our review on the typical patient. In this case, the podiatric scenario would clearly dominate and applying a 10-day global period to capture the post-procedure office visit appears appropriate. However, we would be willing to discuss this issue further with the specialties involved and with the RUC. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         The American Society of Anesthesiologists (ASA) provided comments asking that we consider revising the current teaching regulations to place teaching anesthesiologists' reimbursements on par with the teaching of resident physicians in surgery and other high-risk specialties. Also, that we redefine the HCPCS claims service modifier “AA” to include both the personal administration of the anesthesia by the physician and teaching up to two resident physicians concurrently. In its comments, the ASA stated that it believes we possess the authority under the terms of section 1871 of the Medicare statute to make the requested change in its teaching reimbursement rules, effective January 1, 2005, as follows: the agency can treat the rule as a logical outgrowth of a prior proposal; it can issue a final rule with comment period as part of the 2005 physician payment final rule; or, it can promptly issue a free-standing rule proposing the change and allow for public comment and subsequent effectiveness along with the 2005 physician payment rule. The American Association of Nurse Anesthetists (AANA) asked that, if we review proposed revisions to the teaching anesthesiologist rules, that we carefully consider how these revisions might impact teaching Certified Registered Nurse Anesthetists (CRNAs). The AANA commented that our rules should not favor one type of provider over another. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         Surgical services are paid differently than anesthesia services. For example, surgical codes usually have global periods and payment includes the payment for the surgical procedure and postoperative visits during the global period. Anesthesia services include the preanesthesia examination and evaluation, the anesthesia service associated with the surgical service, and immediate postanesthesia care. Currently, the teaching physician's presence during the key or critical period criteria applies to both the services of the teaching surgeon and the teaching anesthesiologist. The key or critical services are different for the service of each specialty. 
                    </P>
                    <P>We plan to explore these issues further prior to deciding whether to include this change in the proposed rule for 2006. </P>
                    <P>
                        <E T="03">Comment:</E>
                         We received comments from a manufacturer, many providers and individuals requesting that new HCPCS codes be created for a specific laser surgery treatment for benign prostatic hyperplasia. Commenters stated that current CPT codes used for billing this service under the physician fee schedule are not specific to the unique technology involved with this laser surgery treatment and result in underpayment when this technology is used. They noted that under the hospital OPPS, this treatment was assigned to a new technology code. 
                    </P>
                    <P>We also received requests from other individuals for new G codes and payment for other specific services, and for certain HCPCS codes that currently are paid only under OPPS. </P>
                    <P>
                        <E T="03">Response:</E>
                         We do not believe that it is necessary to create new HCPCS codes for these services. Commenters that believe the existing CPT codes do not reflect their technology or services, may contact the AMA's CPT Editorial Panel to review these matters, particularly since the CPT Editorial Panel has a new coding classification specifically for new and emerging technologies. 
                    </P>
                    <P>There will be situations where codes are used under OPPS but not recognized under the physician fee schedule (PFS) because of the different payment methodologies. </P>
                    <P>
                        <E T="03">Comment:</E>
                         A specialty society urged us to discontinue use of the HCPCS codes for positron emission tomography (PET) procedures and to instruct physicians to use the available CPT codes. They also urged us to adopt RUC recommendations for new PET codes rather than carrier price these services. The commenter stated they would like to meet to discuss these new codes and PET/computed tomography (CT) technology. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We will continue to use HCPCS codes and carrier price these services at this time. We will be examining the overall issue of Medicare coding, payment, and coverage of PET services and would be happy to meet with the specialty society to discuss this issue. 
                    </P>
                    <HD SOURCE="HD2">General Issues </HD>
                    <P>We also received comments on issues and concerns that were beyond the scope of the proposed rule. These include: The need for quality standards for diagnostic imaging; concerns about outreach and access; requests for revisions to current policy; and, concerns about the accuracy of code descriptors. While we will try to ensure these comments are provided to appropriate CMS components, commenters should also feel free to contact the appropriate CMS components about their concerns. To the extent that these comments involved valuation of services under the physician fee schedule, we are also soliciting comments on services for which the physician work may be misvalued. See section VI for additional information on this process. </P>
                    <HD SOURCE="HD1">V. Refinement of Relative Value Units for Calendar Year 2005 and Response to Public Comments on Interim Relative Value Units for 2004 </HD>
                    <FP>[If you choose to comment on issues in this section, please include the caption “Interim Work Relative Value Units” at the beginning of your comments.] </FP>
                    <HD SOURCE="HD2">A. Summary of Issues Discussed Related to the Adjustment of Relative Value Units </HD>
                    <P>Section V.B. and V.C. of this final rule describes the methodology used to review the comments received on the RVUs for physician work and the process used to establish RVUs for new and revised CPT codes. Changes to codes on the physician fee schedule reflected in Addendum B are effective for services furnished beginning January 1, 2005. </P>
                    <HD SOURCE="HD2">B. Process for Establishing Work Relative Value Units for the 2004 Physician Fee Schedule </HD>
                    <P>
                        Our November 7, 2003 final rule (69 FR 1084) contained the work RVUs for Medicare payment for existing 
                        <PRTPAGE P="66362"/>
                        procedure codes under the physician fee schedule and interim RVUs for new and revised codes beginning January 1, 2004. We considered the RVUs for the interim codes to be subject to public comment under the annual refinement process. (Note that the November rule was subsequently revised on January 7, 2004 to reflect revisions to procedure codes required by the MMA.) In this section, we summarize the refinements to the interim work RVUs published in the November 7, 2003 rule and our establishment of the work RVUs for new and revised codes for the 2005 physician fee schedule. 
                    </P>
                    <HD SOURCE="HD2">C. Work Relative Value Unit Refinements of Interim Relative Value Units </HD>
                    <HD SOURCE="HD3">1. Methodology (Includes Table Titled “Work Relative Value Unit Refinements of the 2003 Interim and Related Relative Value Units”) </HD>
                    <P>Although the RVUs in the January 2004 final rule were used to calculate 2004 payment amounts, we considered the RVUs for the new or revised codes to be interim. We accepted comments for a period of 60 days. We received substantive comments on approximately 12 CPT codes with interim work RVUs. </P>
                    <P>To evaluate these comments we used a process similar to the process used since 1997. (See the October 31, 1997 final rule (62 FR 59084) for the discussion of refinement of CPT codes with interim work RVUs.) We convened a multispecialty panel of physicians to assist us in the review of the comments. The comments that we did not submit to panel review are discussed at the end of this section, as well as those that were reviewed by the panel. We invited representatives from the organizations from which we received substantive comments to attend a panel for discussion of the code on which they had commented. The panel was moderated by our medical staff, and consisted of the following voting members: </P>
                    <P>• One or two clinicians representing the commenting organization. </P>
                    <P>• One primary care clinician nominated by the American College of Physicians and American Society of Internal Medicine. </P>
                    <P>• Four carrier medical directors. </P>
                    <P>• Four clinicians with practices in related specialties who were expected to have knowledge of the service under review. </P>
                    <P>The panel discussed the work involved in the procedure under review in comparison to the work associated with other services under the physician fee schedule. We assembled a set of 300 reference services and asked the panel members to compare the clinical aspects of the work of the service a commenter believed was incorrectly valued to one or more of the reference services. In compiling the set, we attempted to include: (1) Services that are commonly performed whose work RVUs are not controversial; (2) services that span the entire spectrum from the easiest to the most difficult; and (3) at least three services performed by each of the major specialties so that each specialty would be represented. The intent of the panel process was to capture each participant's independent judgment based on the discussion and his or her clinical experience. Following the discussion, each participant rated the work for the procedure. Ratings were individual and confidential, and there was no attempt to achieve consensus among the panel members. </P>
                    <P>We then analyzed the ratings based on a presumption that the interim RVUs were correct. To overcome this presumption, the inaccuracy of the interim RVUs had to be apparent to the broad range of physicians participating in each panel. </P>
                    <P>Ratings of work were analyzed for consistency among the groups represented on each panel. In addition, we used statistical tests to determine whether there was enough agreement among the groups of the panel and whether the agreed-upon RVUs were significantly different from the interim RVUs published in Addendum C of the final rule. We did not modify the RVUs unless there was a clear indication for a change. If there was agreement across groups for change, but the groups did not agree on what the new RVUs should be, we eliminated the outlier group and looked for agreement among the remaining groups as the basis for new RVUs. We used the same methodology in analyzing the ratings that we first used in the refinement process for the 1993 physician fee schedule. The statistical tests were described in detail in the November 25, 1992 final rule (57 FR 55938). </P>
                    <P>Our decision to convene multispecialty panels of physicians and to apply the statistical tests described above was based on our need to balance the interests of those who commented on the work RVUs against the redistributive effects that would occur in other specialties. </P>
                    <P>We also received comments on RVUs that were interim for 2004, but for which we did not submit the RVUs to the panel for review for a variety of reasons. These comments and our decisions on those RVUs commented upon are discussed in further detail below. </P>
                    <P>Table 17 below lists those interim codes reviewed under the refinement panel process described in this section. This table includes the following information: </P>
                    <P>• CPT Code. This is the CPT code for a service. </P>
                    <P>• Description. This is an abbreviated version of the narrative description of the code. </P>
                    <P>• 2004 Work RVU. The work RVUs that appeared in the January 2004 rule are shown for each reviewed code. </P>
                    <P>• Requested Work RVU. This column identifies the work RVUs requested by commenters. </P>
                    <P>• 2005 Work RVU. This column contains the final RVUs for physician work. </P>
                    <GPH SPAN="3" DEEP="170">
                        <PRTPAGE P="66363"/>
                        <GID>ER15NO04.515</GID>
                    </GPH>
                    <HD SOURCE="HD3">2. Interim 2004 Codes </HD>
                    <P>
                        CPT code 43752 
                        <E T="03">Naso- or oro-gastric tube placement, requiring physician's skill and fluoroscopic guidance (includes fluoroscopy, image documentation and report).</E>
                    </P>
                    <P>
                        The RUC recommended a work RVU of 0.82 for this service based on a comparison of this procedure to CPT code 44500, 
                        <E T="03">Introduction of long gastrointestinal tube.</E>
                         While we agreed that CPT code 43752 is similar in work intensity to CPT code 44500, we believed the intra-service time is more appropriately valued at the 25th percentile (15 minutes of intra-service time vs. 20 minutes of intra-service time). This reduced the total time associated with CPT code 43752 from 30 minutes to 25 minutes. We applied the ratio of the RUC recommended value of 0.82 work RVU over 30 minutes to the revised intra-service time of 25 minutes and assigned 0.68 interim work RVUs for CPT code 43752. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         Commenters disagreed with our decision not to accept the RUC recommended WRVU of 0.82 and with our rejection of the survey time, particularly since this service involves both tube placement and imaging. Based on these comments, we referred this code to the multispecialty validation panel for review. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         As a result of the statistical analysis of the 2004 multispecialty validation panel ratings, we have assigned 0.81 work RVUs to CPT code 43752. 
                    </P>
                    <P>
                        CPT code 63103 
                        <E T="03">Vertebral corpectomy (vertebral body resection), partial or complete, lateral extracavitary approach with decompression of spinal cord and/or nerve root(s) (for example, for tumor or retropulsed bone fragments); thoracic or lumbar, each additional segment (List separately in addition to code for primary procedure).</E>
                    </P>
                    <P>The RUC recommended a work RVU of 5.00 for this service based on a comparison of this procedure to CPT code 63088, the add-on code for the vertebral corpectomy, thoracic lumbar approach. We stated that it was unclear from the clinical vignettes supplied by the specialty society whether the additional corpectomy would more commonly involve the lumbar or the thoracic region of the spine. There is a significant difference in work intensity associated with the resection of an additional corpus in the thoracic region as opposed to the lumbar region. For this reason we applied the ratio of the reference service (CPT code 63088) to its primary service (CPT code 63087) to CPT code 63101 (primary service associated with CPT 63103) to assign 3.90 interim work RVUs for CPT code 63103. </P>
                    <P>
                        <E T="03">Comment:</E>
                         Commenters requested that we withdraw the arbitrary reduction of the work RVU for CPT code 63103 stating that the unique aspects of the lateral extracavitary approach make the location in the lumbar and thoracic spine less relevant than the actual exposure of an additional level itself. The commenters stated that in contrast to anterior thoracic or lumbar approaches for vertebral corpectomy, the lateral extracavitary approach requires an unrelated and significantly greater muscle dissection of spinal/paraspinal tissues, as well as an additional rib, transverse process, and pedicle removal with isolation and division of another pair of segmental vessels. Based on these comments, we referred this code to the multispecialty validation panel for review. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         As a result of the statistical analysis of the 2004 multispecialty validation panel ratings, we have assigned 4.82 work RVUs to CPT code 63103. 
                    </P>
                    <P>
                        CPT codes 38207 
                        <E T="03">Transplant preparation of hematopoietic progenitor cells; cryopreservation and storage,</E>
                         38208 
                        <E T="03">Transplant preparation of hematopoietic progenitor cells; thawing of previously frozen harvest, without washing,</E>
                         38209 
                        <E T="03">Transplant preparation of hematopoietic progenitor cells; thawing of previously frozen harvest, with washing</E>
                         38210 
                        <E T="03">Transplant preparation of hematopoietic progenitor cells; specific cell depletion within harvest, T-cell depletion,</E>
                         38211 
                        <E T="03">Transplant preparation of hematopoietic progenitor cells; tumor cell depletion,</E>
                         38212 
                        <E T="03">Transplant preparation of hematopoietic progenitor cells; red blood cell removal,</E>
                         38213 
                        <E T="03">Transplant preparation of hematopoietic progenitor cells; platelet depletion,</E>
                         38214 
                        <E T="03">Transplant preparation of hematopoietic progenitor cells; plasma (volume) depletion,</E>
                         38215 
                        <E T="03">Transplant preparation of hematopoietic progenitor cells; cell concentration in plasma, mononuclear, or buffy coat layer.</E>
                        —These codes were new for CY 2003 but we did not receive the final RUC recommendations in time for inclusion in the final rule. In the December 31, 2002 rule we discussed the interim RUC recommendations and our concerns for removing these codes from the laboratory fee schedule, and paying them instead on the physician fee schedule (67 FR 80007). We received the final RUC recommendations in May 2003 and in the November 7, 2003 final rule we stated we were maintaining a status indicator “I” for these services making them not valid for payment under the physician fee schedule. (Note: In the December 31, 2002 rule, as part of the discussion about these CPT codes, we discussed the creation of HCPCS codes G0265, 
                        <E T="03">Cryopreservation, freezing and storage of cells for therapeutic use, each cell line;</E>
                         G0266 
                        <E T="03">Thawing and expansion of frozen cells for therapeutic use, each aliquot;</E>
                         and G0267, 
                        <E T="03">
                            Bone marrow or peripheral stem cell harvest, 
                            <PRTPAGE P="66364"/>
                            modification or treatment to eliminate cell type(s) (for example, T-cells, metastic carcinoma).
                        </E>
                         We stated that these HCPCS codes are paid under the laboratory fee schedule.) 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         We received comments regarding these codes in response to the 2002 and 2003 final rules. Commenters expressed concern, which was shared by the RUC about the CMS decision pertaining to these CPT codes. They stated that CMS was invited to conduct site visits to observe and have a better understanding of these services. They believe such visits would provide additional information on these services and allow for a more informed decision about their placement on the physician fee schedule. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         CPT codes 38207, 38208, 38209, 38210, 38211, 38212, 38213, 38214 and 38215 reflect services that are typically provided by laboratory personnel who require general oversight and supervision by a laboratory physician, analogous to a physician providing oversight in a blood banking facility. Based on site visits, we continue to believe that these services are not typically provided by a physician. We recognize that variability pertaining to the clinical and laboratory management of patients does exist and that in some bone marrow transplant centers these laboratory services are closely supervised and managed by physicians. These centers, however, do not reflect the typical practice pattern for the majority of bone marrow transplant centers. Therefore, we will continue to allow use of HCPCS codes G0265 Cryopreservation, freezing and storage of cells for therapeutic use, each cell line and G0266 Thawing and expansion of frozen cells for therapeutic use, each aliquot to report these services, and G0267 Bone marrow or peripheral stem cell harvest, modification or treatment to eliminate cell type(s) (for example, T-cells, metastatic carcinoma). These services are currently on the laboratory fee schedule. We welcome additional comments to help us better determine whether to place CPT codes 38207 through 38215 on either the physician or laboratory fee schedule.
                    </P>
                    <P>
                        <E T="04">Note:</E>
                         We identified the services provided within transplant centers as clinical services typically provided by a physician in conjunction with the following codes: CPT codes 38205—Blood-derived hematopoietic progenitor cell harvesting for transplantation, per collection; allogenic, CPT 38206—Blood-derived hematopoietic progenitor cell harvesting for transplantation, per collection; autologous, CPT codes 38240—Bone Marrow or bone derived peripheral stem cell transplantation; allogenic, CPT code 38241—Bone Marrow or bone derived peripheral stem cell transplantation; autologous, and CPT code 38242—Bone Marrow or bone derived peripheral stem cell transplantation; allogeneic lymphocyte donor infusions. We believe the physician work RVUs assigned by the RUC to these codes (CPT code 38205-1.50, CPT code 38206-1.50, CPT code 38240-2.24 RVUs, CPT code 38241-2.24 RVUs, and CPT code 38242-1.71 RVUs) appropriately reflect the physician work intensity for each of these services and reaffirm our prior decision announced in 2002. CPT code 38204—Management of recipient hematopoietic progenitor cell donor search and cell acquisition was valued at 2.00 RVUs by the RUC in 2002. We believe there may be physician work when providing this service. However, information obtained during our site visits revealed that the bulk of the service was provided by the transplant coordinator, who worked closely with the physician. It is unclear at this point what the appropriate value will be for the physician who provides this service. We welcome comments on this issue.
                    </P>
                    <P>
                        CPT code 76514 
                        <E T="03">Ophthalmic ultrasound, echography, diagnostic; corneal pachymetry, unilateral or bilateral (determination of corneal thickness)</E>
                        .—We accepted the RUC recommendation of 0.17 work RVUs. 
                    </P>
                    <P>
                        <E T="03">Comments:</E>
                         The American Academy of Ophthalmology commented that the assigned work RVU does not accurately reflect the value intended by the RUC or CPT; the value should be doubled. The Academy stated that the problem arose when the RUC recommended to CPT that the descriptor should be changed from unilateral to unilateral or bilateral. The commenter suggested that either the descriptor be changed to reflect only the unilateral, which will take a while to accomplish, or that we increase valuation to correctly reflect valuation by RUC. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         Because we have no data that indicates whether the unilateral or bilateral procedure is more typical, we are not changing the RVUs at this time. We would suggest that the Academy contact the CPT Editorial Panel if a change to the descriptor would be helpful to the specialty. 
                    </P>
                    <HD SOURCE="HD2">Establishment of Interim Work Relative Value Units for New and Revised Physician's Current Procedural Terminology (CPT) Codes and New Healthcare Common Procedure Coding System Codes (HCPCS) for 2005 (Includes Table Titled “American Medical Association Specialty Relative Value Update Committee and Health Care Professionals Advisory Committee Recommendations and CMS's Decisions for New and Revised 2005 CPT Codes”) </HD>
                    <P>One aspect of establishing RVUs for 2005 was to assign interim work RVUs for all new and revised CPT codes. As described in our November 25, 1992 notice on the 1993 physician fee schedule (57 FR 55983) and in section III.B. of the November 22, 1996 final rule (61 FR 59505 through 59506), we established a process, based on recommendations received from the AMA's RUC, for establishing interim work RVUs for new and revised codes. </P>
                    <P>This year we received work RVU recommendations for 149 new and revised CPT codes from the RUC. Our staff and medical officers reviewed the RUC recommendations by comparing them to our reference set or to other comparable services for which work RVUs had previously been established. We also considered the relationships among the new and revised codes for which we received RUC recommendations and agreed with the majority of the relative relationships reflected in the RUC values. In some instances, although we agreed with the relationships, we nonetheless revised the work RVUs to achieve work neutrality within families of codes. That is, the work RVUs have been adjusted so that the sum of the new or revised work RVUs (weighted by projected frequency of use) for a family will be the same as the sum of the current work RVUs (weighted by projected frequency of use) for the family of codes. We reviewed all the RUC recommendations and accepted approximately 99 percent of the RUC recommended values. For approximately 1 percent of the recommendations, we agreed with the relativity established by the RUC, but needed to adjust work RVUs to retain budget neutrality. </P>
                    <P>We received four recommendations from the HCPAC. We agreed with two of these recommendations and disagreed with two of them. </P>
                    <P>
                        Table 18, titled “AMA RUC and HCPAC Recommendations and CMS Decisions for New and Revised 2005 CPT Codes,” lists the new or revised CPT codes, and their associated work RVUs, that will be interim in 2005. This 
                        <PRTPAGE P="66365"/>
                        table includes the following information: 
                    </P>
                    <P>• A “#” identifies a new code for 2005. </P>
                    <P>• CPT code. This is the CPT code for a service. </P>
                    <P>• Modifier. A “26” in this column indicates that the work RVUs are for the professional component of the code. </P>
                    <P>• Description. This is an abbreviated version of the narrative description of the code. </P>
                    <P>• RUC recommendations. This column identifies the work RVUs recommended by the RUC. </P>
                    <P>• HCPAC recommendations. This column identifies the work RVUs recommended by the HCPAC. </P>
                    <P>• CMS decision. This column indicates whether we agreed or we disagreed with the RUC recommendation. Codes for which we did not accept the RUC recommendation are discussed in greater detail following this table. An “(a)” indicates that no RUC recommendation was provided. </P>
                    <P>• 2005 Work RVUs. This column establishes the interim 2005 work RVUs for physician work.</P>
                    <BILCOD>BILLING CODE 4120-01-P </BILCOD>
                    <GPH SPAN="3" DEEP="454">
                        <GID>ER15NO04.516</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="615">
                        <PRTPAGE P="66366"/>
                        <GID>ER15NO04.517</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="614">
                        <PRTPAGE P="66367"/>
                        <GID>ER15NO04.518</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="380">
                        <PRTPAGE P="66368"/>
                        <GID>ER15NO04.519</GID>
                    </GPH>
                    <BILCOD>BILLING CODE 4120-01-C</BILCOD>
                    <P>Table 19, which is titled “AMA RUC ANESTHESIA RECOMMENDATIONS AND CMS DECISIONS FOR NEW AND REVISED 2005 CPT CODES”, lists the new or revised CPT codes for anesthesia and their base units that will be interim in 2005. This table includes the following information: </P>
                    <P>• CPT code. This is the CPT code for a service. </P>
                    <P>• Description. This is an abbreviated version of the narrative description of the code. </P>
                    <P>• RUC Recommendations. This column identifies the base units recommended by the RUC.</P>
                    <P>• CMS decision. This column indicates whether we agreed or we disagreed with the RUC recommendation. Codes for which we did not accept the RUC recommendation are discussed in grreater detail following this table.</P>
                    <P>• 2005 Base Units. This column establishes the 2005 base units for these services.</P>
                    <GPH SPAN="3" DEEP="133">
                        <GID>ER15NO04.520</GID>
                    </GPH>
                    <PRTPAGE P="66369"/>
                    <HD SOURCE="HD2">Discussion of Codes for Which There Were No RUC Recommendations or for Which the RUC Recommendations Were Not Accepted</HD>
                    <P>The following is a summary of our rationale for not accepting particular RUC work RVU or base unit recommendations. It is arranged by type of service in CPT order. Additionally, we discuss those CRP codes for which we received no RUC recommendations for physician work RVUs. This summary refers only to work RVUs or base units.</P>
                    <HD SOURCE="HD2">New and Revised Codes for 2005</HD>
                    <P>
                        CPT mode 97605 
                        <E T="03">Negative pressure wound therapy (for example, vacuum assisted drainage collection), including topical application(s), wound assessment, and instruction(s) for ongoing care, per session; total wound(s) surface area less than or equal to 50 square centimeters</E>
                         and CPT code 97606 
                        <E T="03">Negative pressure wound therapy</E>
                         (for example, vacuum assisted drainage collection), including topical application(s), wound assessment, and instruction(s) for ongoing care, per session; total wound(s) surface area greater than 50 square centimeters.—The RUC HCPAC review board recommended 0.55 work RVUs for CPT code 97605 and 0.60 work RVUs for CPT code 97606, which we did not accept. We disagree with their recommendation that these services contain physician work and will not assign work RVUs. Further, when the negative pressure wound therapy service does not encompass selective debridement, we consider this service to represent a dressing change and will not make separate payment. When the negative pressure wound therapy service includes the need for selective debridement, we consider the services represented by CPT codes 97605 and 97606 to be bundled into CPT codes 97597 or 97598, the new debridement codes, which will be appropriately billed. We are assigning a status indicator of “B” to these two new CPT codes (97605 and 97606), meaning that we will not make separate payment for these services.
                    </P>
                    <P>
                        CPT code 57282, 
                        <E T="03">Colpopexy, vaginal; extra-peritoneal approach (sacrospinous, iliococcygeus) and CPT code 57283 Colpopexy, vaginal; intra-peritoneal approach (uterosacral, levator myorrhaphy).</E>
                        —The CPT Editorial Panel revised an existing code (57282) and created a new code (57283) to describe vaginal extra and intraperitoneal colpopexies. The RUC recommended maintaining the current work PVUs of 8.85 for 57282 and recommended 14.00 work PVUs for 57283. Previously, both the extra-peritoneal approach and intra-peritoneal approach were billed under CPT code 57282. Effective January 1, 2005, CPT code 57282 will be used to report colpopexy, vaginal; extra-peritoneal approach, while CPT code 57283 will be used to report colpopexy vaginal; intraperitoneal approach. Although we agree with the relativity established by the RUC, we believe that the work RVUs for CPT code 57282 should have been adjusted to reflect that the intra-peritoneal approach is now being reported using CPT code 57283. In order to retain work neutrality between these two services, we adjusted the work RVUs using the utilization crosswalks provided by the specialty survey to account for the work that was previously associated with performing these procedures when only one code existed. This results in work RVUs of 6.86 for CPT code 57282 and 10.84 work RVUs for CPT code 57283.
                    </P>
                    <P>We have not received the final recommendations from the RUC on these services and carriers will price these services in 2005. </P>
                    <P>
                        CPT Code 32855 
                        <E T="03">Backbench standard preparation of cadaver donor lung allograft prior to transplantation, including dissection of allograft from surrounding soft tissues to prepare pulmonary venous/atrial cuff, pulmonary artery, and bronchus; unilateral;</E>
                         CPT Code 32856 
                        <E T="03">Backbench standard preparation of cadaver donor lung allograft prior to transplantation, including dissection of allograft from surrounding soft tissues to prepare pulmonary venous/atrial cuff, pulmonary artery, and bronchus; bilateral;</E>
                         CPT Code 33933 
                        <E T="03">Backbench standard preparation of cadaver donor heart/lung allograft prior to transplantation, including dissection of allograft from surrounding soft tissues to prepare aorta, superior vena cava, inferior vena cava, and trachea for implantation;</E>
                         CPT Code 33944 
                        <E T="03">Backbench standard preparation of cadaver donor heart allograft prior to transplantation, including dissection of allograft from surrounding soft tissues to prepare aorta, superior vena cava, inferior vena cava, pulmonary artery, and left atrium for implantation;</E>
                         CPT Code 44715 
                        <E T="03">Backbench standard preparation of cadaver or living donor intestine allograft prior to transplantation, including mobilization and fashioning of the superior mesenteric artery and vein;</E>
                         CPT Code 47143 
                        <E T="03">Backbench standard preparation of cadaver donor whole liver graft prior to allotransplantation, including cholecystectomy, if necessary, and dissection and removal of surrounding soft tissues to prepare the vena cava, portal vein, hepatic artery, and common bile duct for implantation; without trisegment or lobe spilt;</E>
                         CPT Code 47144 
                        <E T="03">Backbench standard preparation of cadaver donor whole liver graft prior to allotransplantation, including cholecystectomy, if necessary, and dissection and removal of surrounding soft tissues to prepare the vena cava, portal vein, hepatic artery, and common bile duct for implantation; with trisegment split of whole liver graft into two partial liver grafts (that is, left lateral segment (segments II and III) and right trisegment (segments I and IV through VIII));</E>
                         CPT Code 47145 
                        <E T="03">Backbench standard preparation of cadaver donor whole liver graft prior to allotransplantation, including cholecystectomy, if necessary, and dissection and removal of surrounding soft tissues to prepare the vena cava, portal vein, hepatic artery, and common bile duct for implantation; with lobe split of whole liver graft into two partial liver grafts (that is, left lobe (segments II, III, and IV) and right lobe (segments I and V through VIII));</E>
                         CPT Code 48551 
                        <E T="03">Backbench standard preparation of cadaver donor pancreas allograft prior to transplantation, including dissection of allograft from surrounding soft tissues, splenectomy, duodenotomy, ligation of bile duct, ligation of mesenteric vessels, and Y-graft arterial anastomoses from iliac artery to superior mesenteric artery and to splenic artery,</E>
                         CPT Code 50323 
                        <E T="03">Backbench standard preparation of cadaver donor renal allograft prior to transplantation, including dissection and removal of perinephric fat, diaphragmatic and retroperitoneal attachments, excision of adrenal gland, and preparation of ureter(s), renal vein(s), and renal artery(s), ligating branches, as necessary;</E>
                         CPT Code 50325 
                        <E T="03">Backbench standard preparation of living donor renal allograft (open or laparoscopic) prior to transplantation, including dissection and removal of perinephric fat and preparation of ureter(s), renal vein(s), and renal artery(s), ligating branches, as necessary;</E>
                         and CPT Code 93745 
                        <E T="03">Initial set-up and programming by a physician of wearable cardioverter-defibrillator includes initial programming of system, establishing baseline electronic ECG, transmission of data to data repository, patient instruction in wearing system and patient reporting of problem or events.</E>
                        <PRTPAGE P="66370"/>
                    </P>
                    <HD SOURCE="HD2">Establishment of Interim Practice Expense RVUs for New and Revised Physician's Current Procedural Terminology (CPT) Codes and New Healthcare Common Procedure Coding System (HCPCS) Codes for 2005 </HD>
                    <P>We have developed a process for establishing interim practice expense RVUs for new and revised codes that is similar to that used for work RVUs. Under this process, the RUC recommends the practice expense direct inputs (the staff time, supplies and equipment) associated with each new code. We then review the recommendations in a manner similar to our evaluation of the recommended work RVUs. </P>
                    <P>The RUC recommendations on the practice expense inputs for the new and revised 2005 codes were submitted to us as interim recommendations. </P>
                    <P>We have accepted, in the interim, the practice expense recommendations submitted by the RUC for the codes listed in the table titled “AMA RUC and HCPAC RVU Recommendations and CMS Decisions for New and Revised 2005 CPT Codes.” However, we will be reviewing the supplies, including the DNA probes, for the new and revised in situ hybridization codes (CPT 88365, 88367 and 88368) to ensure that the practice expense database accurately reflects the supplies associated with these services. </P>
                    <HD SOURCE="HD2">Other Issues </HD>
                    <P>
                        <E T="03">Comment:</E>
                         The RUC requested that we modify the definition of the “preservice” portion for the 0-, 10- and 90-day global periods to state, “The preservice period includes the physicians' services following the visit at which the decision for surgery is finalized until the time of the operative procedure.” The current definition of the preservice time for the 0 and 10-day global periods includes the preservice work occurring on the day of surgery, while the 90-day global period includes the preservice work occurring the day before surgery. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We are reluctant to revise the definition of preservice until there is further review of the issue. Though the suggested change in preservice definition for physician work would correspond to the change made in the definition for practice expense purposes, that revision was made at the beginning of the practice expense refinement. It is not clear to us how the relativity would be maintained between existing codes valued under the current definition and new codes valued using an expanded definition of preservice work. In addition, among different procedures, there is most likely much variation in the time period between the decision to perform surgery and the time of the operative procedure. The absence of a specific timeframe could result in an inconsistent application of the definition. However, we would look forward to further discussion with the RUC concerning this issue. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         Solid compensator-based intensity modulated radiation therapy (IMRT) is one of the IMRT technologies currently paid using the radiation therapy CPT code 77418, 
                        <E T="03">Intensity modulated treatment delivery.</E>
                         For 2005, CPT created a Category III tracking code 0073T, 
                        <E T="03">Compensator-based beam modulation treatment delivery of inverse planned treatment using three or more high resolution (milled or cast) compensatory convergent beam modulated fields, per treatment session.</E>
                         CPT instructions for CPT code 77418 now specifically exclude this technology. 
                    </P>
                    <P>Physicians performing compensator-based IMRT expressed concern that we generally carrier price tracking codes and that carriers often will not pay for them, considering services reported with a tracking code to be experimental. One commenter requested that, in order to allow payment for solid compensator-based IMRT under the physician fee schedule, we assign RVUs to the new CPT tracking code 0073T. </P>
                    <P>
                        <E T="03">Response:</E>
                         As noted by the commenters, we generally do not nationally price tracking codes, which are most often used to report new or experimental services. Rather, we designate them as carrier priced until there is sufficient volume and information to develop appropriate RVUs. However, solid compensator based IMRT is an established technology that is currently paid both under the physician fee schedule and in the hospital outpatient department. We are concerned that having this service be reported using a carrier-priced tracking code could have an adverse effect on access to this technology. Therefore, we are assigning interim RVUs to this tracking code. For payment under the physician fee schedule, we will crosswalk the practice expense and malpractice RVUs assigned to CPT code 77418 to the Category III tracking code 0073T. (Note that this is a technical component only service and there are no associated physician work RVUs.) 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         For 2005, CPT has eliminated CPT code 79900, 
                        <E T="03">Provision of Therapeutic Radiopharmaceuticals.</E>
                         We received comments from several organizations and individuals concerning elimination of this CPT code. Commenters requested we either grant a grace period for the CPT code or reinstate the HCPCS code Q3001, 
                        <E T="03">Radioelements for brachytherapy, any type, each,</E>
                         so that payment can be made under the physician fee schedule. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We are reinstating HCPCS code Q3001 under the physician fee schedule. This service will be carrier priced. 
                    </P>
                    <P>Note that there have been new HCPCS drug administration codes for physicians' services established for CY 2005. Please see section III.E.2 for specific information related to these new HCPCS codes. </P>
                    <HD SOURCE="HD1">VI. Five-Year Refinement of Relative Value Units </HD>
                    <FP>[If you choose to comment on issues in this section, please include the caption “Five Year Refinement of Work Relative Value Units for Calendar Year 2004” at the beginning of your comments.] </FP>
                    <HD SOURCE="HD2">A. Background </HD>
                    <P>The work RVUs were originally developed by a research team at the Harvard School of Public Health in a cooperative agreement with us. Harvard established the work RVUs for almost all fee schedule codes. The RVUs for anesthesia services were based on relative values from the American Society of Anesthesiology. The original RVUs for radiology codes were based on the American College of Radiology relative value scale. The work RVUs reflect the physician's effort in providing a service by accounting for: the physician's time; the technical difficulty of the procedure; the average severity of illness among patients receiving the procedure; and the degree of physical and mental effort required of the physician to perform the procedure. </P>
                    <P>Section 1848(c)(2)(B)(i) of the Act requires that we review all RVUs no less than every 5 years. We initiated the first 5-year review in 1994 and refinements went into effect beginning in 1997. The second 5-year review began in 1999 and refinements went into effect beginning in 2002. It is now time to begin the third 5-year review of the physician work RVUs with the resulting changes being effective beginning in 2007. </P>
                    <P>
                        As part of the final rule published December 8, 1994 (59 FR 63453), we solicited public comment on all work RVUs for approximately 7,000 CPT and HCPCS codes. The scope of the 5-year review was limited to work values, since at that time, the statute required practice expense and malpractice RVUs be calculated based on 1991 allowed charges and practice expense and malpractice expense shares for the specialties performing the services. Also, the December 8, 1994 final rule 
                        <PRTPAGE P="66371"/>
                        outlined the proposed process for refinement of the work RVUs and provided a suggested format for submission of comments. 
                    </P>
                    <P>
                        We indicated that we were particularly interested in receiving comments on physicians' services for which medical practice had changed since the Harvard surveys were performed, but for which there were no code changes and, therefore, no reconsideration of whether the work RVUs were still accurate. As a result of the December 8, 1994 final rule, we received more than 500 comments on approximately 1,100 codes. Subsequent to review of the comments by our medical staff, comments on approximately 700 codes were forwarded to the AMA's Specialty Society RUC for review. An additional 300 codes identified by our staff as potentially misvalued were also forwarded to the RUC. A process similar to that used for the annual physician fee schedule update was used for evaluating the proposed changes to the work RVUs and a notice discussing these proposed changes was published in the May 3, 1996 
                        <E T="04">Federal Register</E>
                         (61 FR 19992). As outlined in this notice, we proposed to increase the work RVUs for 28 percent of the codes; we proposed to maintain the work RVUs for 61 percent of the codes and we proposed to decrease the work RVUs for 11 percent of the codes. (Our proposed work RVUs agreed with the RUC recommendations for 93 percent of the codes.) In response to the May 3, 1996 proposed notice, we received more than 2,900 comments on approximately 133 codes plus all anesthesia services. In order to address these comments, we convened multi-specialty panels of physicians. A detailed discussion of this process, as well as the results of the 5-year review were included in the final rule with comment period published November 22, 1996 (61 FR 59490). 
                    </P>
                    <P>We initiated the second 5-year review by soliciting comments on potentially misvalued work RVUs for all services in the CY 2000 physician fee schedule in the November 2, 1999, final rule (64 FR 59427). We indicated that the scope of the second 5-year review would be restricted to work RVUs, since resource-based malpractice RVUs had only just been implemented in CY 2000, and we were in the middle of transitioning to a fully resource-based system for practice expense RVUs. </P>
                    <P>In our July 17, 2000 proposed rule (66 FR 31028), we explained the process used to conduct the second 5-year review of work, beginning with the solicitation of comments on services that were potentially misvalued, in our November 2, 1999 final rule with comment period. </P>
                    <P>We received comments from approximately 30 specialty groups, organizations, and individuals involving over 900 procedure codes. After review by our medical staff, we shared all of the comments we received concerning potentially misvalued services with the RUC. </P>
                    <P>The RUC submitted work RVU recommendations for all of the codes we forwarded with the exception of the anesthesia codes and conscious sedation codes. We analyzed all of the RUC recommendations and evaluated both the recommended work RVUs and the rationale for the recommendations. If we had concerns about the application of a particular methodology, but thought the recommended work RVUs were reasonable, we verified that the recommended work RVUs were appropriate by using alternative methodologies. We announced our proposed decisions on the revised work RVUs in the proposed notice published June 8, 2001 (66 FR 31028). </P>
                    <P>Overall, we proposed to accept 92 percent of RUC recommended work RVUs (RVUs or 792 services). Of the RUC recommendations we disagreed with, we proposed to increase the work RVUs for 37 services and decrease the work RVUs for 22 services. We did not accept the RUC recommendations of an increase for 6 services that were previously reviewed by a multi-specialty physician panel in 2000. The Health Care Professional Advisory Committee (HCPAC), an advisory committee to the RUC representing non-physician health professionals, also reviewed a total of 12 services as part of the 5-year review. For 5 of the services reviewed, the HCPAC did not offer a recommendation. Of the remaining 7 services, we proposed to accept the HCPAC recommendations. </P>
                    <P>Comments received on the June 8, 2001 proposed notice generally supported our proposed changes. In addition, we received more than 125 comments on approximately 39 specific codes plus all the anesthesia services. The majority of these comments addressed the gastrointestinal endoscopy codes and anesthesia services. As with the first 5-year review, we convened a multi-specialty panel of physicians to assist us in the review of the comments. For additional information about this process, the comments received, and the results of the second 5-year review, see the final rule with comment period published November 2, 2001 (66 FR 55285). </P>
                    <HD SOURCE="HD2">B. Scope of the 5-Year Refinement </HD>
                    <P>As with the second 5-year review, we are soliciting comments only on the work RVUs that may be inappropriately valued. The malpractice RVUs were implemented in CY 2000 and revisions to these RVUs are addressed as part of this final rule. </P>
                    <P>We are not including the practice expense RVUs as part of this refinement. The PEAC, an advisory committee of the RUC, has been providing us with recommendations for refining the direct practice expense inputs (clinical staff, supplies, and equipment) used in calculating the practice expense RVUs for established codes. As discussed in the August 5, 2004 proposed rule, the PEAC held its last meeting March 2004 and future practice expense issues, including the refinement of the remaining codes not addressed by the PEAC, would be handled by the RUC. As we determine the process that will be used to refine the remaining codes, we will also be considering how to address future review of practice expense RVUs. We would also welcome comments on how this might be addressed. However, to the extent that there are changes in physician time or in the number or level of post procedure visits as a result of the 5-year review of work, there would be a potential impact on the practice expense inputs, and we would revise the inputs accordingly. </P>
                    <HD SOURCE="HD2">C. Refinement of Work Relative Value Units </HD>
                    <P>During the first and second 5-year reviews, we relied on public commenters to identify services that were potentially misvalued. </P>
                    <P>For the third 5-year review, we are again requesting comments on potentially misvalued work RVUs for all services in the CY 2005 physician fee schedule. However, we recognize that this process generally elicits comments focusing on undervalued codes. Therefore, in addition to the codes submitted by commenters, we will also identify codes (especially high-volume codes across specialties) that: </P>
                    <P>• Are valued as being performed in the inpatient setting, but that are now predominantly performed on an outpatient basis; and </P>
                    <P>• Were not reviewed by the RUC, (that is, Harvard RVUs are still being used, or there is no information). </P>
                    <P>
                        Public comments must include the appropriate CPT code (for example, CPT code 90918) and the suggested RVUs (for example, 11.00 RVUs), and evidence that the current work RVU is misvalued. Failure to provide this information may result in our inability 
                        <PRTPAGE P="66372"/>
                        to evaluate the comments adequately. We will consider all comments on all work RVUs in the development of a proposed rule that we intend to publish in 2006. In that rule, we will propose the revisions to work RVUs that we believe are needed. We will then review and analyze the comments received in response to our proposed revisions and publish our decisions in the 2006 final rule. 
                    </P>
                    <P>In addition to internal review and analysis, we propose to share comments we receive on all work RVUs with the RUC, which currently makes recommendations to us on the assignment of RVUs to new and revised CPT codes. This process was used during the last 5-year review, and we believe that it was beneficial. The RUC's perspective will be helpful because of its experience in recommending RVUs for new and revised CPT codes since we implemented the physician fee schedule. Furthermore, the RUC, by virtue of its multispecialty membership and consultation with approximately 65 specialty societies, involves the medical community in the refinement process. </P>
                    <HD SOURCE="HD2">D. Nature and Format of Comments on Work Relative Value Units </HD>
                    <P>While all written public comments are welcomed, based on our past experience we have found it particularly beneficial if the comments include certain information: the CPT code or codes recommended for review, a clinical description of the service(s), the current work RVUs and the suggested work RVUs. Because our initial assumption will be that each code is currently appropriately valued, the commenter may also include some rationale to support the need for review. For example, one approach would be to compare the physician work of each nominated code to the work involved in an analogous service that has higher or lower work RVUs. In other situations, the commenter could demonstrate that there is a rank order anomaly within a family of codes. Another reason for reviewing the physician work involved in a service could be that the physician time or intensity required by the procedure has changed since it was last reviewed, perhaps because of a change in technology or in patient characteristics. </P>
                    <P>The RUC has also developed more detailed “Compelling Evidence Standards” which are used by the RUC as part of their process to determine if a recommendation to change the work RVUs is warranted for a given code. We are including these standards below solely for informational purposes so that commenters are aware what kind of information will be needed to make a successful argument to the RUC for changing work RVUs. </P>
                    <HD SOURCE="HD2">RUC Compelling Evidence Standards </HD>
                    <P>The RUC operates with the initial presumption that the current values assigned to the codes under review are correct. This presumption can be challenged by a society or other organization presenting a compelling argument that the existing values are no longer rational or appropriate for the codes in question. The argument for a change must be substantial and meet the RUC's compelling evidence standards. This argument must be provided in the comment letter to us, and then later to the RUC in writing on the Summary of Recommendation form. The following guidelines may be used to develop a “compelling argument” that the published relative value for a service is inappropriately valued: </P>
                    <P>• Documentation in the peer-reviewed medical literature or other reliable data that there have been changes in physician work due to one or more of the following: </P>
                    <FP SOURCE="FP-1">+ Technique </FP>
                    <FP SOURCE="FP-1">+ Knowledge and technology </FP>
                    <FP SOURCE="FP-1">+ Patient population </FP>
                    <FP SOURCE="FP-1">+ Site-of-service </FP>
                    <FP SOURCE="FP-1">+ Length of hospital stay </FP>
                    <FP SOURCE="FP-1">+ Physician time </FP>
                    <P>• An anomalous relationship between the code being valued and other codes. For example, if code A describes a service that requires more work than codes B, C, and D, but is nevertheless valued lower. The specialty would need to assemble evidence on service time, technical skill, patient severity, complexity, length of stay and other factors for the code being considered and the codes to which it is compared. These reference services may be both inter- and intra-specialty. </P>
                    <P>• Evidence that technology has changed physician work that is, diffusion of technology. </P>
                    <P>• Analysis of other data on time and effort measures, such as operating room logs or national and other representative databases. </P>
                    <P>• Evidence that incorrect assumptions were made in the previous valuation of the service, as documented, such as: </P>
                    <P>+ A misleading vignette, survey or flawed crosswalk assumptions in a previous evaluation; </P>
                    <P>+ A flawed mechanism or methodology used in the previous valuation, for example, evidence that no pediatricians were consulted in assigning pediatric values; and </P>
                    <P>+ A previous survey was conducted by one specialty to obtain a value, but in actuality that service is currently provided primarily by physicians from a different specialty according to utilization data. </P>
                    <P>We emphasize, however, as we reiterated for the last 5-year review, that we retain the responsibility for analyzing the comments on the suggested work RVU revisions, developing the proposed rule, evaluating the comments on the proposed rule, and deciding whether to revise RVUs. We are not delegating this responsibility to the RUC or any other organization. </P>
                    <HD SOURCE="HD1">VII. Update to the Codes for Physician Self-Referral Prohibition </HD>
                    <FP>[If you choose to comment on issues in this section, please include the caption “Physician Self-Referral Designated Health Services” at the beginning of your comments.] </FP>
                    <HD SOURCE="HD2">A. Background </HD>
                    <P>Section 1877 of the Act prohibits a physician from referring a Medicare beneficiary for certain designated health services (DHS) to a health care entity with which the physician (or a member of the physician's immediate family) has a financial relationship, unless an exception applies. The following services are DHS, as specified in section 1877 of the Act and in regulations at § 411.351: </P>
                    <P>• Clinical laboratory services. </P>
                    <P>• Physical therapy, occupational therapy, and speech-language pathology services. </P>
                    <P>• Radiology and certain other imaging services. </P>
                    <P>• Radiation therapy services and supplies. </P>
                    <P>• Durable medical equipment and supplies. </P>
                    <P>• Parenteral and enteral nutrients, equipment, and supplies. </P>
                    <P>• Prosthetics, orthotics, and prosthetic devices and supplies. </P>
                    <P>• Home health services. </P>
                    <P>• Outpatient prescription drugs. </P>
                    <P>• Inpatient and outpatient hospital services. </P>
                    <P>
                        In § 411.351, the entire scope of the first four of these DHS categories is defined in a list of CPT/HCPCS codes (the Code List), which is updated annually to account for changes in the most recent CPT and HCPCS publications. The updated Code List appears as an addendum to the physician fee schedule final rule and is available on our Web site at 
                        <E T="03">http://cms.hhs.gov/medlearn/refphys.asp.</E>
                         We also include in the Code List those items and services that may qualify for either of the following two exceptions to the physician self-referral prohibition: 
                        <PRTPAGE P="66373"/>
                    </P>
                    <P>• EPO and other dialysis-related drugs furnished in or by an ESRD facility (§ 411.351(g)). </P>
                    <P>• Preventive screening tests, immunizations or vaccines (§ 411.351(h)). </P>
                    <P>
                        The Code List was updated in the physician fee schedule final rule published in the 
                        <E T="04">Federal Register</E>
                         on November 7, 2003 (68 FR 63196). It was subsequently corrected in a notice that was published in the 
                        <E T="04">Federal Register</E>
                         on March 26, 2004 (69 FR 15729). We also published the Phase II physician self-referral interim final rule with comment period on March 26, 2004 in the 
                        <E T="04">Federal Register</E>
                         (69 FR 16054), which made several additional changes to the Code List, effective July 26, 2004. 
                    </P>
                    <P>The updated all-inclusive Code List effective January 1, 2005 is presented in Addendum L of this final rule. </P>
                    <HD SOURCE="HD2">B. Response to Comments </HD>
                    <P>We received two public comments relating to the Code List published in the November 7, 2003 physician fee schedule final rule. One commenter supported the exclusion of interventional radiology services from the definition of radiology and certain other imaging services, as reflected on the Code List. The other commenter raised a concern over the exclusion of nuclear medicine services as a DHS. </P>
                    <P>
                        Additionally, the proposed physician fee schedule rule that was published on August 5, 2004 in the 
                        <E T="04">Federal Register</E>
                         (69 FR 47488) generated one comment relating to the Code List. That comment and our response also are provided below. We note that we will address in a separate 
                        <E T="04">Federal Register</E>
                         document those public comments relating to the Code List that were received in response to the Phase II physician self-referral final rule published on March 26, 2004. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         One commenter requested that we include nuclear medicine services as DHS. The commenter is concerned that physicians may engage in lucrative financial relationships associated with nuclear medicine studies such as PET scans. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We are mindful of the issue raised by the commenter, and we continue to consider the application of section 1877 of the Act to nuclear medicine procedures. However, we note that the purpose of this update is merely to conform the Code List to the most recent publications of HCPCS and CPT codes. Substantive changes to DHS definitions, such as that advocated by the commenter, are beyond the scope of this rulemaking. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         One commenter asked us to clarify that the Code List does not define all DHS and that we indicate where providers can obtain more information on the remaining categories. Additionally, the commenter suggested that we define all DHS in the Code List and that the definitions be included in the quarterly updated Microsoft Excel spreadsheet of RVU values, global periods and supervision levels for Medicare covered services posted on our Web site. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We believe that most readers are aware that the Code List does not define every DHS category. Nevertheless, we will add a footnote to the Code List indicating that § 411.351 defines those DHS categories not reflected on the Code List. 
                    </P>
                    <P>
                        The comment advocating that we define all DHS by CPT or HCPCS code on the Code List would require a substantive change to existing DHS definitions and is therefore beyond the scope of this rulemaking. We will explore the possibility of identifying certain DHS in the National Physician Fee Schedule Relative Value File (
                        <E T="03">http://www.cms.hhs.gov/providers/pufdownload/rvudown.asp</E>
                        ). 
                    </P>
                    <HD SOURCE="HD2">C. Revisions Effective for 2005 </HD>
                    <P>Tables 20 and 21, in this section, identify the additions and deletions, respectively, to the comprehensive Code List included in the Phase II physician self-referral interim final rule published March 26, 2004. Tables 20 and 21 also identify the additions and deletions to the lists of codes used to identify the items and services that may qualify for the exceptions in § 411.355(g) (regarding EPO and other dialysis-related outpatient prescription drugs furnished in or by an ESRD facility) and in § 411.355(h) (regarding preventive screening tests, immunizations and vaccines). </P>
                    <P>
                        We will consider comments for the codes listed in Tables 20 and 21 below, if we receive them by the date specified in the 
                        <E T="02">DATES</E>
                         section of this final rule. We will not consider any comment that advocates a substantive change to any of the DHS defined in § 411.351. 
                    </P>
                    <BILCOD>BILLING CODE 4120-01-P </BILCOD>
                    <GPH SPAN="3" DEEP="486">
                        <PRTPAGE P="66374"/>
                        <GID>ER15NO04.521</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="648">
                        <PRTPAGE P="66375"/>
                        <GID>ER15NO04.522</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="621">
                        <PRTPAGE P="66376"/>
                        <GID>ER15NO04.523</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="203">
                        <PRTPAGE P="66377"/>
                        <GID>ER15NO04.524</GID>
                    </GPH>
                    <BILCOD>BILLING CODE 4120-01-C </BILCOD>
                    <P>The additions specified in Table 20 generally reflect new CPT and HCPCS codes that become effective January 1, 2005 or that became effective since our last update. It also reflects the addition of codes that will be recognized by Medicare for payment purposes effective January 1, 2005. </P>
                    <P>Additionally, we are adding HCPCS code Q0092 to the category of radiology and certain other imaging services since it may be billed in conjunction with the provision of portable x-ray services and had been inadvertently omitted. </P>
                    <P>We are also adding two existing brachytherapy codes (CPT 57155 and 58346) to the category of radiation therapy services and supplies. As noted in the March 26, 2004 Phase II physician self-referral interim final rule (69 FR at 16104-16105), brachytherapy is a DHS. We inadvertently omitted these codes when compiling the Code List. </P>
                    <P>Table 20 also reflects the addition of a flu vaccine code (CPT 90656), CV screening blood tests (CPT 80061, 82465, 83718 and 84478) and diabetes screening tests (CPT 82947, 82950 and 82951) to the list that identifies preventive screening tests, immunizations and vaccines that may qualify for the exception described in § 411.355(h) for such items and services. The physician self-referral prohibition will not apply to these services if the conditions set forth in § 411.355(h) are satisfied. We note that CPT codes 80061, 82465, 83718, 84478, 82947, 82950, and 82951 are eligible for the exception at § 411.355(h) only when billed with the appropriate screening diagnosis codes specified on the Code List for each test. </P>
                    <P>Table 21 reflects the deletions necessary to conform the Code List to the most recent publications of CPT and HCPCS codes. </P>
                    <HD SOURCE="HD1">VIII. Physician Fee Schedule Update for Calendar Year 2005 </HD>
                    <HD SOURCE="HD2">A. Physician Fee Schedule Update </HD>
                    <P>The physician fee schedule update is determined using a formula specified by statute. Under section 1848(d)(4) of the Act, the update is equal to the product of 1 plus the percentage increase in the MEI (divided by 100) and 1 plus the update adjustment factor (UAF). For CY 2005, the MEI is equal to 3.1 percent (1.031). The UAF is −7.0 percent (0.930). Section 1848(d)(4)(F) of the Act requires an additional 0.8 percent (1.008) increase to the update for 2005. The product of the MEI (1.031), the UAF (0.930), and the statutory adjustment factor (1.008) equals the CY 2005 update of −3.3 percent (0.967). However, section 601 of the MMA amended section 1848(d) of the Act to specify that the update to the single CF for 2005 cannot be less than 1.5 percent. Because the statutory formula will yield an update of −3.3 percent, consistent with section 601 of the MMA, we are establishing a 2005 physician fee schedule update of 1.5 percent. </P>
                    <P>Our calculations of all of the above figures are explained below. </P>
                    <HD SOURCE="HD2">B. The Percentage Change in the Medicare Economic Index Medicare Economic Index (MEI) </HD>
                    <P>The MEI measures the weighted-average annual price change for various inputs needed to produce physicians' services. The MEI is a fixed-weight input price index, with an adjustment for the change in economy-wide multifactor productivity. This index, which has 2000 base year weights, is comprised of two broad categories: physician's own time and physician's practice expense. </P>
                    <P>The physician's own time component represents the net income portion of business receipts and primarily reflects the input of the physician's own time into the production of physicians' services in physicians' offices. This category consists of two subcomponents: wages and salaries, and fringe benefits. </P>
                    <P>The physician's practice expense category represents nonphysician inputs used in the production of services in physicians' offices. This category consists of wages and salaries and fringe benefits for nonphysician staff and other nonlabor inputs. The physician's practice expense component also includes the following categories of nonlabor inputs: office expense, medical materials and supplies, professional liability insurance, medical equipment, professional car, and other expenses. The components are adjusted to reflect productivity growth in physicians' offices by the 10-year moving average of multifactor productivity in the private nonfarm business sector. The Table 22 below presents a listing of the MEI cost categories with associated weights and percent changes for price proxies for the 2005 update. For calendar year 2005, the increase in the MEI is 3.1 percent, which includes a 0.9 percent change in the 10-year moving average of multifactor productivity. This result is the result of a 3.0 percent increase in Physician's Own Time and a 5.2 percent increase in Physician's Practice Expense. Within the Physician's Practice Expense, the largest increase occurred in Professional Liability Insurance, which increased 23.9 percent.</P>
                    <BILCOD>BILLING CODE 4120-01-P</BILCOD>
                    <GPH SPAN="3" DEEP="547">
                        <PRTPAGE P="66378"/>
                        <GID>ER15NO04.525</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="546">
                        <PRTPAGE P="66379"/>
                        <GID>ER15NO04.526</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="546">
                        <PRTPAGE P="66380"/>
                        <GID>ER15NO04.527</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="544">
                        <PRTPAGE P="66381"/>
                        <GID>ER15NO04.528</GID>
                    </GPH>
                    <HD SOURCE="HD2">C. The Update Adjustment Factor </HD>
                    <P>Section 1848(d) of the Act provides that the physician fee schedule update is equal to the product of the MEI and a UAF. The UAF is applied to make actual and target expenditures (referred to in the statute as “allowed expenditures”) equal. Allowed expenditures are equal to actual expenditures in a base period updated each year by the sustainable growth rate (SGR). The SGR sets the annual rate of growth in allowed expenditures and is determined by a formula specified in section 1848(f) of the Act. </P>
                    <HD SOURCE="HD3">1. Calculation Under Current Law </HD>
                    <P>Under section 1848(d)(4)(B) of the Act, the UAF for a year beginning with 2001 is equal to the sum of the following— </P>
                    <P>• Prior Year Adjustment Component. An amount determined by— </P>
                    <P>+ Computing the difference (which may be positive or negative) between the amount of the allowed expenditures for physicians' services for the prior year (the year prior to the year for which the update is being determined) and the amount of the actual expenditures for those services for that year; </P>
                    <P>+ Dividing that difference by the amount of the actual expenditures for those services for that year; and </P>
                    <P>
                        + Multiplying that quotient by 0.75. 
                        <PRTPAGE P="66382"/>
                    </P>
                    <P>• Cumulative Adjustment Component. An amount determined by— </P>
                    <P>+ Computing the difference (which may be positive or negative) between the amount of the allowed expenditures for physicians' services from April 1, 1996, through the end of the prior year and the amount of the actual expenditures for those services during that period; </P>
                    <P>+ Dividing that difference by actual expenditures for those services for the prior year as increased by the sustainable growth rate for the year for which the update adjustment factor is to be determined; and </P>
                    <P>+ Multiplying that quotient by 0.33. </P>
                    <P>Section 1848(d)(4)(E) of the Act requires the Secretary to recalculate allowed expenditures consistent with section 1848(f)(3) of the Act. Section 1848(f)(3) specifies that the SGR (and, in turn, allowed expenditures) for the upcoming CY (2005 in this case), the current CY (2004) and the preceding CY (2003) are to be determined on the basis of the best data available as of September 1 of the current year. Allowed expenditures are initially estimated and subsequently revised twice. The second revision occurs after the CY has ended (that is, we are making the final revision to 2003 allowed expenditures in this final rule). Once the SGR and allowed expenditures for a year have been revised twice, they are final. </P>
                    <P>Table 23 shows annual and cumulative allowed expenditures for physicians' services from April 1, 1996 through the end of the current CY, including the transition period to a CY system that occurred in 1999. Also shown is the SGR corresponding with each period. The calculation of the SGR is discussed in detail below. </P>
                    <BILCOD>BILLING CODE 4120-01-P</BILCOD>
                    <GPH SPAN="3" DEEP="610">
                        <PRTPAGE P="66383"/>
                        <GID>ER15NO04.529</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="608">
                        <PRTPAGE P="66384"/>
                        <GID>ER15NO04.530</GID>
                    </GPH>
                    <BILCOD>BILLING CODE 4120-01-C</BILCOD>
                    <P>
                        Consistent with section 1848(d)(4)(E) of the Act, Table 23 includes our final revision of allowed expenditures for 2003, a recalculation of allowed expenditures for 2004, and our initial estimate of allowed expenditures for 2005. To determine the update adjustment factor for 2005, the statute requires that we use allowed and actual expenditures from April 1, 1996 through December 31, 2004 and the 2005 SGR. Consistent with section 1848(d)(4)(E) of the Act, we will be making further revisions to the 2004 and 2005 SGRs 
                        <PRTPAGE P="66385"/>
                        and 2004 and 2005 allowed expenditures. Because we have incomplete actual expenditure data for 2004, we are using an estimate for this period. Any difference between current estimates and final figures will be taken into account in determining the update adjustment factor for future years. 
                    </P>
                    <P>We are using figures from Table 23 in the statutory formula illustrated below:</P>
                    <MATH SPAN="3" DEEP="26">
                        <MID>ER15NO04A.058</MID>
                    </MATH>
                    <FP SOURCE="FP-2">UAF = Update Adjustment Factor </FP>
                    <FP SOURCE="FP-2">
                        Target
                        <E T="52">04</E>
                         = Allowed Expenditures for 2004 or $77.1 billion 
                    </FP>
                    <FP SOURCE="FP-2">
                        Actual
                        <E T="52">04</E>
                         = Estimated Actual Expenditures for 2004 = $84.9 billion 
                    </FP>
                    <FP SOURCE="FP-2">
                        Target 
                        <E T="52">4/96-12/04</E>
                         = Allowed Expenditures from 4/1/1996-12/31/2004 = $531.8 billion 
                    </FP>
                    <FP SOURCE="FP-2">
                        Actual 
                        <E T="52">4/96-12/04</E>
                         = Estimated Actual Expenditures from 4/1/1996-12/31/2003 = $545.5 billion 
                    </FP>
                    <FP SOURCE="FP-2">
                        SGR
                        <E T="52">05</E>
                         = 4.3 percent (1.043) 
                    </FP>
                    <MATH SPAN="3" DEEP="23">
                        <MID>ER15NO04A.059</MID>
                    </MATH>
                    <P>Section 1848(d)(4)(D) of the Act indicates that the UAF determined under section 1848(d)(4)(B) of the Act for a year may not be less than −0.070 or greater than 0.03. Since −0.120 is less than −0.070, the UAF for 2005 will be −0.070. </P>
                    <P>Section 1848(d)(4)(A)(ii) of the Act indicates that 1 should be added to the UAF determined under section 1848(d)(4)(B) of the Act. Thus, adding 1 to −0.070 makes the update adjustment factor equal to 0.930. </P>
                    <HD SOURCE="HD1">IX. Allowed Expenditures for Physicians' Services and the Sustainable Growth Rate </HD>
                    <HD SOURCE="HD2">A. Medicare Sustainable Growth Rate </HD>
                    <P>The SGR is an annual growth rate that applies to physicians' services paid by Medicare. The use of the SGR is intended to control growth in aggregate Medicare expenditures for physicians' services. Payments for services are not withheld if the percentage increase in actual expenditures exceeds the SGR. Rather, the physician fee schedule update, as specified in section 1848(d)(4) of the Act, is adjusted based on a comparison of allowed expenditures (determined using the SGR) and actual expenditures. If actual expenditures exceed allowed expenditures, the update is reduced. If actual expenditures are less than allowed expenditures, the update is increased. </P>
                    <P>Section 1848(f)(2) of the Act specifies that the SGR for a year (beginning with 2001) is equal to the product of the following four factors: </P>
                    <P>(1) The estimated change in fees for physicians' services. </P>
                    <P>(2) The estimated change in the average number of Medicare fee-for-service beneficiaries. </P>
                    <P>(3) The estimated projected growth in real GDP per capita. </P>
                    <P>(4) The estimated change in expenditures due to changes in law or regulations. </P>
                    <P>
                        In general, section 1848(f)(3) of the Act requires us to publish SGRs for 3 different time periods, no later than November 1 of each year, using the best data available as of September 1 of each year. Under section 1848(f)(3)(C)(i) of the Act, the SGR is estimated and subsequently revised twice (beginning with the FY and CY 2000 SGRs) based on later data. (There were also provisions in the Act to adjust the FY 1998 and FY 1999 SGRs. See the February 28, 2003 
                        <E T="04">Federal Register</E>
                         (68 FR 9567) for a discussion of these SGRs). Under section 1848(f)(3)(C)(ii) of the Act, there are no further revisions to the SGR once it has been estimated and subsequently revised in each of the 2 years following the preliminary estimate. In this final rule, we are making our preliminary estimate of the 2005 SGR, a revision to the 2004 SGR, and our final revision to the 2003 SGR. 
                    </P>
                    <HD SOURCE="HD2">B. Physicians' Services </HD>
                    <P>
                        Section 1848(f)(4)(A) of the Act defines the scope of physicians' services covered by the SGR. The statute indicates that “the term “physicians' services” includes other items and services (such as clinical diagnostic laboratory tests and radiology services), specified by the Secretary, that are commonly performed or furnished by a physician or in a physician's office, but does not include services furnished to a Medicare+Choice plan enrollee.” We published a definition of physicians' services for use in the SGR in the 
                        <E T="04">Federal Register</E>
                         (66 FR 55316) on November 1, 2001. We defined physicians' services to include many of the medical and other health services listed in section 1861(s) of the Act. For purposes of determining allowed expenditures, actual expenditures, and SGRs through December 31, 2002, we have specified that physicians' services include the following medical and other health services if bills for the items and services are processed and paid by Medicare carriers (and those paid through intermediaries where specified): 
                    </P>
                    <P>• Physicians' services. </P>
                    <P>• Services and supplies furnished incident to physicians' services. </P>
                    <P>• Outpatient PT services and outpatient OT services. </P>
                    <P>• Antigens prepared by, or under the direct supervision of, a physician. </P>
                    <P>• Services of PAs, certified registered nurse anesthetists, CNMs, clinical psychologists, clinical social workers, NPs, and CNSs. </P>
                    <P>• Screening tests for prostate cancer, colorectal cancer, and glaucoma. </P>
                    <P>• Screening mammography, screening pap smears, and screening pelvic exams. </P>
                    <P>• Diabetes outpatient self-management training services. </P>
                    <P>• Medical nutrition therapy services. </P>
                    <P>• Diagnostic x-ray tests, diagnostic laboratory tests, and other diagnostic tests (including outpatient diagnostic laboratory tests paid through intermediaries). </P>
                    <P>• X-ray, radium, and radioactive isotope therapy. </P>
                    <P>• Surgical dressings, splints, casts, and other devices used for the reduction of fractures and dislocations. </P>
                    <P>• Bone mass measurements. </P>
                    <P>
                        Sections 611 through 613 of the MMA, respectively, modified section 1861(s) of the Act to add Medicare coverage for an initial preventive exam, 
                        <PRTPAGE P="66386"/>
                        CV screening blood tests, and diabetes screening tests. We believe that these services are commonly performed or furnished by a physician or in a physician's office and are including them in the definition of physicians' services for purposes of the SGR. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         We received a number of comments requesting that we use our administrative authority to remove drugs from the SGR. According to one of these comments, drugs are not physicians' services and should never have been included in the SGR. One of these comments indicated that the SGR “is a seriously flawed formula that will continue to require frequent Congressional intervention to avoid payment cuts * * *” According to this comment, “the Administration should reduce the price tag and help pave the way for an appropriate long-term solution by removing drugs from the SGR pool.” We also received a number of comments suggesting that we use our administrative authority to adjust the SGR for changes in spending associated with national coverage determinations (NCDs). 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We remain concerned about forecasts of reductions in physician fees and will carefully consider the issues raised by the comments when we make changes to the physician fee schedule for 2006. We believe that the physician payment system should be structured to control costs and achieve predictable and stable changes to Medicare's rates while being equitable to physicians. We note that administrative changes affecting the SGR would have significant long-term cost implications but will not have an impact on the update for 2006 or the subsequent few years. Therefore, without a statutory change, there will still be a reduction in physicians' fee schedule rates for 2006 and subsequent years. Towards those goals, we have already taken several actions that will improve Medicare's physician payment system: 
                    </P>
                    <P>• Using multifactor productivity in place of labor productivity in the MEI beginning in 2003. This change increased the physician fee schedule update by 0.7 percentage points for 2003 and was estimated to increase Medicare spending by $14.5 billion over 10 years. </P>
                    <P>• Increasing the weight of malpractice costs in the MEI from 3.2 to 3.9 percent, a 21 percent increase beginning in 2004. </P>
                    <P>• Incorporating an increase in malpractice premiums of 16.9 percent into the 2004 MEI and 23.9 percent into the 2005 MEI. The increased weight for malpractice in the MEI makes the index a more accurate representation of inflation in physician office costs. </P>
                    <HD SOURCE="HD2">C. Preliminary Estimate of the SGR for 2005 </HD>
                    <P>Our preliminary estimate of the 2005 SGR is 4.3 percent. We first estimated the 2005 SGR in March and made the estimate available to the Medicare Payment Advisory Commission and on our Web site. Table 24 shows that March 2004 and our current estimates of the factors included in the 2005 SGR. </P>
                    <GPH SPAN="3" DEEP="111">
                        <GID>ER15NO04.531</GID>
                    </GPH>
                    <NOTE>
                        <HD SOURCE="HED">Note:</HD>
                        <P>Consistent with section 1848(f)(2) of the Act, the statutory factors are multiplied, not added, to produce the total (that is, 1.013 × 0.997 × 1.022 × 1.010 = 1.37). A more detailed explanation of each figure is provided below in section H.1.</P>
                    </NOTE>
                    <HD SOURCE="HD2">D. Revised Sustainable Growth Rate for 2004 </HD>
                    <P>
                        Our current estimate of the 2004 SGR is 7.0 percent. Table 25 shows our preliminary estimate of the 2004 SGR that was published in the 
                        <E T="04">Federal Register</E>
                         on November 7, 2003 (68 FR 63249) and our current estimate. 
                    </P>
                    <GPH SPAN="3" DEEP="124">
                        <GID>ER15NO04.532</GID>
                    </GPH>
                    <FP>A more detailed explanation of each figure is provided below in section H.2. </FP>
                    <HD SOURCE="HD2">E. Final Sustainable Growth Rate for 2003 </HD>
                    <P>
                        The SGR for 2003 is 7.3 percent. Table 26 shows our preliminary estimate of the SGR published in the 
                        <E T="04">Federal Register</E>
                         on December 31, 2002 (67 FR 80027), our revised estimate published in the 
                        <E T="04">Federal Register</E>
                         on November 7, 2003 (67 FR 63249) and the final figures 
                        <PRTPAGE P="66387"/>
                        determined using the latest available data. 
                    </P>
                    <GPH SPAN="3" DEEP="177">
                        <GID>ER15NO04.533</GID>
                    </GPH>
                    <FP>A more detailed explanation of each figure is provided below in section H.2. </FP>
                    <HD SOURCE="HD2">F. Calculation of 2005, 2004, and 2003 Sustainable Growth Rates </HD>
                    <HD SOURCE="HD3">1. Detail on the 2005 SGR </HD>
                    <P>All of the figures used to determine the 2005 SGR are estimates that will be revised based on subsequent data. Any differences between these estimates and the actual measurement of these figures will be included in future revisions of the SGR and allowed expenditures and incorporated into subsequent physician fee schedule updates. </P>
                    <HD SOURCE="HD1">Factor 1—Changes in Fees for Physicians' Services (Before Applying Legislative Adjustments) for CY 2005 </HD>
                    <P>This factor is calculated as a weighted average of the 2005 fee increases for the different types of services included in the definition of physicians' services for the SGR. Medical and other health services paid using the physician fee schedule are estimated to account for approximately 83.9 percent of total allowed charges included in the SGR in 2005 and are updated using the MEI. The MEI for 2005 is 3.1 percent. Diagnostic laboratory tests are estimated to represent approximately 7.1 percent of Medicare allowed charges included in the SGR for 2005. Medicare payments for these tests are updated by the Consumer Price Index for Urban Areas (CPI-U). However, section 629 of the MMA specifies that diagnostic laboratory services will receive an update of 0.0 percent from 2004 through 2008. </P>
                    <P>Drugs are estimated to represent 9.0 percent of Medicare allowed charges included in the SGR in 2005. As indicated earlier in this final rule, sections 303 and 304 of the MMA require Medicare to pay for most drugs at 106 percent of ASP beginning January 1, 2005. We estimated a weighted average change in fees for drugs included in the SGR using the ASP plus 6 percent pricing methodology of −14.7 percent for 2005. Table 27 shows the weighted average of the MEI, laboratory and drug price changes for 2005. </P>
                    <GPH SPAN="3" DEEP="83">
                        <GID>ER15NO04.534</GID>
                    </GPH>
                    <P>We estimate that the weighted-average increase in fees for physicians' services in 2005 under the SGR (before applying any legislative adjustments) will be 1.3 percent. </P>
                    <HD SOURCE="HD1">Factor 2—The Percentage Change in the Average Number of Part B Enrollees From 2004 to 2005 </HD>
                    <P>This factor is our estimate of the percent change in the average number of fee-for-service enrollees from 2004 to 2005. Services provided to Medicare+Choice (M+C) plan enrollees are outside the scope of the SGR and are excluded from this estimate. OACT estimates that the average number of Medicare Part B fee-for-service enrollees will decrease by 0.3 percent from 2004 to 2005. Table 28 illustrates how this figure was determined. </P>
                    <GPH SPAN="3" DEEP="82">
                        <PRTPAGE P="66388"/>
                        <GID>ER15NO04.535</GID>
                    </GPH>
                    <P>An important factor affecting fee-for-service enrollment is beneficiary enrollment in M+C plans. Because it is difficult to estimate the size of the M+C enrollee population before the start of a calendar year, at this time we do not know how actual enrollment in M+C plans will compare to current estimates. For this reason, the estimate may change substantially as actual Medicare fee-for-service enrollment for 2005 becomes known. </P>
                    <HD SOURCE="HD1">Factor 3—Estimated Real Gross Domestic Product Per Capita Growth in 2005 </HD>
                    <P>We estimate that the growth in real per capita GDP from 2004 to 2005 will be 2.2 percent. Our past experience indicates that there have also been large changes in estimates of real per capita GDP growth made before the year begins and the actual change in GDP computed after the year is complete. Thus, it is likely that this figure will change as actual information on economic performance becomes available to us in 2005. </P>
                    <HD SOURCE="HD1">Factor 4—Percentage Change in Expenditures for Physicians' Services Resulting From Changes in Law or Regulations in CY 2005 Compared With CY 2004 </HD>
                    <P>There are a number of statutory provisions that will affect the 2005 SGR. As indicated above, sections 303 and 304 of the MMA changed Medicare payment for drugs. These provisions also changed Medicare payments for the administration of drugs. Section 303(a)(1) amended section 1848(c)(2) of the Act to require the Secretary to make a number of changes that increased Medicare payment for drug administration beginning January 1, 2004. These changes permanently increased Medicare payments for drug administration by a weighted average of 110 percent. Section 303(a)(4) of the MMA required an additional transitional adjustment (temporary increase) to Medicare's payment for drug administration of 32 percent for 2004 and 3 percent for 2005. The change in the transitional adjustment of 32 percent for 2004 to 3 percent for 2005 would reduce Medicare payments for drug administration between 2004 and 2005. However, some of this reduction will be lessened because we are also adopting changes to the codes and payment amounts for drug administration based on recommendations from the AMA's CPT Editorial Panel and Relative Value Update Committee (RUC), under the authority of section 1848(c)(2)(J) of the Act. We are further increasing physician fee schedule payments by paying separately for injections provided on the same day as another physician fee schedule service. We are further increasing physician fee schedule payments by paying separately for injections provided on the same day as another physician fee schedule service. We estimate that changes to our policy on injections and the changes to our drug administration payments taken together will increase physician spending by 0.2 percent. </P>
                    <P>We are also adjusting the SGR to account for OACT's assumptions about predicted physician behavior in response to the payment reductions. OACT assumes that reduced fees are likely to be met by a combination of an increase in volume and a shift in the mix or intensity of services furnished to Medicare beneficiaries so as to offset 30 percent of the payment reduction that would otherwise occur. Because OACT assumes that physicians will offset some of the loss in payments that will occur from changes in Medicare payments for drugs (as described earlier) and drug administration and the change in payment can be attributed to a change in law, we are increasing the SGR by 0.4 percent for this factor. (Discussion may change based on recent decisions.) </P>
                    <P>There are several other statutory provisions that are estimated to increase Medicare spending for physicians' services under the SGR. Section 413(a) of the MMA establishes a 5 percent increase in the physician fee schedule payment for services provided in physician scarcity areas. Section 413(b) improves the procedures for paying the 10 percent physician fee schedule bonus payment for services provided in health professional shortage areas. We estimate that the provisions of section 413 will increase Medicare physician fee schedule payments by 0.1 percent. </P>
                    <P>Sections 611 through 613 of the MMA, respectively, provide Medicare coverage for an initial preventive physical examination, CV and diabetes screening tests. We estimate that new Medicare coverage for these preventive services will increase spending for physicians' services under the SGR by 0.3 percent. Taken together, we estimate that all of the statutory provisions for 2005 will increase Medicare spending for physicians' services by 0.5 percent. </P>
                    <P>
                        <E T="03">Comment:</E>
                         We received comments concerned that we will underestimate the costs associated with the initial preventive physical examination. These comments suggested that we should account for “both spending due to use of the new or expanded benefit, as well as additional services triggered by implementation of the new benefit.” We received other comments concerned that we will underestimate the cost of CV and diabetes screening tests because we will use the national coverage determination (NCD) process to decide if any additional tests may be eligible for coverage. The commenters have this concern because we do not adjust the SGR for NCDs. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         Our estimates of the costs of the initial preventive physical exam and the CV and diabetes screening tests account for utilization of other Medicare services (preventive and nonpreventive) that may result from coverage of the new preventive services. We also note that our current estimates of the initial preventive examination and CV and diabetes screening tests are based only on our projections without any data on actual use of the benefits. The statute requires us to revise our current estimate of the 2005 SGR no later than November 1, 2005 and to make a final revision to our estimate no later than November 1, 2006. At the time we make the final revision to the 2005 SGR, we will have complete data on use of the new preventive services that will enable us to more accurately reflect these costs in the SGR. 
                    </P>
                    <P>
                        With respect to the comments about use of the NCD process to establish additional CV and diabetes screening tests that will be eligible for Medicare coverage, the regulation lists the common types of tests that are currently 
                        <PRTPAGE P="66389"/>
                        used to screen patients for these conditions. Our adjustment to the SGR will cover all of the costs associated with these new Medicare covered screening tests. However, if we use the NCD process to cover additional tests, we will consider this issue further. 
                    </P>
                    <HD SOURCE="HD3">2. Detail on the 2004 SGR </HD>
                    <P>A more detailed discussion of our revised estimates of the four elements of the 2004 SGR follows. </P>
                    <HD SOURCE="HD1">Factor 1—Changes in Fees for Physicians' Services (Before Applying Legislative Adjustments) for 2004 </HD>
                    <P>This factor was calculated as a weighted average of the 2004 fee increases that apply for the different types of services included in the definition of physicians' services for the SGR. </P>
                    <P>
                        We estimate that services paid using the physician fee schedule account for approximately 83.7 percent of total allowed charges included in the SGR in 2004. These services were updated using the 2004 MEI of 2.9 percent. We estimate that diagnostic laboratory tests represent approximately 7.1 percent of total allowed charges included in the SGR in 2004. Medicare payments for these tests are updated by the CPI-U. However, section 629 of the MMA specifies that diagnostic laboratory services will receive an update of 0.0 percent from 2004 through 2008. We estimate that drugs represent 9.2 percent of Medicare allowed charges included in the SGR in 2004. Historically, Medicare paid for drugs under section 1842(o) of the Act at 95 percent of average wholesale price (AWP). However, with some exceptions, sections 303 and 304 of the MMA generally require Medicare to pay for drugs at 85 percent of the AWP determined as of April 1, 2003 or a specified percentage of AWP based on studies by the Government Accountability Office and the Office of the Inspector General in 2004. (We implemented section 303 and 304 of the MMA in an interim final rule published in the 
                        <E T="04">Federal Register</E>
                         on January 7, 2004 (see 69 FR 1086). Taking sections 303 and 304 of the MMA into account, we estimate a weighted average change in fees for drugs included in the SGR of −11.7 percent for 2004. Table 29 shows the weighted average of the MEI, laboratory and drug price changes for 2004. 
                    </P>
                    <GPH SPAN="3" DEEP="97">
                        <GID> ER15NO04.536</GID>
                    </GPH>
                    <P>After taking into account the elements described in Table 29, we estimate that the weighted-average increase in fees for physicians' services in 2004 under the SGR (before applying any legislative adjustments) will be 1.4 percent. Our November 7, 2003 estimate of this factor was 2.7 percent. The reduction from 2.7 percent to our current estimate of 1.4 percent is primarily due to application of the drug pricing changes required by sections 303 and 304 of the MMA. </P>
                    <HD SOURCE="HD1">Factor 2—The Percentage Change in the Average Number of Part B Enrollees From 2003 to 2004 </HD>
                    <P>OACT estimates that the average number of Medicare Part B fee-for-service enrollees (excluding beneficiaries enrolled in M+C plans) increased by 1.7 percent in 2004. Table 30 illustrates how we determined this figure. </P>
                    <GPH SPAN="3" DEEP="98">
                        <GID>ER15NO04.537</GID>
                    </GPH>
                    <P>OACT's estimate of the 1.7 percent change in the number of fee-for-service enrollees, net of M+C enrollment for 2004 compared to 2003, is the same as our original estimate published in the November 7, 2003 final rule (68 FR 63250). While our current projection based on data from 8 months of 2004 is the same as our original estimate when we had no data, it is still possible that our final estimate of this figure will be different once we have complete information on 2004 fee-for-service enrollment. </P>
                    <HD SOURCE="HD1">Factor 3—Estimated Real Gross Domestic Product Per Capita Growth in 2004 </HD>
                    <P>
                        We estimate that the growth in real per capita GDP will be 2.2 percent for 2004. Our past experience indicates that there have also been large differences between our estimates of real per capita GDP growth made prior to the year's end and the actual change in this factor. Thus, it is likely that this figure will change further as complete actual information on 2004 economic performance becomes available to us in 2005. 
                        <PRTPAGE P="66390"/>
                    </P>
                    <HD SOURCE="HD1">Factor 4—Percentage Change in Expenditures for Physicians' Services Resulting From Changes in Law or Regulations in 2004 Compared With 2003 </HD>
                    <P>There are four statutory provisions that are increasing 2004 Medicare spending relative to 2003. Section 412 of the MMA established a floor of 1.0 on adjustments to the physician work relative value unit for the geographic practice cost index (GPCI) for the years 2004 through 2006. Section 602 of the MMA increases the GPCIs for work, practice expense, and malpractice in Alaska to 1.67. Because these provisions increase the work GPCIs that are below 1.0 to 1.0 and, for services in Alaska, we estimate that sections 412 and 602 of the MMA are increasing 2004 Medicare spending included in the SGR by 0.6 percent. Sections 303 and 304 of the MMA increased Medicare's payments for drug administration in 2004. It further exempted the increases in payment from the budget neutrality provisions of section 1848(c)(2) of the Act. We estimate the section 303 and 304 provisions will increase spending for physicians' services by 0.8 percent in 2004. Taken together, we estimate that statutory provisions are increasing 2004 spending for physicians' services by 1.5 percent (after accounting for rounding). </P>
                    <HD SOURCE="HD3">3. Detail on the 2003 SGR </HD>
                    <P>A more detailed discussion of our revised estimates of the four elements of the 2003 SGR follows. </P>
                    <HD SOURCE="HD1">Factor 1—Changes in Fees for Physicians' Services (Before Applying Legislative Adjustments) for 2003 </HD>
                    <P>This factor was calculated as a weighted average of the 2003 fee increases that apply for the different types of services included in the definition of physicians' services for the SGR. </P>
                    <P>Services paid using the physician fee schedule accounted for approximately 83.0 percent of total Medicare allowed charges included in the SGR for 2003 and are updated using the MEI. The MEI for 2003 was 3.0 percent. Diagnostic laboratory tests represent approximately 7.2 percent of total Medicare allowed charges included in the SGR and are updated by the CPI-U. The CPI-U applied to payments for laboratory services for 2003 was 1.1 percent. Drugs represented approximately 9.8 percent of total Medicare allowed charges included in the SGR for 2003. According to section 1842(o) of the Act, Medicare pays for drugs based on 95 percent of AWP. Using wholesale pricing information and Medicare utilization for drugs included in the SGR, we estimate a weighted average fee increase for drugs of 1.9 percent for 2003. Table 31 shows the weighted average of the MEI, laboratory, and drug price increases for 2003. </P>
                    <GPH SPAN="3" DEEP="97">
                        <GID>ER15NO04.538</GID>
                    </GPH>
                    <P>After taking into account the elements described in Table 31, we estimate that the weighted-average increase in fees for physicians' services in 2003 under the SGR (before applying any legislative adjustments) was 2.8 percent. </P>
                    <HD SOURCE="HD1">Factor 2—The Percentage Change in the Average Number of Part B Enrollees From 2002 to 2003 </HD>
                    <P>We estimate the increase in the number of fee-for-service enrollees (excluding beneficiaries enrolled in M+C plans) from 2002 to 2003 was 2.3 percent. Our calculation of this factor is based on complete data from 2003. Table 32 illustrates the calculation of this factor. </P>
                    <GPH SPAN="3" DEEP="97">
                        <GID>ER15NO04.539</GID>
                    </GPH>
                    <HD SOURCE="HD1">Factor 3—Estimated Real Gross Domestic Product Per Capita Growth in 2003 </HD>
                    <P>We estimate that the growth in real per capita GDP was 2.0 percent in 2003. This figure is a final one based on complete data for 2003. </P>
                    <HD SOURCE="HD1">Factor 4—Percentage Change in Expenditures for Physicians' Services Resulting From Changes in Law or Regulations in 2003 Compared With 2002 </HD>
                    <P>There are no statutory or regulatory changes that affect Medicare expenditures for services included in the SGR in 2003. </P>
                    <HD SOURCE="HD1">X. Anesthesia and Physician Fee Schedule Conversion Factors (CF) for Calendar Year 2005 </HD>
                    <P>
                        The 2005 physician fee schedule CF will be $37.8975. The 2005 national average anesthesia conversion factor is $17.7594. 
                        <PRTPAGE P="66391"/>
                    </P>
                    <HD SOURCE="HD2">Physician Fee Schedule Conversion Factor </HD>
                    <P>Under section 1848(d)(1)(A) of the Act, the physician fee schedule CF is equal to the CF for the previous year multiplied by the update determined under section 1848(d)(4) of the Act. Using this formula would result in a 3.3 percent reduction to the physician fee schedule CF for 2005. However, section 601 of the MMA amended section 1848(d) of the Act to specify that the update to the single CF for 2004 and 2005 will not be less than 1.5 percent. Because the statutory formula will yield a 3.3 percent reduction to the 2005 physician fee schedule CF and the amendments to the statute indicate that the update for 2005 cannot be less than 1.5 percent, we are increasing the physician fee schedule conversion factor by 1.5 percent. </P>
                    <P>We illustrate the calculation for the 2005 physician fee schedule CF in Table 33 below. </P>
                    <GPH SPAN="3" DEEP="95">
                        <GID>ER15NO04.540</GID>
                    </GPH>
                    <HD SOURCE="HD2">• Anesthesia Fee Schedule Conversion Factor</HD>
                    <P>Anesthesia services do not have RVUs like other physician fee schedule services. Therefore, we account for any necessary RVU adjustments through an adjustment to the anesthesia fee schedule CF. The only adjustment we are applying to the anesthesia fee schedule CF for 2005 is the physician fee schedule update. We used the following figures to determine the anesthesia fee schedule CF (see Table 34). </P>
                    <GPH SPAN="3" DEEP="95">
                        <GID>ER15NO04.541</GID>
                    </GPH>
                    <HD SOURCE="HD1">XI. Telehealth Originating Site Facility Fee Payment Amount Update </HD>
                    <P>Section 1834(m) of the Act establishes the payment amount for the Medicare telehealth originating site facility fee for telehealth services provided from October 1, 2001 through December 31, 2002, at $20. For telehealth services provided on or after January 1 of each subsequent calendar year, the telehealth originating site facility fee is increased by the percentage increase in the MEI as defined in section 1842(i)(3) of the Act. The MEI increase for 2005 is 3.1 percent. </P>
                    <P>Therefore, for CY 2005, the payment amount for HCPCS code “Q3014, telehealth originating site facility fee” is 80 percent of the lesser of the actual charge or $21.86. The Medicare telehealth originating site facility fee and MEI increase by the applicable time period is shown in Table 35. </P>
                    <GPH SPAN="3" DEEP="96">
                        <GID>ER15NO04.542</GID>
                    </GPH>
                    <HD SOURCE="HD1">XII. Provisions of the Final Rule </HD>
                    <P>The provisions of this final rule restate the provisions of the August 2004 proposed rule, except as noted elsewhere in the preamble. </P>
                    <HD SOURCE="HD1">XIII. Waiver of Proposed Rulemaking </HD>
                    <P>
                        We ordinarily publish a notice of proposed rulemaking in the 
                        <E T="04">Federal Register</E>
                         and invite public comment on the proposed rule. The notice of proposed rulemaking includes a reference to the legal authority under which the rule is proposed, and the terms and substances of the proposed rule or a description of the subjects and issues involved. This procedure can be waived, however, if an agency finds 
                        <PRTPAGE P="66392"/>
                        good cause that a notice-and-comment procedure is impracticable, unnecessary, or contrary to the public interest and incorporates a statement of the finding and its reasons in the rule issued. 
                    </P>
                    <P>We believe that providing a notice and comment procedure with regard to the RNHCI home benefit would be contrary to the public interest. The RNHCI home benefit provisions were added by the Congress to get a RNHCI benefit to those beneficiaries who are confined to the home. We believe that the Congress intended to provide the benefit to the homebound RNHCI beneficiaries as means of providing a similar home option as is offered to the general Medicare population. However, this expanded benefit is, by statute, a time limited benefit. Any delay in implementation could prevent beneficiaries from utilizing this expanded benefit at all or could seriously impinge on the amount of time they can use the benefit. Therefore, we find good cause to waive notice and comment procedures as contrary to the public interest with regard to the RNHCI home benefit. We are, however, providing a 60-day period for public comment. </P>
                    <HD SOURCE="HD1">XIV. Collection of Information Requirements </HD>
                    <P>
                        Under the Paperwork Reduction Act of 1995 (PRA), we are required to provide 60-day notice in the 
                        <E T="04">Federal Register</E>
                         and solicit public comment before a collection of information requirement is submitted to the Office of Management and Budget (OMB) for review and approval. In order to fairly evaluate whether OMB should approve an information collection, section 3506(c)(2)(A) of the PRA requires that we solicit comment on the following issues: 
                    </P>
                    <P>• The need for the information collection and its usefulness in carrying out the proper functions of our agency. </P>
                    <P>• The accuracy of our estimate of the information collection burden. </P>
                    <P>• The quality, utility, and clarity of the information to be collected. </P>
                    <P>• Recommendations to minimize the information collection burden on the affected public, including automated collection techniques. </P>
                    <HD SOURCE="HD2">Section 403.766 Requirements for Coverage/Payment of Home Services </HD>
                    <P>In summary, § 403.766 states the RNHCI provider must submit a written letter of intent to us if they choose to participate in offering the home service benefit. </P>
                    <P>The burden associated with this requirement is the time and effort of the RNHCI provider to prepare and submit a letter of intention. It is estimated that this two-sentence letter should take no longer than 15 minutes to prepare and submit. There are currently 16 RNHCI providers and, if all elected to participate, it would result in a one-time burden of 4 hours. </P>
                    <P>We have submitted a copy of this final rule with comment to OMB for its review of the information collection requirements described above. These requirements are not effective until they have been approved by OMB. </P>
                    <HD SOURCE="HD2">Section 410.16 Initial Preventive Physical Examination: Conditions for Limitations on Coverage </HD>
                    <P>In summary, § 410.16 requires the furnishing of education, counseling and referral services as part of an initial preventive physical examination, a written plan for obtaining the appropriate screening and other preventive services which are also covered as separate Medicare B Part services. </P>
                    <P>The burden associated with this requirement is the time required of the physician or practitioner to provide beneficiaries with education, counseling, and referral services and to develop and provide a written plan for obtaining screening and other preventive services. </P>
                    <P>While these requirements are subject to the PRA; we believe the burden associated with these requirements to be usual and customary business practice; therefore, the burden for this collection requirement is exempt under 5 CFR 1320.3(b)(2)&amp;(3). </P>
                    <HD SOURCE="HD2">Section 411.404 Criteria for Determining That a Beneficiary Knew That Services Were Excluded From Coverage as Custodial Care or as Not Reasonable and Necessary </HD>
                    <P>In summary, § 411.404 requires that written notice must be given to a beneficiary, or someone acting on his or her behalf, that the services were not covered because they did not meet Medicare coverage guidelines. </P>
                    <P>Although this section is subject to the PRA, the burden associated with this requirement is currently captured and accounted for in two currently approved information collections under OMB numbers 0938-0566 and 0938-0781. </P>
                    <HD SOURCE="HD2">Section 418.205 Special Requirements for Hospice Pre-Election Evaluations and Counseling Services </HD>
                    <P>In summary, § 418.205 states that written documentation is required and must be maintained for referral requests and services furnished. </P>
                    <P>While these information collection requirements are subject to the PRA, the burden associated with them is exempt as defined in 5 CFR 1320.3(b)(2). </P>
                    <P>
                        If you comment on these information collection and recordkeeping requirements, please mail copies directly to the following: Centers for Medicare &amp; Medicaid Services Office of Strategic Operations and Regulatory Affairs, Attn: Melissa Musotto (CMS-1429-FC) Room C5-13-28, 7500 Security Boulevard, Baltimore, MD 21244-1850; and Office of Information and Regulatory Affairs, Office of Management and Budget, Room 10235, New Executive Office Building, Washington, DC 20503,  Attn: Christopher Martin, CMS Desk Officer (CMS-1429-P), 
                        <E T="03">Christopher Martin@omb.eop.gov.</E>
                        FAX (202) 395-6974. 
                    </P>
                    <HD SOURCE="HD1">XV. Response to Comments </HD>
                    <P>
                        Because of the large number of public comments we normally receive on 
                        <E T="04">Federal Register</E>
                         documents, we are not able to acknowledge or respond to them individually. We will consider all comments we receive by the date and time specified in the “DATES” section of this preamble, and, when we proceed with a subsequent document, we will respond to the comments in the preamble to that document. 
                    </P>
                    <HD SOURCE="HD1">XVI. Regulatory Impact Analysis </HD>
                    <P>We have examined the impact of this rule as required by Executive Order 12866 (September 1993, Regulatory Planning and Review), the Regulatory Flexibility Act (RFA) (September 16, 1980 Pub. L. 96-354), section 1102(b) of the Social Security Act, the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4), and Executive Order 13132. </P>
                    <P>
                        Executive Order 12866 (as amended by Executive Order 13258, which merely reassigns responsibilities of duties) directs agencies to assess all costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). A regulatory impact analysis must be prepared for final rules with economically significant effects (that is, a final rule that would have an annual effect on the economy of $100 million or more in any 1 year, or would adversely affect in a material way the economy, a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local, or tribal governments or communities). 
                        <PRTPAGE P="66393"/>
                    </P>
                    <P>As indicated in more detail below, we expect that the physician fee schedule provisions included in this final rule will redistribute more than $100 million in 1 year. We also anticipate that the combined effect of several provisions of the MMA implemented in this final rule will increase spending by more than $100 million. Other MMA provisions implemented in this final rule are expected to reduce spending by more than $100 million. We are considering this final rule to be economically significant because its provisions are expected to result in an increase, decrease or aggregate redistribution of Medicare spending that will exceed $100 million. Therefore, this final rule is a major rule and we have prepared a regulatory impact analysis. </P>
                    <P>The RFA requires that we analyze regulatory options for small businesses and other entities. We prepare a regulatory flexibility analysis unless we certify that a rule would not have a significant economic impact on a substantial number of small entities. The analysis must include a justification concerning the reason action is being taken, the kinds and number of small entities the rule affects, and an explanation of any meaningful options that achieve the objectives with less significant adverse economic impact on the small entities. </P>
                    <P>Section 1102(b) of the Act requires us to prepare a regulatory impact analysis for any final rule that may have a significant impact on the operations of a substantial number of small rural hospitals. This analysis must conform to the provisions of section 603 of the RFA. For purposes of section 1102(b) of the Act, we define a small rural hospital as a hospital that is located outside a Metropolitan Statistical Area and has fewer than 100 beds. We have determined that this final rule would have minimal impact on small hospitals located in rural areas. Of 517 hospital-based ESRD facilities located in rural areas, only 40 are affiliated with hospitals with fewer than 100 beds. </P>
                    <P>For purposes of the RFA, physicians, nonphysician practitioners, and suppliers are considered small businesses if they generate revenues of $6 million or less. Approximately 95 percent of physicians are considered to be small entities. There are about 875,000 physicians, other practitioners and medical suppliers that receive Medicare payment under the physician fee schedule. There are in excess of 20,000 physicians and other practitioners that receive Medicare payment for drugs. As noted previously in this final rule and described further below, we are implementing significant changes to the payments for drugs.) The 20,000 physicians that receive payments for drugs are generally concentrated in the specialties of oncology, urology, rheumatology and infectious disease. Of the physicians in these specialties, approximately 40 percent are in oncology and 45 percent in urology. </P>
                    <P>For purposes of the RFA, approximately 98 percent of suppliers of durable medical equipment (DME) and prosthetic devices are considered small businesses according to the Small Business Administration's (SBA) size standards. We estimate that 106,000 entities bill Medicare for durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS) each year. Total annual estimated Medicare revenues for DME suppliers exceed approximately $4.0 billion. Of this amount, approximately $1.6 billion are for DME drugs. These suppliers will be affected by the payment changes being made in this final rule for drugs. </P>
                    <P>In addition, most ESRD facilities are considered small entities, either based on nonprofit status, or by having revenues of $29 million or less in any year. We consider a substantial number of entities to be affected if the rule is estimated to impact more than 5 percent of the total number of small entities. Based on our analysis of the 785 nonprofit ESRD facilities considered small entities in accordance with the above definitions, we estimate that the combined impact of the changes to payment for renal dialysis services included in this rule would have a 1.6 percent increase in payments relative to current composite rate payments. </P>
                    <P>The analysis and discussion provided in this section, as well as elsewhere in this final rule, complies with the RFA requirements. Section 202 of the Unfunded Mandates Reform Act of 1995 also requires that agencies assess anticipated costs and benefits before issuing any rule that may result in expenditures in any year by State, local, or tribal governments, in the aggregate, or by the private sector, of $110 million. Medicare beneficiaries are considered to be part of the private sector for this purpose. The net impact of the provisions of this rule, including those related to the MMA, are estimated to result in a savings to beneficiaries of nearly $485 million for FY 2005. However, we note that this savings figure compares FY 2005 beneficiary costs occurring as a result of provisions of this final rule to FY 2005 estimated beneficiary costs in the absence of final rule implementation (that is, the savings figure compare beneficiary costs with implementation of the ASP drug payment provisions to continuing the AWP drug payment methodology). The specific effects of the provisions being implemented in this final rule are explained in greater detail below. </P>
                    <P>We have examined this final rule in accordance with Executive Order 13132 and have determined that this regulation would not have any significant impact on the rights, roles, or responsibilities of State, local, or tribal governments. </P>
                    <P>We have prepared the following analysis, which, together with the information provided in the rest of this preamble, meets all assessment requirements. It explains the rationale for and purposes of the rule; details the costs and benefits of the rule; analyzes alternatives; and presents the measures we use to minimize the burden on small entities. As indicated elsewhere in this final rule, we are refining resource-based practice expense RVUs and making a variety of other changes to our regulations, payments, or payment policy to ensure that our payment systems are updated to reflect changes in medical practice and the relative value of services. We are also implementing several changes resulting from the MMA, including changes to Medicare payment rates for outpatient drugs, changes to the payment for renal dialysis services, creating new preventive health care benefits and creating incentive payment program improvements for physician scarcity. </P>
                    <P>We are providing information for each of the policy changes in the relevant sections of this final rule. We are unaware of any relevant Federal rules that duplicate, overlap or conflict with this final rule. The relevant sections of this final rule contain a description of significant alternatives if applicable. </P>
                    <HD SOURCE="HD2">A. Resource-Based Practice Expense and Malpractice Relative Value Units </HD>
                    <P>Under section 1848(c)(2) of the Act, adjustments to RVUs may not cause the amount of expenditures to differ by more than $20 million from the amount of expenditures that would have resulted without such adjustments. We are implementing several changes that would result in a change in expenditures that would exceed $20 million if we made no offsetting adjustments to either the conversion factor or RVUs. </P>
                    <P>
                        With respect to practice expense RVUs, our policy has been to meet the budget-neutrality requirements in the statute by incorporating a rescaling adjustment in the practice expense methodologies. That is, we estimate the aggregate number of practice expense RVUs that will be paid under current and revised policy in CY 2005. We 
                        <PRTPAGE P="66394"/>
                        apply a uniform adjustment factor to make the aggregate number of revised practice expense RVUs equal the number estimated that would be paid under current policy. While we are continuing to apply this policy for general changes in coding and RVUs, we are increasing aggregate physician fee schedule payments to account for the higher payments for drug administration. These increases in payment are being made under the authority of section 1848(c)(2)(J) of the Act that exempts the changes in payments for drug administration from the budget neutrality requirements of section 1848(c)(2)(B)(iv) of the Act. 
                    </P>
                    <P>Table 36 shows the specialty level impact on payment of the practice expense and malpractice RVU changes being implemented for CY 2005. Our estimates of changes in Medicare revenues for physician fee schedule services compare payment rates for 2005 with payment rates for 2004 using 2003 Medicare utilization for both years. We are using 2003 Medicare claims processed and paid through June 30, 2004, that we estimate are 98.5 percent complete, and have adjusted the figures to reflect a full year of data. Thus, because we are using a single year of utilization, the estimated changes in revenues reflect payment changes only between 2004 and 2005. To the extent that there are year-to-year changes in the volume and mix of services provided by physicians, the actual impact on total Medicare revenues will be different than those shown here. The payment impacts reflect averages for each specialty based on Medicare utilization. The payment impact for an individual physician would be different from the average, based on the mix of services the physician provides. The average change in total revenues would be less than the impact displayed here because physicians furnish services to both Medicare and non-Medicare patients and specialties may receive substantial Medicare revenues for services that are not paid under the physician fee schedule. For instance, independent laboratories receive approximately 80 percent of their Medicare revenues from clinical laboratory services that are not paid under the physician fee schedule. The table shows only the payment impact on physician fee schedule services. </P>
                    <P>
                        The column labeled “NPRM Impacts” shows the effect of the changes in payment attributable to practice expense and malpractice RVUs from the proposed rule. (
                        <E T="03">See</E>
                         69 FR 47556 through 47559 for a complete description of the payment changes shown in this column). We have also made some additional changes to the practice expense and malpractice RVUs since the proposed rule in response to comments and additional information that became available to us during the comment period. The additional changes in payment based on further refinements of the practice expense RVUs generally have no specialty level impact. The 1 percent increase in payment for vascular surgery shown in the practice expense refinements column is attributed to substitution of a vascular ultrasound room for a general ultrasound room in the equipment resources for CPT code 93880. Similarly, the increase in practice expense RVUs for diagnostic testing facilities is also attributable to the increase in payment for 93880 and 93925 due to the substitution of a vascular ultrasound room for a general ultrasound room in the equipment resources. 
                    </P>
                    <P>The column labeled “Additional Malpractice RVU Refinements” show the additional impact of changes in the malpractice expense RVUs since the proposed rule on total payment for physician fee schedule services. As explained earlier, we are making several changes to malpractice RVUs that will change the impacts we illustrated in the proposed rule. We are removing assistants-at-surgery from the Medicare utilization that goes into determining the malpractice RVUs. Relative to the proposed rule, this change will increase total payments to neurosurgeons by nearly 1 percent. We also increased the ISO risk classification for the all physician crosswalk used for podiatry increasing their payments by 1 percent relative to the proposed rule. Several specialty groups, including dermatology commented that the major surgery risk factor should not be used for the dermatology codes. Relative to the proposed rule, payments to dermatologists will decrease by approximately 1 percent as a result of this change. The changes also increase payment to the specialty of allergy/immunology by nearly 1 percent relative to the proposed rule. This increase occurs because we are setting a minimum value of 0.01 malpractice RVUs. In the proposed rule, we did show malpractice RVUs in Addendum B if the rounded RVU equaled 0.0. </P>
                    <P>The column labeled “Immunizations/Injections” shows the impact of making separate payment for injections provided on the same day as another physician fee schedule service and the increase in payment for immunizations. These changes generally benefit those specialties that provide injections and immunizations in their offices. The provision is estimated to increase payment by 2 percent to family practice and by 1 percent to general practice, geriatrics, internal medicine and pediatrics. The column labeled “Total” shows the combined percentage change in payments resulting from the practice expense and malpractice RVU changes including those that were described in the proposed rule and the additional changes we are making in this final rule. </P>
                    <P>As explained in the proposed rule, the practice expense refinements will reduce payments to audiologists by approximately 4 percent. Virtually all of the reduction in payment is due to the refinement of procedure code 92547. We accepted the PEAC recommendation to reduce the clinical staff time of the audiologist involved in this service from 71 minutes to 1 minute. The refinement of clinical staff and equipment resulted in a reduction from 1.15 to 0.08 practice expense RVUs producing the 4 percent reduction in payments shown in table 37. However, this impact assumes no change in how frequently these services are performed. While we received comments suggesting that the code was valued based on only one occurrence of the service, the commenter asserted that it is typically performed more than once per day. Currently, CPT allows it only to be billed once per day. If CPT were to change its policy and the service was billed more frequently, the impact shown in table 37 would be less than shown here. </P>
                    <P>
                        In the proposed rule, we estimated that payments to vascular surgeons would increase by 3 percent as a result of the repricing of medical equipment used in performing noninvasive vascular diagnostic tests. As indicated above, the total increase in payments including the additional refinements we made to equipment will make the total increase in payment from RVU changes equal to 4 percent. We originally estimated that payments to interventional radiology would increase by 2 percent due practice expense refinements and the establishment of nonfacility pricing for procedure codes 35470 to 35476. Due to additional practice expense RVU refinements, we are now estimating that the total increase in payments will be 3 percent. We are estimating slightly less than a 3.5 percent increase in payment to oral and maxillofacial surgeons from the refinement of medical supplies for procedure codes 21210 and 21215. The estimated impact for this specialty is slightly less than we were estimating for the proposed rule. As we indicated in the proposed rule, the 1 percent decrease in payment to nurse practitioners and geriatricians is 
                        <PRTPAGE P="66395"/>
                        attributed to the refinement of the nonfacility practice expense RVUs for nursing facility visits (procedure codes 99301 through 99316). These impacts are unchanged from the proposed rule. 
                    </P>
                    <P>As we indicated in the proposed rule, the increases for pathology and independent laboratories result from use of a practice expense survey provided by the College of American Pathology (CAP). The increases in the final rule are similar to the figures we estimated for the proposed rule. We further note that independent laboratories receive approximately 20 percent of their total Medicare revenues from physician fee schedule services. The remaining 80 percent of their Medicare revenues are from clinical diagnostic laboratory services that will be unchanged by use of the CAP survey data. Thus, total Medicare revenues to independent laboratories as a result of using the CAP survey will increase by slightly more than 1 percent (or 20 percent of the 6 percent increase in physician fee schedule revenues). There will be little or no impact on all other specialties from use of the CAP survey. </P>
                    <BILCOD>BILLING CODE 4120-01-P</BILCOD>
                    <GPH SPAN="3" DEEP="545">
                        <GID>ER15NO04.543</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="544">
                        <PRTPAGE P="66396"/>
                        <GID>ER15NO04.544</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="543">
                        <PRTPAGE P="66397"/>
                        <GID>ER15NO04.545</GID>
                    </GPH>
                    <BILCOD>BILLING CODE 4120-01-C</BILCOD>
                    <P>As discussed in section II.C of this rule, we are making changes to the malpractice RVUs based on more current malpractice premium data. As anticipated from past revisions to the malpractice RVUs, use of more current malpractice premium data results in minimal impacts on the specialty level payments. The table below shows the impact on total physician fee schedule revenues from the changes to the malpractice RVUs, the additional changes resulting from this final rule and the total impact. See Table 37, “Impact of Malpractice RVU Changes Proposed Rule and Final Rule”, for a breakdown of the impacts of these revisions on individual specialties. As described above, policies we are adopting in this final rule will increase payments for allergy, neurosurgery and podiatry and decrease payments for dermatology relative to the proposed rule. These changes will also slightly increase payments to cardiac surgery, orthopedic surgery, thoracic surgery and result in a smaller increase in payment for vascular surgery. </P>
                    <GPH SPAN="3" DEEP="611">
                        <PRTPAGE P="66398"/>
                        <GID>ER15NO04.546</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="169">
                        <PRTPAGE P="66399"/>
                        <GID>ER15NO04.547</GID>
                    </GPH>
                    <P>Section 1848(d) and (f) of the Act requires the Secretary to set the physician fee schedule update under the sustainable growth rate (SGR) system. For 2004 and 2005, the statute requires the update to be no less than 1.5 percent. Using the statutory formula in section 1848(d)(4) will produce an update of less than 1.5 percent for 2005. Therefore, the physician fee schedule update for 2005 will be 1.5 percent. We have included a complete discussion of our methodology for calculating the SGR and physician fee schedule update in another section of this final rule. Table 38 below shows the estimated change in average payments by specialty resulting from changes to the practice expense and malpractice RVUs and the 2005 physician fee schedule update. (Please note that the table does not include the specialties of Hematology/Oncology, Urology, Rheumatology, Obstetrics/Gynecology and Infectious Disease. There are unique issues related to drug administration that will further affect these specialties that are presented in detail below). </P>
                    <GPH SPAN="3" DEEP="493">
                        <PRTPAGE P="66400"/>
                        <GID>ER15NO04.548</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="412">
                        <PRTPAGE P="66401"/>
                        <GID>ER15NO04.549</GID>
                    </GPH>
                    <P>Table 39 shows the impact on payments for selected high-volume procedures of all of the changes previously discussed. We selected these procedures because they are the most commonly provided procedures by a broad spectrum of physician specialties, or they are of particular interest to the physician community (for example, the initial preventive physical exam and EKG, codes G0344, G0366, G0367 and G0368). We note that the table below shows Medicare payment for the administration of an influenza vaccine, G0008, increasing from $8.21 to $18.57, or 126 percent. As explained earlier, we are establishing the same RVUs for the administration of a vaccine and an injection. For 2005 only, we will pay 3 percent more for the injection ($19.13) because of the transitional adjustment required by section 303. After 2005, the payment for the administration of a vaccine and an injection will be the same. This table shows the combined impact of the change in the practice expense and malpractice RVUs and the estimated physician fee schedule update on total payment for the procedure. There are separate columns that show the change in the facility rates and the nonfacility rates. For an explanation of facility and nonfacility practice expense RVUs refer to § 414.22(b)(5)(i). The table shows the estimated change in payment rates based on provisions of this final rule and the estimated physician fee schedule update. </P>
                    <BILCOD>BILLING CODE 4120-01-P</BILCOD>
                    <GPH SPAN="3" DEEP="547">
                        <PRTPAGE P="66402"/>
                        <GID>ER15NO04.550</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="388">
                        <PRTPAGE P="66403"/>
                        <GID>ER15NO04.551</GID>
                    </GPH>
                    <BILCOD>BILLING CODE 4120-01-C</BILCOD>
                    <P>Section 303(a)(1) of the MMA amended section 1848(c)(2) of the Act to require increased work and practice expense RVUs for drug administration services. Section 303(a)(4) of the MMA required an additional temporary increase in payment to specific drug administration services of 32 percent for 2004 and 3 percent for 2005. Table 41 shows the payment amounts for selected high-volume drug administration CPT codes from 2002 to 2006 including the effect of the transition adjustment of 32 percent required for 2004 and 3 percent for 2005. Because we may also pay an additional $130 per encounter under the national demonstration project in 2005, we are also including the effect of this additional payment where applicable. Table 42 that follows table 41 shows the payment amount for 2004 and 2005 without the additional transition adjustment required by the MMA and national demonstration payment amount. By showing the payment amounts without the transition and demonstration, we can isolate the permanent change in the payment amounts that is occurring as a result of the MMA, the CPT/RUC review and the physician fee schedule update. The amounts shown in the table include the effect of the 1.5 percent update for 2004 and 2005. As described above, the CPT and RUC have recommended changes to the coding and payment for drug administration services. The CPT/RUC review was undertaken at our request under the authority of section 1848(c)(2)(J) of the Act that requires the Secretary to promptly evaluate existing drug administration codes using existing processes. While this review was completed expeditiously, CPT did not have sufficient time to adopt the coding recommendations into the 2005 version of CPT. For this reason, we are establishing new G-codes for 2005 that correspond with the new CPT codes that will become active in 2006. </P>
                    <P>
                        Tables 41 and 42 show the payment amounts for the most frequently performed drug administration services from 2002 to 2004 under the CPT codes and payment for the comparable service in 2005 using the G code. For instance, a therapeutic injection was previously billed under the CPT code 90782. This same service will now be billed using HCPCS code G0351. As a result of the RUC review, our acceptance of their recommendations for refinements to the practice expense inputs, our policy of pooling the utilization for the injection with vaccine administration, and the required reduction in the transitional adjustment, payment for this service will be reduced from $24.64 in 2004 to $19.13 in 2005. However, the 2004 transition adjustment largely accounts for the decline. If the transitional adjustment of 32 percent for 2004 and 3 percent for 2005 were not applied, payment for the injection would be virtually the same in 2005 as in 2004, a decline of $0.10 from $18.67 to $18.57. This table shows the permanent large increase in payment for this code from 2002 to 2005. The payment for a therapeutic injection increased from $3.98 in 2002 to $19.13 in 2005, a 381 
                        <PRTPAGE P="66404"/>
                        percent increase (or $18.57 if the transitional adjustment were not applied, a 367 percent increase). 
                    </P>
                    <P>CPT is also recommending separate codes for the administration of hormonal anti-neoplastic subcutaneous/intramuscular (SC/IM) injections from other anti-neoplastic injections. Under the current CPT codes, all anti-neoplastics administered SC/IM are billed using CPT code 96400. HCPCS code G0356 will be used for the administration of hormonal anti-neoplastic injections. CPT code 96400 is currently paid $64.07. Its comparable code for 2005 (G0356) will be paid $36.69 or a reduction of 43 percent. Without the transition, payment for the code would have been reduced from $48.54 to $35.62 or 27 percent between 2004 and 2005. However, payment for this code increased from $5.07 to $35.62 (without the transition) between 2002 and 2005 or by 603 percent. </P>
                    <P>There is currently one CPT code for anti-neoplastic drugs administered by intravenous (IV) push (96408). In 2004, physicians are receiving $154.76 for CPT code 96408. Payment in 2005 for G0351 (the comparable code) will be $125.69. In addition, Medicare may also pay an additional $130.00 per encounter under the demonstration increasing the total payment to $255.69 or an increase of 65 percent between 2004 and 2005. Without the transitional adjustments or the demonstration, payment for this service would have increased from $117.24 in 2004 to $122.03 in 2003 or by 4 percent. From 2002 to 2005, payment will have increased from $35.11 to $122.03 (without the transition), or a 248 percent increase. </P>
                    <P>CPT will be creating new codes that distinguish between the first and subsequent administration of a drug by IV push to the same patient on the same day. The RUC is recommending fewer inputs for the subsequent administration of a drug by IV push than the initial drug. We are creating code G0358 for each subsequent drug administered by IV push for 2005. Before the enactment of the MMA, Medicare allowed CPT code 96408 to be paid only once per patient per day. However, as a result of the MMA, we changed our policy and allowed physicians to bill and be paid for more than one administration of a chemotherapy drug by IV push to the same patient on a single day (see 69 FR 1094-1095). Thus, because separate codes do not currently exist for the multiple administrations of chemotherapy drugs by IV push on a single day, physicians currently are paid at the rate for 96408 (or $154.76) for each subsequent administration. Using the CPT's and RUC recommendations, we will pay $72.99 for subsequent drugs administered by IV push using HCPCS code G0358. While the payment is less in 2005 and 2004, payment remains higher in 2005 than in 2003 and prior years when Medicare provided no payment for the subsequent administration of a drug by IV push. </P>
                    <P>We are creating HCPCS codes G0359 and G0360 for the initial and subsequent hour respectively of chemotherapy drugs administered by IV infusion. As described in the drug administration section, CPT has changed its definition of chemotherapy to include infusion of substances such as monoclonal antibody agents or other biologic response modifiers in addition to anti-neoplastic drugs. Thus, services previously billed under the CPT code 90780 (initial hour) and 90781 (each additional hour) that meet this new definition of chemotherapy will now be billed under CPT code G0359 (initial hour) and G0360 (each additional hour). Payment for the infusion of substances such as monoclonal antibody agents or other biologic response modifiers paid under CPT code 90780 will be increasing from $117.79 in 2004 to $177.61 in 2005 using HCPCS code G0359, a 51 percent increase. Without including the transition adjustment, payment for these services will have increased by 93 percent from $89.24 in 2004 to $172.43 in 2005 or by 325 percent from the 2002 rate of $40.54. Payment for the subsequent hour infusion under CPT code 90781 will increase from $33.02 in 2004 to $40.21 in 2005 under HCPCS code G0360 or by 22 percent. Without including the transition adjustment, payment for the subsequent hour infusion will have increased 56 percent from $25.02 in 2004 to $39.03 in 2005 or 93 percent from its 2002 rate of $20.27. </P>
                    <P>Anti-neoplastic agents that were previously billed under CPT code 96410 (initial hour) and 96412 (each additional hour) will also be billed under codes G0359 and G0360. We have listed codes G0359 and G0360 twice to reflect that Medicare payment for each respective code is paid under two different CPT codes for services rendered prior to January 1, 2005. Payment for the initial hour of an anti-neoplastic agent administered by infusion under CPT code 96410 will be going from $217.35 in 2004 to $177.61 in 2005. Including the $130.00 per encounter demonstration payment in this amount brings the total payment to $307.61, an increase of 65 percent. Without including the transition adjustment, payment for these services will have increased by 5 percent from $164.66 in 2004 to $172.43 in 2005 or by 209 percent from the 2002 rate of $55.75. Payment for the subsequent hour infusion under CPT code 96412 will decrease from $48.30 in 2004 to $40.21 in 2005 under HCPCS code G0360 or by 17 percent. Without including the transition adjustment, payment for the subsequent hour infusion will have increased 7 percent from $36.59 in 2004 to $39.03 in 2005. Payment for the subsequent hour infusion of an anti-neoplastic agent has been reduced by 6 percent from its 2002 rate of $41.63. The reduction in payment is occurring because resource-based pricing replaced the use of charge-based RVUs when the services were removed from the nonphysician work pool in 2004. </P>
                    <P>The CPT is also recommending a new code for the initial hour of a subsequent chemotherapy drug administered by infusion. The new code would recognize that there are higher resources associated with the first hour of infusion of a subsequent drug than there are in the subsequent hour of the initial drug. Under current CPT coding, the first hour of a subsequent drug administered by IV infusion is paid under CPT code 96412. In 2004, Medicare pays $48.30 for this service. In 2005, we will pay $86.66 or 79 percent more for HCPCS code G0362 that will be used for the initial hour of a subsequent drug administered by IV infusion. Without including the transition adjustment, payment for this service will have increased 130 percent from $36.59 in 2004 to $84.13 in 2005 or 102 percent from the 2002 rate of $41.63. </P>
                    <P>The volume-weighted average permanent increase in payment among all drug administration services is approximately 117 percent from 2003 to 2005 including the effect of the CPT/RUC recommendations but excluding the effect of the transition adjustment. Including the effect of the transition (but not the demonstration payment) makes the volume-weighted increase in payment for these codes more than 120 percent from 2003 to 2005. </P>
                    <BILCOD>BILLING CODE 4120-01-P</BILCOD>
                    <GPH SPAN="3" DEEP="622">
                        <PRTPAGE P="66405"/>
                        <GID>ER15NO04.552</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="564">
                        <PRTPAGE P="66406"/>
                        <GID>ER15NO04.553</GID>
                    </GPH>
                    <BILCOD>BILLING CODE 4120-01-C</BILCOD>
                    <P>
                        Table 42 below shows the impact of physician fee schedule changes for selected specialties that receive a significant portion of their total Medicare revenues from drugs. Table 43 that follows table 42 shows the combined impact of the physician fee schedule and drug payment changes on total Medicare revenues. Our estimates of changes in Medicare revenues for drugs and physician fee schedule services compare payment rates for 2005 with payment rates for 2004 using 2003 Medicare utilization for both years. For physician fee schedule services, we mapped the 2003 Medicare utilization to the code set in use for 2005 based on assumptions about how the new drug administration codes will be billed. These assumptions are based on our consultations with the American Society of Clinical Oncology and other physician specialty societies that participated in the CPT's Drug Administration workgroup. We are using 2003 Medicare claims processed and paid through June 30, 2004 that we 
                        <PRTPAGE P="66407"/>
                        estimate are 98.5 complete and have adjusted the figures to reflect a full year of data. Thus, because we are using a single year of utilization, the estimated changes in revenues reflect payment changes only between 2004 and 2005. To the extent that there are year-to-year changes in the volume and mix of drugs and physician fee schedule services provided by physicians, the actual impact on total Medicare revenues will be different than those shown here. 
                    </P>
                    <P>The column labeled “NPRM Impacts” shows the impact of the practice expense and malpractice RVU changes described earlier. The refinements of the practice expense RVUs and 5-year review of malpractice will have little or no impact on physician fee schedule payments for the 5 specialties shown. The column labeled “Coding and RVU Changes” shows the impact of our adoption of the CPT/RUC recommended revisions to the codes and payment amount for drug administration services. We estimate that the changes from the CPT/RUC process will increase physician fee schedule payments for oncologists by 5 percent. This impact is generally attributable to higher permanent increases in payment for the administration of drugs by IV push (G0357), infusion (G0359 and G0360) and the ability to be paid at a higher rate for the initial hour of infusion of a subsequent drug administered. We estimate that the changes from the CPT/RUC process will increase payments to rheumatologists by 4 percent. This impact is due to the change in the definition of the chemotherapy that will allow rheumatologists to bill substances such as monoclonal antibody agents or other biologic response modifiers using the chemotherapy administration codes. The CPT/RUC changes will have little or no specialty level impact on other specialties that administer drugs. </P>
                    <P>The next column shows the effect of the drug administration transition on Medicare physician fee schedule revenues for the specialties shown. As explained earlier, section 303(a)(4) requires that the transition adjustment percentage be reduced from 32 percent in 2004 to 3 percent in 2005. The change to the transition payment percentage will reduce payments for the specialties that provide drug administration services. The reduction has a larger impact on oncologists than the other physician specialties shown because drug administration services represent a larger proportion of their physician fee schedule revenues. </P>
                    <P>The column labeled “Additional Payments for Injections” shows the effect of paying for injections (as well as non-chemotherapy drugs administered by IV push) provided on the same day as other physician fee schedule services. We estimate that this policy change will increase payment an estimated 3 percent for oncologists and 1 percent for other specialties. This policy change will also modestly increase payment to other specialties that provide injections (primarily family practitioners and internists) and has been incorporated into the earlier impact tables. </P>
                    <P>The next column shows the impact of the 1.5 percent physician fee schedule update. The column labeled “One-Year Demonstration Project” shows the impact of our plan to establish a national demonstration project that will pay oncologists $130 for providing specific services to their patients and reporting patient quality data. If oncologists participate in this demonstration project and provide the required services and requested information, we estimate that their payments will increase by 15 percent. Taken together, we estimate that the coding and RVU changes, the change to the transition amount for drug administration, the additional payments for injections, the physician fee schedule update and the national demonstration project will increase physician fee schedule payments to oncologists by 10 percent. The combined impact of these factors (other than the national demonstration project) will increase physician fee schedule payments by 1 percent urologists, 5 percent for rheumatologists, 1 percent for obstetrics/gynecologists and 0 percent for infectious disease. </P>
                    <P>
                        Table 43 shows the combined impact of changes we are making to Medicare drug and physician fee schedule payments for the same specialties shown in table 42. The payment impacts for drugs are based on the 2nd quarter ASP submissions from drug manufacturer's and reflect 
                        <FR>3/4</FR>
                         of an annualized increase in drug prices between the 2nd quarter of 2004 and the 1st quarter of 2005 of 3.39 percent or 2.54 percent. The drug payment impacts are based on ASP prices for drugs accounting for approximately 94 percent of Medicare's total drug payments. Of Medicare's total payments for drugs, at least 4 percent are paid under “not otherwise classified (NOC)” codes (
                        <E T="03">i.e.</E>
                         J3490 and J0999). Thus, we based our impacts on ASP prices for drugs accounting for approximately 98 percent of Medicare revenues that are not in the NOC category. 
                    </P>
                    <P>The column labeled “% of Total Medicare Revenues from Fee Schedule” shows the proportion of total Medicare revenues received from physician fee schedule services. The following column shows the physician fee schedule payment impact. All of the payment impacts are the same as those shown in Table 43. The following column shows the proportion of total Medicare revenues received from drugs, while the next column shows the payment impact from adoption of the ASP drug payment methodology. The next 3 columns show combined Medicare revenues from all sources and the combined Medicare payment impact from the earlier described changes being adopted for 2005. </P>
                    <P>
                        Our estimates of changes in Medicare revenues for both drugs and drug administration services compare payment rates for 2005 with payment rates for 2004 using the same utilization in both years. We used 2003 utilization for these comparative impacts since they are the latest data available. Thus, the estimated changes in revenues reflect 
                        <E T="03">purely</E>
                         price changes between 2004 and 2005. We note that these impacts and percentages represent averages for each specialty or supplier. The percentages and impacts for any individual physician are dependent on the mix of drugs and physician fee schedule services they provide to Medicare beneficiaries. For this analysis, we are also supplementing the data showing the change in revenues with volume growth based on historical trends. 
                    </P>
                    <P>
                        As indicated in Table 43, physician fee schedule services account for approximately 28 percent of oncology's 2004 Medicare revenues. The changes we are adopting in this final rule are estimated to increase Medicare payments for physician fee schedule services by 10 percent from 2004 to 2005. We estimate that approximately 69 percent of total 2004 Medicare revenues for oncologists are attributed to drugs and the adoption of the ASP pricing methodology will reduce these revenues by 13 percent. We based our analysis on drugs accounting for approximately 92 percent of total oncology drug revenues (and 99 percent of oncology drug revenues not paid under NOC codes). The actual impact on oncologists' total Medicare revenues will be different from these estimated impacts to the extent that utilization of drugs and drug administration services does increase. In recent years, increasing utilization, for example, drug spending growth in excess of 20 percent per year, has occurred. The weighted average of the drug and physician fee schedule changes assuming no change in utilization would decrease Medicare revenues to oncology by 6 percent. However, if the volume of drugs and physician fee schedule services 
                        <PRTPAGE P="66408"/>
                        increased at historical rates, total Medicare revenues for oncologists are estimated to increase by 4 percent between 2004 and 2005, excluding the demonstration project. If we include the demonstration project, Medicare revenues to oncologists are estimated to increase by 8 percent between 2004 and 2005. We note that our actuaries' estimates of section 303 with the drug prices and policy changes in this final rule match earlier estimates of the FY 2005 and 10-year savings figures. 
                    </P>
                    <P>We estimate that urology receives approximately 57 percent of their 2004 total revenues from physician fee schedule services and 35 percent from drugs. We estimate that physician fee schedule revenues for urologists will increase by approximately 1 percent from 2004 to 2005. Based on ASP prices for drugs accounting for 100 percent of urologists' drug revenues, we estimate a 40 percent reduction assuming no growth in the volume of services provided. In this scenario, combined Medicare payments to urologists would decline approximately 14 percent. However, if the volume of physician fee schedule services and drugs were to grow at historical rates, we estimate that Medicare revenues to urologists would decline by 8 percent. </P>
                    <P>We estimate that physician fee schedule revenues account for approximately 49 percent of rheumatology's total revenues. Drugs account for approximately 44 percent rheumatology's total revenues. Physician fee schedule revenues are estimated to increase 5 percent for rheumatology and revenues from drugs are estimated to decline by 8 percent. Assuming no growth in utilization, the combined reduction in rheumatologists' revenues would be 1 percent. If the volume of drugs and physician fee schedule services grew at historical rates, rheumatologists' revenues from Medicare would increase by 9 percent. </P>
                    <P>We estimate that physician fee schedule revenues account for approximately 87 percent of total revenues for obstetrics/gynecology. These revenues are anticipated to increase by 1 percent. Drug revenues represent 13 percent of total Medicare revenues for obstetrics/gynecology and are estimated to decline by 21 percent. Assuming no growth in utilization, we estimated that obstetrics/gynecology's combined Medicare revenues would decline by 2 percent. Using the historical projected rates of growth for the volume of drugs and physician fee schedule services would make the estimated change in revenues equal an increase of 4 percent. </P>
                    <P>We estimate that physician fee schedule revenues account for approximately 94 percent of total revenues for infectious disease physicians. These payments are not estimated to change. The remainder of Medicare revenues for infectious disease physicians can be attributed to drugs. These payments are expected to decline by 25 percent. The weighted average change in infectious disease revenues from the changes we are adopting in this final rule is −2 percent assuming no growth in the volume of drugs and physician fee schedule services. If future growth in the volume of drugs and physician fee schedule services were to grow at historical rates, revenues to infectious disease physicians would increase would increase 7 percent. </P>
                    <BILCOD>BILLING CODE 4120-01-P</BILCOD>
                    <GPH SPAN="3" DEEP="595">
                        <PRTPAGE P="66409"/>
                        <GID>ER15NO04.554</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="594">
                        <PRTPAGE P="66410"/>
                        <GID>ER15NO04.555</GID>
                    </GPH>
                    <BILCOD>BILLING CODE 4120-01-C</BILCOD>
                    <HD SOURCE="HD2">B. Geographic Practice Cost Indices </HD>
                    <P>
                        As discussed in section II.B, in this rule, we are proposing changes to the work and practice expense GPCIs based on new census data. The resulting geographic redistributions would not result in an overall increase in the current geographic adjustment indices by more than 3.5 percent or a decrease by more than 1.6 percent for any given locality in 2005. These geographic redistributions would not result in an overall increase in the current geographic adjustment indices by more than 7 percent or a decrease by more than 3.5 percent for any given locality in 2006. Addenda F and G illustrate the 
                        <PRTPAGE P="66411"/>
                        locality specific overall impact of this proposal. The GAF, as displayed in Addenda F and G is a weighted composite index of the individual revisions to the work, practice expense, and malpractice expense GPCIs, respectively. The malpractice GPCI was updated as part of the November 7, 2003 final rule, and the MMA provisions were addressed in the final rule published on January 7, 2004. 
                    </P>
                    <HD SOURCE="HD2">C. Coding Issues </HD>
                    <HD SOURCE="HD3">1. Additions to the List of Medicare Telehealth Services </HD>
                    <P>In section II.D, we are adding end stage renal disease (ESRD) services, as represented by HCPCS codes G0308, G0309, G0311, G0312, G0314, G0315, G0317, G03178 to the list of telehealth services. We believe that this change will have little effect on Medicare expenditures. </P>
                    <HD SOURCE="HD3">2. National Pricing of G0238/G0239 (Respiratory Therapy Service Codes) </HD>
                    <P>As discussed earlier in the preamble, we are using the nonphysician workpool to value two respiratory therapy service codes (G0238 and G0239) that are currently carrier priced. We believe that this change will eliminate the uncertainty surrounding payment of these codes when performed in comprehensive outpatient rehabilitation facilities that are paid under the physician fee schedule through fiscal intermediaries. We do not anticipate that nationally pricing these services will have a significant impact on Medicare expenditures. </P>
                    <HD SOURCE="HD3">3. New HCPCS Code for Bone Marrow Aspiration </HD>
                    <P>We are implementing a new HCPCS add-on code, GO367 for instances when a bone marrow aspiration and a bone marrow biopsy are performed on the same day through a single incision. While this coding change will allow for a small additional payment for the second procedure performed through a single incision on the same day, we anticipate that the costs will be insignificant. </P>
                    <HD SOURCE="HD3">4. New HCPCS Code for Venous Mapping </HD>
                    <P>As stated earlier in the preamble, we are implementing a new HCPCS code G0365, for mapping of vessels for hemodialysis access. Payment for this code will be crosswalked by CPT code 93990, Doppler Flow Testing. We anticipate that the costs of this change will be minor and may result in improved care to Medicare beneficiaries and less long-term costs to Medicare. </P>
                    <HD SOURCE="HD2">D. MMA Provisions </HD>
                    <HD SOURCE="HD3">1. Section 611—Preventive Physical Examination </HD>
                    <P>As discussed earlier in this preamble, the MMA authorizes coverage of an initial preventive physical examination effective January 1, 2005, subject to certain eligibility and other limitations. This new benefit will result in an increase in Medicare expenditures for new payments made to physicians and other practitioners who provide these examinations and for any medically necessary follow-up tests, counseling, or treatment that may be required as a result of the coverage of these examinations. The impact of this provision is shown in the following table. </P>
                    <GPH SPAN="3" DEEP="115">
                        <GID>ER15NO04.556</GID>
                    </GPH>
                    <HD SOURCE="HD3">2. Section 613—Diabetes Screening </HD>
                    <P>Section 613 of the MMA adds subsection (yy) to section 1861 of the Social Security Act and mandates coverage of diabetes screening tests, effective on or after January 1, 2005. We expect that this change in coverage for certain beneficiaries will result in an increase in Medicare payments. These payments will be made to physicians' office laboratories and other laboratory suppliers who perform these tests as a result of the increased frequency of coverage of these tests. The impact of this provision is shown in Table 45 that follows. </P>
                    <HD SOURCE="HD3">3. Section 612—Cardiovascular Screening </HD>
                    <P>Section 612 of the MMA provides for Medicare coverage for cholesterol and other lipid or triglyceride levels of cardiovascular screening blood tests for the early detection of abnormalities associated with an elevated risk for such diseases effective on or after January 1, 2005. We estimate that this change in coverage for certain beneficiaries will result in an increase in Medicare payments. These payments will be made to physician office laboratories and other laboratory suppliers who perform these tests as a result of the increased frequency of coverage of these tests. Increased Medicare program expenditures for this provision are shown in Table 45 below. </P>
                    <GPH SPAN="3" DEEP="130">
                        <PRTPAGE P="66412"/>
                        <GID>ER15NO04.557</GID>
                    </GPH>
                    <HD SOURCE="HD3">4. Section 413—Incentive Payment for Physician Scarcity </HD>
                    <HD SOURCE="HD2">a. Physician Scarcity Areas </HD>
                    <P>Section 413(a) of the MMA provides a new 5-percent incentive payment to physicians who furnish services in physician scarcity areas. The MMA provides for paying primary care physicians furnishing services in a primary care scarcity area, and specialty physicians furnishing services in a specialist care scarcity county, an additional amount equal to 5 percent of the amount paid for their professional services under the fee schedule from January 1, 2005 to December 31, 2007. We estimate that this new incentive payment for physicians' services will result in an increase in Medicare payments that are shown in Table 46. </P>
                    <HD SOURCE="HD2">b. Improvement to Medicare HPSA Incentive Payment Program </HD>
                    <P>Section 413(b) of the MMA amended section 1833(m) of the Act to mandate that we automate payment of the 10 percent HPSA incentive payment to eligible physicians. Since the inception of the HPSA incentive payment program, physicians have been required to determine their eligibility and correctly code their Medicare claims using modifiers. We estimate that this change to the HPSA incentive payment program to provide for automation of payment will result in an increase in Medicare payments because many eligible physicians are not applying for bonuses due to the burden of verifying eligibility. The impact of this provision is shown in Table 46. </P>
                    <GPH SPAN="3" DEEP="118">
                        <GID>ER15NO04.558</GID>
                    </GPH>
                    <HD SOURCE="HD3">5. Sections 303-304—Payment for Covered Outpatient Drugs and Biologicals and Section 305—Payment for Inhalation Drugs </HD>
                    <P>
                        Sections 303 and 304 of the MMA make changes to Medicare payment for covered outpatient drugs and biologicals and changes to the administration of those drugs. Section 305 makes changes to payment for inhalation drugs. We implemented provisions of sections 303 through 305 changing payments in 2004 for drugs and their administration in the January 7, 2004 
                        <E T="04">Federal Register</E>
                         (69 FR 1084). In this final rule, we are making further changes to Medicare's payment for drugs and drug administration for 2005 required by sections 303 through 305 of the MMA. As indicated earlier in this final rule, we are revising the codes and payments for drug administration based on recommendations of the CPT Editorial Board and the Relative Value Update Committee. Consistent with section 1848(c)(2)(J) of the Act (as amended by section 303(a) of the MMA), the increase in payment resulting from this review are exempt from the budget neutrality requirements that apply to changes in RVUs. We are further increasing payments to physicians that treat patients with cancer who participate in a national demonstration project. In addition, we are also paying a supplying fee of $50 per month for the first month and $24 for each subsequent month for Medicare Part B oral drug prescriptions. We are also proposing to pay a furnishing fee of $0.14 per unit of clotting factor and a dispensing fee of $57 per month for inhalation drugs. Taking all of these provisions into account, we estimate Medicare savings for section 303-305 as follows: 
                    </P>
                    <GPH SPAN="3" DEEP="103">
                        <PRTPAGE P="66413"/>
                        <GID>ER15NO04.559</GID>
                    </GPH>
                    <HD SOURCE="HD3">6. Section 952—Reassignment </HD>
                    <P>The reassignment provisions discussed in section III.F is currently estimated to have no significant impact on Medicare expenditures. </P>
                    <HD SOURCE="HD3">7. Section 623—Payment for Renal Dialysis Services </HD>
                    <HD SOURCE="HD2">a. Effects on the Medicare Program (Budgetary Effect) </HD>
                    <P>Because the basic case mix adjusted composite payment rate and the revised payment for ESRD drugs must be budget neutral in accordance with section 623(d)(1) of the MMA, except for the statutorily required 1.6 percent increase set forth in section 623(a), we estimate that there would be no budgetary impact for the Medicare program beyond this increase. The impact of this provision (net of beneficiary liability) is shown in the following table: </P>
                    <GPH SPAN="3" DEEP="104">
                        <GID>ER15NO04.560</GID>
                    </GPH>
                    <HD SOURCE="HD2">b. Impact on ESRD Providers </HD>
                    <P>To understand the impact of the changes affecting payments to ESRD facilities that result from enactment of the MMA on different categories of ESRD facilities, it is necessary to compare estimated payments under the current payment system (current payments) to estimated payments under the revisions to the composite rate payment system as set forth in this final rule (MMA payments). To estimate the impact among various classes of ESRD facilities, it is imperative that the estimates of current payments and MMA payments contain similar inputs. Therefore, we simulated MMA payments only for those ESRD facilities for which we are able to calculate both current payment and MMA payment. </P>
                    <P>Due to data limitations, we are unable estimate current and MMA payments for 461 facilities that bill for ESRD drugs. ESRD providers were grouped into the categories based on characteristics provided in the Online Survey and Certification and Reporting (OSCAR) file and the most recent cost report data from HCRIS. We also used the June 2004 update of CY 2003 Standard Analytical File (SAF) claims as a basis for Medicare dialysis treatments and separately billable drugs and biologicals. As we stated in the proposed rule, this final rule impact on providers uses updated OSCAR, cost report and claims data. </P>
                    <BILCOD>BILLING CODE 4120-01-P</BILCOD>
                    <GPH SPAN="3" DEEP="615">
                        <PRTPAGE P="66414"/>
                        <GID>ER15NO04.561</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="605">
                        <PRTPAGE P="66415"/>
                        <GID>ER15NO04.562</GID>
                    </GPH>
                    <BILCOD>BILLING CODE 4120-01-C</BILCOD>
                    <P>Table 49 shows the impact of MMA Section 623 on hospital based and independent facilities. We have included both composite rate payments as well as payments for separately billable drugs and biologicals because both are effected by section 623 of the MMA. The first column of Table 49 identifies the type of ESRD provider, the second column indicates the number of ESRD facilities for each type, and the third column indicates the number of dialysis treatments. </P>
                    <P>
                        The fourth column shows the effect of the changes in drug payments to ESRD 
                        <PRTPAGE P="66416"/>
                        providers. The overall effect of changes in drug payments is budget-neutral as required by MMA. The drug add-on adjustment is designed to result in the same aggregate amount of expenditures as would have been made without the statutory policy change. 
                    </P>
                    <P>Current payments for drugs represent 2005 Medicare reimbursement using 95 percent of AWP prices for the top ten drugs. Medicare spending for drugs other than EPO is estimated using 2004 AWP prices updated by a 3 percent inflation factor times actual drug utilization from 2003 claims. EPO is priced $10 per 1000 units (EPO units are estimated using payments because the units field on bills represents the number of EPO administrations rather than the number EPO units). Medicare spending under the MMA is 2003 average acquisition cost for the top ten drugs updated to 2005 figures (using the PPI for prescriptions drugs) times actual drug utilization from 2003 claims. These inflation factors were 4.81 percent and 3.72 percent for 2004 and 2005, respectively. </P>
                    <P>Payment for drugs under MMA also includes the 8.7 percent drug add-on to the composite rate. This amount is computed by multiplying the composite rate for each provider (with the 1.6 percent increase) times dialysis treatments from 2003 claims. Column 4 is computed by comparing spending under MMA provisions for drugs including the 8.7 percent drug add-on amount to spending under current payments for drugs. In order to make column 4 comparable with rest of Table 49, current composite rate payments to ESRD facilities were included in both current and MMA spending calculations. </P>
                    <P>Column 5 shows the effect of the 1.6 percent increase to the composite rate on total payments to ESRD providers. While all ESRD providers will get a 1.6 percent increase to their composite rate, this table shows the net effect of this increase on ESRD providers' total Medicare revenues (both drug and composite rate payments combined), and therefore does not show a 1.6 percent increase. </P>
                    <P>On average, ESRD providers receive an average of 39 percent of their total revenues from separately billable drugs and 61 percent of their total revenues from composite rate payment. Since the 1.6 percent increase is applied to the 61 percent portion of their total Medicare revenues, the 1.6 percent composite rate increase is also arithmetically equal to a 1.0 percent increase in ESRD providers' total Medicare revenues. Column 5 is computed by combining MMA payment for drugs (including the 8.7 percent drug add-on amount) with: (1) current composite rate times dialysis treatments from 2003 claims or (2) composite rate with 1.6 percent increase times dialysis treatments from 2003 claims. The difference between these two combinations is the net effect of the 1.6 percent increase on total payments to ESRD providers. In order to isolate the effect of the 1.6 percent increase, the computation in Column 5 assumes that drug payments to ESRD providers remain constant. </P>
                    <P>Column 6 shows the impact of the case-mix adjustments as described earlier in this preamble of this final rule. Because MMA requires this adjustment to be budget-neutral in the aggregate, there is no overall impact on ESRD providers as a whole. While the case-mix adjustment will have an impact within the various provider types, Column 6 shows that the effect between provider groupings is minimal. Column 6 is computed as the difference between payments to ESRD providers with the case-mix adjustments compared to payments to providers without the case-mix adjustments. As described earlier in this preamble, we developed a case-mix budget neutrality factor to meet the MMA requirement that payment be budget-neutral with respect to aggregate payments. Therefore, there is no change for ESRD providers in the aggregate. We note that when applying the case-mix adjustments, we did so at the facility level. </P>
                    <P>Column 7 shows the overall effect of all changes in drug and composite rate payments to ESRD providers. The overall effect of payments to ESRD facilities is measured as the difference between payment with and without application of MMA section 623 as described in this final rule and current payment. MMA payment is computed by multiplying the composite rate for each provider (with both 1.6 percent increase and the 8.7 percent add-on) times dialysis treatments from 2003 claims times the appropriate case-mix adjustment by provider. In addition, MMA payment includes payments for separately billable drugs under the revised pricing methodology as described in this preamble. Current payment is the current composite rate for each provider times dialysis treatments from 2003 claims plus current drug payments for separately billable drugs. </P>
                    <P>The overall impact to ESRD providers in aggregate is 1.0 percent. Among the three separately shown effects, the effect of changes in drug payments has the most variation among provider type and contributes most to the overall effect. Separately billable ESRD drugs are paid differently to hospital-based and independent ESRD providers. As discussed earlier in this preamble, we are using a single drug add-on to the composite rates for both hospital based and independent facilities. The 6.6 percent increase in payments to hospital-based providers is largely due to the single drug add-on to the composite rate. </P>
                    <HD SOURCE="HD3">8. Section 731—Coverage of Routine Costs for Category A Clinical Trials </HD>
                    <P>The coverage of routine costs associated with certain Category A clinical trials as discussed in MMA section 731(b) will have no significant impact on Medicare expenditures. </P>
                    <HD SOURCE="HD3">9. Section 629—Part B Deductible </HD>
                    <P>
                        As explained earlier in the preamble, section 629 of the MMA provides for annual updates to the Medicare Part B deductible. The MMA stipulates that the Medicare Part B deductible will be $110 for calendar year 2005, and, for subsequent years, the deductible will be the previous year's deductible increased by the annual percentage increase in the monthly actuarial rate under section 1839(a)(1) of the Act, ending with that subsequent year (rounded to the nearest dollar). We note that while this MMA provision results in a savings to the Medicare program, it also increases beneficiary costs by an equal amount and was implemented in a 
                        <E T="04">Federal Register</E>
                         notice published on September 9, 2004 (69 FR 54675). 
                    </P>
                    <GPOTABLE COLS="6" OPTS="L2" CDEF="s50,10C,10C,10C,10C,10C">
                        <TTITLE>TABLE 50: Estimated Medicare Savings for MMA Provision 629 </TTITLE>
                        <TDESC>[in millions] </TDESC>
                        <BOXHD>
                            <CHED H="1">MMA provision </CHED>
                            <CHED H="1">FY 2005 </CHED>
                            <CHED H="1">FY 2006 </CHED>
                            <CHED H="1">FY 2007 </CHED>
                            <CHED H="1">FY 2008 </CHED>
                            <CHED H="1">FY 2009 </CHED>
                        </BOXHD>
                        <ROW>
                            <ENT I="01">Sec. 629 </ENT>
                            <ENT>110 </ENT>
                            <ENT>290 </ENT>
                            <ENT>440 </ENT>
                            <ENT>590 </ENT>
                            <ENT>770 </ENT>
                        </ROW>
                    </GPOTABLE>
                    <PRTPAGE P="66417"/>
                    <HD SOURCE="HD3">10. Section 512—Hospice Consultation Service </HD>
                    <P>As explained in section III.K of this preamble, effective January 1, 2005, section 512 of the MMA provides for payment to be made to a hospice for specified services furnished by a physician who is either the medical director of, or an employee of, a hospice agency. We estimate that this MMA provision will increase Medicare expenditures by $10 million per year beginning in 2005. </P>
                    <HD SOURCE="HD3">11. Section 706 Coverage of Religious Nonmedical Health Care Institution (RNHCI) Services Furnished in the Home </HD>
                    <P>We anticipate that the time limited RNHCI home benefit will either meet or fall short of the annual $700,000 per calendar year statutory spending limit and therefore will not have a significant financial impact on the Medicare program. </P>
                    <HD SOURCE="HD2">E. Other Issues </HD>
                    <HD SOURCE="HD3">1. Outpatient Therapy Services Performed “Incident To” Physicians' Services </HD>
                    <P>As discussed in section IV.A, we are amending the regulations to include the statutory requirement that only individuals meeting the existing qualification and training standards for therapists (with the exception of licensure) consistent with § 484.4 qualify to provide therapy services incident to physicians' services. We believe that while this will have little impact on Medicare expenditures, it will assist in ensuring the quality of services provided to beneficiaries. </P>
                    <HD SOURCE="HD3">2. Supervision Requirements for Therapy Assistants in Private Practice </HD>
                    <P>As discussed earlier in section IV.A, we are revising the regulations at § 410.59 and § 410.60 to replace a requirement to provide personal supervision and instead require direct supervision of physical therapist assistants and occupational therapy assistants when therapy services are provided by physical therapists or occupational therapists in private practice. This policy change will provide beneficiaries access to medically necessary therapy services, under a physician-certified plan of care. We believe that this change could result in a 5 percent increase in therapy billing in therapy private practice settings with an estimated cost of $9 million for FY 2005. Projected costs for FY 2006 are $17 million while each subsequent year would only increase by $1 million each year, assuming the therapy caps are applied. </P>
                    <HD SOURCE="HD3">3. Low Osmolar Contrast Media </HD>
                    <P>As discussed earlier in the preamble, we are revising the regulations at § 414.38 to eliminate the restrictive criteria for the payment of LOCM. This regulation will make payment for LOCM consistent across Medicare payment systems. Shown in the following table are estimates of program costs due to the removal of the restrictive criteria for administering LOCM, assuming increased utilization and removal of the 8 percent reduction. Without current ASP data, we could not include the additional impact of the change in payment for LOCM to ASP plus 6 percent, effective April 1, 2005. Contrast-enhanced procedures that most commonly use LOCM, the typical ranges of LOCM amounts used by modality, and the cost ranges for LOCM in the marketplace were considered in valuing the additional program costs. </P>
                    <GPH SPAN="3" DEEP="67">
                        <GID>ER15NO04.563</GID>
                    </GPH>
                    <HD SOURCE="HD3">4. Payments for Physicians and Practitioners Managing Patients on Dialysis </HD>
                    <P>We believe that the proposals with respect to ESRD-related services furnished to patients in observation settings and payment for outpatient ESRD-related services for partial month scenarios discussed earlier in section xx provide clarification of current policy surrounding these issues. We do not believe these proposals will have a significant impact on Medicare expenditures. </P>
                    <HD SOURCE="HD3">5. Supervision of Clinical Psychological Testing </HD>
                    <P>We are changing the supervision requirements regarding who can supervise diagnostic psychological testing services. As previously discussed, having ancillary staff supervised by clinical psychologists will enable these practitioners with a higher level of expertise to oversee psychological testing and potentially relieve burdens on physicians and healthcare facilities. </P>
                    <P>Additionally, in rural areas, we anticipate that permitting psychologists to supervise diagnostic psychological testing services will reduce delays in testing, diagnosis, and treatment that could result from the unavailability of physicians to supervise the tests. We believe that this revision to the supervision requirements will have little impact on Medicare expenditures. </P>
                    <HD SOURCE="HD3">6. Care Plan Oversight </HD>
                    <P>As discussed earlier in the preamble, we are revising § 414.39 to clarify that NPPs can perform home health care plan oversight even though they cannot certify a patient for home health services and sign the plan of care. We do not expect that this change will have an impact on Medicare expenditures, since it is primarily a clarification in policy. </P>
                    <HD SOURCE="HD3">7. Assignment of Medicare Claims </HD>
                    <P>The changes with respect to assignment of Medicare claims are currently estimated to have no significant impact on Medicare expenditures. However, as stated earlier in this preamble at section IV.G, we believe the changes will reduce the paperwork burden on beneficiaries and suppliers. </P>
                    <HD SOURCE="HD2">F. Alternatives Considered </HD>
                    <P>This final rule contains a range of policies, including proposals related to specific MMA provisions. The preamble provides descriptions of the statutory provisions that are addressed, identifies those policies when discretion has been exercised and presents rationale for our decisions and, when possible, alternatives that were considered. </P>
                    <HD SOURCE="HD2">G. Impact on Beneficiaries </HD>
                    <P>
                        There are a number of changes made in this rule that would have an effect on 
                        <PRTPAGE P="66418"/>
                        beneficiaries. In general, we believe these changes will improve beneficiary access to services that are currently covered or will expand the Medicare benefit package to include new services. As explained in more detail below, the MMA or regulatory provisions may increase beneficiary liability in some cases. Any changes in aggregate beneficiary liability from a particular provision will be a function of the coinsurance (20 percent if applicable for the particular provision after the beneficiary has met the deductible) and the effect of the aggregate cost (savings) of the provision on the calculation of the Medicare Part B premium rate (generally 25 percent of the provision's cost or savings). 
                    </P>
                    <P>The MMA provisions that expand Medicare benefits include: Section 611, adding an initial preventive physical exam for newly eligible Medicare beneficiaries; section 612 providing coverage of cardiovascular screening blood tests; and section 613, providing coverage for diabetes screening tests for Medicare beneficiaries at risk for diabetes. While the initial preventive physical examination for newly eligible Medicare beneficiaries is subject to deductible and coinsurance, we believe Medicare beneficiaries will continue to benefit from expanded coverage for this service. We believe many beneficiaries have supplemental insurance coverage or Medicaid that pays the Medicare deductible on their behalf and there will be no immediate additional out-of-pocket cost. Further, even if a beneficiary pays nearly all of the costs of this new benefit, the preventive office visit will substitute for another service a beneficiary may need to meet the annual deductible and the beneficiary will receive more covered benefits at little additional cost. There are no out-of-pocket costs to the beneficiary for the cardiovascular screening blood tests and diabetes screening tests. </P>
                    <P>Other proposals in this rule related to the MMA will also impact beneficiary liability, with the most significant related to indexing of the part B deductible (section 629 of the MMA) and the drug administration payment changes (sections 303 and 305 of the MMA). MMA provisions that improve administration of the 10 percent HPSA bonus and provide an additional 5 percent bonus payment to physicians in Medicare scarcity areas will have no impact on beneficiary liability because the bonus payments are applied to the amount Medicare pays the physician net of beneficiary liability. These provisions will also improve access for Medicare beneficiaries by increasing payments to physicians in areas that traditionally have had a low ratio of physicians to population. </P>
                    <P>We are summarizing the impact of all of the changes we are adopting in this rule in table 52. We note that Medicare savings estimates are relative to projected expenditures that would occur if the provisions of the MMA and this final regulation were not implemented. Thus, the savings figures are reductions in beneficiary liability relative to the amounts they otherwise would have paid. The figures do not necessarily mean that we are estimating that beneficiaries will have lower out-of-pocket costs in 2005 than 2004. </P>
                    <GPH SPAN="3" DEEP="233">
                        <GID>ER15NO04.564</GID>
                    </GPH>
                    <P>
                        The implementation of MMA provisions related to drugs and drug administration will reduce Medicare beneficiary liability for Medicare covered services even after including the additional increases in payment for drug administration and establishing a supplying fee for immunosuppressive drugs, a furnishing fee for the clotting factor and a dispensing fee for immunosuppressive drugs. We do not believe that the drug and drug administration payment changes required by the MMA are intended to lessen beneficiary access to care. As indicated earlier, the changes we are making to Medicare payments for the administration of drugs are permanently increasing them by a weighted average of more than 117 percent between 2003 and 2005 and they are being increased by an additional 3 percent for 2005 only. While payments for drugs are being reduced between 2004 and 2005, the statute requires Medicare to pay for them at 6 percent more than their average sales price or the price they are purchased at in the market after taking into account rebates and discounts. Nevertheless, we acknowledge that there is a concern among physicians and others that the large changes in Medicare's payments may affect their ability or willingness to continue making drugs and related services available. CMS' Office of Research 
                        <PRTPAGE P="66419"/>
                        Demonstrations and Information is analyzing Medicare utilization for drugs and drug administration beginning in 2002 and plans to continue to analyze the data for shifts or changes in utilization patterns as the information becomes available to us. To date, we have no evidence that beneficiaries are having any problems with access to drugs. While we do not believe the payment changes for drugs and drug administration will result in access problems, we plan to continue studying this issue. We also note that the MMA requires the Medicare Payment Advisory Commission (MedPAC) to study related issues. Specifically, section 303(a)(5) of the MMA requires MedPAC to study items and services furnished by oncologists and drug administration services furnished by other specialists. 
                    </P>
                    <P>We are also undertaking several changes using our administrative authority that will affect Medicare beneficiaries. Our proposal to remove restrictions that limit Medicare payment for use of low osmolar contrast material to specific indications would update Medicare's payment policy to be consistent with the standard practice of medicine and will improve the quality of care for beneficiaries. </P>
                    <P>In accordance with the provisions of Executive Order 12866, this regulation was reviewed by the Office of Management and Budget. </P>
                    <LSTSUB>
                        <HD SOURCE="HED">List of Subjects </HD>
                        <CFR>42 CFR Part 403 </CFR>
                        <P>Grant programs-health, Health insurance, Hospitals, Intergovernmental relations, Medicare, Reporting and recordkeeping requirements. </P>
                        <CFR>42 CFR Part 405 </CFR>
                        <P>Administrative practice and procedure, Health facilities, Health professions, Kidney diseases, Medical devices, Medicare, Reporting and recordkeeping requirements, Rural areas, X-rays. </P>
                        <CFR>42 CFR Part 410 </CFR>
                        <P>Health facilities, Health professions, Kidney diseases, Laboratories, Medicare, Reporting and recordkeeping requirements, Rural areas, X-rays. </P>
                        <CFR>42 CFR Part 411 </CFR>
                        <P>Kidney diseases, Medicare, Reporting and recordkeeping requirements. </P>
                        <CFR>42 CFR Part 414 </CFR>
                        <P>Administrative practice and procedure, Health facilities, Health professions, Kidney diseases, Medicare, Reporting and recordkeeping requirements. </P>
                        <CFR>42 CFR Part 418 </CFR>
                        <P>Health facilities, Hospice care, Medicare, Reporting and recordkeeping requirements. </P>
                        <CFR>42 CFR Part 424 </CFR>
                        <P>Emergency medical services, Health facilities, Health professions, Medicare, Reporting and recordkeeping requirements. </P>
                        <CFR>42 CFR Part 484 </CFR>
                        <P>Health facilities, Health professions, Medicare, Reporting and recordkeeping requirements. </P>
                        <CFR>42 CFR Part 486 </CFR>
                        <P>Grant programs-health, Health facilities, Medicare, Reporting and recordkeeping requirements, X-rays.</P>
                    </LSTSUB>
                    <REGTEXT TITLE="42" PART="403">
                        <AMDPAR>For the reasons set forth in the preamble, the Centers for Medicare &amp; Medicaid Services amends 42 CFR chapter IV as follows: </AMDPAR>
                        <PART>
                            <HD SOURCE="HED">PART 403—SPECIAL PROGRAMS AND PROJECTS </HD>
                            <SUBPART>
                                <HD SOURCE="HED">Subpart G—Religious Nonmedical Health Care Institutions—Benefits, Conditions of Participation, and Payment </HD>
                            </SUBPART>
                        </PART>
                        <AMDPAR>1. The authority citation for part 403 continues to read as follows: </AMDPAR>
                        <AUTH>
                            <HD SOURCE="HED">Authority: </HD>
                            <P>42 U.S.C. 1359b-3 and secs 1102 and 1871 of the Social Security act (42 U.S.C. 1302 and 1395hh).</P>
                        </AUTH>
                    </REGTEXT>
                    <REGTEXT TITLE="42" PART="403">
                        <AMDPAR>2. Section 403.746 is amended by adding a new paragraph (c) to read as follows: </AMDPAR>
                        <SECTION>
                            <SECTNO>§ 403.746 </SECTNO>
                            <SUBJECT>Condition of participation: Utilization review. </SUBJECT>
                            <STARS/>
                            <P>
                                (c) 
                                <E T="03">Standard: Utilization review committee role in RNHCI home services.</E>
                                 In addition to the requirements in paragraphs (a) and (b) of this section, the utilization review committee is responsible for: 
                            </P>
                            <P>(1) The admission, and at least every 30 days, the continued care review of each patient in the RHNCI home services program. </P>
                            <P>(2) Oversight and monitoring of the home services program, including the purchase and utilization of designated durable medical equipment items for beneficiaries in the program.</P>
                        </SECTION>
                    </REGTEXT>
                    <REGTEXT TITLE="42" PART="403">
                        <AMDPAR>3. In subpart G, § 403.764 through § 403.770 are added to read as follows: </AMDPAR>
                        <SECTION>
                            <SECTNO>§ 403.764 </SECTNO>
                            <SUBJECT>Basis and purpose of religious nonmedical health care institutions providing home service. </SUBJECT>
                            <P>
                                (a)
                                <E T="03"> Basis.</E>
                                 This subpart implements sections 1821, 1861, 1861(e), 1861(m), 1861(y), 1861(ss) and 1861(aaa), 1869 and 1878 of the Act regarding Medicare payment for items and services provided in the home setting furnished to eligible beneficiaries by religious nonmedical health care institutions (RNHCIs). 
                            </P>
                            <P>
                                (b) 
                                <E T="03">Purpose.</E>
                                 The home benefit provides for limited durable medical equipment (DME) items and RNHCI services in the home setting that are fiscally limited to $700,000 per calendar year, with an expiration date of December 31, 2006, or the date on which the 2006 spending limit is reached. 
                            </P>
                        </SECTION>
                        <SECTION>
                            <SECTNO>§ 403.766 </SECTNO>
                            <SUBJECT>Requirements for coverage and payment of RNHCI home services. </SUBJECT>
                            <P>(a) Medicare Part B pays for RNHCI home services if the RNHCI provider does the following: </P>
                            <P>(1) Submit a notice of intent to CMS to exercise the option of providing home service. </P>
                            <P>(2) Provide RNHCI services to eligible beneficiaries, </P>
                            <P>(3) Arrange with suppliers to furnish appropriate DME items as required to meet documented eligible beneficiary needs. </P>
                            <P>(4) Arrange for RNHCI nurse home visits to eligible beneficiaries. </P>
                            <P>(5) Have a utilization committee that assumes the additional responsibility for the oversight and monitoring of the items and RNHCI nursing services provided under the home benefit. </P>
                            <P>(6) Meet all applicable requirements set forth in subpart G of this part. </P>
                            <P>(b) To be an eligible beneficiary to RNHCI home services the beneficiary must: </P>
                            <P>(1) Have an effective election in place. </P>
                            <P>(2) Be confined to the home, as specified in § 409.42(a) of this chapter. </P>
                            <P>(3) Have a condition that makes him or her eligible to receive services covered under Medicare home health. </P>
                            <P>(4) Receive home services and DME items from a RNHCI. </P>
                            <P>(5) Be responsible for deductible and coinsurance for DME, as specified in § 409.50 of this chapter. </P>
                        </SECTION>
                        <SECTION>
                            <SECTNO>§ 403.768 </SECTNO>
                            <SUBJECT>Excluded services. </SUBJECT>
                            <P>In addition to items and services excluded in § 409.49 of this chapter, items and services are also excluded if they are provided by: </P>
                            <P>(a) A HHA that is not a RNHCI. </P>
                            <P>(b) A supplier who is not providing RNHCI designated items under arrangement with a RNHCI. </P>
                            <P>(c) A nurse who is not providing RNHCI home nursing services under arrangement with a RNHCI. </P>
                        </SECTION>
                        <SECTION>
                            <SECTNO>§ 403.770 </SECTNO>
                            <SUBJECT>Payments for home services. </SUBJECT>
                            <P>
                                (a) The RNHCI nursing visits are paid at the modified low utilization payment 
                                <PRTPAGE P="66420"/>
                                adjusted (LUPA) rate used under the home health prospective payment system at § 484.230 of this chapter. 
                            </P>
                            <P>(b) Appropriate DME items are paid as priced by Medicare, minus the deductible and coinsurance liability of the beneficiary.</P>
                        </SECTION>
                    </REGTEXT>
                    <REGTEXT TITLE="42" PART="405">
                        <PART>
                            <HD SOURCE="HED">PART 405—FEDERAL HEALTH INSURANCE FOR THE AGED AND DISABLED </HD>
                        </PART>
                        <AMDPAR>4. The authority citation for part 405 continues to read as follows: </AMDPAR>
                        <AUTH>
                            <HD SOURCE="HED">Authority:</HD>
                            <P>Secs. 1102, 1861, 1862(a), 1871, 1874, 1881, and 1886(k) of the Social Security Act (42 U.S.C. 1302, 1395x, 1395y(a), 1395hh, 1395kk, 1395rr, and 1395ww(k)), and sec. 353 of the Public Health Service Act (42 U.S.C. 263a).   </P>
                        </AUTH>
                    </REGTEXT>
                    <REGTEXT TITLE="42" PART="405">
                        <AMDPAR>5. Section 405.207 is amended by revising paragraph (b) to read as follows: </AMDPAR>
                        <SECTION>
                            <SECTNO>§ 405.207 </SECTNO>
                            <SUBJECT>Services related to a noncovered device. </SUBJECT>
                            <STARS/>
                            <P>
                                (b) 
                                <E T="03">When payment is made.</E>
                                 Medicare payment may be made for— 
                            </P>
                            <P>(1) Covered services to treat a condition or complication that arises due to the use of a noncovered device or a noncovered device-related service; or </P>
                            <P>(2) Routine care services related to experimental/investigational (Category A) devices as defined in § 405.201(b); and furnished in conjunction with an FDA-approved clinical trial. The trial must meet criteria established through the national coverage determination process; and if the trial is initiated before January 1, 2010, the device must be determined as intended for use in the diagnosis, monitoring or treatment of an immediately life-threatening disease or condition. </P>
                            <P>(3) Routine care services related to a non-experimental/investigational (Category B) device defined in § 405.201(b) that is furnished in conjunction with an FDA-approved clinical trial. </P>
                        </SECTION>
                        <AMDPAR>6. Section 405.517 is amended by adding a new paragraph (a)(3) to read as follows: </AMDPAR>
                        <SECTION>
                            <SECTNO>§ 405.517 </SECTNO>
                            <SUBJECT>Payment for drugs and biologicals that are not paid on a cost or prospective payment basis. </SUBJECT>
                            <P>
                                (a) 
                                <E T="03">Applicability.</E>
                                 * * * 
                            </P>
                            <P>
                                (3) 
                                <E T="03">Payment for drugs and biologicals on or after January 1, 2005.</E>
                                 Effective January 1, 2005, payment for drugs and biologicals that are not paid on a cost or prospective payment basis are paid in accordance with part 414, subpart K of this chapter. 
                            </P>
                            <STARS/>
                              
                        </SECTION>
                    </REGTEXT>
                    <REGTEXT TITLE="42" PART="410">
                        <PART>
                            <HD SOURCE="HED">PART 410—SUPPLEMENTARY MEDICAL INSURANCE (SMI) BENEFITS </HD>
                        </PART>
                        <AMDPAR>7. The authority citation for part 410 continues to read as follows: </AMDPAR>
                        <AUTH>
                            <HD SOURCE="HED">Authority:</HD>
                            <P>Secs. 1102 and 1871 of the Social Security Act (42 U.S.C. 1302 and 1395hh).</P>
                        </AUTH>
                    </REGTEXT>
                    <REGTEXT TITLE="42" PART="410">
                        <AMDPAR>8. Section 410.1 is amended by adding a new paragraph (a)(6) to read as follows: </AMDPAR>
                        <SECTION>
                            <SECTNO>§ 410.1 </SECTNO>
                            <SUBJECT>Basis and scope. </SUBJECT>
                            <P>(a) * * * </P>
                            <P>(6) Section 1842(o)—Payment for drugs and biologicals not paid on a cost or prospective payment basis. </P>
                            <STARS/>
                              
                        </SECTION>
                    </REGTEXT>
                    <REGTEXT TITLE="42" PART="410">
                        <AMDPAR>9. Section 410.10 is amended by adding new paragraph (y) to read as follows: </AMDPAR>
                    </REGTEXT>
                    <REGTEXT TITLE="42" PART="410">
                        <SECTION>
                            <SECTNO>§ 410.10 </SECTNO>
                            <SUBJECT>Medical and other health services: Included services. </SUBJECT>
                            <STARS/>
                            <P>(y) Intravenous immune globulin administered in the home for the treatment of primary immune deficiency diseases. </P>
                        </SECTION>
                    </REGTEXT>
                    <REGTEXT TITLE="42" PART="410">
                        <AMDPAR>10. Section 410.16 is added to read as follows: </AMDPAR>
                        <SECTION>
                            <SECTNO>§ 410.16 </SECTNO>
                            <SUBJECT>Initial preventive physical examination: Conditions for and limitations on coverage. </SUBJECT>
                            <P>
                                (a) 
                                <E T="03">Definitions.</E>
                                 As used in this section, the following definitions apply: 
                            </P>
                            <P>
                                <E T="03">Eligible beneficiary</E>
                                 means an individual who receives his or her initial preventive physical examination within 6 months after the effective date of his or her first Medicare Part B coverage period, but only if that first Part B coverage period begins on or after January 1, 2005. 
                            </P>
                            <P>
                                <E T="03">Initial preventive physical examination</E>
                                 means all of the following services furnished to an eligible beneficiary by a physician or other qualified nonphysician practitioner with the goal of health promotion and disease detection: 
                            </P>
                            <P>(1) Review of the beneficiary's medical and social history with attention to modifiable risk factors for disease, as those terms are defined in this section. </P>
                            <P>(2) Review of the beneficiary's potential (risk factors) for depression, including current or past experiences with depression or other mood disorders, based on the use of an appropriate screening instrument for persons without a current diagnosis of depression, which the physician or other qualified nonphysician practitioner may select from various available standardized screening tests designed for this purpose and recognized by national professional medical organizations. </P>
                            <P>(3) Review of the beneficiary's functional ability, and level of safety as those terms are defined in this section, as described in paragraph (4) of this definition, based on the use of appropriate screening questions or a screening questionnaire, which the physician or other qualified nonphysician practitioner may select from various available screening questions or standardized questionnaires designed for this purpose and recognized by national professional medical organizations. </P>
                            <P>(4) An examination to include measurement of the beneficiary's height, weight, blood pressure, a visual acuity screen, and other factors as deemed appropriate, based on the beneficiary's medical and social history, and current clinical standards. </P>
                            <P>(5) Performance and interpretation of an electrocardiogram. </P>
                            <P>(6) Education, counseling, and referral, as deemed appropriate by the physician or qualified nonphysician practitioner, based on the results of the review and evaluation services described in this section. </P>
                            <P>(7) Education, counseling, and referral, including a brief written plan such as a checklist provided to the beneficiary for obtaining the appropriate screening and other preventive services that are covered as separate Medicare Part B benefits as described in section 1861(s)(10), section 1861(jj), section 1861(nn), section 1861(oo), section 1861(pp), section 1861(qq)(1), section 1861(rr), section 1861(uu), section 1861(vv), section 1861(xx)(1), and section 1861(yy) of the Act. </P>
                            <P>
                                <E T="03">Medical history</E>
                                 is defined to include, at a minimum, the following: 
                            </P>
                            <P>(1) Past medical and surgical history, including experiences with illnesses, hospital stays, operations, allergies, injuries, and treatments. </P>
                            <P>(2) Current medications and supplements, including calcium and vitamins. </P>
                            <P>(3) Family history, including a review of medical events in the beneficiary's family, including diseases that may be hereditary or place the individual at risk. </P>
                            <P>
                                A 
                                <E T="03">physician</E>
                                 for purposes of this section means a doctor of medicine or osteopathy (as defined in section 1861(r)(1) of the Act). 
                            </P>
                            <P>
                                <E T="03">A qualified nonphysician practitioner</E>
                                 for purposes of this section means a physician assistant, nurse practitioner, or clinical nurse specialist (as authorized under section 1861(s)(2)((K)(i) and section 
                                <PRTPAGE P="66421"/>
                                1861(s)(2)((K)(ii) of the Act and defined in section 1861(aa)(5) of the Act, or in § 410.74, § 410.75, and § 410.76). 
                            </P>
                            <P>
                                <E T="03">Review of the beneficiary's functional ability and level of safety</E>
                                 must include, at a minimum, a review of the following areas: 
                            </P>
                            <P>(1) Hearing impairment. </P>
                            <P>(2) Activities of daily living. </P>
                            <P>(3) Falls risk. </P>
                            <P>(4) Home safety</P>
                            <P>
                                <E T="03">Social history</E>
                                 is defined to include, at a minimum, the following:
                            </P>
                            <P>(1) History of alcohol, tobacco, and illicit drug use. </P>
                            <P>(2) Diet. </P>
                            <P>(3) Physical activities.</P>
                            <P>
                                (b) 
                                <E T="03">Condition for coverage of an initial preventive physical examination.</E>
                                 Medicare Part B pays for an initial preventive physical examination provided to an eligible beneficiary, as described in this section, if it is furnished by a physician or other qualified nonphysician practitioner, as defined in this section. 
                            </P>
                            <P>
                                (c) 
                                <E T="03">Limitations on coverage of initial preventive physical examinations.</E>
                                 Payment may not be made for an initial preventive physical preventive examination that is performed for an individual who is not an eligible beneficiary as described in this section. 
                            </P>
                        </SECTION>
                    </REGTEXT>
                    <REGTEXT TITLE="42" PART="410">
                        <AMDPAR>11. A new § 410.17 is added to read as follows: </AMDPAR>
                        <SECTION>
                            <SECTNO>§ 410.17 </SECTNO>
                            <SUBJECT>Cardiovascular disease screening tests. </SUBJECT>
                            <P>
                                (a) 
                                <E T="03">Definition.</E>
                                 For purposes of this subpart, the following definition apply: 
                            </P>
                            <P>
                                <E T="03">Cardiovascular screening blood test</E>
                                 means: 
                            </P>
                            <P>(1) A lipid panel consisting of a total cholesterol, HDL cholesterol, and triglyceride. The test is performed after a 12-hour fasting period. </P>
                            <P>(2) Other blood tests, previously recommended by the U.S. Preventive Services Task Force (USPSTF), as determined by the Secretary through a national coverage determination process. </P>
                            <P>(3) Other non-invasive tests, for indications that have a blood test recommended by the USPSTF, as determined by the Secretary through a national coverage determination process. </P>
                            <P>
                                (b) 
                                <E T="03">General conditions of coverage.</E>
                                 Medicare Part B covers cardiovascular disease screening tests when ordered by the physician who is treating the beneficiary (
                                <E T="03">see</E>
                                 § 410.32(a)) for the purpose of early detection of cardiovascular disease in individuals without apparent signs or symptoms of cardiovascular disease. 
                            </P>
                            <P>
                                (c) 
                                <E T="03">Limitation on coverage of cardiovascular screening tests.</E>
                                 Payment may be made for cardiovascular screening tests performed for an asymptomatic individual only if the individual has not had the screening tests paid for by Medicare during the preceding 59 months following the month in which the last cardiovascular screening tests were performed.
                            </P>
                        </SECTION>
                    </REGTEXT>
                    <REGTEXT TITLE="42" PART="410">
                        <AMDPAR>12. A new § 410.18 is added to read as follows: </AMDPAR>
                        <SECTION>
                            <SECTNO>§ 410.18 </SECTNO>
                            <SUBJECT>Diabetes screening tests. </SUBJECT>
                            <P>
                                (a) 
                                <E T="03">Definitions.</E>
                                 For purposes of this section, the following definitions apply: 
                            </P>
                            <P>
                                <E T="03">Diabetes</E>
                                 means diabetes mellitus, a condition of abnormal glucose metabolism diagnosed using the following criteria: a fasting blood sugar greater than or equal to 126 mg/dL on two different occasions; a 2-hour post-glucose challenge greater than or equal to 200 mg/dL on two different occasions; or a random glucose test over 200 mg/dL for a person with symptoms of uncontrolled diabetes. 
                            </P>
                            <P>
                                <E T="03">Pre-diabetes</E>
                                 means a condition of abnormal glucose metabolism diagnosed using the following criteria: a fasting glucose level of 100—125 mg/dL, or a 2-hour post-glucose challenge of 140—199 mg/dL. The term pre-diabetes includes the following conditions: 
                            </P>
                            <P>(1) Impaired fasting glucose. </P>
                            <P>(2) Impaired glucose tolerance.</P>
                            <P>
                                (b) 
                                <E T="03">General conditions of coverage.</E>
                                 Medicare Part B covers diabetes screening tests after a referral from a physician or qualified nonphysician practitioner to an individual at risk for diabetes for the purpose of early detection of diabetes. 
                            </P>
                            <P>
                                (c) 
                                <E T="03">Types of tests covered.</E>
                                 The following tests are covered if all other conditions of this subpart are met: 
                            </P>
                            <P>(1) Fasting blood glucose test. </P>
                            <P>(2) Post-glucose challenges including, but not limited to, an oral glucose tolerance test with a glucose challenge of 75 grams of glucose for non-pregnant adults, a 2-hour post glucose challenge test alone. </P>
                            <P>(3) Other tests as determined by the Secretary through a national coverage determination. </P>
                            <P>
                                (d) 
                                <E T="03">Amount of testing covered.</E>
                                 Medicare covers the following for individuals: 
                            </P>
                            <P>(1) Diagnosed with pre-diabetes, two screening tests per calendar year. </P>
                            <P>(2) Previously tested who were not diagnosed with pre-diabetes, or who were never tested before, one screening test per year. </P>
                            <P>
                                (e) 
                                <E T="03">Eligible risk factors.</E>
                                 Individuals with the following risk factors are eligible to receive the benefit: 
                            </P>
                            <P>(1) Hypertension. </P>
                            <P>(2) Dyslipidemia. </P>
                            <P>
                                (3) Obesity, defined as a body mass index greater than or equal to 30 kg/m
                                <SU>2</SU>
                                . 
                            </P>
                            <P>(4) Prior identification of impaired fasting glucose or glucose intolerance. </P>
                            <P>(5) Any two of the following characteristics: </P>
                            <P>
                                (i) Overweight, defined as body mass index greater than 25, but less than 30 kg/m
                                <SU>2</SU>
                                . 
                            </P>
                            <P>(ii) A family history of diabetes. </P>
                            <P>(iii) 65 years of age or older. </P>
                            <P>(iv) A history of gestational diabetes mellitus or delivery of a baby weighing more than 9 pounds. </P>
                        </SECTION>
                    </REGTEXT>
                    <REGTEXT TITLE="42" PART="410">
                        <AMDPAR>13. Section 410.26 is amended by revising paragraph (c) to read as follows: </AMDPAR>
                        <SECTION>
                            <SECTNO>§ 410.26 </SECTNO>
                            <SUBJECT>Services and supplies incident to a physician's professional services: Conditions. </SUBJECT>
                            <STARS/>
                            <P>
                                (c) 
                                <E T="03">Limitations.</E>
                                 (1) Drugs and biologicals are also subject to the limitations specified in § 410.29. 
                            </P>
                            <P>(2) Physical therapy, occupational therapy and speech-language pathology services provided incident to a physician's professional services are subject to the provisions established in § 410.59(a)(3)(iii), § 410.60(a)(3)(iii), and § 410.62(a)(3)(ii). </P>
                        </SECTION>
                    </REGTEXT>
                    <REGTEXT TITLE="42" PART="410">
                        <AMDPAR>14. Section 410.32 is amended by revising paragraph (b)(2)(iii) to read as follows: </AMDPAR>
                        <SECTION>
                            <SECTNO>§ 410.32 </SECTNO>
                            <SUBJECT>Diagnostic x-ray tests, diagnostic laboratory tests, and other diagnostic tests: Conditions. </SUBJECT>
                            <STARS/>
                            <P>(b) * * * </P>
                            <P>(2) * * * </P>
                            <P>(iii) Diagnostic psychological testing services when— </P>
                            <P>(A) Personally furnished by a clinical psychologist or an independently practicing psychologist as defined in program instructions; or </P>
                            <P>(B) Furnished under the general supervision of a physician or a clinical psychologist. </P>
                            <STARS/>
                              
                        </SECTION>
                    </REGTEXT>
                    <REGTEXT TITLE="42" PART="410">
                        <AMDPAR>15. Section 410.59 is amended by— </AMDPAR>
                        <AMDPAR>A. Revising paragraph (a) introductory text and paragraph (a)(3)(ii). </AMDPAR>
                        <AMDPAR>B. Adding new paragraph (a)(3)(iii). </AMDPAR>
                        <AMDPAR>C. Revising paragraph (b) heading. </AMDPAR>
                        <AMDPAR>C. Revising paragraph (c)(2). </AMDPAR>
                        <AMDPAR>D. Adding new paragraph (e)(1)(iii). </AMDPAR>
                        <P>The additions and revisions read as follows: </P>
                        <SECTION>
                            <SECTNO>§ 410.59 </SECTNO>
                            <SUBJECT>Outpatient occupational therapy services: Conditions. </SUBJECT>
                            <P>
                                (a) 
                                <E T="03">Basic rule.</E>
                                 Except as specified in paragraph (a)(3)(iii) of this section, Medicare Part B pays for outpatient occupational therapy services only if they are furnished by an individual meeting the qualifications in § 484.4 of 
                                <PRTPAGE P="66422"/>
                                this chapter for an occupational therapist or by an appropriately supervised occupational therapy assistant but only under the following conditions: 
                            </P>
                            <STARS/>
                            <P>(3) * * * </P>
                            <P>(ii) By, or under the direct supervision of, an occupational therapist in private practice as described in paragraph (c) of this section; or </P>
                            <P>(iii) By, or incident to the service of, a physician, physician assistant, clinical nurse specialist, or nurse practitioner when those professionals may perform occupational therapy services within the scope of State law. When an occupational therapy service is provided incident to the service of a physician, physician assistant, clinical nurse specialist, or nurse practitioner, by anyone other than a physician, physician assistant, clinical nurse specialist, or nurse practitioner, the service and the person who furnishes the service must meet the standards and conditions that apply to occupational therapy and occupational therapists, except that a license to practice occupational therapy in the State is not required. </P>
                            <P>
                                (b) 
                                <E T="03">Conditions for coverage of outpatient therapy services furnished to certain inpatients of a hospital or a CAH or SNF.</E>
                                 * * * 
                            </P>
                            <P>(c) * * * </P>
                            <P>
                                (2) 
                                <E T="03">Supervision of occupational therapy services.</E>
                                 Occupational therapy services are performed by, or under the direct supervision of, an occupational therapist in private practice. All services not performed personally by the therapist must be performed by employees of the practice, directly supervised by the therapist, and included in the fee for the therapist's services. 
                            </P>
                            <STARS/>
                            <P>(e) * * * </P>
                            <P>(1) * * * </P>
                            <P>(iii) The limitation is not applied for services furnished from December 8, 2003 through December 31, 2005. </P>
                            <STARS/>
                              
                        </SECTION>
                    </REGTEXT>
                    <REGTEXT TITLE="42" PART="410">
                        <AMDPAR>16. Section 410.60 is amended by— </AMDPAR>
                        <AMDPAR>A. Revising paragraph (a) introductory text. </AMDPAR>
                        <AMDPAR>B. Revising paragraph (a)(3)(ii). </AMDPAR>
                        <AMDPAR>C. Adding new paragraph (a)(3)(iii). </AMDPAR>
                        <AMDPAR>D. Revising paragraph (b) heading. </AMDPAR>
                        <AMDPAR>E. Revising paragraph (c)(2). </AMDPAR>
                        <AMDPAR>F. Adding new paragraph (e)(1)(iii). </AMDPAR>
                        <P>The additions and revisions read as follows: </P>
                        <SECTION>
                            <SECTNO>§ 410.60 </SECTNO>
                            <SUBJECT>Outpatient physical therapy services: Conditions. </SUBJECT>
                            <P>
                                (a) 
                                <E T="03">Basic rule.</E>
                                 Except as specified in paragraph (a)(3)(iii) of this section, Medicare Part B pays for outpatient physical therapy services only if they are furnished by an individual meeting the qualifications in § 484.4 of this chapter for a physical therapist or by an appropriately supervised physical therapist assistant but only under the following conditions: 
                            </P>
                            <STARS/>
                            <P>(3) * * * </P>
                            <P>(ii) By, or under the direct supervision of a physical therapist in private practice as described in paragraph (c) of this section; or </P>
                            <P>(iii) By, or incident to the service of, a physician, physician assistant, clinical nurse specialist, or nurse practitioner when those professionals may perform physical therapy services under State law. When a physical therapy service is provided incident to the service of a physician, physician's assistant, clinical nurse specialist, or nurse practitioner, by anyone other than a physician, physician assistant, clinical nurse specialist, or nurse practitioner, the service and the person who furnishes the service must meet the standards and conditions that apply to physical therapy and physical therapists, except that a license to practice physical therapy in the State is not required. </P>
                            <P>
                                (b) 
                                <E T="03">Condition for coverage of outpatient physical therapy services furnished to certain inpatients of a hospital or a CAH or SNF.</E>
                                 * * * 
                            </P>
                            <P>(c) * * * </P>
                            <P>
                                (2) 
                                <E T="03">Supervision of physical therapy services.</E>
                                 Physical therapy services are performed by, or under the direct supervision of, a physical therapist in private practice. All services not performed personally by the therapist must be performed by employees of the practice, directly supervised by the therapist, and included in the fee for the therapist's services. 
                            </P>
                            <STARS/>
                            <P>(e) * * *</P>
                            <P>(1) * * *</P>
                            <P>(iii) The limitation is not applied for services furnished from December 8, 2003 through December 31, 2005. </P>
                            <STARS/>
                        </SECTION>
                    </REGTEXT>
                    <REGTEXT TITLE="42" PART="410">
                        <AMDPAR>17. Section 410.62 is amended by—</AMDPAR>
                        <AMDPAR>A. Revising paragraph (a) introductory text and (a)(2)(i), (a)(2)(iii) and (a)(3). </AMDPAR>
                        <AMDPAR>B. Revising paragraphs (b) and (c). </AMDPAR>
                        <P>The revisions read as follows:</P>
                        <SECTION>
                            <SECTNO>§ 410.62 </SECTNO>
                            <SUBJECT>Outpatient speech-language pathology services: Conditions and exclusions. </SUBJECT>
                            <P>
                                (a) 
                                <E T="03">Basic rule.</E>
                                 Except as specified in paragraph (a)(3)(ii) of this section, Medicare Part B pays for outpatient speech-language pathology services only if they are furnished by an individual who meets the qualifications for a speech-language pathologist in § 484.4 of this chapter and only under the following conditions: 
                            </P>
                            <STARS/>
                            <P>(2) * * * </P>
                            <P>(i) Is established by a physician or, effective January 1, 1982, by either a physician or the speech-language pathologist who provides the services to the particular individual; </P>
                            <P>(ii) * * * </P>
                            <P>(iii) Meets the requirements of § 410.61. </P>
                            <P>(3) They are furnished— </P>
                            <P>(i) By a provider as defined in § 489.2 of this chapter, or by others under arrangements with, and under the supervision of, a provider; or </P>
                            <P>(ii) By, or incident to the service of, a physician, physician assistant, clinical nurse specialist, or nurse practitioner when those professionals may perform speech-language pathology services under State law. When a speech-language pathology service is provided incident to the services of a physician, physician assistant, clinical nurse specialist, or nurse practitioner, by anyone other than a physician, physician assistant, clinical nurse specialist, or nurse practitioner, the service and the person who furnishes the service must meet the standards and conditions that apply to speech-language pathology and speech-language pathologists, except that a license to practice speech-language pathology services in the State is not required. </P>
                            <P>
                                (b) 
                                <E T="03">Condition for coverage of outpatient speech-language pathology services to certain inpatients of a hospital, CAH, or SNF.</E>
                                 Medicare Part B pays for outpatient speech-language pathology services furnished to an inpatient of a hospital, CAH, or SNF who requires the services but has exhausted or is otherwise ineligible for benefit days under Medicare Part A. 
                            </P>
                            <P>(c) Excluded services. No service is included as an outpatient speech-language pathology service if it is not included as an inpatient hospital service if furnished to a hospital or CAH inpatient. </P>
                            <STARS/>
                        </SECTION>
                    </REGTEXT>
                    <REGTEXT TITLE="42" PART="410">
                        <AMDPAR>18. Section 410.63 is amended by— </AMDPAR>
                        <AMDPAR>A. Revising paragraph (b) heading. </AMDPAR>
                        <AMDPAR>B. Adding a new paragraph (c). </AMDPAR>
                        <P>The revision and addition reads as follows:</P>
                        <SECTION>
                            <SECTNO>§ 410.63 </SECTNO>
                            <SUBJECT>Hepatitis B vaccine and blood clotting factors: Conditions. </SUBJECT>
                            <STARS/>
                            <P>
                                (b) 
                                <E T="03">Blood clotting factors: Conditions.</E>
                                 * * * 
                                <PRTPAGE P="66423"/>
                            </P>
                            <P>
                                (c) 
                                <E T="03">Blood clotting factors: Furnishing Fee.</E>
                            </P>
                            <P>(1) Effective January 1, 2005, a furnishing fee of $0.14 per unit of clotting factor is paid to entities that furnish blood clotting factors unless the costs associated with furnishing the clotting factor are paid through another payment system, for example, hospitals that furnish clotting factor to patients during a Part A covered inpatient hospital stay. </P>
                            <P>(2) The furnishing fee for blood clotting factors furnished in 2006 or a subsequent year is be equal to the furnishing fee paid the previous year increased by the percentage increase in the consumer price index for medical care for the 12-month period ending with June of the previous year. </P>
                        </SECTION>
                    </REGTEXT>
                    <REGTEXT TITLE="42" PART="410">
                        <AMDPAR>19. Section 410.78 is amended by—</AMDPAR>
                        <AMDPAR>A. Revising paragraph (a)(4). </AMDPAR>
                        <AMDPAR>B. Revising paragraph (b) introductory text. </AMDPAR>
                        <P>The revisions read as follows:</P>
                        <SECTION>
                            <SECTNO>§ 410.78 </SECTNO>
                            <SUBJECT>Telehealth services. </SUBJECT>
                            <P>* * * </P>
                            <P>
                                (4) 
                                <E T="03">Originating site</E>
                                 means the location of an eligible Medicare beneficiary at the time the service being furnished via a telecommunications system occurs. For asynchronous store and forward telecommunications technologies, the only originating sites are Federal telemedicine demonstration programs conducted in Alaska or Hawaii. 
                            </P>
                            <P>
                                (b) 
                                <E T="03">General rule.</E>
                                 Medicare Part B pays for office and other outpatient visits, professional consultation, psychiatric diagnostic interview examination, individual psychotherapy, pharmacologic management and end stage renal disease related services included in the monthly capitation payment (except for one visit per month to examine the access site) furnished by an interactive telecommunications system if the following conditions are met: 
                            </P>
                            <STARS/>
                        </SECTION>
                    </REGTEXT>
                    <REGTEXT TITLE="42" PART="410">
                        <AMDPAR>20. Section 410.160 is amended by revising paragraph (f) to read as follows: </AMDPAR>
                        <SECTION>
                            <SECTNO>§ 410.160 </SECTNO>
                            <SUBJECT>Part B annual deductible. </SUBJECT>
                            <STARS/>
                            <P>
                                (f) 
                                <E T="03">Amount of the Part B annual deductible.</E>
                                 (1) Beginning with expenses for services furnished during calendar year 2006, and for all succeeding years, the annual deductible is the previous year's deductible plus the annual percentage increase in the monthly actuarial rate for Medicare enrollees age 65 and over, rounded to the nearest dollar. 
                            </P>
                            <P>(2) For 2005, the deductible is $110. </P>
                            <P>(3) From 1991 through 2004, the deductible was $100. </P>
                            <P>(4) From 1982 through 1990, the deductible was $75. </P>
                            <P>(5) From 1973 through 1981, the deductible was $60. </P>
                            <P>(6) From 1966 through 1972, the deductible was $50. </P>
                            <STARS/>
                        </SECTION>
                    </REGTEXT>
                    <REGTEXT TITLE="42" PART="411">
                        <PART>
                            <HD SOURCE="HED">PART 411—EXCLUSIONS FROM MEDICARE AND LIMITATIONS ON MEDICARE PAYMENT </HD>
                        </PART>
                        <AMDPAR>21. The authority citation for part 411 continues to read as follows: </AMDPAR>
                        <AUTH>
                            <HD SOURCE="HED">Authority:</HD>
                            <P>Secs. 1102 and 1871 of the Social Security Act (42 U.S.C. 1302 and 1395hh). </P>
                        </AUTH>
                    </REGTEXT>
                    <REGTEXT TITLE="42" PART="411">
                        <AMDPAR>22. Section 411.15 is amended by— </AMDPAR>
                        <AMDPAR>A. Revising paragraph (a)(1). </AMDPAR>
                        <AMDPAR>B. Adding paragraph (k)(11). </AMDPAR>
                        <P>The revision and addition read as follows:</P>
                        <SECTION>
                            <SECTNO>§ 411.15 </SECTNO>
                            <SUBJECT>Particular services excluded from coverage. </SUBJECT>
                            <STARS/>
                            <P>(a) * * * </P>
                            <P>(1) Examinations performed for a purpose other than treatment or diagnosis of a specific illness, symptoms, complaint, or injury, except for screening mammography, colorectal cancer screening tests, screening pelvic exams, prostate cancer screening tests, glaucoma screening exams, or initial preventive physical examinations that meet the criteria specified in paragraphs (k)(6) through (k)(11) of this section. </P>
                            <STARS/>
                            <P>(k) * * * </P>
                            <P>(11) In the case of initial preventive physical examinations, with the goal of health promotion and disease prevention, subject to the conditions and limitations specified in § 410.16 of this chapter. </P>
                            <STARS/>
                        </SECTION>
                    </REGTEXT>
                    <REGTEXT TITLE="42" PART="411">
                        <AMDPAR>23. Section 411.404 is amended by revising paragraph (b) to read as follows: </AMDPAR>
                        <SECTION>
                            <SECTNO>§ 411.404 </SECTNO>
                            <SUBJECT>Criteria for determining that a beneficiary knew that services were excluded from coverage as custodial care or as not reasonable and necessary. </SUBJECT>
                            <STARS/>
                            <P>
                                (b) 
                                <E T="03">Written notice.</E>
                                 (1) Written notice is given to the beneficiary, or to someone acting on his or her behalf, that the services were not covered because they did not meet Medicare coverage guidelines. 
                            </P>
                            <P>(2) A notice concerning similar or reasonably comparable services furnished on a previous occasion also meets this criterion. </P>
                            <P>(3) After a beneficiary is notified that there is no Medicare payment for a service that is not covered by Medicare, he or she is presumed to know that there is no Medicare payment for any form of subsequent treatment for the non-covered condition. </P>
                            <STARS/>
                        </SECTION>
                    </REGTEXT>
                    <REGTEXT TITLE="42" PART="414">
                        <PART>
                            <HD SOURCE="HED">PART 414—PAYMENT FOR PART B MEDICAL AND OTHER HEALTH SERVICES. </HD>
                        </PART>
                        <AMDPAR>24. The authority citation for part 414 continues to read as follows: </AMDPAR>
                        <AUTH>
                            <HD SOURCE="HED">Authority:</HD>
                            <P>Secs. 1102, 1871, and 1881(b)(1) of the Social Security Act (42 U.S.C. 1302, 1395hh, and 1395rr(b)(1)). </P>
                        </AUTH>
                    </REGTEXT>
                    <REGTEXT TITLE="42" PART="414">
                        <SECTION>
                            <SECTNO>§ 414.38 </SECTNO>
                            <SUBJECT>[Removed] </SUBJECT>
                        </SECTION>
                        <AMDPAR>25. Section 414.38 is removed. </AMDPAR>
                        <AMDPAR>26. Section 414.39 is amended by— </AMDPAR>
                        <AMDPAR>A. Revising paragraph (a). </AMDPAR>
                        <AMDPAR>B. Adding paragraph (c). </AMDPAR>
                        <P>The revision and addition read as follows:</P>
                        <SECTION>
                            <SECTNO>§ 414.39 </SECTNO>
                            <SUBJECT>Special rules for payment of care plan oversight. </SUBJECT>
                            <P>
                                (a) 
                                <E T="03">General.</E>
                                 Except as specified in paragraphs (b) and (c) of this section, payment for care plan oversight is included in the payment for visits and other services under the physician fee schedule. For purposes of this section a nonphysician practitioner (NPP) is a nurse practitioner, clinical nurse specialist or physician assistant. 
                            </P>
                            <STARS/>
                            <P>
                                (c) 
                                <E T="03">Special rules for payment of care plan oversight provided by nonphysician practitioners for beneficiaries who receive HHA services covered by Medicare.</E>
                            </P>
                            <P>(1) An NPP can furnish physician care plan oversight (but may not certify a patient as needing home health services) if the physician who signs the plan of care provides regular ongoing care under the same plan of care as does the NPP billing for care plan oversight and either: </P>
                            <P>(i) The physician and NPP are part of the same group practice; or </P>
                            <P>(ii) If the NPP is a nurse practitioner or clinical nurse specialist, the physician signing the plan of care also has a collaborative agreement with the NPP; or </P>
                            <P>(iii) If the NPP is a physician assistant, the physician signing the plan of care is also the physician who provides general supervision of physician assistant services for the practice. </P>
                            <P>(2) Payment may be made for care plan oversight services furnished by an NPP when: </P>
                            <P>(i) The NPP providing the care plan oversight has seen and examined the patient; </P>
                            <P>
                                (ii) The NPP providing care plan oversight is not functioning as a 
                                <PRTPAGE P="66424"/>
                                consultant whose participation is limited to a single medical condition rather than multi-disciplinary coordination of care; and 
                            </P>
                            <P>(iii) The NPP providing care plan oversight integrates his or her care with that of the physician who signed the plan of care. </P>
                        </SECTION>
                    </REGTEXT>
                    <REGTEXT TITLE="42" PART="414">
                        <AMDPAR>27. Section 414.65 is amended by revising paragraph (a)(1) to read as follows: </AMDPAR>
                        <SECTION>
                            <SECTNO>§ 414.65 </SECTNO>
                            <SUBJECT>Payment for telehealth services. </SUBJECT>
                            <P>(a) * * * </P>
                            <P>(1) The Medicare payment amount for office or other outpatient visits, consultation, individual psychotherapy, psychiatric diagnostic interview examination, pharmacologic management and end stage renal disease related services included in the monthly capitation payment (except for one visit per month to examine the access site) furnished via an interactive telecommunications system is equal to the current fee schedule amount applicable for the service of the physician or practitioner. </P>
                            <STARS/>
                        </SECTION>
                    </REGTEXT>
                    <REGTEXT TITLE="42" PART="414">
                        <AMDPAR>28. Section 414.66 is added to subpart B to read as follows: </AMDPAR>
                        <SECTION>
                            <SECTNO>§ 414.66 </SECTNO>
                            <SUBJECT>Incentive payments for physician scarcity areas. </SUBJECT>
                            <P>
                                (a) 
                                <E T="03">Definition.</E>
                                 As used in this section, the following definitions apply. 
                            </P>
                            <P>
                                <E T="03">Physician scarcity area</E>
                                 is defined as an area with a shortage of primary care physicians or specialty physicians to the Medicare population in that area. 
                            </P>
                            <P>
                                <E T="03">Primary care physician</E>
                                 is defined as a general practitioner, family practice practitioner, general internist, obstetrician or gynecologist. 
                            </P>
                            <P>(b) Physicians' services furnished to a beneficiary in a Physician Scarcity Area (PSA) for primary or specialist care are eligible for a 5 percent incentive payment. </P>
                            <P>(c) Primary care physicians furnishing services in primary care PSAs are entitled to an additional 5 percent incentive payment above the amount paid under the physician fee schedule for their professional services furnished on or after January 1, 2005 and before January 1, 2008. </P>
                            <P>(d) Physicians, as defined in section 1861(r)(1) of the Act, furnishing services in specialist care PSAs are entitled to an additional 5 percent payment above the amount paid under the physician fee schedule for their professional services furnished on or after January 1, 2005 and before January 1, 2008. </P>
                        </SECTION>
                        <AMDPAR>29. Section 414.67 is added to subpart B to read as follows: </AMDPAR>
                        <SECTION>
                            <SECTNO>§ 414.67 </SECTNO>
                            <SUBJECT>Incentive payments for Health Professional Shortage Areas. </SUBJECT>
                            <P>(a) Physicians' services furnished to a beneficiary in a geographic-based Health Professional Shortage Area (HPSA) are eligible for a 10 percent incentive payment above the amount paid for their professional services under the physician fee schedule. </P>
                            <P>(b) Physicians furnishing services in a geographic-based primary medical care HPSA are entitled to a 10 percent incentive payment above the amount paid for their professional services under the physician fee schedule. </P>
                            <P>(c) Psychiatrists furnishing services in a mental health HPSA are entitled to a 10 percent incentive payment above the amount paid for their professional services under the physician fee schedule. (The only physicians eligible to receive the 10 percent incentive payment in mental health HPSAs that do not overlap with primary care HPSAs are psychiatrists.) </P>
                        </SECTION>
                    </REGTEXT>
                    <REGTEXT TITLE="42" PART="414">
                        <AMDPAR>30. Part 414 is amended by adding a new subpart K to read as follows: </AMDPAR>
                        <SUBPART>
                            <HD SOURCE="HED">Subpart K—Payment for Drugs and Biologicals in 2005 </HD>
                        </SUBPART>
                        <CONTENTS>
                            <SECHD>Sec. </SECHD>
                            <SECTNO>414.900 </SECTNO>
                            <SUBJECT>Basis. </SUBJECT>
                            <SECTNO>414.902 </SECTNO>
                            <SUBJECT>Definitions. </SUBJECT>
                            <SECTNO>414.904 </SECTNO>
                            <SUBJECT>Basis of payment. </SUBJECT>
                        </CONTENTS>
                        <SUBPART>
                            <HD SOURCE="HED">Subpart K—Payment for Drugs and Biologicals in 2005 </HD>
                            <SECTION>
                                <SECTNO>§ 414.900 </SECTNO>
                                <SUBJECT>Basis. </SUBJECT>
                                <P>(a) This subpart implements section 1842(o) of the Act by specifying the methodology for determining the payment allowance limit for drugs and biologicals covered under Medicare Part B that are not paid on a cost or prospective payment system basis. </P>
                                <P>(b) Examples of drugs that are subject to the requirements specified in this subpart are: </P>
                                <P>(1) Drugs furnished incident to a physician's service; durable medical equipment (DME) drugs. </P>
                                <P>(2) Separately billable drugs at independent dialysis facilities not under the ESRD composite rate. </P>
                                <P>(3) Statutorily covered drugs, for example—</P>
                                <P>(i) Influenza. </P>
                                <P>(ii) Pneumococcal and hepatitis vaccines. </P>
                                <P>(iii) Antigens. </P>
                                <P>(iv) Hemophilia blood clotting factor. </P>
                                <P>(v) Immunosuppressive drugs. </P>
                                <P>(vi) Certain oral anti-cancer drugs. </P>
                            </SECTION>
                            <SECTION>
                                <SECTNO>§ 414.902 </SECTNO>
                                <SUBJECT>Definitions. </SUBJECT>
                                <P>As used in this subpart, unless the context indicates otherwise— </P>
                                <P>
                                    <E T="03">Drug</E>
                                     means both drugs and biologicals. 
                                </P>
                                <P>
                                    <E T="03">Manufacturer's average sales price</E>
                                     means the price calculated and reported by a manufacturer under part 414, subpart J of this chapter. 
                                </P>
                                <P>
                                    <E T="03">Multiple source drug</E>
                                     means a drug described by section 1847A(c)(6)(C) of the Act. 
                                </P>
                                <P>
                                    <E T="03">Single source drug</E>
                                     means a drug described by section 1847A(c)(6)(D) of the Act. 
                                </P>
                                <P>
                                    <E T="03">Unit</E>
                                     is defined as in part 414, subpart J of this chapter. 
                                </P>
                                <P>
                                    <E T="03">Wholesale acquisition cost (WAC)</E>
                                     means the price described by section 1847A(c)(6)(B) of the Act. 
                                </P>
                            </SECTION>
                            <SECTION>
                                <SECTNO>§ 414.904 </SECTNO>
                                <SUBJECT>Basis of payment. </SUBJECT>
                                <P>
                                    (a) 
                                    <E T="03">Method of payment.</E>
                                     Payment for a drug for calendar year 2005 is based on the lesser of— 
                                </P>
                                <P>(1) The actual charge on the claim for program benefits; or </P>
                                <P>(2) 106 percent of the average sales price, subject to the applicable limitations specified in paragraph (d) of this section or subject to the exceptions described in paragraph (e) of this section. </P>
                                <P>
                                    (b) 
                                    <E T="03">Multiple source drugs.</E>
                                     (1) 
                                    <E T="03">Average sales prices.</E>
                                     The average sales price for all drug products included within the same multiple source drug billing and payment code is the volume-weighted average of the manufacturers' average sales prices for those drug products. 
                                </P>
                                <P>
                                    (2) 
                                    <E T="03">Calculation of the average sales price.</E>
                                     The average sales price is determined by— 
                                </P>
                                <P>(i) Computing the sum of the products (for each National Drug Code assigned to the drug products) of the manufacturer's average sales price and the total number of units sold; and </P>
                                <P>(ii) Dividing that sum by the sum of the total number of units sold for all NDCs assigned to the drug products. </P>
                                <P>
                                    (c) 
                                    <E T="03">Single source drugs.</E>
                                     (1) 
                                    <E T="03">Average sales price.</E>
                                     The average sales price is the volume-weighted average of the manufacturers' average sales prices for all National Drug Codes assigned to the drug or biological product. 
                                </P>
                                <P>
                                    (2) 
                                    <E T="03">Calculation of the average sales price.</E>
                                     The average sales price is determined by computing— 
                                </P>
                                <P>(i) The sum of the products (for each National Drug Code assigned to the drug product) of the manufacturer's average sales price and the total number of units sold; and </P>
                                <P>(ii) Dividing that sum by the sum of the total number of units sold for all NDCs assigned to the drug product. </P>
                                <P>
                                    (d) 
                                    <E T="03">Limitations on the average sales price.</E>
                                     (1) 
                                    <E T="03">Wholesale acquisition cost for a single source drug.</E>
                                     The payment limit for a single source drug product is the lesser of 106 percent of the average sales price for the product or 106 percent of 
                                    <PRTPAGE P="66425"/>
                                    the wholesale acquisition cost for the product. 
                                </P>
                                <P>
                                    (2) 
                                    <E T="03">Payment limit for a drug furnished to an end-stage renal disease patient.</E>
                                     (i) Effective for drugs and biologicals furnished in 2005, the payment for such drugs and biologicals, including erythropoietin, furnished to an end-stage renal disease patient that is separately billed by an end-stage renal disease facility and not paid on a cost basis is acquisition cost as determined by the Inspector General report as required by section 623(c) of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 inflated by the percentage increase in the Producer Price Index. 
                                </P>
                                <P>(ii) Except as provided in paragraph (a) of this section, the payment for drugs and biologicals, furnished to an end-stage renal disease patient that is separately billed by an end-stage renal disease facility, is based on 106 percent of the average sales price. </P>
                                <P>
                                    (3) 
                                    <E T="03">Widely available market price and average manufacturer price.</E>
                                     If the Inspector General finds that the average sales price exceeds the widely available market price or the average manufacturer price by 5 percent or more in calendar year 2005, the payment limit in the quarter following the transmittal of this information to the Secretary is the lesser of the widely available market price or 103 percent of the average manufacturer price. 
                                </P>
                                <P>
                                    (e) 
                                    <E T="03">Exceptions to the average sales price.</E>
                                     (1) 
                                    <E T="03">Vaccines.</E>
                                     The payment limits for hepatitis B vaccine furnished to individuals at high or intermediate risk of contracting hepatitis B (as determined by the Secretary), pneumococcal vaccine, and influenza vaccine and are calculated using 95 percent of the average wholesale price. 
                                </P>
                                <P>
                                    (2) 
                                    <E T="03">Infusion drugs furnished through a covered item of durable medical equipment.</E>
                                     The payment limit for an infusion drug furnished through a covered item of durable medical equipment is calculated using 95 percent of the average wholesale price in effect on October 1, 2003 and is not updated in 2005. 
                                </P>
                                <P>
                                    (3) 
                                    <E T="03">Blood and blood products.</E>
                                     In the case of blood and blood products (other than blood clotting factors), the payment limits are determined in the same manner as the payment limits were determined on October 1, 2003. 
                                </P>
                                <P>
                                    (4) 
                                    <E T="03">Payment limit in a case where the average sales price during the first quarter of sales is unavailable.</E>
                                     In the case of a drug during an initial period (not to exceed a full calendar quarter) in which data on the prices for sales of the drug are not sufficiently available from the manufacturer to compute an average sales price for the drug, the payment limit is based on the wholesale acquisition cost or the applicable Medicare Part B drug payment methodology in effect on November 1, 2003. 
                                </P>
                                <P>(f) Except as otherwise specified (see paragraph (e)(2) of this section) for infusion drugs, the payment limits are updated quarterly. </P>
                                <P>(g) The payment limit is computed without regard to any special packaging, labeling, or identifiers on the dosage form or product or package. </P>
                                <P>(h) The payment amount is subject to applicable deductible and coinsurance. </P>
                            </SECTION>
                        </SUBPART>
                    </REGTEXT>
                    <REGTEXT TITLE="42" PART="414">
                        <AMDPAR>31. Part 414 is amended by adding a new subpart L to read as follows: </AMDPAR>
                        <SUBPART>
                            <HD SOURCE="HED">Subpart L—Supplying and Dispensing Fees </HD>
                        </SUBPART>
                        <CONTENTS>
                            <SECHD>Sec. </SECHD>
                            <SECTNO>414.1000</SECTNO>
                            <SUBJECT>Purpose.</SUBJECT>
                            <SECTNO>414.1001</SECTNO>
                            <SUBJECT>Basis of Payment.</SUBJECT>
                        </CONTENTS>
                        <SECTION>
                            <SECTNO>§ 414.1000 </SECTNO>
                            <SUBJECT>Purpose. </SUBJECT>
                            <P>This subpart implements section 1842(o)(2) and section 1842(o)(6) of the Act, as added by section 303(e)(2) of the MMA, by specifying a supplying fee for drugs and biologicals covered under Part B of Title XVIII of the Act that are described in sections 1861(s)(2)(J), 1861(s)(2)(Q), and 1861(s)(2)(T) of the Act. </P>
                        </SECTION>
                        <SECTION>
                            <SECTNO>§ 414.1001 </SECTNO>
                            <SUBJECT>Basis of payment. </SUBJECT>
                            <P>(a) A supplying fee of $24 shall be paid to a pharmacy for each supplied prescription of drugs and biologicals described in sections 1861(s)(2)(J), 1861(s)(2)(Q), and 1861(s)(2)(T) of the Act. </P>
                            <P>(b) A supplying fee of $50 is paid to a pharmacy for the initial supplied prescription of drugs and biologicals described in sections 1861(s)(2)(J) of the Act provided to a patient during the first month following a transplant. </P>
                            <P>(c) During 2005, a dispensing fee of $57 is paid to a supplier for each dispensed 30-day supply of inhalation drugs furnished through durable medical equipment covered under section 1861(n) of the Act, regardless of the number of partial shipments of that 30-day supply. </P>
                            <P>(d) During 2005, a dispensing fee of $80 is paid to a supplier for each dispensed 90-day supply of inhalation drugs furnished through durable medical equipment covered under section 1861(n) of the Act, regardless of the number of partial shipments of that 90-day supply. </P>
                        </SECTION>
                    </REGTEXT>
                    <REGTEXT TITLE="42" PART="418">
                        <PART>
                            <HD SOURCE="HED">PART 418—HOSPICE CARE </HD>
                        </PART>
                        <AMDPAR>32. The authority citation for part 418 continues to read as follows: </AMDPAR>
                        <AUTH>
                            <HD SOURCE="HED">Authority:</HD>
                            <P>Secs. 1102 and 1871 of the Social Security Act (42 U.S.C. 1302 and 1395hh).   </P>
                        </AUTH>
                    </REGTEXT>
                    <REGTEXT TITLE="42" PART="418">
                        <AMDPAR>33. Section 418.205 is added to subpart F to read as follows: </AMDPAR>
                        <SECTION>
                            <SECTNO>§ 418.205 </SECTNO>
                            <SUBJECT>Special requirements for hospice pre-election evaluation and counseling services. </SUBJECT>
                            <P>
                                (a) 
                                <E T="03">Definition.</E>
                                 As used in this section the following definition applies. 
                            </P>
                            <P>
                                <E T="03">Terminal illness</E>
                                 has the same meaning as defined in § 418.3. 
                            </P>
                            <P>
                                (b) 
                                <E T="03">General.</E>
                                 Effective January 1, 2005, payment for hospice pre-election evaluation and counseling services as specified in §418.304(d) may be made to a hospice on behalf of a Medicare beneficiary if the requirements of this section are met. 
                            </P>
                            <P>
                                (1) 
                                <E T="03">The beneficiary.</E>
                                 The beneficiary: 
                            </P>
                            <P>(i) Has been diagnosed as having a terminal illness as defined in § 418.3. </P>
                            <P>(ii) Has not made a hospice election. </P>
                            <P>(iii) Has not previously received hospice pre-election evaluation and consultation services specified under this section. </P>
                            <P>
                                (2) 
                                <E T="03">Services provided.</E>
                                 The hospice pre-election services include an evaluation of an individual's need for pain and symptom management and counseling regarding hospice and other care options. In addition, the services may include advising the individual regarding advanced care planning. 
                            </P>
                            <P>
                                (3) 
                                <E T="03">Provision of pre-election hospice services.</E>
                            </P>
                            <P>(i) The services must be furnished by a physician. </P>
                            <P>(ii) The physician furnishing these services must be an employee or medical director of the hospice billing for this service. </P>
                            <P>(iii) The services cannot be furnished by hospice personnel other than employed physicians, such as but not limited to nurse practitioners, nurses, or social workers, physicians under contractual arrangements with the hospice or by the beneficiary's physician, if that physician is not an employee of the hospice. </P>
                            <P>(iv) If the beneficiary's attending physician is also the medical director or a physician employee of the hospice, the attending physician may not provide nor may the hospice bill for this service because that physician already possesses the expertise necessary to furnish end-of-life evaluation and management, and counseling services. </P>
                            <P>
                                (4) 
                                <E T="03">Documentation.</E>
                                 (i) If the individual's physician initiates the request for services of the hospice medical director or physician, appropriate documentation is required. 
                            </P>
                            <P>
                                (ii) The request or referral must be in writing, and the hospice medical 
                                <PRTPAGE P="66426"/>
                                director or physician employee is expected to provide a written note on the patient's medical record. 
                            </P>
                            <P>(iii) The hospice agency employing the physician providing these services is required to maintain a written record of the services furnished. </P>
                            <P>(iv) If the services are initiated by the beneficiary, the hospice agency is required to maintain a record of the services and documentation that communication between the hospice medical director or physician and the beneficiary's physician occurs, with the beneficiary's permission, to the extent necessary to ensure continuity of care. </P>
                        </SECTION>
                    </REGTEXT>
                    <REGTEXT TITLE="42" PART="418">
                        <AMDPAR>34. Section 418.304 is amended by adding paragraph (d) to read as follows. </AMDPAR>
                        <SECTION>
                            <SECTNO>§ 418.304 </SECTNO>
                            <SUBJECT>Payment for physician services. </SUBJECT>
                            <STARS/>
                            <P>
                                (d) 
                                <E T="03">Payment for hospice pre-election evaluation and counseling services.</E>
                                 The intermediary makes payment to the hospice for the services established in § 418.205. Payment for this service is set at an amount established under the physician fee schedule, for an office or other outpatient visit for evaluation and management associated with presenting problems of moderate severity and requiring medical decision-making of low complexity other than the portion of the amount attributable to the practice expense component. Payment for this pre-election service does not count towards the hospice cap amount.
                            </P>
                        </SECTION>
                    </REGTEXT>
                    <REGTEXT TITLE="42" PART="424">
                        <PART>
                            <HD SOURCE="HED">PART 424—CONDITIONS FOR MEDICARE PAYMENT </HD>
                        </PART>
                        <AMDPAR>35. The authority citation for part 424 continues to read as follows: </AMDPAR>
                        <AUTH>
                            <HD SOURCE="HED">Authority:</HD>
                            <P>Secs. 1102 and 1871 of the Social Security Act (42 U.S.C. 1302 and 1395hh).   </P>
                        </AUTH>
                    </REGTEXT>
                    <REGTEXT TITLE="42" PART="424">
                        <AMDPAR>36. Section 424.55 is amended by adding new paragraph (c) to read as follows: </AMDPAR>
                        <SECTION>
                            <SECTNO>§ 424.55 </SECTNO>
                            <SUBJECT>Payment to the supplier. </SUBJECT>
                            <STARS/>
                            <P>
                                (c) 
                                <E T="03">Exception.</E>
                                 In situations when payment under the Act can only be made on an assignment-related basis or when payment is for services furnished by a participating physician or supplier, the beneficiary (or the person authorized to request payment on the beneficiary's behalf) is not required to assign the claim to the supplier in order for an assignment to be effective. 
                            </P>
                        </SECTION>
                    </REGTEXT>
                    <REGTEXT TITLE="42" PART="424">
                        <AMDPAR>37. Section 424.71 is amended as follows: </AMDPAR>
                        <AMDPAR>A. The definition of “Health care delivery system or system” is removed. </AMDPAR>
                        <AMDPAR>B. The definition of the term “Entity” is added in alphabetical order. </AMDPAR>
                        <P>The addition reads as follows: </P>
                        <SECTION>
                            <SECTNO>§ 424.71 </SECTNO>
                            <SUBJECT>Definitions. </SUBJECT>
                            <STARS/>
                            <P>
                                <E T="03">Entity</E>
                                 means a person, group, or facility that is enrolled in the Medicare program. 
                            </P>
                            <STARS/>
                              
                        </SECTION>
                    </REGTEXT>
                    <REGTEXT TITLE="42" PART="424">
                        <AMDPAR>38. Section 424.80 is amended by— </AMDPAR>
                        <AMDPAR>A. Revising paragraph (a). </AMDPAR>
                        <AMDPAR>B. Revising paragraph (b)(2). </AMDPAR>
                        <AMDPAR>C. Removing paragraph (b)(3). </AMDPAR>
                        <AMDPAR>D. Redesignating paragraphs (b)(4) through (6) as paragraphs (b)(3) through (5), respectively. </AMDPAR>
                        <AMDPAR>E. Revising paragraph (c). </AMDPAR>
                        <AMDPAR>F. Adding a new paragraph (d). </AMDPAR>
                        <P>The revisions and addition read as follows: </P>
                        <SECTION>
                            <SECTNO>§ 424.80 </SECTNO>
                            <SUBJECT>Prohibition of reassignment of claims by suppliers. </SUBJECT>
                            <P>
                                (a) 
                                <E T="03">Basic prohibition.</E>
                                 Except as specified in paragraph (b) of this section, Medicare does not pay amounts that are due a supplier under an assignment to any other person under reassignment, power of attorney, or any other direct arrangement. Nothing in this section alters a party's obligations under the anti-kickback statute (section 1128B(b) of the Act), the physician self-referral prohibition (section 1877 of the Act), the rules regarding physician billing for purchased diagnostic tests (§ 414.50 of this chapter), the rules regarding payment for services and supplies incident to a physician's professional services (§ 410.26 of this chapter), or other laws, rules, and regulations. 
                            </P>
                            <P>(b) * * * </P>
                            <P>(1) * * * </P>
                            <P>
                                (2) 
                                <E T="03">Payment to an entity under a contractual arrangement.</E>
                                 Medicare may pay an entity enrolled in the Medicare program if there is a contractual arrangement between the entity and the supplier under which the entity bills for the supplier's services, subject to the provisions of paragraph (d) of this section. 
                            </P>
                            <STARS/>
                            <P>
                                (c) 
                                <E T="03">Rules applicable to an employer or entity.</E>
                                 An employer or entity that may receive payment under paragraph (b)(1) or (b)(2) of this section is considered the supplier of those services for purposes of subparts C, D, and E of this part, subject to the provisions of paragraph (d) of this section. 
                            </P>
                            <P>
                                (d) 
                                <E T="03">Reassignment to an entity under a contractual arrangement: Conditions and limitations.</E>
                                 (1) 
                                <E T="03">Liability of the parties.</E>
                                 An entity enrolled in the Medicare program that receives payment under a contractual arrangement under paragraph (b)(2) of this section and the supplier that otherwise receives payment are jointly and severally responsible for any Medicare overpayment to that entity. 
                            </P>
                            <P>
                                (2) 
                                <E T="03">Access to records.</E>
                                 The supplier furnishing the service has unrestricted access to claims submitted by an entity for services provided by that supplier. 
                            </P>
                        </SECTION>
                    </REGTEXT>
                    <REGTEXT TITLE="42" PART="484">
                        <PART>
                            <HD SOURCE="HED">PART 484—HOME HEALTH SERVICES </HD>
                        </PART>
                        <AMDPAR>39. The authority citation for part 484 continues to read as follows: </AMDPAR>
                        <AUTH>
                            <HD SOURCE="HED">Authority:</HD>
                            <P>Secs. 1102 and 1871 of the Social Security Act (42 U.S.C. 1302 and 1395hh). </P>
                        </AUTH>
                    </REGTEXT>
                    <REGTEXT TITLE="42" PART="484">
                        <SECTION>
                            <SECTNO>§ 484.4 </SECTNO>
                            <SUBJECT>[Amended] </SUBJECT>
                        </SECTION>
                        <AMDPAR>40. In § 484.4 in the definition of physical therapy assistant the term “physical therapy assistant” is removed and the term “physical therapist assistant” is added in its place wherever it appears. </AMDPAR>
                    </REGTEXT>
                    <REGTEXT TITLE="42" PART="486">
                        <PART>
                            <HD SOURCE="HED">PART 486—CONDITIONS FOR COVERAGE OF SPECIALIZED SERVICES FURNISHED BY SUPPLIERS </HD>
                        </PART>
                        <AMDPAR>41. The authority citation for part 486 continues to read as follows: </AMDPAR>
                        <AUTH>
                            <HD SOURCE="HED">Authority:</HD>
                            <P>Sections 1102 and 1871 of the Social Security Act (42 U.S.C. 1302 and 1395hh). </P>
                        </AUTH>
                    </REGTEXT>
                    <REGTEXT TITLE="42" PART="486">
                        <SUBPART>
                            <HD SOURCE="HED">Subpart D—[Removed and Reserved] </HD>
                        </SUBPART>
                        <AMDPAR>42. Part 486 subpart D, consisting of § 486.150 through § 486.163, is removed and reserved. </AMDPAR>
                    </REGTEXT>
                    <EXTRACT>
                        <FP>(Catalog of Federal Domestic Assistance Program No. 93.774, Medicare—Supplementary Medical Insurance Program) </FP>
                    </EXTRACT>
                    <SIG>
                        <DATED>Dated: November 1, 2004. </DATED>
                        <NAME>Mark B. McClellan, </NAME>
                        <TITLE>Administrator, Centers for Medicare &amp; Medicaid Services. </TITLE>
                        <DATED>Dated: November 1, 2004. </DATED>
                        <NAME>Tommy G. Thompson, </NAME>
                        <TITLE>Secretary. </TITLE>
                    </SIG>
                    <NOTE>
                        <HD SOURCE="HED">Note:</HD>
                        <P>These addenda will not appear in the Code of Federal Regulations. </P>
                    </NOTE>
                    <EXTRACT>
                        <HD SOURCE="HD1">Addendum A—Explanation and Use of Addenda B </HD>
                        <P>The addenda on the following pages provide various data pertaining to the Medicare fee schedule for physicians' services furnished in 2005. Addendum B contains the RVUs for work, non-facility practice expense, facility practice expense, and malpractice expense, and other information for all services included in the physician fee schedule. </P>
                        <P>
                            In previous years, we have listed many services in Addendum B that are not paid under the physician fee schedule. To avoid publishing as many pages of codes for these services, we are not including clinical laboratory codes and most alphanumeric 
                            <PRTPAGE P="66427"/>
                            codes (Healthcare Common Procedure Coding System (HCPCS) codes not included in CPT) in Addendum B. 
                        </P>
                        <HD SOURCE="HD1">Addendum B—2005 Relative Value Units and Related Information Used in Determining Medicare Payments for 2005 </HD>
                        <P>This addendum contains the following information for each CPT code and alphanumeric HCPCS code, except for alphanumeric codes beginning with B (enteral and parenteral therapy), E (durable medical equipment), K (temporary codes for nonphysicians' services or items), or L (orthotics), and codes for anesthesiology. </P>
                        <P>
                            1. 
                            <E T="03">CPT/HCPCS code.</E>
                             This is the CPT or alphanumeric HCPCS number for the service. Alphanumeric HCPCS codes are included at the end of this addendum. 
                        </P>
                        <P>
                            2. 
                            <E T="03">Modifier.</E>
                             A modifier is shown if there is a technical component (modifier TC) and a professional component (PC) (modifier -26) for the service. If there is a PC and a TC for the service, Addendum B contains three entries for the code: one for the global values (both professional and technical); one for modifier -26 (PC); and one for modifier TC. The global service is not designated by a modifier, and physicians must bill using the code without a modifier if the physician furnishes both the PC and the TC of the service. 
                        </P>
                        <P>Modifier -53 is shown for a discontinued procedure. There will be RVUs for the code (CPT code 45378) with this modifier. </P>
                        <P>
                            3. 
                            <E T="03">Status indicator.</E>
                             This indicator shows whether the CPT/HCPCS code is included in the physician fee schedule and whether it is separately payable if the service is covered. 
                        </P>
                        <P>A = Active code. These codes are separately payable under the fee schedule if covered. There will be RVUs for codes with this status. The presence of an “A” indicator does not mean that Medicare has made a national decision regarding the coverage of the service. Carriers remain responsible for coverage decisions in the absence of a national Medicare policy. </P>
                        <P>B = Bundled code. Payment for covered services is always bundled into payment for other services not specified. If RVUs are shown, they are not used for Medicare payment. If these services are covered, payment for them is subsumed by the payment for the services to which they are incident. (An example is a telephone call from a hospital nurse regarding care of a patient.) </P>
                        <P>C = Carrier-priced code. Carriers will establish RVUs and payment amounts for these services, generally on a case-by-case basis following review of documentation, such as an operative report. </P>
                        <P>E = Excluded from physician fee schedule by regulation. These codes are for items or services that we chose to exclude from the physician fee schedule payment by regulation. No RVUs are shown, and no payment may be made under the physician fee schedule for these codes. Payment for them, if they are covered, continues under reasonable charge or other payment procedures. </P>
                        <P>I = Not valid for Medicare purposes. Medicare uses another code for the reporting of, and the payment for these services. (Code not subject to a 90-day grace period.) </P>
                        <P>N = Noncovered service. These codes are noncovered services. Medicare payment may not be made for these codes. If RVUs are shown, they are not used for Medicare payment. </P>
                        <P>P = Bundled or excluded code. There are no RVUs for these services. No separate payment should be made for them under the physician fee schedule. </P>
                        <FP SOURCE="FP-1">—If the item or service is covered as incident to a physician's service and is furnished on the same day as a physician's service, payment for it is bundled into the payment for the physician's service to which it is incident (an example is an elastic bandage furnished by a physician incident to a physician's service). </FP>
                        <FP SOURCE="FP-1">—If the item or service is covered as other than incident to a physician's service, it is excluded from the physician fee schedule (for example, colostomy supplies) and is paid under the other payment provisions of the Act. </FP>
                        <P>R = Restricted coverage. Special coverage instructions apply. If the service is covered and no RVUs are shown, it is carrier-priced. </P>
                        <P>T = Injections. There are RVUs for these services, but they are only paid if there are no other services payable under the physician fee schedule billed on the same date by the same provider. If any other services payable under the physician fee schedule are billed on the same date by the same provider, these services are bundled into the service(s) for which payment is made. </P>
                        <P>X = Exclusion by law. These codes represent an item or service that is not within the definition of “physicians' services” for physician fee schedule payment purposes. No RVUs are shown for these codes, and no payment may be made under the physician fee schedule. (Examples are ambulance services and clinical diagnostic laboratory services.) </P>
                        <P>
                            4. 
                            <E T="03">Description of code.</E>
                             This is an abbreviated version of the narrative description of the code. 
                        </P>
                        <P>
                            5. 
                            <E T="03">Physician work RVUs.</E>
                             These are the RVUs for the physician work for this service in 2005. Codes that are not used for Medicare payment are identified with a “+.” 
                        </P>
                        <P>
                            6. 
                            <E T="03">Facility practice expense RVUs.</E>
                             These are the fully implemented resource-based practice expense RVUs for facility settings. 
                        </P>
                        <P>
                            7. 
                            <E T="03">Non-facility practice expense RVUs.</E>
                             These are the fully implemented resource-based practice expense RVUs for non-facility settings. 
                        </P>
                        <P>
                            8. 
                            <E T="03">Malpractice expense RVUs.</E>
                             These are the RVUs for the malpractice expense for the service for 2005. 
                        </P>
                        <P>
                            9. 
                            <E T="03">Facility total.</E>
                             This is the sum of the work, fully implemented facility practice expense, and malpractice expense RVUs. 
                        </P>
                        <P>
                            10. 
                            <E T="03">Non-facility total.</E>
                             This is the sum of the work, fully implemented non-facility practice expense, and malpractice expense RVUs. 
                        </P>
                        <P>
                            11. 
                            <E T="03">Global period.</E>
                             This indicator shows the number of days in the global period for the code (0, 10, or 90 days). An explanation of the alpha codes follows: 
                        </P>
                        <P>MMM = The code describes a service furnished in uncomplicated maternity cases including antepartum care, delivery, and postpartum care. The usual global surgical concept does not apply. See the 1999 Physicians' Current Procedural Terminology for specific definitions. </P>
                        <P>XXX = The global concept does not apply. </P>
                        <P>YYY = The global period is to be set by the carrier (for example, unlisted surgery codes). </P>
                        <P>ZZZ = Code related to another service that is always included in the global period of the other service. (Note: Physician work and practice expense are associated with intra-service time and in some instances the post-service time.) </P>
                    </EXTRACT>
                    <BILCOD>BILLING CODE 4120-01-P</BILCOD>
                    <GPH SPAN="3" DEEP="584">
                        <PRTPAGE P="66428"/>
                        <GID>ER15NO04.565</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="585">
                        <PRTPAGE P="66429"/>
                        <GID>ER15NO04.566</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="585">
                        <PRTPAGE P="66430"/>
                        <GID>ER15NO04.567</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="585">
                        <PRTPAGE P="66431"/>
                        <GID>ER15NO04.568</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="585">
                        <PRTPAGE P="66432"/>
                        <GID>ER15NO04.569</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="585">
                        <PRTPAGE P="66433"/>
                        <GID>ER15NO04.570</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="589">
                        <PRTPAGE P="66434"/>
                        <GID>ER15NO04.571</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="589">
                        <PRTPAGE P="66435"/>
                        <GID>ER15NO04.572</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="588">
                        <PRTPAGE P="66436"/>
                        <GID>ER15NO04.573</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="588">
                        <PRTPAGE P="66437"/>
                        <GID>ER15NO04.574</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="587">
                        <PRTPAGE P="66438"/>
                        <GID>ER15NO04.575</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="587">
                        <PRTPAGE P="66439"/>
                        <GID>ER15NO04.576</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="586">
                        <PRTPAGE P="66440"/>
                        <GID>ER15NO04.577</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="581">
                        <PRTPAGE P="66441"/>
                        <GID>ER15NO04.578</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="587">
                        <PRTPAGE P="66442"/>
                        <GID>ER15NO04.579</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="586">
                        <PRTPAGE P="66443"/>
                        <GID>ER15NO04.580</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="588">
                        <PRTPAGE P="66444"/>
                        <GID>ER15NO04.581</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="588">
                        <PRTPAGE P="66445"/>
                        <GID>ER15NO04.582</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="587">
                        <PRTPAGE P="66446"/>
                        <GID>ER15NO04.583</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="587">
                        <PRTPAGE P="66447"/>
                        <GID>ER15NO04.584</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="587">
                        <PRTPAGE P="66448"/>
                        <GID>ER15NO04.585</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="587">
                        <PRTPAGE P="66449"/>
                        <GID>ER15NO04.586</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="586">
                        <PRTPAGE P="66450"/>
                        <GID>ER15NO04.587</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="586">
                        <PRTPAGE P="66451"/>
                        <GID>ER15NO04.588</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="589">
                        <PRTPAGE P="66452"/>
                        <GID>ER15NO04.589</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="588">
                        <PRTPAGE P="66453"/>
                        <GID>ER15NO04.590</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="588">
                        <PRTPAGE P="66454"/>
                        <GID>ER15NO04.591</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="588">
                        <PRTPAGE P="66455"/>
                        <GID>ER15NO04.592</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="588">
                        <PRTPAGE P="66456"/>
                        <GID>ER15NO04.593</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="588">
                        <PRTPAGE P="66457"/>
                        <GID>ER15NO04.594</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="587">
                        <PRTPAGE P="66458"/>
                        <GID>ER15NO04.595</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="587">
                        <PRTPAGE P="66459"/>
                        <GID>ER15NO04.596</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="587">
                        <PRTPAGE P="66460"/>
                        <GID>ER15NO04.597</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="587">
                        <PRTPAGE P="66461"/>
                        <GID>ER15NO04.598</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="588">
                        <PRTPAGE P="66462"/>
                        <GID>ER15NO04.599</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="588">
                        <PRTPAGE P="66463"/>
                        <GID>ER15NO04.600</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="588">
                        <PRTPAGE P="66464"/>
                        <GID>ER15NO04.601</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="590">
                        <PRTPAGE P="66465"/>
                        <GID>ER15NO04.602</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="589">
                        <PRTPAGE P="66466"/>
                        <GID>ER15NO04.603</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="588">
                        <PRTPAGE P="66467"/>
                        <GID>ER15NO04.604</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="590">
                        <PRTPAGE P="66468"/>
                        <GID>ER15NO04.605</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="589">
                        <PRTPAGE P="66469"/>
                        <GID>ER15NO04.606</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="588">
                        <PRTPAGE P="66470"/>
                        <GID>ER15NO04.607</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="587">
                        <PRTPAGE P="66471"/>
                        <GID>ER15NO04.608</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="588">
                        <PRTPAGE P="66472"/>
                        <GID>ER15NO04.609</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="588">
                        <PRTPAGE P="66473"/>
                        <GID>ER15NO04.610</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="589">
                        <PRTPAGE P="66474"/>
                        <GID>ER15NO04.611</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="587">
                        <PRTPAGE P="66475"/>
                        <GID>ER15NO04.612</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="586">
                        <PRTPAGE P="66476"/>
                        <GID>ER15NO04.613</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="587">
                        <PRTPAGE P="66477"/>
                        <GID>ER15NO04.614</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="586">
                        <PRTPAGE P="66478"/>
                        <GID>ER15NO04.616</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="585">
                        <PRTPAGE P="66479"/>
                        <GID>ER15NO04.617</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="586">
                        <PRTPAGE P="66480"/>
                        <GID>ER15NO04.618</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="585">
                        <PRTPAGE P="66481"/>
                        <GID>ER15NO04.619</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="585">
                        <PRTPAGE P="66482"/>
                        <GID>ER15NO04.620</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="585">
                        <PRTPAGE P="66483"/>
                        <GID>ER15NO04.621</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="589">
                        <PRTPAGE P="66484"/>
                        <GID>ER15NO04.622</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="589">
                        <PRTPAGE P="66485"/>
                        <GID>ER15NO04.623</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="588">
                        <PRTPAGE P="66486"/>
                        <GID>ER15NO04.624</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="588">
                        <PRTPAGE P="66487"/>
                        <GID>ER15NO04.625</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="588">
                        <PRTPAGE P="66488"/>
                        <GID>ER15NO04.626</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="588">
                        <PRTPAGE P="66489"/>
                        <GID>ER15NO04.627</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="588">
                        <PRTPAGE P="66490"/>
                        <GID>ER15NO04.628</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="587">
                        <PRTPAGE P="66491"/>
                        <GID>ER15NO04.629</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="587">
                        <PRTPAGE P="66492"/>
                        <GID>ER15NO04.630</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="586">
                        <PRTPAGE P="66493"/>
                        <GID>ER15NO04.631</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="588">
                        <PRTPAGE P="66494"/>
                        <GID>ER15NO04.632</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="633">
                        <PRTPAGE P="66495"/>
                        <GID>ER15NO04.633</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="587">
                        <PRTPAGE P="66496"/>
                        <GID>ER15NO04.634</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="587">
                        <PRTPAGE P="66497"/>
                        <GID>ER15NO04.635</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="587">
                        <PRTPAGE P="66498"/>
                        <GID>ER15NO04.636</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="588">
                        <PRTPAGE P="66499"/>
                        <GID>ER15NO04.637</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="587">
                        <PRTPAGE P="66500"/>
                        <GID>ER15NO04.638</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="586">
                        <PRTPAGE P="66501"/>
                        <GID>ER15NO04.639</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="588">
                        <PRTPAGE P="66502"/>
                        <GID>ER15NO04.640</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="587">
                        <PRTPAGE P="66503"/>
                        <GID>ER15NO04.641</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="586">
                        <PRTPAGE P="66504"/>
                        <GID>ER15NO04.642</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="587">
                        <PRTPAGE P="66505"/>
                        <GID>ER15NO04.643</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="587">
                        <PRTPAGE P="66506"/>
                        <GID>ER15NO04.644</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="587">
                        <PRTPAGE P="66507"/>
                        <GID>ER15NO04.645</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="587">
                        <PRTPAGE P="66508"/>
                        <GID>ER15NO04.646</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="590">
                        <PRTPAGE P="66509"/>
                        <GID>ER15NO04.647</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="589">
                        <PRTPAGE P="66510"/>
                        <GID>ER15NO04.648</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="589">
                        <PRTPAGE P="66511"/>
                        <GID>ER15NO04.649</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="589">
                        <PRTPAGE P="66512"/>
                        <GID>ER15NO04.650</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="589">
                        <PRTPAGE P="66513"/>
                        <GID>ER15NO04.651</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="589">
                        <PRTPAGE P="66514"/>
                        <GID>ER15NO04.652</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="589">
                        <PRTPAGE P="66515"/>
                        <GID>ER15NO04.653</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="588">
                        <PRTPAGE P="66516"/>
                        <GID>ER15NO04.654</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="589">
                        <PRTPAGE P="66517"/>
                        <GID>ER15NO04.655</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="588">
                        <PRTPAGE P="66518"/>
                        <GID>ER15NO04.656</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="590">
                        <PRTPAGE P="66519"/>
                        <GID>ER15NO04.657</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="591">
                        <PRTPAGE P="66520"/>
                        <GID>ER15NO04.658</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="590">
                        <PRTPAGE P="66521"/>
                        <GID>ER15NO04.659</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="588">
                        <PRTPAGE P="66522"/>
                        <GID>ER15NO04.660</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="589">
                        <PRTPAGE P="66523"/>
                        <GID>ER15NO04.661</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="588">
                        <PRTPAGE P="66524"/>
                        <GID>ER15NO04.662</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="589">
                        <PRTPAGE P="66525"/>
                        <GID>ER15NO04.663</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="587">
                        <PRTPAGE P="66526"/>
                        <GID>ER15NO04.664</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="588">
                        <PRTPAGE P="66527"/>
                        <GID>ER15NO04.665</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="588">
                        <PRTPAGE P="66528"/>
                        <GID>ER15NO04.666</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="587">
                        <PRTPAGE P="66529"/>
                        <GID>ER15NO04.667</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="587">
                        <PRTPAGE P="66530"/>
                        <GID>ER15NO04.668</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="587">
                        <PRTPAGE P="66531"/>
                        <GID>ER15NO04.669</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="587">
                        <PRTPAGE P="66532"/>
                        <GID>ER15NO04.670</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="586">
                        <PRTPAGE P="66533"/>
                        <GID>ER15NO04.671</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="590">
                        <PRTPAGE P="66534"/>
                        <GID>ER15NO04.672</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="589">
                        <PRTPAGE P="66535"/>
                        <GID>ER15NO04.673</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="589">
                        <PRTPAGE P="66536"/>
                        <GID>ER15NO04.674</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="588">
                        <PRTPAGE P="66537"/>
                        <GID>ER15NO04.675</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="587">
                        <PRTPAGE P="66538"/>
                        <GID>ER15NO04.676</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="587">
                        <PRTPAGE P="66539"/>
                        <GID>ER15NO04.677</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="588">
                        <PRTPAGE P="66540"/>
                        <GID>ER15NO04.678</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="587">
                        <PRTPAGE P="66541"/>
                        <GID>ER15NO04.679</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="587">
                        <PRTPAGE P="66542"/>
                        <GID>ER15NO04.680</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="587">
                        <PRTPAGE P="66543"/>
                        <GID>ER15NO04.681</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="590">
                        <PRTPAGE P="66544"/>
                        <GID>ER15NO04.682</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="589">
                        <PRTPAGE P="66545"/>
                        <GID>ER15NO04.683</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="589">
                        <PRTPAGE P="66546"/>
                        <GID>ER15NO04.684</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="589">
                        <PRTPAGE P="66547"/>
                        <GID>ER15NO04.685</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="589">
                        <PRTPAGE P="66548"/>
                        <GID>ER15NO04.686</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="588">
                        <PRTPAGE P="66549"/>
                        <GID>ER15NO04.687</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="589">
                        <PRTPAGE P="66550"/>
                        <GID>ER15NO04.688</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="589">
                        <PRTPAGE P="66551"/>
                        <GID>ER15NO04.689</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="589">
                        <PRTPAGE P="66552"/>
                        <GID>ER15NO04.690</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="590">
                        <PRTPAGE P="66553"/>
                        <GID>ER15NO04.691</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="589">
                        <PRTPAGE P="66554"/>
                        <GID>ER15NO04.692</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="589">
                        <PRTPAGE P="66555"/>
                        <GID>ER15NO04.693</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="589">
                        <PRTPAGE P="66556"/>
                        <GID>ER15NO04.694</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="588">
                        <PRTPAGE P="66557"/>
                        <GID>ER15NO04.695</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="588">
                        <PRTPAGE P="66558"/>
                        <GID>ER15NO04.696</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="588">
                        <PRTPAGE P="66559"/>
                        <GID>ER15NO04.697</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="589">
                        <PRTPAGE P="66560"/>
                        <GID>ER15NO04.698</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="588">
                        <PRTPAGE P="66561"/>
                        <GID>ER15NO04.699</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="589">
                        <PRTPAGE P="66562"/>
                        <GID>ER15NO04.700</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="593">
                        <PRTPAGE P="66563"/>
                        <GID>ER15NO04.701</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="592">
                        <PRTPAGE P="66564"/>
                        <GID>ER15NO04.702</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="590">
                        <PRTPAGE P="66565"/>
                        <GID>ER15NO04.703</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="590">
                        <PRTPAGE P="66566"/>
                        <GID>ER15NO04.704</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="589">
                        <PRTPAGE P="66567"/>
                        <GID>ER15NO04.705</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="589">
                        <PRTPAGE P="66568"/>
                        <GID>ER15NO04.706</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="590">
                        <PRTPAGE P="66569"/>
                        <GID>ER15NO04.707</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="588">
                        <PRTPAGE P="66570"/>
                        <GID>ER15NO04.708</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="590">
                        <PRTPAGE P="66571"/>
                        <GID>ER15NO04.709</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="589">
                        <PRTPAGE P="66572"/>
                        <GID>ER15NO04.710</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="588">
                        <PRTPAGE P="66573"/>
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                </SUPLINF>
                <FRDOC>[FR Doc. 04-24758  Filed 11-2-04; 4:45 pm]</FRDOC>
                <BILCOD>BILLING CODE 4120-01-C</BILCOD>
            </RULE>
        </RULES>
    </NEWPART>
    <VOL>69 </VOL>
    <NO>219 </NO>
    <DATE>Monday, November 15, 2004 </DATE>
    <UNITNAME>Notices </UNITNAME>
    <NEWPART>
        <PTITLE>
            <PRTPAGE P="66917"/>
            <PARTNO>Part IV </PARTNO>
            <BOOK>Book 4 of 4 Books</BOOK>
            <PGS>Pages 66917-67040</PGS>
            <AGENCY TYPE="P">Department of Health and Human Services </AGENCY>
            <SUBAGY>Centers for Medicare &amp; Medicaid Services </SUBAGY>
            <HRULE/>
            <TITLE>Medicare Program; Coverage and Payment of Ambulance Services; Recalibration of Conversion Factor; Inflation Update for CY 2005; Notice </TITLE>
        </PTITLE>
        <NOTICES>
            <NOTICE>
                <PREAMB>
                    <PRTPAGE P="66918"/>
                    <AGENCY TYPE="S">DEPARTMENT OF HEALTH AND HUMAN SERVICES </AGENCY>
                    <SUBAGY>Centers for Medicare &amp; Medicaid Services </SUBAGY>
                    <DEPDOC>[CMS-1267-N] </DEPDOC>
                    <RIN>RIN 0938-AN20 </RIN>
                    <SUBJECT>Medicare Program; Coverage and Payment of Ambulance Services; Recalibration of Conversion Factor; Inflation Update for CY 2005 </SUBJECT>
                    <AGY>
                        <HD SOURCE="HED">AGENCY:</HD>
                        <P>Centers for Medicare &amp; Medicaid Services (CMS), HHS. </P>
                    </AGY>
                    <ACT>
                        <HD SOURCE="HED">ACTION:</HD>
                        <P>Notice. </P>
                    </ACT>
                    <SUM>
                        <HD SOURCE="HED">SUMMARY:</HD>
                        <P>This notice sets forth: (1) A discussion of the annual review of the conversion factor (CF) used to calculate the Medicare program ambulance fee schedule; and (2) the annual ambulance inflation factor for ambulance services for calendar year 2005. </P>
                    </SUM>
                    <DATES>
                        <HD SOURCE="HED">EFFECTIVE DATE:</HD>
                        <P>The revised CF is effective for services furnished on or after January 1, 2005. </P>
                    </DATES>
                    <FURINF>
                        <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                        <P>Anne E. Tayloe, (410) 786-4546. </P>
                    </FURINF>
                </PREAMB>
                <SUPLINF>
                    <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                    <HD SOURCE="HD1">I. Background </HD>
                    <HD SOURCE="HD2">A. Legislative and Regulatory History </HD>
                    <P>The Secretary will annually review the conversion factor (CF) and will adjust the CF if actual experience under the fee schedule is significantly different from the assumptions used to determine the initial CF, as stated in § 414.610(g). Additionally, the ambulance inflation factor (AIF) must be adjusted annually, as stated in section 1834(l)(3)(B) of the Social Security Act (the Act) and in § 414.610(f). </P>
                    <P>Under section 1861(s)(7) of the Act, Medicare Part B (Supplementary Medical Insurance) covers and pays for ambulance services, to the extent prescribed in regulations at 42 CFR parts 410 and 414, when the use of other methods of transportation would be contraindicated for the beneficiary. The House Ways and Means Committee and Senate Finance Committee Reports that accompanied the 1965 legislation creating the Act suggest that the Congress intended that: (1) The ambulance benefit cover transportation services only if other means of transportation are contraindicated by the beneficiary's medical condition; and (2) only ambulance service to local facilities be covered unless necessary services are not available locally, in which case, transportation to the nearest facility furnishing those services is covered (H.R. Rep. No. 213, 89th Cong., 1st Sess. 37 and S. Rep. No. 404, 89th Cong., 1st Sess., Pt I, 43 (1965)). The reports indicate that transportation may also be provided from one hospital to another, to the beneficiary's home, or to an extended care facility. </P>
                    <P>Our regulations relating to ambulance services are located at 42 CFR part 410, subpart B, and 42 CFR part 414, subpart H. Section 410.10(i) lists ambulance services as one of the covered medical and other health services under Medicare Part B. Ambulance services are subject to basic conditions and limitations set forth at § 410.12 and to specific conditions and limitations included at § 410.40. Part 414, subpart H describes how payment is made for ambulance services covered by Medicare. </P>
                    <P>Ambulance services (air and ground) are divided into different levels of services based on the medically necessary treatment provided during transport. These services include the levels of service as follows: </P>
                    <P>
                        <E T="03">For Ground:</E>
                    </P>
                    <P>• Basic Life Support (BLS) </P>
                    <P>• Advanced Life Support, Level 1 (ALS1) </P>
                    <P>• Advanced Life Support, Level 2 (ALS2) </P>
                    <P>• Specialty Care Transport (SCT) </P>
                    <P>• Paramedic ALS Intercept (PI) </P>
                    <P>
                        <E T="03">For Air:</E>
                    </P>
                    <P>• Fixed Wing Air Ambulance (FW) </P>
                    <P>• Rotary Wing Air Ambulance (RW) </P>
                    <P>Historically, payment levels for ambulance services depended, in part, upon the entity that furnished the services. Prior to implementation of the ambulance fee schedule on April 1, 2002, providers (hospitals, including critical access hospitals, skilled nursing facilities, and home health agencies) were paid on a retrospective reasonable cost basis. Suppliers, which are entities that are independent of any provider, were paid on a reasonable charge basis. </P>
                    <P>
                        The Balanced Budget Act of 1997 (BBA) (establishing section 1834(l) of the Act) mandated the development of an ambulance fee schedule (AFS) through negotiated rulemaking. On February 27, 2002, we published a final rule in the 
                        <E T="04">Federal Register</E>
                         (Fee Schedule for Payment of Ambulance Services and Revisions to the Physician Certification Requirements for Coverage of Nonemergency Ambulance Services, 67 FR 9100) that established a fee schedule for the payment of ambulance services under the Medicare program, effective for services furnished on or after April 1, 2002. The fee schedule replaced the retrospective reasonable cost payment system for providers and the reasonable charge system for suppliers of ambulance services. Additionally, the final rule: (1) Implemented a statutory requirement that ambulance suppliers accept Medicare assignment; (2) codified the establishment of new HealthCare Common Procedure Coding System (HCPCS) codes to be reported on claims for ambulance services; (3) established increased payment under the fee schedule for ambulance services furnished in rural areas based on the location of the beneficiary at the time the beneficiary is placed on board the ambulance; (4) revised the certification requirements for coverage of non-emergency ambulance services; and (5) provided for a 5-year transition period during which program payment for Medicare covered ambulance services would be based upon a blended rate comprised of a fee schedule portion and a reasonable cost (providers) or reasonable charge (suppliers) portion. We are now in the third year of that transition over to full payment based solely on the fee schedule amount. 
                    </P>
                    <HD SOURCE="HD2">B. Ambulance CF Review </HD>
                    <P>The February 27, 2002 final rule also provided that we would annually review rates and adjust the CF and air ambulance rates if actual experience under the fee schedule is significantly different from the assumptions used to determine the initial CF and air ambulance rates. The CF and air ambulance rates would not be adjusted solely because of changes in the total number of ambulance transports (§ 414.610(g)). This notice describes the claims data for the first 9 months of the AFS (April 1, 2002 through December 31, 2002) and explains the calculations used to determine whether the existing CF has resulted in a significant discrepancy between assumptions and actual experience under the AFS. These 2002 claims data were used because they were the most recent complete period of claims data under the AFS that were available for this analysis. </P>
                    <HD SOURCE="HD2">C. Ambulance Inflation Factor for CY 2005 </HD>
                    <P>
                        Section 1834(l)(3)(B) of the Act (implemented by regulation at § 414.610(f)) provides the basis for updating payment amounts for ambulance services. This provision requires that the AFS be updated by the AIF annually, based on the percentage increase in the consumer price index (CPI) for all urban consumers (U.S. city average) for the 12-month period ending with June of the previous year (§ 414.610(f)). 
                        <PRTPAGE P="66919"/>
                    </P>
                    <HD SOURCE="HD1">II. Data and Methodology for Recalibration </HD>
                    <P>As stated in section I.B. of this notice, we used claims data from the period April 1, 2002 through December 31, 2002 because this was the latest complete period for which we had claims data during which the AFS was in effect. We used a similar methodology to set the original CF as described in the February 27, 2002 final rule. We counted the number of trips at each level and determined the percentage of utilization of each to the total number of trips, then we compared these percentages to the same percentages from the original data used to set the CF. This method provided a means to evaluate the accuracy of the assumptions that were used to set the original CF. We also examined the degree to which ambulance billers' charges were less than the AFS amounts. This gave the actual amount of “low billing.” We then determined the conversion factor for ground services based on the actual claims data and compared that amount to the CF that has been in use based on the assumptions. The resulting CF was only eight-tenths of 1 percent (0.8 percent) lower than the CF that was in use. We then performed a similar analysis using the 9-month 2002 claims data to evaluate the payment rates for air ambulance services. This resulted in payment rates that were 2.8 percent lower than the rates currently in use. We have determined that this is not a significant difference. Therefore, in accordance with § 414.610(g), we have determined that no adjustment to the existing payment rate structure is warranted. </P>
                    <P>The February 27, 2002 final rule also stated that we would review the basis for the bonus amounts paid for ambulance transports that originate in a rural area. Given that the Congress, through enactment of section 414 of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003, has provided for significant additional spending for these services, we have determined that no further adjustment in the payment amounts for these rural ambulance services is warranted. </P>
                    <HD SOURCE="HD1">III. Provisions of the Notice </HD>
                    <HD SOURCE="HD2">A. AFS CF Update </HD>
                    <P>In accordance with § 414.610(g), we have reviewed actual claims data and determined that actual experience under the AFS is not significantly different than the assumptions used to set the CF. Therefore, we are not revising the existing CF as a consequence of actual experience. </P>
                    <HD SOURCE="HD2">B. AIF for 2005 </HD>
                    <P>Section 1834(l)(3)(B) of the Act, as specified in § 414.610(f), provides for an update in payments for CY 2005 that is equal to the percentage increase in the CPI for all urban consumers (CPI-U) for the 12-month period ending with June of the previous year (that is, June 2004). We will use the actual percentage increase and not an estimate or projection. The AIF for 2005 is 3.3 percent. </P>
                    <P>During the transition period (see § 414.615), the AIF is applied to both the fee schedule portion of the blended payment amount and to the reasonable charge or cost portion of the blended payment amount separately for each ambulance provider or supplier. Then, these two amounts are added together to determine the total payment amount for each provider or supplier. </P>
                    <HD SOURCE="HD1">IV. Waiver of Proposed Rulemaking </HD>
                    <P>
                        We ordinarily publish a notice of proposed rulemaking in the 
                        <E T="04">Federal Register</E>
                         to provide a period of public comment before the provisions of a notice such as this take effect. We can waive this procedure, however, if we find good cause that a notice and comment procedure is impracticable, unnecessary, or contrary to the public interest and incorporate a statement of finding and its reasons in the notice issued. 
                    </P>
                    <P>We find it unnecessary to undertake notice and comment rulemaking because the statute and regulation specify the methods of computation of annual updates, and we have no discretion in this matter. Further, this notice does not change substantive policy, but merely applies the update methods specified in statute and regulation. Therefore, for good cause, we waive notice and comment procedures. </P>
                    <HD SOURCE="HD1">V. Collection of Information Requirements </HD>
                    <P>This document does not impose information collection and recordkeeping requirements. Consequently, it need not be reviewed by the Office of Management and Budget under the authority of the Paperwork Reduction Act of 1995. </P>
                    <HD SOURCE="HD1">VI. Regulatory Impact Analysis </HD>
                    <P>We have examined the impact of this notice as required by Executive Order 12866 (September 1993, Regulatory Planning and Review), the Regulatory Flexibility Act (RFA) (September 19, 1980, Pub. L. 96-354), section 1102(b) of the Act, the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4), and Executive Order 13132. </P>
                    <P>Executive Order 12866 directs agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). A regulatory impact analysis (RIA) must be prepared for major rules with economically significant effects ($100 million or more in any 1 year). As stated above, the AIF (equal to the percentage increase in the CPI-U of June 30, 2004 as compared to June 30, 2003) for 2005 is 3.3 percent. We estimate that the application of the AIF will result in this notice being considered a major rule because it will result in an additional total program expenditure of approximately $100 million in CY 2005. </P>
                    <P>The RFA requires agencies to analyze options for regulatory relief of small businesses. For purposes of the RFA, small entities include small businesses, nonprofit organizations, and government agencies. Most hospitals and most other providers and suppliers are small entities, either by nonprofit status or by having revenues of $6 million to $29 million in any 1 year. For purposes of the RFA, all ambulance providers or suppliers are considered to be small entities. Individuals and States are not included in the definition of a small entity. </P>
                    <P>We consider that a substantial number of entities are affected if the rule impacts more than 5 percent of the total number of small entities as it does in this notice. This notice will impact every ambulance provider and supplier in the same way because all ambulance payment rates for all ambulance services furnished by all types of ambulance suppliers and providers are increased by the same ambulance inflation factor. We estimate the impact of this notice will be an approximate 3 percent increase in Medicare revenues for all ambulance suppliers and providers that furnish services to Medicare beneficiaries. This will be a somewhat less than 2 percent increase in total revenues (that is, Medicare plus non-Medicare revenues). This estimated impact does not meet the threshold established by HHS to be considered a significant impact. Nonetheless, we have prepared the analysis below to describe the impact of this notice. </P>
                    <P>
                        In addition, section 1102(b) of the Act requires us to prepare a regulatory impact analysis if a rule may have a significant impact on the operations of 
                        <PRTPAGE P="66920"/>
                        a substantial number of small rural hospitals. This analysis must conform to the provisions of section 604 of the RFA. For purposes of section 1102(b) of the Act, we define a small rural hospital as a hospital that is located outside of a Metropolitan Statistical Area and has fewer than 100 beds. This notice applies to small rural hospitals that furnish at least one Medicare covered ambulance service to at least one Medicare beneficiary. 
                    </P>
                    <P>Section 202 of the Unfunded Mandates Reform Act of 1995 also requires that agencies assess anticipated costs and benefits before issuing any rule that may result in expenditure in any 1 year by State, local, or tribal governments, in the aggregate, or by the private sector, of $110 million. This notice does not result in an expenditure in any 1 year by State, local, or tribal governments of $110 million. </P>
                    <P>Executive Order 13132 establishes certain requirements that an agency must meet when it publishes a proposed rule (and subsequent final rule) that imposes substantial direct requirement costs on State and local governments, preempts State law, or otherwise has Federalism implications. This notice will not have a substantial effect on State or local governments. </P>
                    <P>We estimate that the total program expenditure for CY 2005 for ambulance services covered by the Medicare program is approximately $3.7 billion. This estimate of program spending includes application of an AIF assumed to be approximately 3 percent. This assumption results in an additional total program expenditure of approximately $100 million distributed over 16,000 suppliers and providers that furnish ambulance services to Medicare beneficiaries. </P>
                    <P>For recalibrating the AFS, there are two alternatives: (1) To make an adjustment to the AFS, if actual experience is significantly different from our initial assumptions; or (2) to make no adjustment to the AFS because actual experience is not significantly different from our initial assumptions. As discussed in section II.A. of this notice, we have decided not to make an adjustment to the AFS because actual experience is not significantly different from our initial assumptions; however, we note that making the adjustment would have lowered payments to suppliers and providers of ambulance services. Therefore, payments to suppliers and providers of ambulance services are slightly higher than would otherwise be made if we were to make these adjustments to the AFS. We estimate the impact of this action will be an approximate 0.8 percent increase in Medicare revenues for all ambulance suppliers and providers that furnish ground ambulance services to Medicare beneficiaries and an approximate 2.8 percent increase in Medicare revenues for all ambulance suppliers and providers that furnish air ambulance services to Medicare beneficiaries. This will be a 0.5 percent and 1.5 percent increase in total revenues for ground and air ambulance services respectively (that is, Medicare plus non-Medicare revenues). The estimated impact of this action is, therefore, not significant. </P>
                    <P>In accordance with the provisions of Executive Order 12866, this notice was reviewed by the Office of Management and Budget. </P>
                    <AUTH>
                        <HD SOURCE="HED">Authority:</HD>
                        <P>Section 1834(l) of the Social Security Act (42 U.S.C. 1395m(l)). </P>
                    </AUTH>
                    <EXTRACT>
                        <FP>(Catalog of Federal Domestic Assistance Program No. 93.774, Medicare—Supplementary Medical Insurance Program)</FP>
                    </EXTRACT>
                    <SIG>
                        <DATED>Dated: July 29, 2004. </DATED>
                        <NAME>Mark B. McClellan, </NAME>
                        <TITLE>Administrator, Centers for Medicare &amp; Medicaid Services. </TITLE>
                        <DATED>Approved: September 21, 2004. </DATED>
                        <NAME>Tommy G. Thompson, </NAME>
                        <TITLE>Secretary. </TITLE>
                    </SIG>
                </SUPLINF>
                <FRDOC>[FR Doc. 04-24757 Filed 11-2-04; 4:45 pm] </FRDOC>
                <BILCOD>BILLING CODE 4120-01-P</BILCOD>
            </NOTICE>
        </NOTICES>
    </NEWPART>
    <VOL>69</VOL>
    <NO>219</NO>
    <DATE>Monday, November 15, 2004</DATE>
    <UNITNAME>Rules and Regulations</UNITNAME>
    <NEWPART>
        <PTITLE>
            <PRTPAGE P="66921"/>
            <PARTNO>Part V</PARTNO>
            <AGENCY TYPE="P">Department of Health and Human Services</AGENCY>
            <SUBAGY>Centers for Medicare &amp; Medicaid Services</SUBAGY>
            <HRULE/>
            <CFR>42 CFR Parts 412 and 413</CFR>
            <TITLE>Medicare Program; Prospective Payment System for Inpatient Psychiatric Facilities; Final Rule</TITLE>
        </PTITLE>
        <RULES>
            <RULE>
                <PREAMB>
                    <PRTPAGE P="66922"/>
                    <AGENCY TYPE="S">DEPARTMENT OF HEALTH AND HUMAN SERVICES</AGENCY>
                    <SUBAGY>Centers for Medicare &amp; Medicaid Services</SUBAGY>
                    <CFR>42 CFR Parts 412 and 413</CFR>
                    <DEPDOC>[CMS-1213-F]</DEPDOC>
                    <RIN>RIN 0938-AL50</RIN>
                    <SUBJECT>Medicare Program; Prospective Payment System for Inpatient Psychiatric Facilities</SUBJECT>
                    <AGY>
                        <HD SOURCE="HED">AGENCY:</HD>
                        <P>Centers for Medicare &amp; Medicaid Services (CMS), HHS.</P>
                    </AGY>
                    <ACT>
                        <HD SOURCE="HED">ACTION:</HD>
                        <P>Final rule.</P>
                    </ACT>
                    <SUM>
                        <HD SOURCE="HED">SUMMARY:</HD>
                        <P>This final rule establishes a prospective payment system for Medicare payment of inpatient hospital services furnished in psychiatric hospitals and psychiatric units of acute care hospitals and critical access hospitals. It implements section 124 of the Medicare, Medicaid, and SCHIP Balanced Budget Refinement Act of 1999 (BBRA). The prospective payment system described in this final rule will replace the reasonable cost-based payment system under which psychiatric hospitals and psychiatric units are paid under Medicare.</P>
                    </SUM>
                    <EFFDATE>
                        <HD SOURCE="HED">DATES:</HD>
                        <P>This rule is effective for cost reporting periods beginning on or after January 1, 2005.</P>
                    </EFFDATE>
                    <FURINF>
                        <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                        <P>Janet Samen, (410) 786-9161 (General information.) Phillip Cotterill, (410) 786-6598 and Fred Thomas (410) 786-6675, (For information regarding the regression analysis).</P>
                    </FURINF>
                </PREAMB>
                <SUPLINF>
                    <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                    <P>
                        <E T="03">Copies:</E>
                         To order copies of the 
                        <E T="04">Federal Register</E>
                         containing this document, send your request to: New Orders, Superintendent of Documents, P.O. Box 371954, Pittsburgh, PA 15250-7954. Specify the date of the issue requested and enclose a check or money order payable to the Superintendent of Documents, or enclose your Visa or Master Card number and expiration date. Credit card orders can also be placed by calling the order desk at (202) 512-1800 or by faxing to (202) 512-2250. The cost for each copy is $10. As an alternative, you can view and photocopy the 
                        <E T="04">Federal Register</E>
                         document at most libraries designated as Federal Depository Libraries and at many other public and academic libraries throughout the country that receive the 
                        <E T="04">Federal Register</E>
                        .
                    </P>
                    <P>
                        This 
                        <E T="04">Federal Register</E>
                         document is also available from the 
                        <E T="04">Federal Register</E>
                         online database through GPO access, a service of the U.S. Government Printing Office. The Website address is 
                        <E T="03">http://www.access.gpo.gov/nara/index.html.</E>
                    </P>
                    <P>To assist readers in referencing sections contained in this document, we are providing he following table of contents.</P>
                    <EXTRACT>
                        <HD SOURCE="HD1">Table of Contents</HD>
                        <FP SOURCE="FP-2">I. Background</FP>
                        <FP SOURCE="FP1-2">A. General and Legislative History</FP>
                        <FP SOURCE="FP1-2">B. Overview of the Payment System for Inpatient Psychiatric Hospitals and Psychiatric Units Before the BBRA</FP>
                        <FP SOURCE="FP1-2">1. Description of the TEFRA Payment Methodology</FP>
                        <FP SOURCE="FP1-2">2. BBA Amendments to TEFRA</FP>
                        <FP SOURCE="FP1-2">3. BBRA Amendments to TEFRA</FP>
                        <FP SOURCE="FP1-2">4. BIPA Amendments to TEFRA</FP>
                        <FP SOURCE="FP-2">II. Provisions of the Proposed Regulations</FP>
                        <FP SOURCE="FP-2">III. Analysis of and Responses to Public Comments</FP>
                        <FP SOURCE="FP-2">IV. Overview of the IPF PPS Proposed Payment Methodology </FP>
                        <FP SOURCE="FP-2">V. Development of the Budget-Neutral Federal Per Diem Base Rate. </FP>
                        <FP SOURCE="FP1-2">A. Calculation of the Federal Per Diem Base Rate </FP>
                        <FP SOURCE="FP1-2">B. Determining the Update Factors for the Budget-Neutrality Calculation </FP>
                        <FP SOURCE="FP1-2">1. The 1997-Based Excluded Hospital with Capital Market Basket </FP>
                        <FP SOURCE="FP1-2">2. Calculating the Budget-Neutrality Adjustment Factor </FP>
                        <FP SOURCE="FP1-2">a. Cost Report Data for January 1, 2005 through June 30, 2006 </FP>
                        <FP SOURCE="FP1-2">b. Estimate of Total Payments Under the TEFRA Payment System </FP>
                        <FP SOURCE="FP1-2">c. Payments Under the IPF PPS without a Budget-Neutrality Adjustment </FP>
                        <FP SOURCE="FP1-2">C. Standardization and Budget-Neutrality Adjustments </FP>
                        <FP SOURCE="FP1-2">D. Calculation of the Budget Neutrality Adjustments </FP>
                        <FP SOURCE="FP1-2">1. Outlier Adjustment </FP>
                        <FP SOURCE="FP1-2">2. Stop Loss Adjustment </FP>
                        <FP SOURCE="FP1-2">3. Behavioral Offset </FP>
                        <FP SOURCE="FP-2">VI. Cost Regression Used To Develop Payment Adjustment Factors </FP>
                        <FP SOURCE="FP1-2">A. Final Regression Analysis </FP>
                        <FP SOURCE="FP1-2">B. Patient-Level Adjustments </FP>
                        <FP SOURCE="FP1-2">1. Adjustment for DRG Assignment </FP>
                        <FP SOURCE="FP1-2">2. Comorbidities </FP>
                        <FP SOURCE="FP1-2">3. Other Coding Issues </FP>
                        <FP SOURCE="FP1-2">4. Patient Age </FP>
                        <FP SOURCE="FP1-2">5. Variable Per Diem Adjustments </FP>
                        <FP SOURCE="FP1-2">6. Other Patient-Level Adjustments </FP>
                        <FP SOURCE="FP1-2">a. Gender </FP>
                        <FP SOURCE="FP1-2">b. Patients admitted through the Hospital's Emergency Department (ED) </FP>
                        <FP SOURCE="FP1-2">c. Patients who Receive Electroconvulsive Therapy (ECT) </FP>
                        <FP SOURCE="FP1-2">d. Patient's Involuntarily Committed to the IPF </FP>
                        <FP SOURCE="FP1-2">e. Administrative Necessary Days </FP>
                        <FP SOURCE="FP1-2">C. Facility-Level Adjustments </FP>
                        <FP SOURCE="FP1-2">1. Wage Index </FP>
                        <FP SOURCE="FP1-2">2. Rural Location </FP>
                        <FP SOURCE="FP1-2">3. Teaching Status Adjustments </FP>
                        <FP SOURCE="FP1-2">4. Other Facility-Level Adjustments </FP>
                        <FP SOURCE="FP1-2">a. Adjustment for Psychiatric Units </FP>
                        <FP SOURCE="FP1-2">b. Cost of Living Adjustment </FP>
                        <FP SOURCE="FP1-2">i. IPFs Located in Alaska and Hawaii </FP>
                        <FP SOURCE="FP1-2">ii. IPFs Located in California </FP>
                        <FP SOURCE="FP1-2">c. Disproportionate Share Intensity </FP>
                        <FP SOURCE="FP1-2">d. IPFs with Full-Service Emergency Departments </FP>
                        <FP SOURCE="FP1-2">D. Other Proposed Adjustments and Policy Changes </FP>
                        <FP SOURCE="FP1-2">1. Outlier Policy </FP>
                        <FP SOURCE="FP1-2">a. Statistical Accuracy of Cost-for-Change Ratios </FP>
                        <FP SOURCE="FP1-2">b. Adjustments of IPF Outlier Payments </FP>
                        <FP SOURCE="FP1-2">2. Interrupted Stays </FP>
                        <FP SOURCE="FP1-2">3. Stop-Loss Provision </FP>
                        <FP SOURCE="FP1-2">4. Physician Recertification Requirements </FP>
                        <FP SOURCE="FP-2">VII. Implementation of the IPF PPS </FP>
                        <FP SOURCE="FP1-2">A. Transition Period </FP>
                        <FP SOURCE="FP1-2">1. Existing Providers </FP>
                        <FP SOURCE="FP1-2">2. New Providers </FP>
                        <FP SOURCE="FP1-2">B. Claims Processing </FP>
                        <FP SOURCE="FP1-2">C. Annual Update </FP>
                        <FP SOURCE="FP-2">VIII. Future Refinements </FP>
                        <FP SOURCE="FP-2">IX. Comments Beyond the Scope of the Final Rule </FP>
                        <FP SOURCE="FP-2">X. Provisions of the Final Rule </FP>
                        <FP SOURCE="FP-2">XI. Collection of Information Requirements </FP>
                        <FP SOURCE="FP-2">XII. Regulatory Impact Analysis </FP>
                        <FP SOURCE="FP1-2">A. Overall Impact </FP>
                        <FP SOURCE="FP1-2">B. Anticipated Effects </FP>
                        <FP SOURCE="FP1-2">1. Budgetary Impacts </FP>
                        <FP SOURCE="FP1-2">2. Impacts on Providers </FP>
                        <FP SOURCE="FP1-2">3. Results </FP>
                        <FP SOURCE="FP1-2">a. Facility Type </FP>
                        <FP SOURCE="FP1-2">b. Location </FP>
                        <FP SOURCE="FP1-2">c. Teaching Status Adjustment </FP>
                        <FP SOURCE="FP1-2">d. Census Region </FP>
                        <FP SOURCE="FP1-2">e. Size </FP>
                        <FP SOURCE="FP1-2">4. Effect on the Medicare Program </FP>
                        <FP SOURCE="FP1-2">5. Effect on Beneficiaries </FP>
                        <FP SOURCE="FP1-2">6. Computer Hardware and Software </FP>
                        <FP SOURCE="FP1-2">C. Alternatives Considered </FP>
                        <FP SOURCE="FP-2">Regulation Text </FP>
                        <FP SOURCE="FP-2">Addendum A: Proposed Inpatient PPS Adjustments </FP>
                        <FP SOURCE="FP-2">Addendum B: Wages </FP>
                        <FP SOURCE="FP-2">Addendum C: “Code First” List </FP>
                        <HD SOURCE="HD1">Acronyms </HD>
                        <P>Because of the many terms to which we refer by acronym in this final rule, we are listing the acronyms used and their corresponding terms in alphabetical order below: </P>
                        <FP SOURCE="FP-1">BBA Balanced Budget Act of 1997 (Pub. L. 105-33) </FP>
                        <FP SOURCE="FP-1">BBRA Medicare, Medicaid and SCHIP [State Children's Health Insurance Program] Balanced Budget Refinement Act of 1999 (Pub. L. 106-113) </FP>
                        <FP SOURCE="FP-1">BIPA Medicare, Medicaid, and SCHIP [State Children's Health Insurance Program] Benefits Improvement and Protection Act of 2000 (Pub. L. 106-554) </FP>
                        <FP SOURCE="FP-1">CMS Centers for Medicare &amp; Medicaid Services </FP>
                        <FP SOURCE="FP-1">DSM-IV-TR Diagnostic and Statistical Manual of Mental Disorders Fourth Edition—Text Revision </FP>
                        <FP SOURCE="FP-1">DRGs Diagnosis-related groups </FP>
                        <FP SOURCE="FP-1">FY Federal fiscal year </FP>
                        <FP SOURCE="FP-1">HCRIS Hospital Cost Report Information System </FP>
                        <FP SOURCE="FP-1">ICD-9-CM International Classification of Diseases, 9th Revision, Clinical Modification </FP>
                        <FP SOURCE="FP-1">IPFs Inpatient psychiatric facilities </FP>
                        <FP SOURCE="FP-1">IPPS Hospital Inpatient Prospective Payment System </FP>
                        <FP SOURCE="FP-1">IRFs Inpatient rehabilitation facilities </FP>
                        <FP SOURCE="FP-1">LTCHs Long-term care hospitals </FP>
                        <FP SOURCE="FP-1">
                            MedPAR Medicare provider analysis and review file 
                            <PRTPAGE P="66923"/>
                        </FP>
                        <FP SOURCE="FP-1">MMA Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (Pub. L. 108-173) </FP>
                        <FP SOURCE="FP-1">PIP Periodic interim payments </FP>
                        <FP SOURCE="FP-1">PPS Prospective Payment System </FP>
                        <FP SOURCE="FP-1">TEFRA Tax Equity and Fiscal Responsibility Act of 1982, (Pub. L. 97-248) </FP>
                    </EXTRACT>
                    <HD SOURCE="HD1">I. Background </HD>
                    <HD SOURCE="HD2">A. General and Legislative History </HD>
                    <P>When the Medicare statute was originally enacted in 1965, Medicare payment for inpatient hospital services was based on the reasonable costs incurred in furnishing services to Medicare beneficiaries. Section 223 of the Social Security Act Amendments of 1972 (Pub. L. 92-603) amended section 1861(v)(1) of the Social Security Act (the Act) to set forth limits on reasonable costs for inpatient hospital services. The statute was later amended by section 101(a) of the Tax Equity and Fiscal Responsibility Act of 1982 (TEFRA) (Pub. L. 97-248) to limit payment by placing a limit on allowable costs per discharge. </P>
                    <P>The Congress directed implementation of a prospective payment system (PPS) for acute care hospitals in 1983, with the enactment of Public Law 98-21. Section 601 of the Social Security Amendments of 1983 (Pub. L. 98-21) added a new section 1886(d) to the Act that replaced the reasonable cost-based payment system for most inpatient hospital services with a PPS. </P>
                    <P>Although most inpatient hospital services became subject to the PPS, certain specialty hospitals were excluded from the PPS and continued to be paid reasonable costs subject to limits imposed by TEFRA. These hospitals included psychiatric hospitals and psychiatric units in acute care hospitals, long-term care hospitals (LTCH), children's hospitals, and rehabilitation hospitals and rehabilitation units in acute care hospitals. Cancer hospitals were added to the list of excluded hospitals by section 6004(a) of the Omnibus Budget Reconciliation Act of 1989 (Pub. L. 101-239). </P>
                    <P>The Congress enacted various provisions in the Balanced Budget Act of 1997 (BBA) (Pub. L. 105-33), the Medicare, Medicaid, and SCHIP [State Children's Health Insurance Program] Balanced Budget Refinement Act (BBRA) (Pub. L. 106-113), and the Medicare, Medicaid, and SCHIP Benefits Improvement and Protection Act of 2000 (BIPA) (Pub. L. 106-554) to replace the cost-based methods of reimbursement with a PPS for the following excluded hospitals: </P>
                    <P>• Rehabilitation hospitals and rehabilitation units in acute care hospitals. </P>
                    <P>• Psychiatric hospitals and psychiatric units in acute care hospitals. </P>
                    <P>• Long term care hospitals. </P>
                    <P>The BBA also imposed national limits (or caps) on hospital-specific target amounts (that is, annual per discharge limits) for these hospitals until cost reporting periods beginning on or after October 1, 2002. A detailed description of the TEFRA payment methodology is provided in section B.1. of this final rule. </P>
                    <P>Section 124 of the BBRA mandated that the Secretary—(1) develop a per diem PPS for inpatient hospital services furnished in psychiatric hospitals and psychiatric units (hereinafter referred to as inpatient psychiatric facilities (IPFs)); (2) include in the PPS an adequate patient classification system that reflects the differences in patient resource use and costs among psychiatric hospitals and psychiatric units; (3) maintain budget neutrality; (4) permit the Secretary to require psychiatric hospitals and psychiatric units to submit information necessary for the development of the PPS; and (5) submit a report to the Congress describing the development of the PPS. </P>
                    <P>Section 124 of the BBRA also required that the PPS for IPFs be implemented for cost reporting periods beginning on or after October 1, 2002. In general, the creation of a prospective payment system requires an extraordinary amount of lead-time in order to conduct the research that is required to create a completely new payment system. For example, we must create data files, develop models to test individual variables and those variables' ability to explain costs, as well as perform extensive empirical analysis of the collected data. </P>
                    <P>With respect to the creation of the IPF PPS, more lead time than usual was necessary. This is because the research we had conducted before the passage of the BBRA dated back to the 1980s and was focused on developing a per discharge IPF PPS. The research efforts to develop a discharged-based IPF PPS, however, failed to adequately explain cost variation among psychiatric cases. Because diagnosis in psychiatry is complicated and the criteria for diagnosis and treatment are less well defined in psychiatry than in general medicine and surgery, developing an IPF PPS was more elusive. Moreover, there have been significant changes in mental health treatment, for example, new medications and outpatient treatment options. Thus, to develop an adequate patient classification system that reflects the differences in patient resource use and costs, we had to embark on numerous courses of research that could be used as a possible foundation for the proposed IPF PPS. </P>
                    <P>When we began the process of developing a proposed IPF PPS, we believed pursuing an assessment instrument, incorporating key indicators of functional status, was the most logical place to begin. This approach is consistent with the approach we followed in developing patient classification systems for other Medicare prospective payment systems (for example., home health agencies, skilled nursing facilities, and inpatient rehabilitation facilities). Our administrative data was inadequate to develop other patient classification systems because, although it provides useful information on diagnoses, services, and procedures, it does not include many patient and clinical characteristics and functional status indicators, which have been established as key components of a patient classification system. Therefore, to obtain the patient-level data we needed to develop an assessment-based patient classification system, we contracted with the University of Michigan's Public Health Institute in September 2002. We selected this contractor because it had developed a protocol assessment instrument, precursors of which had shown promise in explaining variation in resource utilization among psychiatric patients. Although there continues to be progress in completing the initial phase of this research, that is, adoption of an initial assessment instrument for pilot testing, we are unable to delay implementation of the IPF PPS until the draft assessment instrument is completed. </P>
                    <P>
                        Also, in our effort to meet the requirements of section 124 of the BBRA, we also pursued a second research project with the Health, Economics, Research, Inc. (now known as RTI International
                        <E T="51">®</E>
                        ). RTI International
                        <E T="51">®</E>
                         embarked on a research project to identify patient characteristics and modes of practice believed to account for variation in per diem cost. It became apparent that, despite everyone's best efforts, the ongoing research projects being conducted by the University of Michigan and RTI International
                        <E T="51">®</E>
                        , could not be completed in time for us to engage in notice and comment rulemaking and achieve implementation of the IPF PPS by October 1, 2002. 
                    </P>
                    <P>
                        In addition, shortly before October 1, 2002, the American Psychiatric Association (APA) informed us that The Health Economics and Outcomes 
                        <PRTPAGE P="66924"/>
                        Research Institute (THEORI) of the Greater New York Hospital Association had developed a potential IPF PPS classification model that was based on our currently available administrative data. Based on the model presented to us by the APA, we immediately began our own vigorous review of the “APA” model. We note, however, that although the information shared with us by the APA was extremely valuable in our formulation of a proposed IPF PPS, it came too late for us to be able to do the following: (1) Perform the analysis required to ensure that a system based on our administrative data would fulfill the statutory mandate of section 124 of the BBRA; and (2) engage in notice-and-comment rulemaking and implement the IPF PPS by October 1, 2002. As soon as we completed an analysis of the information presented by the APA and of our administrative data, we published the proposed IPF PPS regulation. 
                    </P>
                    <P>Initially, the proposed rule provided for a 60-day comment period. However, due to the complexity and scope of the proposed rule and because the public requested additional time to examine the rule so that it could provide meaningful comments, we extended the public comment period. The intricacy and complexity of the issues presented in the public comments required us to perform further substantial analysis to adequately address the issues raised by commenters, as well as our duty to satisfy section 124 of the BBRA. We have made every effort to complete this final rule as quickly as possible.</P>
                    <P>(We note that, even though the IPF PPS described in this final rule is effective for cost reporting periods beginning on or after January 1, 2005 and compliance with the IPF PPS requirements is required for cost reporting periods beginning on or after January 1, 2005, we will not have computer system changes in place that are necessary to accommodate claims processing under the IPF PPS until April 4, 2005 (claims processing updates will occur on the first Monday following April 1, 2005). Therefore, claims submitted after January 1, 2005, but before April 4, 2005, will be paid as if the TEFRA rate was still in effect. Payments will be reconciled with the appropriate IPF PPS amount. We have instructed the fiscal intermediaries (FIs) to reconcile the payments that are made to IPFs for covered inpatient hospital services furnished to Medicare beneficiaries for cost reporting periods beginning on or after January 1, 2005, until the date of the systems implementation on April 4, 2005, with the amounts that are payable under the IPF PPS system by May 1, 2005. </P>
                    <P>Since IPFs will receive payment under the IPF PPS starting with their first cost reporting period beginning on or after January 1, 2005, only those IPFs with cost reporting periods beginning on or after January 1, 2005 but before April 1, 2005 will experience payment reconciliation. </P>
                    <HD SOURCE="HD2">Requirements for Issuance of Regulations </HD>
                    <P>Section 902 of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) amended section 1871(a) of the Act and requires the Secretary, in consultation with the Director of the Office of Management and Budget, to establish and publish timelines for the publication of Medicare final regulations based on the previous publication of a Medicare proposed or interim final regulation. Section 902 of the MMA also states that the timelines for these regulations may vary but will not exceed 3 years after publication of the preceding proposed or interim final regulation except under exceptional circumstances. </P>
                    <P>This rule finalizes provisions set forth in the November 28, 2003 proposed rule (68 FR 66920). In addition, this final rule has been published within the 3-year time limit imposed by section 902 of the MMA. Therefore, we believe that the final rule is in accordance with the Congress' intent to ensure timely publication of final regulations. </P>
                    <HD SOURCE="HD2">B. Overview of the Payment System for Inpatient Psychiatric Hospitals and Psychiatric Units Before the BBRA </HD>
                    <HD SOURCE="HD3">1. Description of the TEFRA Payment Methodology </HD>
                    <P>Hospitals and units that are excluded from the hospital inpatient prospective payment system (IPPS) under section 1886(d)(1)(B) of the Act are paid for their inpatient operating costs under the provisions of the TEFRA (Pub. L. 97-248). </P>
                    <P>
                        The TEFRA provisions are found in section 1886(b) of the Act and implemented in regulations at 42 CFR 413. TEFRA established payments based on hospital-specific limits for inpatient operating costs. As specified in § 413.40, TEFRA established a ceiling on payments for hospitals excluded from the IPPS. The ceiling on payments is determined by calculating the product of a facility's base year costs (the year in which its target reimbursement limit is based) per discharge, updated to the current year by a rate-of-increase percentage, and multiplied by the number of total current year discharges. A detailed discussion of target amount payment limits under TEFRA can be found in the final rule concerning the IPPS published in the 
                        <E T="04">Federal Register</E>
                         on September 1, 1983 (48 FR 39746). 
                    </P>
                    <P>The base year for a facility varied, depending on when the facility was initially determined to be an IPPS excluded provider. The base year for facilities that were established before the implementation of the TEFRA provision was 1982. For facilities established after the implementation of the TEFRA provision, facilities were allowed to choose which of their first 3 cost reporting years would be used in the future to determine their target limit. In 1992, the “new provider” period was shortened to 2 full years of cost reporting periods (§ 413.40(f)(1)). </P>
                    <P>Excluded facilities whose costs were below their target amounts would receive bonus payments equal to the lesser of half of the difference between costs and the target amount, up to a maximum of 5 percent of the target amount, or the hospital's costs. For excluded hospitals whose costs exceeded their target amounts, Medicare provided relief payments equal to half of the amount by which the hospital's costs exceeded the target amount up to 10 percent of the target amount. Excluded facilities that experienced a more significant increase in patient acuity could also apply for an additional amount as specified in § 413.40(d) for Medicare exception payments. </P>
                    <HD SOURCE="HD3">2. BBA Amendments to TEFRA </HD>
                    <P>
                        The BBA amendments to section 1886 of the Act significantly altered the payment provisions for hospitals and units paid under the TEFRA provisions and added other qualifying criteria for certain hospitals excluded from the IPPS. A complete explanation of these amendments can be found in the final rule concerning the IPPS we published in the 
                        <E T="04">Federal Register</E>
                         on August 29, 1997 (62 FR 45966). 
                    </P>
                    <P>The BBA made the following changes to section 1886 of the Act for TEFRA hospitals: </P>
                    <P>• Section 4411 of the BBA amended section 1886(b)(3)(B) of the Act and restricted the rate-of-increase percentages that are applied to each provider's target amount so that excluded hospitals and units experiencing lower inpatient operating costs relative to their target amounts receive lower rates of increase. </P>
                    <P>
                        • Section 4412 of the BBA amended section 1886(g) of the Act to establish a 15-percent reduction in capital payments for excluded psychiatric and rehabilitation hospitals and units and LTCHs, for portions of cost reporting periods occurring during the period of 
                        <PRTPAGE P="66925"/>
                        October 1, 1997, through September 30, 2002. 
                    </P>
                    <P>• Section 4414 of the BBA amended section 1886(b)(3) of the Act to establish caps on the target amounts for excluded hospitals and units at the 75th percentile of target amounts for similar facilities for cost reporting periods beginning on or after October 1, 1997, through September 30, 2002. The caps on these target amounts apply only to psychiatric hospitals and rehabilitation hospital units and LTCHs. Payments for these excluded hospitals and units are based on the lesser of a provider's cost per discharge or its hospital-specific cost per discharge, subject to this cap. </P>
                    <P>• Section 4415 of the BBA amended section 1886(b)(1) of the Act by revising the percentage factors used to determine the amount of bonus and relief payments and establishing continuous improvement bonus payments for excluded hospitals and units for cost reporting periods beginning on or after October 1, 1997. If a hospital is eligible for the continuous improvement bonus, the bonus payment is equal to the lesser of: (1) 50 percent of the amount by which operating costs are less than expected costs; or (2) 1 percent of the target amount. </P>
                    <P>• Sections 4416 and 4419 of the BBA amended sections 1886(b) of the Act to establish a new framework for payments for new excluded providers. Section 4416 of the BBA added a new section 1886(b)(7) to the Act that established a new statutory methodology for new psychiatric and rehabilitation hospitals and units, and LTCHs. Under section 4416 of the BBA, payment to these providers for their first two cost reporting periods is limited to the lesser of the operating costs per case, or 110 percent of the national median of target amounts. This is adjusted for differences in wage levels, for the same class of hospital for cost reporting periods ending during FY 1996, updated to the applicable period. </P>
                    <HD SOURCE="HD3">3. BBRA Amendments to TEFRA </HD>
                    <P>
                        The BBRA of 1999 refined some of the policies mandated by the BBA for hospitals and units paid under the TEFRA provisions. The provisions of the BBRA, amending section 1886(b)(3)(H) of the Act, were explained in detail and implemented in the IPPS interim final rule published in the 
                        <E T="04">Federal Register</E>
                         on August 1, 2000 (65 FR 47026) and in the IPPS final rule also published on August 1, 2000 (65 FR 47054). 
                    </P>
                    <P>With respect to the TEFRA payment methodology, section 4414 of the BBA had provided for caps on target amounts for excluded hospitals and units for cost reporting periods beginning on or after October 1, 1997. Section 121 of the BBRA amended section 1886(b)(3)(H) of the Act to provide for an appropriate wage adjustment to these caps on the target amounts for certain hospitals and units paid under the TEFRA provisions, effective for cost reporting periods beginning on or after October 1, 1999 through September 30, 2002. </P>
                    <HD SOURCE="HD3">4. BIPA Amendments to TEFRA </HD>
                    <P>Section 306 of BIPA amended section 1886 of the Act by increasing the incentive payments for psychiatric hospitals and psychiatric units to 3 percent for cost reporting periods beginning on or after October 1, 2000 and before October 1, 2001. </P>
                    <HD SOURCE="HD1">II. Provisions of the Proposed Regulations </HD>
                    <P>
                        On November 28, 2003, we published a proposed rule in the 
                        <E T="04">Federal Register</E>
                         (68 FR 66920) as required by section 124 of the BBRA that proposed a PPS for Medicare payment of inpatient hospital services furnished in IPFs. The IPF PPS would replace the current reasonable cost-based payment system under the TEFRA provisions. 
                    </P>
                    <P>We proposed to base the IPF PPS on data from the fiscal year (FY) 1999 Medicare Provider Analysis and Review (MedPAR) file, which includes patient characteristics (for example, patients' diagnoses and age), and data from the FY 1999 Hospital Cost Report Information System (HCRIS), which includes facility characteristics (for example, location and teaching status). We proposed the following policies and methodology for the IPF PPS. We proposed to: </P>
                    <P>• Add a new subpart N in 42 CFR 412 for the IPF PPS, and make conforming changes to parts 412 and 413 regarding the implementation of the IPF PPS. </P>
                    <P>• Compute a standardized Federal per diem payment to be paid to all IPFs based on the sum of the national average routine operating, ancillary, and capital costs for each patient day of psychiatric care in an IPF adjusted for budget neutrality. </P>
                    <P>• Adjust the Federal per diem payment to reflect certain patient and facility characteristics that were found in the regression analysis to be associated with statistically significant cost differences. </P>
                    <P>• Provide patient-level adjustments for age, specified diagnosis-related groups (DRGs), and selected comorbidity categories. </P>
                    <P>• Provide facility adjustments that include a wage index adjustment, rural location adjustment, and a teaching status adjustment. </P>
                    <P>• Recognize variable per diem adjustments to account for the higher costs incurred in the early days of a psychiatric stay. </P>
                    <P>• Adopt an outlier policy to target greater payment to the high cost cases. </P>
                    <P>• Provide an interrupted stay policy for the purpose of applying the variable per diem adjustment and the outlier policy. </P>
                    <P>• Implement the IPF PPS for IPF cost reporting periods beginning on or after April 1, 2004, with a 3-year transition period. We proposed that the first update would occur on July 1, 2005. </P>
                    <P>• Include a coding policy that would require IPFs to report patient diagnoses using the International Classification of Diseases-9th Revision, Clinical Modification (ICD-9-CM) code set. </P>
                    <P>• Update a regulatory reference to the Diagnostic and Statistical Manual of Mental Disorders (DSM) from the Third Edition to the Fourth Edition, Text Revision (DSM-IV-TR). </P>
                    <P>• Use the 1997-based excluded hospital with capital market basket to establish the labor-related share of the Federal per diem base rate, to calculate the budget neutrality adjustment, and to update the Federal per diem base rate. </P>
                    <P>• Provide the annual update strategy for the IPF PPS. </P>
                    <P>• Include research information for future refinement of the patient classification system. </P>
                    <HD SOURCE="HD1">III. Analysis of and Responses to Public Comments </HD>
                    <P>
                        In the November 28, 2003 
                        <E T="04">Federal Register</E>
                         (68 FR 66920), we published the proposed IPF PPS and provided for a 60-day comment period. On January 30, 2004, we published a notice in the 
                        <E T="04">Federal Register</E>
                         (68 FR 4464) extending the comment period for an additional 30 days in response to public requests. The comment period that would have closed on January 27, 2004, was extended 30 days. Thus, the comment period for the proposed rule closed on February 26, 2004. 
                    </P>
                    <P>
                        We received 273 comments from hospital associations, psychiatric hospitals, providers, acute care hospitals, health research organizations, patient advocacy organizations, State associations, and physicians. We reviewed each commenter's letter and grouped related comments. Some comments were identical. After associating like comments, we placed them in categories based on subject matter or based on the section(s) of the regulation affected. Summaries of the public comments received and our responses to those comments are set forth below. 
                        <PRTPAGE P="66926"/>
                    </P>
                    <HD SOURCE="HD1">IV. Overview of the IPF PPS Proposed Payment Methodology </HD>
                    <P>In the November 2003 proposed rule, we proposed to establish a Federal payment for each patient day in an IPF derived from the national average daily routine operating, ancillary, and capital costs in IPFs. The Federal per diem payment would comprise a Federal per diem base rate adjusted by factors for patient and facility characteristics that account for variation in patient resource use. The Federal per diem base rate would be updated to the midpoint of the first year under the IPF PPS, standardized to account for the overall positive effects of the IPF PPS payment adjustments, and adjusted for budget neutrality. </P>
                    <P>We proposed that psychiatric hospitals and psychiatric units paid under section 1886(b) of the Act would be paid under the IPF PPS for cost reporting periods beginning on or after April 1, 2004. We proposed that the IPF PPS would apply to inpatient hospital services furnished by Medicare participating entities in the United States that are classified as psychiatric hospitals or psychiatric units as specified in § 412.22, § 412.23, § 412.25, and § 412.27. As specified in § 400.200, the United States means the 50 States, the District of Columbia, the Commonwealth of Puerto Rico, the Virgin Islands, Guam, American Samoa, and the Northern Mariana Islands. </P>
                    <P>However, the following hospitals are paid under special payment provisions specified in § 412.22(c) and, therefore, would not be paid under the IPF PPS: </P>
                    <P>• Veterans Administration hospitals. </P>
                    <P>• Hospitals that are reimbursed under State cost control systems approved under 42 CFR part 403. </P>
                    <P>• Hospitals that are reimbursed in accordance with demonstration projects specified in section 402(a) of Public Law 90-248 (42 U.S.C. 1395b-1) or section 222(a) of Public Law 92-603 (42 U.S.C. 1395b-1(note)). </P>
                    <P>• Non-participating hospitals furnishing emergency services to Medicare beneficiaries. </P>
                    <P>We received a variety of comments on the proposed applicability requirements of the IPF PPS. In this final rule, we are adopting the proposed policies regarding applicability of the IPF PPS. </P>
                    <P>
                        <E T="03">Comment:</E>
                         One commenter recommended that CMS develop a separate payment system for government-operated IPFs. The commenter believes that these hospitals provide a different service than other psychiatric hospitals and psychiatric units. 
                    </P>
                    <P>Several commenters requested that psychiatric units be excluded from the IPF PPS until a more equitable system can be created. </P>
                    <P>
                        <E T="03">Response:</E>
                         Section 124 of Public Law 106-113 requires the Secretary to implement a prospective payment system for psychiatric hospitals described in clause (i) of section 1886(d)(1)(B) of the Act and psychiatric units described in clause (v) of this section. Government-operated psychiatric hospitals and psychiatric units fall within the definition of a psychiatric hospital and unit outlined in section 124 of the BBRA to which this IPF PPS applies. Consequently, these entities, like all other psychiatric hospitals and units, must be paid under this system effective with the start of the implementation of the IPF PPS. 
                    </P>
                    <P>With regard to the equity of the payment system, we believe that we are implementing an equitable prospective payment system based on the best data available. </P>
                    <P>We also believe it is important to note that a per diem approach explains a significant percentage of the cost variation among inpatient psychiatric patients. We estimate that the final IPF PPS explains the 33 percent variation in per diem cost among IPF cases. A commenter indicated that the combination of the explanatory power of a per diem system and the proposed adjustments on case level costs is approximately 80 percent. Our analysis confirmed the commenter's findings, however, we found the explanatory power of a per diem system and the final adjustment factors to be approximately 85 percent, solidifying our belief that the payment model combination we are using, a per diem system with adjustments based on case level costs, is equitable. </P>
                    <P>
                        <E T="03">Comment:</E>
                         One commenter questioned whether psychiatric units that are currently paid under the IPPS and do not meet the requirements of § 412.22, § 412.25, and § 412.27 would be excluded from the IPF PPS. The commenter also asked whether these providers would be paid under the IPF PPS if they would meet the requirements of § 412.22, § 412.25, and § 412.27. A few commenters asked if “DRG-exempt status” for psychiatric units would continue to be an option after the effective date of the IPF PPS. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         If a hospital has a psychiatric unit that meets the requirements specified in § 412.22, § 412.25, and § 412.27, the psychiatric unit is excluded from the IPPS (that is, DRG-exempt). The IPF PPS will replace the reasonable cost-based payments currently paid to excluded psychiatric hospitals and units for cost reporting periods beginning on or after January 1, 2005. Once the IPF PPS is implemented, hospitals will be paid under the IPF PPS for all patients admitted to the excluded psychiatric unit. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         One commenter recommended that critical access hospitals (CAHs) be allowed cost-based reimbursement for services in their psychiatric units. If a hospital or unit treats psychiatric patients but it does not meet the statutory definition of a psychiatric hospital or unit, then the IPF PPS would not apply. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         Section 405(g)(2) of the MMA specifies that the amount of payment for services in psychiatric units of a CAH described in section 1820(c)(2)(E) of the Act shall be equal to the amount that would otherwise be made if the services were inpatient hospital services provided in a distinct part psychiatric unit. Therefore, we have amended § 413.70(e) to clarify that, effective for cost reporting periods beginning on or after January 1, 2005, certified psychiatric units in CAHs will be paid under the IPF PPS. We believe the statute is very clear concerning methodology. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         Several commenters requested an exceptions process through which an IPF could seek additional payment. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We believe that the final IPF PPS explains a sufficient amount of the cost variation among IPF patients and that an exceptions process is not necessary. 
                    </P>
                    <P>More importantly, when we become aware of patient or facility characteristics that lead to higher per diem costs, we would propose to establish an adjustment factor to the IPF PPS so that all IPFs that qualify could benefit from the adjustment as part of routine claims processing rather than through an exceptions process through which an individual IPF could request additional payment. Therefore, we will be accounting for their differences in costs. </P>
                    <HD SOURCE="HD1">V. Development of the Budget-Neutral Federal Per Diem Base Rate </HD>
                    <P>
                        In the proposed rule, we proposed that the IPF PPS be based on a standardized Federal per diem base rate calculated from IPF average per diem costs and adjusted for budget-neutrality. We proposed that the Federal per diem base rate would be used as the standard payment per day for the IPF PPS. In addition, the Federal per diem base rate would be adjusted by the applicable wage index factor and the patient-level and facility-level adjustments that are applicable to the stay. 
                        <PRTPAGE P="66927"/>
                    </P>
                    <HD SOURCE="HD2">A. Calculation of the Average Per Diem Cost </HD>
                    <P>To calculate the proposed Federal per diem base rate, we estimated the cost per day for—(1) routine services from FY 1999 cost reports (supplemented with FY 1998 cost reports if the FY 1999 cost report is missing); and (2) ancillary costs per day using data from the FY 1999 Medicare claims and corresponding data from facility cost reports. </P>
                    <P>For routine services, the per diem operating and capital costs were used to develop the base for the psychiatric per diem amount. The per diem routine costs were obtained from each facility's Medicare cost report. To estimate the costs for routine services included in the proposed Federal per diem base rate calculation, we added the total routine costs (including costs for capital) submitted on the cost report for each provider and divided it by the total Medicare days. </P>
                    <P>Some average routine costs per day were determined to be aberrant, that is, the costs were extraordinarily high or low and most likely contained data errors. The following method was used to trim extraordinarily high or low cost values in order to improve the accuracy of our results. </P>
                    <P>First, the average and standard deviations of the total per diem cost (routine and ancillary costs) were computed separately for cases from psychiatric hospitals and psychiatric units. Separate statistics were computed because we did not want to systematically exclude a larger proportion of cases from the higher cost psychiatric units. Before calculating the means, we trimmed cases from the file when covered days were zero or routine costs were less than $100 or greater than $3,000. We selected these amounts because we believe this range captured the grossly aberrant cases. Elimination of the grossly aberrant cases would prevent the means from being distorted. </P>
                    <P>Second, we trimmed cases when the provider's total cost per day was outside the generally-accepted statistical trim points of plus or minus 3.00 standard deviations from the respective means for each facility type (psychiatric hospitals and psychiatric units). If the total cost per day was outside the trim value, we deleted the data for that provider from the per diem rate development file because it helped eliminate skewing of the data. After trimming the data, the average routine cost per day in FY 1999 was calculated to be $495. </P>
                    <P>For ancillary services, we calculated the costs by converting charges from the FY 1999 Medicare claims into costs using facility-specific, cost-center specific cost-to-charge ratios obtained from each provider's applicable cost reports. We matched each provider's departmental cost-to-charge ratios from their Medicare cost report to each charge on their claims reported in the MedPAR file. Multiplying the total charges for each type of ancillary service by the corresponding cost-to-charge ratio provided an estimate of the costs for all ancillary services received by the patient during the stay. </P>
                    <P>For those departmental cost-to-charge ratios that we considered to be aberrant because they were outside the generally-accepted statistical trim points of plus or minus 3.00 standard deviations from the facility-type mean, we replaced the individual cost-to-charge ratios for each department with the median department cost-to-charge ratio by facility type (psychiatric hospital or psychiatric unit). We considered using the mean of the cost to-charge ratio as the substitution value, but because the distribution of ratios of cost-to-charges is not normally distributed and there is no limit to the upper ceiling of the ratio, the mean ratio would be overstated due to the higher values on the upper tail of the bell curve. Therefore, we chose the median by facility type as a better measure for the substitution value when the facility's actual cost-to-charge ratio was outside the trim values. </P>
                    <P>After computing the estimated costs of applying the applicable cost-to-charge ratios, and, when appropriate, the median cost-to charge ratio, to the total ancillary charges for each patient stay, we determined the average ancillary amount per day by dividing the total ancillary costs for all stays by the total number of covered Medicare days. Using this methodology, the average ancillary cost per day in FY 1999 was calculated to be $67. </P>
                    <P>Adding the average ancillary costs per day ($67) and the average routine costs per day including capital costs ($495) provides the estimated average per diem cost for each patient day of inpatient psychiatric care in FY 1999 ($562). We used the above described procedures to calculate the average per diem cost in this final rule as well. </P>
                    <P>
                        <E T="03">Comment:</E>
                         Several commenters recommended that CMS use more current data for the final IPF PPS. The commenters suggested that CMS use the FY 2002 MedPAR data and the FY 2002 HCRIS data, supplemented with FY 2001 cost report data when necessary. 
                    </P>
                    <P>A few commenters indicated it would be preferable to use the most current cost report data, with an appropriate audit adjustment factor, if necessary. </P>
                    <P>
                        <E T="03">Response:</E>
                         We used the best available data when we developed the proposed rule. We are continuing to use the best data available for this final rule. Specifically, we calculated the average cost per day using FY 2002 claims and cost report data supplemented with FY 2001 cost report data if the FY 2002 cost report was missing. Using FY 2002 data and the methodology described above, we calculated the per diem cost for each patient day of inpatient psychiatric care in an IPF in FY 2002. We note that currently, less than 50 percent of the hospitals have filed their FY 2003 cost reports. Therefore, we believe that FY 2002 cost report data provides the best available information for this final rule. 
                    </P>
                    <HD SOURCE="HD2">B. Determining the Update Factors for the Budget-Neutrality Calculation </HD>
                    <P>Section 124(a)(1) of the BBRA requires that the IPF PPS be budget neutral. In other words, the amount of total payments under the IPF PPS, including any payment adjustments, must be projected to be equal to the amount of total payments that would have been made if the IPF PPS were not implemented. Therefore, in the proposed rule as well as in this final rule, we have calculated the budget-neutrality factor by setting the total estimated PPS payments to be equal to the total estimated payments that would have been made under the TEFRA methodology had the IPF PPS not been implemented. </P>
                    <P>In the proposed rule, we based the rate setting calculations and estimated impacts on an April 1, 2004 implementation date. However, in order to create a more efficient process of updates for the various Medicare payment systems, we proposed to establish a July 1 annual update cycle for the IPF PPS. We also indicated we would not update the rates on July 1, 2004 because we believed there would be an insufficient time under the new IPF PPS to generate data that would be useful in updating the IPF PPS. As a result, we calculated the proposed Federal per diem base rate to be budget neutral for the 15-month period April 1, 2004 through June 30, 2005. </P>
                    <P>
                        In this final rule, we calculated the final Federal per diem base rate to be budget neutral during the implementation period under the IPF PPS. As in the proposed rule, we will use a July 1 update cycle. Similar to the proposed rule, we will not update the IPF PPS during the first year of implementation because we believe there would be an insufficient amount of time under the IPF PPS to generate data useful in updating the system. Thus, the implementation period for the 
                        <PRTPAGE P="66928"/>
                        final IPF PPS is the 18-month period January 1, 2005 through June 30, 2006. As a result, we updated the Federal per diem base rate to the midpoint of the January 1, 2005 through June 30, 2006, implementation period (that is, October 1, 2005). 
                    </P>
                    <HD SOURCE="HD3">1. The 1997-Based Excluded Hospital with Capital Market Basket </HD>
                    <P>Since FY 2003, the 1997-based excluded hospital with capital market basket has been used to establish the rates-of-increase for excluded hospitals and units paid under TEFRA. As a result, in the proposed rule, we proposed to use the 1997-based excluded hospital capital market basket to update the Federal per diem base rate to the midpoint of the implementation period under the IPF PPS, to establish the labor-related share for applying the wage index (see section V. of this final rule), and to update the Federal per diem base rate after the implementation period (see section V. of this final rule). </P>
                    <P>In the proposed rule, we explained that we periodically rebase (moving the base year for the structure of costs), and revise (changing data sources, cost categories, or price proxies used) the market basket to reflect more current cost data. We provided a detailed comparison of the 1992-based excluded hospital with capital market basket that had been in effect prior to October 1, 2002 to the rebased and revised 1997-based excluded hospital with capital market basket. </P>
                    <P>
                        In the proposed rule, we explained that the operating portion of the 1997-based excluded hospital with capital market basket is derived from the 1997-based excluded hospital market basket. The methodology used to develop the operating portion was described in the IPPS final rule published in the 
                        <E T="04">Federal Register</E>
                         on August 1, 2002  (67 FR 50042 through 50044). In brief, the operating cost category weights in the 1997-based excluded hospital market basket were determined from the 1997 Medicare cost reports, the 1997 Business Expenditure Survey from the Bureau of the Census and the 1997 Annual Input-Output data from the Bureau of Economic Analysis. As was discussed in the IPPS final rule, we made two methodological revisions in developing the 1997-based excluded hospital market basket: (1) Changing the wage and benefit price proxies to use the Employment Cost Index (ECI) wage and benefit data for hospital workers; and (2) adding a cost category for blood and blood products. 
                    </P>
                    <P>As we indicated in the proposed rule (68 FR 66926), when we add the weight for capital costs to the excluded hospital market basket, the sum of the operating and capital weights must still equal 100.0. Because capital costs account for 8.968 percent of total costs for excluded hospitals in 1997, operating costs must account for 91.032 percent. Each operating cost category weight in the 1997-based excluded hospital market basket was multiplied by 0.91032 to determine its weight in the 1997-based excluded hospital with capital market basket. </P>
                    <P>The aggregate capital component of the 1997-based excluded hospital market basket (8.968 percent) was determined from the same set of Medicare cost reports used to derive the operating component. The detailed capital cost categories of depreciation, interest, and other capital expenses were also determined using the Medicare cost reports. There are two sets of weights for the capital portion of the market basket. The first set of weights identifies the proportion of capital expenditures attributable to each capital cost category, while the second set represents relative vintage weights for depreciation and interest. The vintage weights identify the proportion of capital expenditures that is attributable to each year over the useful life of capital assets within a cost category (see the IPPS final rule on August 1, 2002 (67 FR 50045 through 50047), for a discussion on how vintage weights are determined). </P>
                    <P>The cost categories, price proxies, and base-year FY 1997 weights for the excluded hospital with capital market basket are presented in Table 1 below. The vintage weights for the 1997-based excluded hospital with capital market basket are presented in Table 1(A) below. </P>
                    <BILCOD>BILLING CODE 4120-03-P</BILCOD>
                    <GPH SPAN="3" DEEP="640">
                        <PRTPAGE P="66929"/>
                        <GID>ER15NO04.439</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="355">
                        <PRTPAGE P="66930"/>
                        <GID>ER15NO04.440</GID>
                    </GPH>
                    <BILCOD>BILLING CODE 4120-03-C</BILCOD>
                    <P>In the proposed rule (68 FR 66928) we described an analysis we conducted to ensure that the excluded hospital with capital market basket provides a reasonable measure of the price changes facing IPFs. We conducted an analysis of annual percent changes in the market basket when the weights for wages, pharmaceuticals, and capital in IPFs were substituted into the 1997-based excluded hospital with capital market basket. Other cost categories were recalibrated using ratios available from the IPPS market basket. Our analysis found that on average between 1995 and 2002, the excluded hospital with capital market basket increased at nearly the same average annual rate (3.4 percent) as the market basket with IPF weights for wages, pharmaceuticals, and capital (3.5 percent). This difference is less than the 0.25 percentage point criterion that determines whether a forecast error adjustment is warranted under the IPPS update framework. </P>
                    <P>Based on this analysis, we believe that the excluded hospital with capital market basket is doing an adequate job of reflecting the price changes facing IPFs. For this reason, in this final rule we are adopting the 1997-based excluded hospital with capital market basket to update the Federal per diem base rate to the midpoint of the IPF PPS implementation period, to establish the labor-related share of the Federal per diem base rate, and to update the IPF PPS after the implementation period. </P>
                    <HD SOURCE="HD3">2. Calculating the Budget-Neutrality Adjustment Factor </HD>
                    <P>Many commenters stated that they were concerned that the data used in the proposed rule were not current and did not reflect an accurate view of the services provided to Medicare psychiatric patients. The data sources we used to calculate the proposed budget-neutrality factor were the best data available for IPFs at that time and included FY 1999 cost report data and FY 1999 Medicare claims data from the June 2001 update of the MedPAR files. We updated the data for each IPF to the midpoint of the proposed 15-month implementation period (April 1, 2004 through June 30, 2005) and used the projected market basket update factors for each applicable year. For this final rule, we used FY 2002 data, the best data available. </P>
                    <HD SOURCE="HD3">a. Cost Report Data for January 1, 2005 Through June 30, 2006 </HD>
                    <P>In the proposed rule, we proposed to update each IPF's cost to the midpoint of the proposed implementation period April 1, 2004 through June 30, 2005. We explained that to calculate the operating costs, we would use the applicable percentage increases to the TEFRA target amounts for FY 1999 through FY 2002 in accordance with § 413.40(c)(3)(vii) and the full excluded hospital market-basket percentage increase for FY 2003 and later in accordance with § 413.40(c)(3)(viii). </P>
                    <P>In this final rule, in order to determine each provider's projected operating cost for the IPF PPS implementation period adopted in this final rule, we updated each IPF's per diem cost in FY 2002 to the midpoint of the implementation period January 1, 2005 through June 30, 2006. We used the most recent projection of the full percentage increase in the 1997-based excluded hospital market basket index for FY 2003 and later in accordance with § 413.40(c)(3)(viii). </P>
                    <P>
                        <E T="03">Comment:</E>
                         A few commenters recommended that CMS project IPF 
                        <PRTPAGE P="66931"/>
                        operating and capital costs using the full TEFRA market basket indexes. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We used FY 1999 data in the proposed rule. In order to update the data to the midpoint of the proposed implementation period, we applied the cap imposed by section 4414 of the BBA in accordance with § 413.40(c)(3)(vii). The BBA caps sunset after FY 2002. Since we used the FY 2002 cost reports to project TEFRA costs and payments in this final rule, we used the full excluded hospital market basket indexes to project the costs and payments to the midpoint of the IPF PPS implementation period in accordance with § 413.40(c)(3)(viii). 
                    </P>
                    <P>Since the IPF PPS includes both the operating and capital-related costs, we projected the capital-related cost under the TEFRA system as well. We used the excluded capital market basket to project the capital-related costs under the TEFRA system. Table 2 below summarizes the excluded hospital market basket (without capital) and the excluded capital market basket indexes. </P>
                    <GPH SPAN="3" DEEP="139">
                        <GID>ER15NO04.441</GID>
                    </GPH>
                    <HD SOURCE="HD3">b. Estimate of Total Payments Under the TEFRA Payment System </HD>
                    <P>Consistent with the proposed rule, in this final rule, we estimated payments for inpatient operating and capital costs under the current TEFRA system using the following methodology: </P>
                    <HD SOURCE="HD2">Step 1: IPF's Facility-Specific Target Amount </HD>
                    <P>The facility-specific target amount for an IPF was calculated based on the IPF's allowable inpatient operating cost per discharge for the base period, excluding capital-related, non-physician anesthetist, and graduate medical education costs. We updated the target amount using the rate-of-increase percentages specified in § 413.40(c)(3)(viii). </P>
                    <HD SOURCE="HD2">Step 2: Calculating Each IPF's TEFRA Payments for Inpatient Operating Services </HD>
                    <P>Under the TEFRA system, an IPF's payment amount for inpatient operating services is the lower of—</P>
                    <P>• The hospital-specific target amount multiplied by the number of Medicare discharges (the ceiling); or </P>
                    <P>• The hospital's average inpatient operating cost per case multiplied by the number of Medicare discharges. </P>
                    <P>In addition, under the TEFRA system, payments may include a bonus or relief payment, as follows: </P>
                    <P>• IPFs whose net inpatient operating costs are lower than or equal to the ceiling would receive the lower payment of—(1) the net inpatient operating costs plus 15 percent of the difference between the inpatient operating costs and the ceiling; or (2) the net inpatient operating costs plus 2 percent of the ceiling. </P>
                    <P>• IPFs whose net inpatient operating costs are greater than the ceiling, but less than 110 percent of the ceiling, would receive the ceiling payment. </P>
                    <P>• IPFs whose net inpatient operating costs are greater than 110 percent of the ceiling would receive the ceiling payment plus the lower of—(1) 50 percent of the difference between the 110 percent of the ceiling and the net inpatient operating costs; or (2) 10 percent of the ceiling payment. </P>
                    <HD SOURCE="HD2">Step 3: IPF Payments for Capital-Related Costs </HD>
                    <P>Under the TEFRA system, in accordance with section 1886(g) of the Act, Medicare allowable capital-related costs are paid on a reasonable cost basis. Each IPF's payment for capital-related costs is taken directly from the cost report and updated for inflation using the excluded capital market basket. </P>
                    <HD SOURCE="HD2">Step 4: IPF Total Operating and Capital-Related Costs Under the TEFRA Payment System </HD>
                    <P>Once estimated payments for inpatient operating costs were determined (including bonus and relief payments, as appropriate), we added the TEFRA adjusted operating payments and capital-related cost payments together to determine each IPF's total payments under the TEFRA payment system. </P>
                    <HD SOURCE="HD3">c. Payments Under the IPF PPS Without a Budget-Neutrality Adjustment </HD>
                    <P>Consistent with the proposed rule, in this final rule, we used the 1997-based excluded hospital with capital market basket to trend the FY 2002 base year data to the midpoint of the IPF PPS implementation period and, for the purpose of applying a wage index adjustment, to establish the labor-related portion of the Federal per diem base rate. </P>
                    <P>In this final rule, by trending the cost using the applicable market basket increase factors, we updated the average per diem cost to the midpoint of the January 1, 2005 through June 30, 2006 implementation period. The updated average cost per day of $724.43 was then used in the payment model to project future payments under the IPF PPS. </P>
                    <P>The next step is to apply the associated wage index and all applicable patient-level and facility-level adjustments to determine the appropriate IPF PPS payment amount for each stay in the final payment model file. </P>
                    <HD SOURCE="HD3">C. Standardization of the Federal Per Diem Base Rate </HD>
                    <P>
                        We must standardize the IPF PPS payments in order to account for the overall positive effects of the final IPF PPS payment adjustment factors. The proposed standardization factor was calculated to be 17 percent. However, in the proposed rule, we included a 19-percent budget-neutrality adjustment and a 2-percent outlier adjustment, and 
                        <PRTPAGE P="66932"/>
                        did not identify the percentage of the overall budget-neutrality adjustment that was attributable to standardization. 
                    </P>
                    <P>As was done in the proposed rule and in this final rule, to standardize the IPF PPS payments, we compared the IPF PPS payment amounts calculated from the psychiatric stays in the FY 2002 MedPAR file to the projected TEFRA payments from the FY 2002 cost report file updated to the midpoint of the IPF PPS implementation period. The standardization factor was calculated by dividing total estimated payments under the TEFRA payment system by estimated payments under the IPF PPS. The standardization factor was calculated to be 0.8367. As a result, the $724.43 Federal per diem base rate was reduced by 16.33 percent. </P>
                    <HD SOURCE="HD3">D. Calculation of the Budget Neutrality Adjustment </HD>
                    <P>As we noted above, in the proposed rule we identified a 19-percent budget-neutrality factor, but did not break it out into separate components. In this final rule, we are identifying each component of the budget neutrality adjustment, that is, the outlier adjustment, stop-loss adjustment, and behavioral offset. </P>
                    <HD SOURCE="HD3">1. Outlier Adjustment </HD>
                    <P>Since the IPF PPS payment amount for each IPF includes applicable outlier amounts, using an approach consistent with the proposed rule, we reduced the standardized Federal per diem base rate to account for aggregate IPF PPS payments estimated to be made as outlier payments. The appropriate outlier amount was determined by comparing the adjusted prospective payment for the entire stay to the computed cost per case. If costs were above the prospective payment plus the adjusted fixed dollar loss threshold, an outlier payment was computed using the applicable risk-sharing percentages, as explained in greater detail in section VI.D.1. of this final rule. The outlier amount was computed for all stays, and the total outlier amount was added to the final IPF PPS payment. The outlier adjustment was calculated to be 2 percent. As a result, the Federal per diem base rate includes a reduction of 2 percent. </P>
                    <HD SOURCE="HD3">2. Stop-Loss Provision Adjustment </HD>
                    <P>As explained in detail in section VI.D.3. of this final rule, we will provide stop-loss payments to ensure that an IPF's total PPS payments are no less than a minimum percentage of their TEFRA payment, had the IPF PPS not been implemented. As with outlier payments, in this final rule, we reduced the standardized Federal per diem base rate by the percentage of aggregate IPF PPS payments estimated to be made for stop-loss payments. </P>
                    <P>The stop-loss payment amount was determined by comparing aggregate prospective payments that the provider would receive under the IPF PPS to aggregate TEFRA payments that the provider would have otherwise received without implementation of the IPF PPS. If an IPF's aggregate IPF PPS payments are less than 70 percent of its aggregate payments under TEFRA, a stop-loss payment was computed for that IPF. The stop-loss payment amounts were computed for those IPFs that were projected to receive the payments, and the total amount was added to the final IPF PPS payment amount. In our calculation, we needed to include a reduction of 0.39 percent in the standardized Federal per diem base rate to maintain budget neutrality in the final IPF PPS. </P>
                    <P>We note that the 0.39 percent adjustment due to the stop-loss provision is temporary in nature. This adjustment will be removed after the transition because, as explained in section IV.D.3. of this final rule, the stop-loss provision is applicable only during the transition period. </P>
                    <HD SOURCE="HD3">3. Behavioral Offset </HD>
                    <P>As explained in the proposed rule, we expect that once the IPF PPS is implemented, IPFs may experience usage patterns that are significantly different from those they currently experience. For example, since the IPF PPS is a per diem system, IPFs might have an incentive to keep patients in the facility longer to maximize their use of beds or to receive outlier payments. In addition, the current TEFRA payment system does not depend on coding a principal diagnosis; however, payment will depend on properly coding the principal diagnosis under the IPF PPS. Therefore, we expect that IPFs will have an incentive to comprehensively code for the presence of comorbidities and ultimately the coding practice of IPFs should improve once the IPF PPS is implemented. </P>
                    <P>As a result of these behavioral changes, Medicare may incur higher payments than assumed in our calculations. These effects were taken into account when we calculated the proposed budget-neutral Federal per diem base rate. Accounting for these effects through an adjustment is commonly known as a behavioral offset. </P>
                    <P>Based on accepted actuarial practices and consistent with the assumptions made under the Inpatient Rehabilitation Facility PPS, we assumed in determining the behavioral offset, that IPFs would regain 15 percent of potential “losses” and augment payment increases by 5 percent. We applied this actuarial assumption, which is based on our historical experience with new payment systems, to the estimated “losses” and “gains” among the IPFs. </P>
                    <P>
                        <E T="03">Comment:</E>
                         A few commenters disagreed with CMS's concern that the IPF PPS would provide an incentive for IPFs to increase length of stay. They stated that the incentive to increase length of stay already exists under the current TEFRA payment system. The commenters stated that under TEFRA, the longer the stay, the higher the payment as long as the hospital stays under its TEFRA limit. 
                    </P>
                    <P>Commenters stated that despite this incentive, length of stay has continuously declined over the last decade. One commenter mentioned that IPFs use clinical practice guidelines used by Quality Improvement Organizations, rather than Medicare reimbursement standards, to determine when a patient is ready for discharge. </P>
                    <P>Several commenters stated that they do not foresee any significant increase in length of stay for psychiatric admissions and recommended that CMS adopt a smaller behavioral offset initially. They suggested that the length of stay could easily be monitored by CMS and adjusted in the future, if necessary. </P>
                    <P>
                        <E T="03">Response:</E>
                         Since per diem payment systems pay on a per day basis rather than a per discharge basis, there is an incentive to keep patients more days. Therefore, we believe that including a behavioral offset will make our calculations and impact analysis more accurate. We will monitor the extent to which current practice in IPFs changes such as how the average length of stay is affected by implementation of a per diem payment system and may propose adjustments to the behavioral assumptions, accordingly. 
                    </P>
                    <P>In addition to the length of stay, the final IPF PPS payment model depends on the accurate coding of diagnoses for the DRG and comorbidity adjustments. We expect that IPFs will try to code diagnoses for each stay more accurately after the implementation of the IPF PPS in order to receive payment adjustments. This behavior change could result in significantly higher Medicare payments to IPFs than we assumed when we calculated the final Federal per diem base amount. </P>
                    <P>
                        The behavioral offset for the final IPF PPS was calculated to be 2.66 percent. As a result, we reduced the standardized Federal per diem base rate 
                        <PRTPAGE P="66933"/>
                        by 2.66 percent to maintain budget neutrality. 
                    </P>
                    <P>To summarize, the proposed Federal per diem base rate with an outlier adjustment and budget neutrality with a behavioral offset was calculated to be $530. This amount included a 2-percent reduction to account for proposed outlier payments and a 19 percent reduction to account for budget neutrality and the behavioral offset to the Federal per diem base rate otherwise calculated under the methodology as described above. Of that 19-percent reduction, 17 percent is attributable to standardization, and 2 percent is attributable to the behavioral offset (see section V.C. of this final rule for an explanation of standardization). </P>
                    <P>Using the FY 2002 data for this final rule, the final budget-neutral Federal per diem base rate with an outlier adjustment, a stop loss provision with a behavioral offset is calculated to be $575.95. This amount includes a 16.33-percent reduction from $724.43 to account for standardization to the projected TEFRA per diem payment for the implementation period, a 2-percent reduction to account for outlier payments, a 0.39-percent reduction to account for stop-loss payments and a 2.66-percent reduction to account for the behavioral offset. </P>
                    <HD SOURCE="HD1">VI. Cost Regression Used To Develop Payment Adjustment Factors </HD>
                    <P>In the proposed rule, we provided a detailed description of the data file used for the regression analysis, our trimming methods, and the limitations associated with IPFs reporting routine per diem costs as an average. As a result of the regression analysis, we proposed patient-level payment adjustments for age, DRG assignment based on patients' principal diagnoses, selected comorbidities, and a day of stay adjustment (the variable per diem adjustments) to reflect higher resource use in the early days of an IPF stay. We also proposed facility-level payment adjustments for wage area and rural location, and a teaching status adjustment. </P>
                    <P>
                        <E T="03">Comment:</E>
                         One commenter stated that the regression models used in the proposed rule may not have appropriately modeled the data. The commenter believes that data entered into the regression model(s) are of a hierarchical nature, namely patients within facilities. Therefore, within a facility they cannot be considered independent observations, a requirement of simple regression models. To account for the fact that patients are nested within hospitals, hierarchical linear models need to be used. This will allow the covariance structure to be modeled. The commenter also believes that this will allow facility level variables to be modeled in the appropriate place. The commenter stated that although this would have to be explored, a model might estimate average facility costs while individual variability attributable to the patients and their covariates would be estimated separately. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         There are two parts to our response to this comment. The first part addresses why our data are not well-suited for the use of hierarchical linear models. The second part addresses the potential consequences for the payment adjustment factors of using ordinary least squares to estimate the cost regression instead of a method applicable for hierarchical linear models. We use ordinary least squares in the proposed rule as well as in this final rule. 
                    </P>
                    <P>First, the commenter is correct that, in principle, multi-level or hierarchical linear models would be appropriate for cost data that varied among patients within psychiatric facilities (commonly referred to as within group variation) and among psychiatric facilities (commonly called between group variation). However, in our cost data, each facility assigns the same per diem routine cost to all of its patients. As a result, there is no per diem routine cost variation among patients within the same facility, and, since routine costs are a large proportion of total cost, our measure of routine cost contains relatively little within group variation. In our data, ancillary cost differences are the only source of within group variation in per diem cost. This constraint substantially limits our ability to model patient effects within facilities. We concluded that under these circumstances, we are not able to meaningfully estimate a hierarchical linear model and that the data could be appropriately modeled using ordinary least squares. </P>
                    <P>Second, there are two potential consequences of using ordinary least squares to estimate the cost regression rather than a statistical method applicable for hierarchical models. According to statistical theory, the first consequence is that the standard errors of the regression coefficients may differ in the 2 cases. These differences could influence the conclusions drawn from tests of statistical inference about the role of the regression's independent variables (for example, patient age and length of stay) in explaining variation in per diem costs. The significance of this problem is that, potentially, we might develop a payment adjustment based on a variable that we believe to be a significant determinant of per diem cost, when we would not have developed a payment adjustment for that variable if we had estimated the cost regression using a statistical technique that would yield more accurate standard errors. To test whether this problem applies to our cost regression, we estimated the regression using a method applicable to hierarchical models. </P>
                    <P>As noted by the commenter, the advantage of hierarchical linear models is that they allow modeling of the covariance structure. The method we used (the SAS procedure named Proc Mixed) allows the user to select among alternative models of the data's covariance structure. Among the options in Proc Mixed, we used a random effects model with “compound symmetry” as a compromise between the assumptions of ordinary least squares and the completely unstructured case, which imposes no assumptions on the covariance structure. The results of this test were, as predicted by statistical theory, that the standard errors from Proc Mixed often differed from those estimated using ordinary least squares. However, there was no change in the conclusions drawn from statistical inference tests because the variables that were significant using ordinary least squares remained highly significant using Proc Mixed. As a result, both statistical techniques imply that the same variables are important determinants of per diem cost and, hence, potential candidates for payment adjustment factors. </P>
                    <P>The second potential statistical consequence of using ordinary least squares rather than a hierarchical model method to estimate the cost regression is that the size of the regression coefficients of the independent variables may be different. In turn, differences in regression coefficients will produce differences in sizes of the payment adjustment factors. However, statistical theory does not predict that the ordinary least squares estimates are subject to statistical bias. Furthermore, statistical theory implies that very large sample sizes such as ours will improve the accuracy of ordinary least squares estimates. Therefore, statistical theory does not imply that the regression coefficients estimated using ordinary least squares are necessarily less accurate than those estimated with Proc Mixed or a similar method. </P>
                    <P>
                        Based on the three considerations just described, we believe that the statistical methods we used in the proposed and final rule enabled us to model the data appropriately. That is, although in principle our data is hierarchical, in 
                        <PRTPAGE P="66934"/>
                        practice, it does not contain the full extent of variation at the patient and facility levels that would yield meaningful hierarchical modeling. In addition, our conclusions about which variables are important in explaining cost variation are not affected by our use of ordinary least squares. Finally, statistical theory of hierarchical modeling does not imply that there is necessarily a problem with the size of the regression coefficients obtained from ordinary least squares. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         A commenter stated that CMS estimated a “structural model” rather than a “payment model” by including variables in the regression that were not used as payment adjustors (size and the occupancy rate). The commenter acknowledged that there is some debate about which type of model is most appropriate in constructing payment systems, but expressed the opinion that the “research and policy community” believes that payment models are preferred to structural models. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         This commenter is referring to two different approaches in using cost regressions to develop payment adjustments. In the “payment model” approach, the only independent variables included in the cost regression are those variables that are used as payment adjustments. In the “structural model” approach, all variables that are hypothesized to be important determinants of cost are included in the cost regression, whether or not they are going to be used as payment adjustments. Omitting “structural” variables from the cost regression will affect the sizes of the regression coefficients for “payment” variables if the omitted variables are correlated with some or all of the payment variables, which will in turn affect the magnitude of the payment adjustment factors. If omitted structural variables are completely uncorrelated with any of the payment variables, omission of the structural variables from the cost regression will lower the overall explanatory power of the regression, but will not affect the sizes of the regression coefficients for the payment variables. Debate over whether the payment or the structural approach is preferred generally centers on the case when one or more structural variables are positively correlated with one or more payment variables. In this case, the payment approach will result in paying for some of the effects of the omitted structural variable(s) via the payment adjustments of some of the payment variables. That is, the payment adjustment factors for some payment variables will be greater than they would have been had the structural model been used. The structural approach will result in smaller payment adjustment factors for some payment variables because the effects of the omitted structural variables are not reflected in the regression coefficients of those payment variables, but rather are captured by the regression coefficients of the structural variables included in the cost regression. 
                    </P>
                    <P>We believe the commenter is questioning whether CMS included variables in the cost regression that were not used as payment adjustors. The two variables cited in the comment are measures of facility size and occupancy. In fact, in neither the proposed nor the final rule did we include facility size in our cost regression. We followed the payment model approach with respect to the size variable because facility size has never been regarded as an acceptable payment variable in any of our prospective payment systems since it is a variable over which a facility has a substantial degree of control. However, in adopting the payment model approach for the size variable, we are allowing the effects of size to increase payment adjustment factors to the extent that facility size is positively correlated with acceptable payment variables. For example, small facilities that are small because of other factors such as rural location will be compensated for their higher costs due to those factors. Therefore, adopting a structural payment model approach would have adversely penalized small facilities and we recognize that small facilities may be important providers of psychiatric services in many circumstances. In the case of the occupancy rate, we adopted the structural approach and included the variable in the regression. Whether a facility is large or small, we think that it is appropriate to control for variations in the occupancy rate in estimating the effects of the payment variables on per diem cost to avoid compensating facilities for inefficiency associated with underutilized fixed costs. </P>
                    <P>
                        <E T="03">Comment:</E>
                         A commenter asked whether the age and comorbidity variables identified the same groups of patients, and as a result, whether by including both variables in our regression, we were making the same adjustment twice. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         Although the presence of comorbidities is more common among the elderly, the age and comorbidity variables do not identify exactly the same groups of patients. In the proposed rule, the age variable grouped all patients over age 65 in the same category and the comorbidity variables identified 17 different conditions. Comorbidities were present for patients under age 65 as well as those over age 65. Further, since we identified 17 separate comorbid categories, some elderly patients have no comorbidities, others have a single comorbidity, and still others may have multiple comorbidities. Including the age and comorbidity variables in the regression does not measure the same adjustment twice, but rather utilizes the fact that the variables are not perfectly correlated to measure separate effects for age and comorbidities. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         One commenter recommended that CMS compare the relationship between costs per day among the various types of IPFs to the same relationship among types of SNFs. 
                    </P>
                    <P>The commenter stated that hospital-based SNFs have higher per diem costs than freestanding SNFs, but the shorter lengths of stay for hospital-based SNFs result in approximately equal per case costs for freestanding and hospital-based SNFs. </P>
                    <P>
                        <E T="03">Response:</E>
                         The government-operated psychiatric hospitals have relatively low per diem costs, relatively long lengths of stay, and relatively high per case costs. However, among the other main types of psychiatric facilities (non-profit hospitals, for-profit hospitals, and psychiatric units), there is a direct relationship between per diem and per case costs because lengths of stay are very similar for these types of facilities. Psychiatric units have the highest per diem and per case costs, followed by non-profit hospitals, and last by for-profit hospitals. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         A few commenters suggested that CMS adopt the DRG methodology used under the IPPS instead of utilizing adjustment factors for age, comorbidities, and DRG assignment. The commenters believe that by using this method, the DRGs would be established for cases with and without the presence of comorbidities and for various age categories. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         As we discussed in the proposed rule, adopting a patient classification system based on diagnosis alone may not explain the wide variation in resource use among IPF patients. There is no indication that regrouping the psychiatric DRGs as the commenter suggests will explain more of the variation in per diem cost than the methodology we are adopting. 
                    </P>
                    <P>
                        Since the DRGs are also used to pay inpatient psychiatric cases treated outside the distinct part psychiatric unit, we believe that before any basic changes to the DRG structure could be proposed, we would first need to conduct a thorough examination of the 
                        <PRTPAGE P="66935"/>
                        potential effects on both the IPPS and the IPF PPS. We have not conducted such an approach because there was insufficient time, and we did not want to delay implementing the IPF PPS. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         Several commenters described a recent study in which the researchers regrouped psychiatric diagnoses and comorbidities and included variables for certain activity of daily living deficits (toileting, transferring, and personal hygiene), patient dangerousness (strong suicide or assaultive tendencies), and patients who undergo electroconvulsive therapy (ECT). The commenters recommended that we adopt the study findings in the final IPF PPS. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         Although the commenters did not explicitly identify the study, we believe that they are referring to the CMS funded RTI International
                        <E T="51">®</E>
                         (trade name of Research Triangle Institute) study of inpatient psychiatric care that was designed to complement the development of the IPF PPS. RTI International
                        <E T="51">®</E>
                         addressed two major limitations of the administrative claims and cost report data available to CMS for the IPF PPS. 
                    </P>
                    <P>First, the administrative data only captures the uniform routine daily cost assigned to each patient treated in the same facility, so that no variation in routine daily cost can be observed for patients in the same facility, but who have different resource requirements. This artificial reduction in cost variation may impede efforts to accurately identify and measure the effects of certain patient characteristics. Second, the patient characteristics collected on the claims are limited to demographic and diagnostic information and do not include other characteristics that may be more important in explaining resource use. </P>
                    <P>
                        The RTI International
                        <E T="51">®</E>
                         study is noteworthy for its success in dealing with these two issues. First, RTI International
                        <E T="51">®</E>
                         developed a measure of cost per patient day that captured variations in patients' daily resource use both within and across facilities. This task was accomplished by collecting information on the time spent in various activities by patients and facility staff over the course of a 3-shift day for a period of 7 days. After converting the staff time data to daily patient costs, RTI International
                        <E T="51">®</E>
                         was able to go beyond the potential constraints of administrative data to study differences among patients across days of the stay. 
                    </P>
                    <P>
                        Second, RTI International
                        <E T="51">®</E>
                         collected a small set of patient characteristics that are not in CMS administrative data. They were able to test the importance of these variables in explaining cost variation. Most important among these factors were certain activities of daily living (toileting, transferring, and personal hygiene) and patient dangerousness (strong suicidal or assaultive tendencies). 
                    </P>
                    <P>
                        Like virtually all studies that collect primary data for a sample population, RTI International
                        <E T="51">®</E>
                         faced choices about how to obtain the most useful information possible with the limited funds available. RTI International
                        <E T="51">®</E>
                         collected information for 4,149 Medicare patient days of care delivered to 834 unique Medicare patients in 40 facilities. We believe that RTI's sample is large enough to provide reliable information about the types of patients treated in all psychiatric facilities. However, the sample is small compared to even the typical 10 or 20 percent samples of the MedPAR data, and data collection costs made it uneconomical to sample all types of IPFs. In particular, rural facilities and small and government-operated hospitals could not be represented as robustly as other types of IPF providers. 
                    </P>
                    <P>
                        In addition, although they collected data for 7 days in each facility, it was uneconomical to collect information for entire stays in a large number of cases. Also, in order to limit the costs of data collection, RTI International
                        <E T="51">®</E>
                         did not collect ancillary service use, but instead relied on claims data for this information. 
                    </P>
                    <P>
                        The findings of the RTI International
                        <E T="51">®</E>
                         study have played an important role in the development of the IPF PPS in several ways. First, RTI International
                        <E T="51">®</E>
                         analysis of its daily cost variable supports the use of the administrative data in developing the IPF PPS without being seriously misled about the relative importance of different variables. For example, both sets of analysis found age to be very important in explaining per diem cost variation. Although RTI International
                        <E T="51">®</E>
                         elected to group diagnoses differently than using DRGs, both analyses supported prior findings that diagnosis plays a limited role in explaining cost variation. RTI International
                        <E T="51">®</E>
                         also found ECT to be an important cost factor. 
                    </P>
                    <P>However, many other variables commonly thought to affect cost either produced inconsistent results or were found to have a minor effect, once more important factors were taken into account. Among these variables were cognitive impairment, risk of falls, Global Assessment of Function (GAF) score, gender, dual diagnosis, and number of medications. </P>
                    <P>
                        Second, RTI International
                        <E T="51">®</E>
                        's analysis of cost variation by day of stay proved a very useful point of comparison for the variable per diem adjustment factors that we present in this rule. Third, the RTI International
                        <E T="51">®</E>
                         study provides us with a starting point for future refinements of the IPF PPS. As noted above, RTI International
                        <E T="51">®</E>
                        's identification of certain patient characteristics not currently collected in the administrative data is very helpful for starting the process of considering whether we might want to collect some or all of these data items in the future. As a result of this research, we did not choose to adopt adjustment variables for activity of daily living deficits or patient dangerousness. We discuss the adjustment for patients who undergo ECT in section VI.B.6.of this final rule. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         One commenter expressed the opinion that the regression results for the age and diagnosis variables would not be skewed by the inability of CMS routine cost variable to capture cost variations among patients within the same facility. The commenter further predicted that the research conducted by RTI International
                        <E T="51">®</E>
                         would find that elderly psychiatric patients use fewer resources than younger patients. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         The commenter's prediction that RTI International
                        <E T="51">®</E>
                         would find that elderly psychiatric patients use fewer resources than younger patients was not supported. RTI International
                        <E T="51">®</E>
                         found, as we did in our cost regressions, that elderly patients are more costly than younger patients. There is no way to directly test the commenter's assertion that our regression results are not affected by the limitations of our routine cost variable. In addition, since the RTI International
                        <E T="51">®</E>
                         data was able to capture cost variations among patients within the same facility and RTI International
                        <E T="51">®</E>
                         had results similar to ours about the effects of diagnosis and age on per diem costs, this consistency in results leads us to believe our regression were accurate. 
                    </P>
                    <HD SOURCE="HD2">A. Final Regression Analysis </HD>
                    <P>In this final rule, in order to ensure that the IPF PPS would be able to account adequately for each IPF's case-mix, we performed an extensive regression analysis of the relationship between the per diem costs and both patient and facility characteristics to determine those characteristics associated with statistically significant cost differences. For characteristics with statistically significant cost differences, we used the regression coefficients of those variables to determine the size of the corresponding payment adjustments. </P>
                    <P>
                        The final IPF PPS payment adjustments were derived from a regression analysis of 100 percent of the 
                        <PRTPAGE P="66936"/>
                        FY 2002 MedPAR data file because this was the best data available. The MedPAR data file used for the final regression analysis contains 483,038 cases that have a LOS of 1 day or more. We deleted 8,012 (1.66 percent) from this file because cost report or reasonable routine cost data for certain IPFs were not available. In order to include as many IPFs as possible in the regression, we substituted the FY 2001 Medicare cost report data for routine cost and ancillary cost-to-charge ratios (using the FY 2001 Medicare cost report data). 
                    </P>
                    <P>For the remaining 475,026 cases, we used the same method to trim extraordinarily high or low cost values that we used for the per diem rate development file and in the proposed regression analysis (see section V.A. of this final rule). </P>
                    <P>The trimming criteria eliminated another 3,490 cases, leaving 471,536 cases that were used in the final regression. </P>
                    <P>We computed a per diem cost for each Medicare inpatient psychiatric stay, including routine operating, ancillary, and capital components using information from the FY 2002 MedPAR file and data from the FY 2002 Medicare cost reports. </P>
                    <P>To calculate the cost per day for each inpatient psychiatric stay, routine costs were estimated by multiplying the routine cost per day from the IPF's FY 2002 Medicare cost report by the number of Medicare covered days on the FY 2002 MedPAR stay record. Ancillary costs were estimated by multiplying each departmental cost-to-charge ratio by the corresponding ancillary charges on the MedPAR stay record. The total cost per day was calculated by summing routine and ancillary costs for the stay and dividing it by the number of Medicare covered days for each day of the stay. </P>
                    <P>Since we will pay for emergency department (ED) costs of IPFs with qualifying EDs and IPFs that are part of hospitals with qualifying EDs, as described in section VI.B.5.b. of this final rule, through a specific adjustment to the day one variable per diem adjustment factor, ED costs were excluded from the dependent variable used in the cost regression. ED costs were excluded in order to remove the effects of ED costs from other payment adjustment factors with which ED costs may be correlated. We need to remove the effects on other payment adjustments to avoid overpaying ED costs. Removing ED costs from the regression has no effect on the calculation of the Federal per diem base rate or on budget neutrality because ED costs were not excluded from those calculations. </P>
                    <P>The log of per diem cost, like most health care cost measures, appears to be normally distributed. Therefore, the natural logarithm of the per diem cost was the dependent variable in the regression analysis. We included variables in the regression to control for psychiatric hospitals that do not bill ancillary costs and for ECT costs that we will pay separately (see the section VI.A. of this final rule). </P>
                    <P>The per diem cost was adjusted for differences in labor cost across geographic areas using the FY 2005 hospital wage index unadjusted for geographic reclassifications, in order to be consistent with our use of the market basket labor share in applying the wage index adjustment. </P>
                    <P>We computed a wage adjustment factor for each case by multiplying the Medicare 2005 hospital wage index based on MSA definitions defined by OMB in 1993 for each facility by the labor-related share (.72528) and adding the non-labor share (.27472). We used the 1997-based excluded hospital with capital market basket to determine the labor-related share. The per diem cost for each case was divided by this factor before taking the natural logarithm (that is, a standard mathematical practice accepted by the scientific community). The payment adjustment for the wage index was computed consistently with the wage adjustment factor, which is equivalent to separating the per diem cost into a labor portion and a non-labor portion and adjusting the labor portion by the wage index. </P>
                    <P>With the exception of the teaching adjustment, the independent variables were specified as one or more categorical variables. Once the regression model was finalized based on the log normal variables, the regression coefficients for these variables were converted to payment adjustment factors by treating each coefficient as an exponent of the base e for natural logarithms, which is approximately equal to 2.718. The payment adjustment factors represent the proportional effect of each variable relative to a reference variable. </P>
                    <HD SOURCE="HD2">B. Patient-Level Adjustments </HD>
                    <P>We proposed adjustments for the DRG assignment of the patient's principal diagnosis, selected comorbidities, and patient age. The proposed rule included a discussion regarding a gender variable, however, we did not propose a gender adjustment. </P>
                    <HD SOURCE="HD3">1. Adjustment for DRG Assignment </HD>
                    <P>In the proposed rule, we proposed adjustment factors for 15 diagnosis-related groups (DRGs). The adjustment factors were expressed relative to the most frequently reported DRG (DRG 430) and were derived from the proposed regression analysis. We did not propose payments under the IPF PPS for all DRGs that contain a psychiatric ICD-9-CM code because for some DRGs, there were too few psychiatric cases to obtain a reliable adjustment factor. </P>
                    <P>In this final rule, we are providing payment under the IPF PPS for all DRGs that contain a psychiatric ICD-9-CM code. However, as discussed later in this section, we are not providing a DRG adjustment for these cases. </P>
                    <P>We proposed that IPFs would continue to report diagnoses using the ICD-9-CM coding system. In addition, we specified that current regulations at § 412.27 require that a psychiatric unit admit only those patients who have a principal diagnosis that is listed in the Diagnostic and Statistical Manual of Mental Disorders (DSM) or classified in Chapter Five (“Mental Disorders”) of the ICD-9-CM. We requested public comment on whether we should continue to reference the DSM. The DSM is currently in its fourth edition, text revision (DSM-IV-TR). </P>
                    <P>We received a significant number of public comments expressing support for the DSM, including several requesting that we permit IPFs to report diagnoses using DSM codes. Many comments asserted that the DSM provides a common language for psychiatrists and other health care professionals and sets forth diagnostic criteria for mental disorders and ways of measuring and reporting severity. Others agreed that the DSM established validity and provides standardized definitions. </P>
                    <P>
                        <E T="03">Comment:</E>
                         One commenter indicated that Chapter Five of the ICD-9-CM is too limited to be the only diagnostic codes considered and that symptoms that are commonly treated in inpatient psychiatry include DSM codes that are not in the ICD-9-CM. Another commenter suggested that CMS use a combination or subset of diagnostic codes that includes codes that appear in both Chapter Five of the ICD-9-CM and the DSM-IV-TR. 
                    </P>
                    <P>
                        One commenter expressed concern that misalignment between the DSM-IV-TR and the ICD-9-CM codes would cause underpayment of certain cases. The commenter recommended that CMS develop a modifier to the ICD-9-CM code to ensure that DSM codes 
                        <PRTPAGE P="66937"/>
                        crosswalk to the most appropriate case mix weight. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We agree that the DSM serves an essential function in the diagnosis and treatment of mental illness. For this reason, we are retaining the reference to the DSM in § 412.27 and updating the reference of the DSM-III-TR to the DSM-IV-TR. As explained in the proposed rule, we acknowledge that the DSM is routinely used by clinical staff to diagnose patients and plan treatment, while the ICD-9-CM coding system is currently used for reporting diagnostic information for payment purposes. However, the Standards for Electronic Transaction final rule published in the 
                        <E T="04">Federal Register</E>
                         on August 17, 2000 (65 FR 50312), identifies the ICD-9-CM as the designated code set for reporting diseases, injuries, impairments, other health related problems, their manifestations, and causes of injury, disease, impairment, or other health-related problems. As a result, the DSM codes may not be reported on Medicare claims. 
                    </P>
                    <P>Several commenters included examples of ICD-9-CM codes that do not crosswalk to the DSM-IV-TR, as well as DSM-IV-TR definitions and codes that do not crosswalk to the ICD-9-CM. Preliminary analysis of the codes confirmed the commenters' findings. We considered the possibility of using a modifier to crosswalk certain ICD-9-CM codes to their respective DSM-IV-TR counterpart, but found this method to be too complex and cumbersome for the purposes of billing since each ICD-9-CM code would require a modifier. </P>
                    <P>More importantly, as we previously explained in section VI of this final rule, we believe it is essential to maintain the same diagnostic coding for IPFs that is used under the IPPS for providing the same psychiatric care. For these reasons, we are not limiting the Chapter Five ICD-9-CM diagnosis codes that may be reported by IPFs under the IPF PPS at this time. We intend to continue our analysis as we implement the IPF PPS to ensure that we identify the appropriate ICD-9-CM codes for coding of patients' principal diagnoses. </P>
                    <P>We will reconsider these coding issues as we develop the FY 2006 hospital IPPS proposed rule in order to maintain consistent coding rules for all psychiatric cases. </P>
                    <P>
                        <E T="03">Comment:</E>
                         One commenter asked why CMS used the existing DRGs, rather than developing new groupings for the DRG classification system based on current data. This commenter also asked whether the DRGs would change if they were designed to explain differences in cost per day, rather than cost per case. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We did not attempt to modify the DRG classifications. (see section VI of this final rule for a detailed explanation). Our rationale for proposing to use the existing DRGs to group IPF PPS cases is that the DRGs are currently used to pay inpatient psychiatric cases under the hospital IPPS. 
                    </P>
                    <P>Instead of explicitly attempting to adapt the DRGs to a per diem system by changing the DRG definitions, we analyzed whether there was empirical support for using the existing DRGs. Specifically, we tested whether the DRGs contributed explanatory power to the explanation of differences in per diem costs. Although previous research indicates that diagnosis plays a limited role in explaining cost variation for psychiatric care, existing DRGs provide an acceptable degree of explanatory power. </P>
                    <P>Additional research will be needed to determine how the DRG classification system or payment weights under the IPPS would change if they were redesigned to measure cost per day. </P>
                    <P>
                        <E T="03">Comment:</E>
                         One commenter requested that CMS delay implementation of the IPF PPS until the ICD-10-CM is adopted for Medicare billing purposes. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         The National Committee on Vital and Health Statistics (NCVHS) has recommended that HHS, under its HIPAA responsibilities, prepare a proposed regulation to require that the ICD-10-CM be adopted as the HIPAA standard code set to replace the ICD-9-CM. HHS is assessing the NCVHS recommendation. We do not believe it is appropriate to tie implementation of the IPF PPS to another initiative that has not been developed. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         Many commenters requested that CMS adopt the clinical structure of the DSM (the DSM diagnostic categories) to classify IPF cases rather than the DRG classification system. A few commenters suggested that CMS use a modified version of the DSM diagnostic categories. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We tested various groupings of diagnoses. Our data analysis indicated that regrouping the ICD-9-CM codes into the DSM diagnostic categories or other similar categories raised the explanatory power of the payment model by less than one-half of one percent. Thus, the DRGs and the DSM diagnostic categories explain the same amount of per diem cost differences. Moreover, the research conducted by THEORI, a research component of the Greater New York Hospital Association, confirmed our results. Therefore, since we were unable to detect a measurable difference in the explanatory power of the DSM and DRGs with respect to the grouping of the ICD-9-CM codes, we are finalizing the DRG approach. 
                    </P>
                    <P>As mentioned earlier, we are concerned about establishing a different classification scheme for IPF PPS than is used for psychiatric discharges under IPPS. We are also concerned about the fiscal burden associated with establishing a separate classification system for the IPF PPS. </P>
                    <P>As a result, this final rule includes adjustment factors for the DRG assigned to the claim. The coefficient values and adjustment factors were derived from the final regression analysis. The adjustment factors are expressed relative to DRG 430. See Table 3 at the end of this section and Addendum A. </P>
                    <P>
                        <E T="03">Comment:</E>
                         Commenters overwhelmingly disagreed with the proposed policy to only pay for a limited selection of psychiatric diagnoses under the IPF PPS. The commenters indicated that all DRGs containing psychiatric codes should be recognized in the final IPF PPS. Other commenters recommended that CMS add a new DRG “Other Psychiatric Diagnosis” to include the ICD-9-CM diagnosis codes that are excluded when crosswalked to the DSM-IV-TR. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         As we explained earlier in this section, we agree that the IPF PPS should recognize all ICD-9-CM psychiatric codes regardless of their DRG assignment. Therefore, we will provide the Federal per diem base rate payment under the IPF PPS for claims with a principal diagnosis included in Chapter Five of the ICD-9-CM or the DSM-IV-TR. However, only those claims with diagnoses that group to a psychiatric DRG will receive a DRG adjustment. Although the IPF will not receive a DRG adjustment for a principal diagnosis not found in one of our identified 15 psychiatric DRGs, the IPF will still receive the Federal per diem base rate and all other applicable adjustments. Since there are only a few non-psychiatric DRGs that contain one or two rarely used psychiatric codes, whose frequencies were so low that we were unable to calculate an adjustment, we believe this is an equitable way to pay for these cases. 
                    </P>
                    <P>We have not established a new DRG for these psychiatric ICD-9-CM codes that are assigned to non-psychiatric DRGs. Rather, we plan to monitor the data from these other codes and, if indicated through data analysis, may consider proposing revisions to this policy in the future. </P>
                    <P>
                        <E T="03">Comment:</E>
                         One commenter requested that we revise the DRG adjustment factor to 1.00 for DRG 433 Alchohol/Drug Abuse or Dependence, Left Against 
                        <PRTPAGE P="66938"/>
                        Medical Advise. The commenter indicated that the 0.88 proposed adjustment factor would be insufficient to cover the extensive diagnostic procedures, complex treatment, and monitoring these patients often needed. 
                    </P>
                    <P>The commenter also indicated that since the total reimbursement for these patients is directly related to their length of stay, there should be no penalty attached to the DRG assignment. </P>
                    <P>
                        <E T="03">Response:</E>
                         Our analysis did not indicate or reflect that a 1.00 adjustment was appropriate. The analysis, a cost regression analysis that used hospital claims data resulted in 0.88 adjustment factor for DRG 433 Alchohol/Drug Abuse or Dependence, Left Against Medical Advise. Unlike IPPS that uses DRG weights as the basis for payment, the IPF PPS payment is based on a Federal per diem base rate and numerous additional payment adjustments. In addition to DRG adjustments, the IPF PPS payment includes payment adjusters to accommodate differing lengths of stays (the variable per diem adjustment) that is intended to account for the increased cost in the early days of an inpatient stay. For more information on the variable per diem adjustments, see section VI.B.5 of this preamble. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         A commenter asked for clarification as to the classification of substance abuse as a psychiatric condition. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         Substance abuse is not only included in Chapter Five (Mental Disorders) of the ICD-9-CM and defined in the DSM-IV-TR (Substance-Related Disorders) but is also included in the Psychiatric Boards, which physicians take to become Board Certified in the field of psychiatry. However, substance abuse is rarely the primary diagnosis for inpatient psychiatric treatment, and in those rare cases, there are generally mitigating factors to justify why the patient cannot be treated in an outpatient setting. To be covered as an inpatient hospital service, it must meet the criteria for being medically necessary. 
                    </P>
                    <GPH SPAN="3" DEEP="212">
                        <GID>ER15no04.442</GID>
                    </GPH>
                    <HD SOURCE="HD3">2. Comorbidities </HD>
                    <P>In the proposed rule, we proposed 17 comorbidity categories and identified specific ICD-9-CM codes that would generate a payment adjustment. Our intent was to identify conditions that would require comparatively more costly treatment during an IPF stay than other comorbid conditions. </P>
                    <P>We specifically solicited comments on other conditions that may be expected to increase the per diem cost of care in IPFs. In response, we received a number of comments regarding our proposed comobidity adjustments. A number of commenters expressed support that the proposed IPF PPS recognized the increased cost associated with comorbid medical conditions. Others identified what they believe to be flaws in the analysis used to develop the proposed comorbidity adjustments. A majority of the commenters indicated that hospitals design specialized programs with highly trained staff to treat Medicare beneficiaries who are disabled or geriatric psychiatric patients. The commenters stated that the proposed comorbidity adjustments are inadequate to capture these coexisting medical and psychiatric conditions requiring treatment during a hospital stay. </P>
                    <P>We also received comments offering suggestions on how we could improve the comorbidity list. The suggestions ranged from a request for addition of a single ICD-9-CM code to a request for comorbidity categories to account for every ICD-9-CM and DSM-IV-TR diagnosis. </P>
                    <P>
                        <E T="03">Comment:</E>
                         Commenters expressed concern that payment for treating complex cases would decrease because the proposed comorbidity list does not include the conditions seen in their patient populations. Several comments stated that most psychiatric patients are treated for multiple common conditions and illnesses (for example, heart conditions, stroke), none of which would trigger a payment adjustment under the proposed IPF PPS. 
                    </P>
                    <P>Other commenters stated that the proposed comorbidity list includes mostly acute medical conditions that would require transfer to an acute care hospital. One commenter indicated that the adjustment proposed for renal failure should be much higher. Many commenters stated that the range of diagnostic codes proposed for adjustment often did not include all the ICD-9-CM codes within a diagnostic category. For example, the list of codes under diabetes did not include all the diabetes codes. </P>
                    <P>
                        <E T="03">Response:</E>
                         We have reconsidered our approach to the comorbidity adjustments and have revised the comorbidity list. We analyzed the FY 2002 data to determine the prevalence of the diagnoses suggested most often in the public comments (for example, 
                        <PRTPAGE P="66939"/>
                        hypertension, chronic constructive pulmonary disease, and urinary tract infection). In an attempt to address the commenters concerns, we had CMS staff physicians and FI Medical Directors who are psychiatrists review the list of proposed comorbidities and cost and frequency data on all ICD-9-CM diagnoses codes that had been submitted on the FY 2002 claims. 
                    </P>
                    <P>We explained to the CMS staff physicians and FI Medical Directors that the data used in calculating the Federal per diem base rate for both the proposed rule and the final rule included all the costs for comorbid diagnoses submitted in the FY 2002 claims. Therefore, the cost for providing patient care (for example, medications, and routine nursing care required for the common conditions seen in the psychiatric population and recommended for comorbidity adjustment by the commenters (that is, heart conditions or strokes) are included already in the Federal per diem base rate and a comorbidity adjustment for their presence was unnecessary. </P>
                    <P>One significant issue raised by the CMS physician and FI Medical Director panel was the extent of medical treatment permitted in a psychiatric unit. In the secure environment of a psychiatric unit, common treatments such as IV antibiotics therapy would not be permitted as they could compromise patient safety. The prohibition of items that present a potential risk as a mechanism to inflict injury on oneself or others is strictly enforced. Thus, for many medical treatments for the more complex and costly comorbid, medical, or surgical conditions the psychiatric patient would be required to be moved to a medical floor for treatment with one-on-one staff observation. Consequently, since the patient would no longer be a patient of the IPF, it would be unnecessary to give the IPF an adjustment for such a case. </P>
                    <P>The intent of the comorbidity adjustments is to provide additional payments for a concurrent medical or psychiatric condition that is expensive to treat. The physicians determined that the high cost of certain diagnoses is related to the cost of the therapy to treat the diagnoses. For example, the cost to treat a patient with a malignant neoplasm is related primarily to the cost of the therapy to treat the tumor, whether it is chemotherapy or radiation therapy, or both. As a result, we have added two ICD-9-CM V codes, one for chemotherapy (V58.0) and for one radiation treatment (V58.1). We are also requiring that, in order to receive the comorbidity adjustment for malignant neoplasm, IPFs will need to code the ICD-9-CM code for the specific malignant neoplasm from the ICD-9-CM chapter 2 codes (140-239) and one of the two ICD-9-CM procedures codes (chemotherapy ((V58.0)) or radiation treatment ((V58.1)) to indicate the treatment modality the patient received. </P>
                    <P>Based on the clinical expertise of the CMS physicians and FI Medical Directors, we made numerous changes to the list of ICD-9-CM codes eligible for a comorbidity adjustment. These changes include adding one new category entitled, “Developmental Disabilities,” deleting the “HIV” category and moving it into the “Infectious Diseases” category, and changing the titles of two categories from “Malignant Neoplasms” to “Oncology Treatments” and for “Atherosclerosis of extremity with Gangrene” to “Gangrene.” </P>
                    <P>In response to comments requesting adjustment for Developmental Disabilities and the results of the regression analysis on the FY 2002 data, the higher cost of caring for patients with developmental disabilities indicated a comorbidity adjustment of 1.04 was appropriate. The regression analysis of FY 2002 data would have provided the same adjustment for the “HIV” category as for the “Infectious Disease” category. Therefore, we merged the two categories under the “Infectious Disease” category with an adjustment factor of 1.07. The “Malignant Neoplasm” category was modified to “Onocology Treatments” since the CMS staff physicians and FI Medical Directors believed the higher cost was related to the treatment of the neoplasms rather than the presence of the tumor. We are also requiring that the treatment code be included on the claim form to receive the 1.07 comorbidity adjustment. The last category change was in the title of “Atheroscleosis of Extremity with Gangrene to “Gangrene” to account for the higher cost of a patient with gangrene regardless of the cause. </P>
                    <P>The design of the IPF PPS with Federal per diem base rate, together with the numerous available adjustments, outlier policy, and stop loss policy during the 3-year transition should prevent the facility from being disadvantaged by decrease in payment for their more complex patients. </P>
                    <P>We are providing below a table that compares the proposed comorbidity categories to the categories we are adopting in this final rule. </P>
                    <BILCOD>BILLING CODE 4120-03-P</BILCOD>
                    <GPH SPAN="3" DEEP="583">
                        <PRTPAGE P="66940"/>
                        <GID>ER15NO04.443</GID>
                    </GPH>
                    <BILCOD>BILLING CODE 4120-03-C</BILCOD>
                    <PRTPAGE P="66941"/>
                    <P>
                        <E T="03">Comment:</E>
                         Several commenters suggested that CMS include all psychiatric and non-psychiatric diagnoses submitted on the claim, whether they are designated as the primary or secondary. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         Billing instructions require hospitals to enter the ICD-9-CM code for the patient's principal diagnosis. The code must be the full ICD-9-CM diagnosis code, including all five digits when applicable. The principal diagnosis is the condition established after study to be chiefly responsible for this admission. Even though another diagnosis may be more severe than the principal diagnosis, the hospital enters the principal diagnosis. Entering any other diagnosis as principal on the claim form may result in incorrect DRG assignment and cause the hospital to be incorrectly paid. The hospital is also instructed to enter the full ICD-9-CM codes for up to 8 additional conditions if they co-existed at the time of admission or develope subsequently, and which had an effect upon the treatment or the length of stay. These codes may not duplicate the principal diagnosis. 
                    </P>
                    <P>The regression analysis established the DRG adjustment factors based on the principal diagnoses reported by hospitals and the comorbidity category adjustments based on the all the diagnoses reported by hospitals as other diagnoses. The principal diagnoses were used to establish the DRG adjustment and were not accounted for in establishing the comorbidity category adjustments, except where ICD-9-CM “code first” instructions apply. A description of the “code first” instructions appears in the next section of this final rule. </P>
                    <P>
                        <E T="03">Comment:</E>
                         Several commenters indicated that the comorbidity adjustment factors did not take into account the extensive workup their patients require, such as the need for additional ancillary services (for example, specific medical or neurological examinations, specialized laboratory and radiological tests, supplies, medications, and consultations). In many instances, the commenter stated that these additional services are needed to identify the numerous physical conditions that exacerbate or first present as psychiatric symptoms. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         The adjustment factors for the proposed comorbidity categories were derived from the proposed regression analysis. Similarly, the final adjustment factors for the final comorbidity categories were derived from the final regression analysis. With regard to the additional ancillary services the commenters' patients require to establish their principal diagnoses, the variable per diem adjustments discussed in section VI.B. 5. of this final rule are intended to account for higher per diem costs early in an inpatient stay. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         Commenters expressed concern that the comorbidity policy does not account for the costs associated with social issues (for example, poverty, lack of housing, poor nutrition, lack of primary medical care, and the cost of involuntary commitments and guardianship hearings). The commenters also expressed concern that the comorbidity policy does not account for the costs of patients with hearing, sight, and mobility disabilities or when English is not the patient's primary language. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         Most of the social issues identified by the commenters are not captured in the FY 2002 IPF claims data. As a result, we are not able to determine whether the psychiatric hospitalizations of patients with various social issues are more costly on a per diem basis than other psychiatric patients. Because we lack data that indicates IPFs that treat patients with various social issues are more costly on a per diem basis, we are not providing an adjustment in these cases. 
                    </P>
                    <P>We note that codes are currently available that describe some of the social issues that impact care delivery and management. For example, there are V codes to indicate that the patient has problems with sight (V41.0), problems with hearing (V41.2), or lack of housing (V60.0). Even though we have codes for problems with sight, hearing, or lack of housing, we had too few cases to be able to extrapolate any valuable empirical data that the presence of these codes correlated to higher per diem costs. We encourage IPFs to code all relevant diagnoses that impact the resources associated with their patient population for future analysis. </P>
                    <P>We note that one of the fields on the claim form indicates if patients were referred to the IPF by law enforcement or if the commitment were court ordered (FL 20 item 8, court/law enforcement). As a result, we were able to analyze the impact on per diem cost. The results of our analysis are included in section VI of this rule with other patient variables considered. </P>
                    <P>
                        <E T="03">Comment:</E>
                         One commenter stated that diagnostic data alone may not be descriptive enough to supply the information CMS is seeking regarding comorbidities. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         Section 124 of the BBRA provides authority for CMS to require IPFs to submit additional data. We are not mandating new reporting requirements at this time, however, we may establish new reporting requirements based on results of the research underway to refine the IPF PPS. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         One commenter asked how the comorbidity adjustment would be applied if a patient has multiple diagnoses within the same comorbidity category. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         IPFs may only receive one adjustment factor for each comorbidity category. However, if a patient has multiple diagnoses in several categories, the adjustment factors for each applicable category are multiplied by the Federal per diem base rate. The following is an example illustrating how payment would be made under the IPF PPS for a patient with multiple comorbidities
                    </P>
                    . 
                    <EXAMPLE>
                        <HD SOURCE="HED">Example: </HD>
                        <P>A 68 year old Female Caucasian presents at a qualified ED and is subsequently admitted to a non-teaching inpatient psychiatric facility within the “I'll Feel Better Hospital” in rural Smalltown, North Dakota. The ED is determined to be full-service and the patient had not been discharged from an IPPS stay. The patient had a primary diagnosis of Neurotic Depression (IDC-9-CM code 3004) DRG 426 Depressive Neuroses, and comorbid conditions of Obstructive Chronic Bronchitis without exacerbation 491.20, and mechanical complication of Tracheostomy ICD-9-CM code (ICD-9-CM code 519.02), Diabetes with ophthalmic manifestations (ICD-9-CM code 250.53), and Diabetes with peripheral circulatory manifestations (ICD-9-CM code 250.73). The patient length of stay was 10 days. In addition, the patient did not receive ECT during her inpatient stay.</P>
                    </EXAMPLE>
                    <GPH SPAN="3" DEEP="418">
                        <PRTPAGE P="66942"/>
                        <GID>ER15NO04.444</GID>
                    </GPH>
                    <HD SOURCE="HD1">Calculate Total Wage Adjusted Rate: </HD>
                    <P>
                        <E T="03">Step 1:</E>
                         Multiply the 
                        <E T="03">Wage Index Factor</E>
                         (for North Dakota) by the Labor Portion of the Federal base rate to get the 
                        <E T="03">Adjusted Labor Portion</E>
                         of the Federal per diem base rate = (0.7743 x 417.73 = $323.45). 
                    </P>
                    <P>
                        <E T="03">Step 2:</E>
                         Add the 
                        <E T="03">Adjusted Labor Portion of the Federal Base Rate</E>
                         to the 
                        <E T="03">Non-Labor Portion</E>
                         of the Federal per diem base rate to get the 
                        <E T="03">Total Wage Adjusted Rate</E>
                         = (323.45 + 158.22 = $481.67). 
                    </P>
                    <HD SOURCE="HD1">Apply Facility- and Patient-Level Adjusters </HD>
                    <P>
                        <E T="03">Step 1:</E>
                         Using the information in Addendum A, determine which facility- and patient-level adjustment factors are applicable. 
                    </P>
                    <P>1. Teaching Adjustment: None. </P>
                    <P>2. Rural Adjustment: North Dakota—1.17. </P>
                    <P>3. COLA: None. </P>
                    <P>4. DRG Adjustment: DRG 426—Depressive Neuroses—0.99. </P>
                    <P>5. Age Adjustment: Age 68—1.10. </P>
                    <P>
                        6. 
                        <E T="03">Comorbidity</E>
                         (All comorbidity codes are cited as presented in the ICD-9-CM text) 
                    </P>
                    <P>Comorbidity 491.20—Obstructive Chronic Bronchitis without exacerbation—None. </P>
                    <P>Comorbidity 519.02: Mechanical complication of Tracheostomy—1.06. </P>
                    <P>
                        Comorbidity 250.53: Diabetes with ophthalmic—manifestations (
                        <E T="03">Use additional code to identify manifestation as</E>
                         362.02)—1.05. 
                    </P>
                    <P>
                        Proliferative Diabetic Retinopathy [
                        <E T="03">not allowed as principal Dx-“CODE FIRST” underlying disease as DIABETES 250.5</E>
                        ) and Comorbidity—250.73—Diabetes with peripheral Circulatory—None 2nd in Category manifestations, (
                        <E T="03">Use additional code to identify manifestation as</E>
                         443.81—Diabetic Peripheral angiopathy [
                        <E T="03">not allowed as principal Dx-“CODE FIRST” underlying disease as DIABETES MELLITUS 250.7</E>
                        ). 
                    </P>
                    <P>7. ECT Treatments—None. </P>
                    <P>
                        <E T="03">Step 2.</E>
                         Multiply the applicable adjustment factors to determine the 
                        <E T="03">PPS Adjustment Factor.</E>
                         = (1.17 x 0.99 x 1.10 x 1.06 x 1.05 = 1.4181). 
                    </P>
                    <P>
                        <E T="03">Step 3.</E>
                         Calculate the Adjusted Per Diem.
                    </P>
                    <FP SOURCE="FP-2">Multiply the Total Wage Adjusted Rate by the PPS Adjustment Factor. </FP>
                    <FP SOURCE="FP1-2">= ($481.67 x 1.4181 = 683.06).</FP>
                    <P>Calculate the variable per diem adjustment. </P>
                    <P>
                        <E T="03">Step 1.</E>
                         Determine the number of days in the stay. 
                    </P>
                    <P>Length of Stay: 10 days and the facility has a qualifying ED.</P>
                    <FP SOURCE="FP-1">Day 1—1.31 </FP>
                    <FP SOURCE="FP-1">Day 2—1.12 </FP>
                    <FP SOURCE="FP-1">Day 3—1.08 </FP>
                    <FP SOURCE="FP-1">Day 4—1.05 </FP>
                    <FP SOURCE="FP-1">Day 5—1.04 </FP>
                    <FP SOURCE="FP-1">
                        Day 6—1.02 
                        <PRTPAGE P="66943"/>
                    </FP>
                    <FP SOURCE="FP-1">Day 7—1.01 </FP>
                    <FP SOURCE="FP-1">Day 8—1.01 </FP>
                    <FP SOURCE="FP-1">Day 9—1.00 </FP>
                    <FP SOURCE="FP-1">Day 10—1.00</FP>
                    <P>
                        <E T="03">Step 2.</E>
                         Multiply the 
                        <E T="03">Variable Per Diem Adjustment Factors</E>
                         by the Total Wage and PPS-Adjusted Per Diem for each day of the stay to get the 
                        <E T="03">Total Variable Per Diem Amounts</E>
                         for each day of the stay. (See multiplication in step 3 below.)
                    </P>
                    <P>
                        <E T="03">Step 3.</E>
                         Add the 
                        <E T="03">Adjusted Variable Per Diem Amounts</E>
                         to get the 
                        <E T="03">Total Inpatient Psychiatric Facility PPS Payment.</E>
                    </P>
                    <FP SOURCE="FP-1">Day 1 (adjustment factor 1.31) × 683.06 = $894.81 </FP>
                    <FP SOURCE="FP-1">Day 2 (adjustment factor 1.12) × 683.06 = $765.03 </FP>
                    <FP SOURCE="FP-1">Day 3 (adjustment factor 1.08) × 683.06 = $737.70 </FP>
                    <FP SOURCE="FP-1">Day 4 (adjustment factor 1.05) × 683.06 = $717.21 </FP>
                    <FP SOURCE="FP-1">Day 5 (adjustment factor 1.04) × 683.06 = $710.38 </FP>
                    <FP SOURCE="FP-1">Day 6 (adjustment factor 1.02) × 683.06 = $696.72 </FP>
                    <FP SOURCE="FP-1">Day 7 (adjustment factor 1.01) × 683.06 = $689.89 </FP>
                    <FP SOURCE="FP-1">Day 8 (adjustment factor 1.01) × 683.06 = $689.89 </FP>
                    <FP SOURCE="FP-1">Day 9 (adjustment factor 1.00) × 683.06 = $683.06 </FP>
                    <FP SOURCE="FP-1">Day 10 (adjustment factor 1.00) × 683.06 = $683.06 </FP>
                    <FP SOURCE="FP-1">Federal per diem payment amount $7,267.75</FP>
                    <P>
                        <E T="03">Comment:</E>
                         A commenter asked if the comorbidity adjustments would be applied to each day of the stay regardless of the patient's length of stay. For example, poisoning and arteriosclerosis of the extremity with gangrene may have higher cost only for the early days of a stay. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         The comorbidity adjustments are applied to each day of the stay. In estimating the cost impact of the comorbidity conditions, our dependent variable reflects the average cost per day over the entire stay. A significant effect on this cost variable for a comorbidity condition means that the average cost per day was higher for cases with the specific condition. Therefore, it is appropriate to apply the estimated effect to each day of the stay. 
                    </P>
                    <P>We would be especially concerned if data analysis began to show longer lengths of stay for DRG 424 stays or significantly more DRG 424 stays, with DRG 424 being the surgical DRG. We intend to monitor for changes in length of stay and the distribution of IPF cases across DRGs to ensure that the decision to pay all applicable adjustments throughout the stay does not lead to inappropriate increases in the length of stay or frequency of those cases. </P>
                    <P>
                        <E T="03">Comment:</E>
                         One commenter indicated that the comorbidity policy does not distinguish between dormant serious medical conditions and labor-intensive procedures requiring additional behavioral and medical treatments during the IPF stay. Another commenter stated that when a non-psychiatric diagnosis exists in addition to a psychiatric diagnosis, the ICD-9-CM code for the non-psychiatric diagnosis should also be reported on the claim. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         In § 412.402 definitions, we proposed the following definition of comorbidity: “Comorbidity means all specific patient conditions that are secondary to the patient's primary diagnosis and that coexist at the time of admission, develop subsequently, or affect the treatment received or the length of stay or both. Diagnoses that relate to an earlier episode of care that have no bearing on the current hospital stay are excluded.” A serious medical condition that does not require treatment during the hospital stay must not be reported as a secondary or tertiary diagnosis and will not qualify for a comorbidity adjustment. We are retaining the proposed comorbidity definition in this final rule. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         One commenter recommended that we provide an adjustment to reflect the increased staffing, greater frequency of comorbid conditions, and longer length of stay for developmentally disabled patients. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We analyzed the frequency and costs in the FY 2002 claims data associated with developmentally disabled patients. We identified relevant claims by the presence of an ICD-9-CM code in the 317 through 319 range entered as a diagnosis in addition to a psychiatric principal diagnosis. We found that per diem costs associated with inpatient psychiatric stays of developmentally disabled mentally ill patients, are approximately 4 percent higher than stays for other patients. As a result of this analysis, we are establishing a new comorbidity category to reflect the higher per diem costs of developmentally disabled patients. The final IPF PPS comorbidity categories and adjustment factors are presented in the table below and Addendum A. 
                    </P>
                    <BILCOD>BILLING CODE 4120-03-P</BILCOD>
                    <GPH SPAN="3" DEEP="558">
                        <PRTPAGE P="66944"/>
                        <GID>ER15NO04.445</GID>
                    </GPH>
                    <BILCOD>BILLING CODE 4120-03-C</BILCOD>
                    <HD SOURCE="HD3">3. Other Coding Issues </HD>
                    <P>We received several comments related to discrepancies with established coding conventions. </P>
                    <P>
                        <E T="03">Comment:</E>
                         One commenter requested that CMS specify that hospitals must follow the ICD-9-CM Official Guidelines for Coding and Reporting and the Coding Clinic for ICD-9-CM. In addition, the commenter advocated the use of certified coding professionals to assign and validate codes and assist in the development of hospital coding policy. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We agree with the commenter about the value of certified coding professionals. The ICD-9-CM Official Guidelines for Coding and Reporting was developed and approved by the Cooperating Parties for ICD-9-CM: The American Hospital Association, the American Health Information Management Association, the Centers for Medicare &amp; Medicaid Services (formerly the Health Care Financing Administration or HCFA) and the National Center for Health Statistics to be used as a companion document to the official version of the ICD-9-CM as 
                        <PRTPAGE P="66945"/>
                        published by the Department of Health and Human Services and the Coding Clinic for ICD-9-CM, published by the American Hospital Association. In addition, this decision is consistent with the Standards for Electronic Transaction final rule (65 FR 50312). The ICD-9-CM Official Guidelines for Coding and Reporting can be found at 
                        <E T="03">www.cdc.gov/nchs/data/ics9/icdguide.pdf</E>
                        . 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         Several commenters requested that CMS provide detailed information about medical necessity requirements to support an IPF stay. The commenters expressed concern that IPFs are not experienced with medical review and the need to document medical necessity to support the stay. The commenters believe that in the absence of clear national standards for determining medical necessity, IPFs will be subject to various local coverage decisions promulgated by FIs. 
                    </P>
                    <P>Other commenters were concerned about the potential of differential access to inpatient psychiatric care depending on the geographic location of the IPF and how each FI interprets medical necessity. These commenters suggested that CMS incorporate safeguards against clinically unrealistic, inefficient, or inappropriate medical review practices by FIs. The commenters recommended that CMS include a mechanism for impartial appeal of FI decisions to ensure appropriate payment of IPF claims. </P>
                    <P>
                        <E T="03">Response:</E>
                         Inpatient psychiatric services are intended for patients that require more intense services than can be provided in an outpatient setting. As a result, the patients admitted to an IPF must require intensive, comprehensive, multimodal treatment including 24 hours per day of medical supervision and coordination because of the mental disorder. The need for 24 hours of supervision may be due to the need for patient safety, psychiatric diagnostic evaluation, potential severe side effects of psychotropic medication associated with medical or psychiatric comorbidities, or evaluation of behaviors consistent with an acute psychiatric disorder for which a medical cause has not been ruled out. 
                    </P>
                    <P>The acute psychiatric condition being evaluated or treated by inpatient psychiatric hospitalization must require active treatment, including a combination of services (for example, intensive nursing and medical interventions, psychotherapy, occupational and patient education). Patients must require inpatient psychiatric hospitalization services at levels of intensity and frequency exceeding what may be rendered in an outpatient setting including partial hospitalization programs. </P>
                    <P>
                        If a provider receives a medical necessity denial, they have the right to appeal the FI's determination that the inpatient hospital services were not reasonable and necessary. A request for reconsideration must be in writing and filed with the FI. The provider should contact their FI for additional information on the appeal process. The prescribed form to request an FI reconsideration “MCS-2649, Request for Reconsideration of Part A Health Insurance Benefits” is located on the CMS web site at 
                        <E T="03">www.cms.hhs.gov/forms</E>
                        . 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         Several commenters indicated that the proposed rule included coding policies that were inconsistent with the ICD-9-CM Official Guidelines for Coding and Reporting with respect to the designation of primary and secondary diagnoses (the “code first” policy). 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         In the proposed rule, we inadvertently failed to include the ICD-9-CM instructions pertaining to the code first diagnosis codes. The introduction of the ICD-9-CM text includes “Instructional Notations” in which “code first” underlying disease is explained. This instruction is for codes that are not intended to be used as a principal diagnosis or for those codes that are not to be sequenced before the underlying disease. The note requires that the underlying disease (etiology) be coded first (identified as the principal and diagnosis) with the code the note is applied to being coded second. This note appears only in the Tabular List (Volume 1). 
                    </P>
                    <P>The ICD-9-CM Official Guidelines for Coding and Reporting includes the following instructional guidance regarding the code first policy: </P>
                    <P>“(1) The guidelines identify codes that have both an underlying etiology and multiple body system manifestations due to the underlying etiology. The coding convention requires the underlying condition be sequenced first followed by the manifestation. Whenever a combination exists, there is a “use additional code” note at the etiology code, and a “code first” note at the manifestation code. These instructional notes indicate the proper sequencing order of the codes, that is, etiology followed by manifestation. </P>
                    <P>(2) “Code first” notes are also under certain codes that are not specifically manifestation codes but may be due to an underlying cause. When a “code first” note is present and an underlying condition is present, the underlying condition should be sequenced first. </P>
                    <P>(3) Code, if applicable any causal condition first, notes indicate that this code may be assigned as a principal diagnosis when the causal condition is unknown or not applicable. If a causal condition is known, then the code for that condition should be sequenced as the principal or first-listed diagnosis. </P>
                    <P>(4) Multiple codes may be needed for late effects, complications and obstetrics to more fully describe a condition. See the specific guidelines for these conditions for further instruction.” </P>
                    <P>For example, diagnosis code 294.1 Dementia in Conditions Classified Elsewhere is designated as a code first diagnosis and appears in the ICD-9-CM as follows: </P>
                    <HD SOURCE="HD1">294.1 Dementia in Conditions Classified Elsewhere </HD>
                    <P>Code first any underlying physical condition, as: </P>
                    <P>Dementia in: </P>
                    <FP SOURCE="FP-1">Alzheimer's disease (331.0) </FP>
                    <FP SOURCE="FP-1">Cerebral lipidosis (330.1) </FP>
                    <FP SOURCE="FP-1">Dementia with Lewy bodies (33.82) </FP>
                    <FP SOURCE="FP-1">Dementia with Parkinsonism (331.81) </FP>
                    <FP SOURCE="FP-1">Epilepsy (345.0-345.9) </FP>
                    <FP SOURCE="FP-1">Frontal dementia (331.19) </FP>
                    <FP SOURCE="FP-1">Frontotemporal dementia (331.19) </FP>
                    <FP SOURCE="FP-1">General paresis [syphilis] (094.1) </FP>
                    <FP SOURCE="FP-1">Hepatolenticular degeneration (275.1) </FP>
                    <FP SOURCE="FP-1">Huntington's chorea (333.4) </FP>
                    <FP SOURCE="FP-1">Jacob-Creutzfeldt disease (046.1) </FP>
                    <FP SOURCE="FP-1">Multiple sclerosis (340) </FP>
                    <FP SOURCE="FP-1">Pick's disease of the brain (331.11) </FP>
                    <FP SOURCE="FP-1">Polyarteritis nodosa (446.0) </FP>
                    <FP SOURCE="FP-1">Syphilis (094.1) </FP>
                    <P>
                        In accordance with the ICD-9-CM Official Guidelines for Coding and Reporting, when a primary (psychiatric) diagnosis code has a “code first” note, the provider would follow the instructions in the ICD-9-CM text. For example, 294.1, 
                        <E T="03">Dementia in conditions classified elsewhere</E>
                         states “code first any underlying physical condition as:” the provider would then code the appropriate physical condition, for example, 333.4 Huntington's chorea as the primary diagnosis and 294.1 as the secondary diagnosis. The submitted claim goes through the CMS processing system that will identify the primary diagnosis code as non-psychiatric and search the secondary codes for a psychiatric code to assign a DRG code for adjustment. The system will continue to search the secondary codes for those that are appropriate for comorbidity adjustment. 
                    </P>
                    <P>A list of ICD-9-CM codes identified as code first is provided in Addendum C. </P>
                    <P>
                        <E T="03">Comment:</E>
                         A commenter questioned whether IPFs would be required to report ICD-9-CM procedure codes. 
                        <PRTPAGE P="66946"/>
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         IPFs will be required to report those ICD-9-CM codes indicated in the billing instructions. As mentioned above, the only unique coding will be for oncology treatment which requires the ICD for the specific neoplasm and the appropriate treatment V code V580 chemotherapy or V581 radiation. In addition, as discussed in section VI.B.5.C. of this final rule, we are providing additional payments for patients who undergo ECT treatments. In order to receive the additional payments, IPFs will have to report the ICD-9-CM procedure code for ECT (code 90870) and indicate the number of ECT treatments the patient received during the IPF stay. We encourage IPFs to provide as much information on the claim form to describe the services furnished to validate the principal diagnosis for payment purposes. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         One commenter asked if delirium is considered a primary, secondary, or medical condition. The commenter also asked if delirium should be considered an adjustment disorder. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         Coding decisions are based on how the physician describes the diagnosis. The physician needs to indicate the type or cause of the delirium, which will determine whether the delirium is psychiatric diagnosis, a psychiatric secondary diagnosis (comorbidity), or a medical comorbid condition. According to the ICD-9-CM, delirium is listed as caused by medical conditions, substance or alcohol abuses, or with psychosis. Delirium is primarily located in the 290 series of ICD codes. If the physician indicates that the patient's diagnosis is “delirium, delirious” the ICD-9-CM index would refer to ICD-9-CM code 780.09—Alteration in consciouusness—Other. However, if the physician specifies that the delirium is acute, then the ICD-9-CM code is 293.0—Delirium Due to Condition Classified Elsewhere, and if the Delirium is caused by alcohol abuse, the ICD-9-CM code is 291.0—Alcohol withdrawal delirium. We recommend that the commenter review the ICD-9-CM index under the term delirium (to determine the different types of diagnosis). 
                    </P>
                    <P>We are not responsible for the determination of clinical definition and criteria. To establish how a condition is defined or identified, providers should review a text of psychiatric diagnoses. We are providing the definition for delirium and adjustment reaction or disorder as defined in the ICD-9-CM (2004) for the convenience of the reader. </P>
                    <P>
                        <E T="03">Delirium</E>
                         is defined as “Transient organic psychotic condition with a short course in which there is a rapidly developing onset of disorganization of higher mental processes manifested by some degree of impairment of information processing, impaired or abnormal attention, perception, memory, and thinking. Clouded consciousness, confusion, disorientation, delusions, illusions, and often vivid hallucination predominate in the clinical picture.” 
                    </P>
                    <P>
                        <E T="03">Adjustment reaction or disorder</E>
                         is defined as “Mild or transient disorders lasting longer than acute stress reactions which occur in individuals of any age without any apparent preexisting mental disorder. Such disorders are often relatively circumscribed or situation-specific, are generally reversible, and usually last only a few months. They are usually closely related in time and in content to stresses such as bereavement, migration, or other experiences. Reactions to major stress that last longer than a few days are also included. In children, such disorders are associated with no significant distortion of development.” 
                    </P>
                    <P>In review of the DSM diagnostic criteria, delirium is not included in the “Adjustment Disorder” category. Based on the ICD-9-CM definition and the DSM diagnostic criteria, we would not expect delirium to be identified as an adjustment disorder. </P>
                    <P>
                        <E T="03">Comment:</E>
                         One commenter asked how to code multiple addictions, for example, drug and alcohol, or two drug diagnoses. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We encourage IPFs to code all diagnoses requiring active treatment during the IPF stay. The ICD-9-CM index entry for addiction provides several sub-terms to direct the coder to the most appropriate ICD-9-CM code. The ICD-9-CM code for alcohol dependence is 303.9. However, the ICD-9-CM indicates under code 303.9 that a fifth digit is required based on whether the physician inidicates that the dependence is continuous, episodic, in remission, or there is no information, that is, unspecified. 
                    </P>
                    <P>Separate codes are listed for drug addiction. The index refers coders to “see dependence”. Under dependence, there are a variety of codes depending upon the specific addiction. The coder would enter as many codes as required to cover all the patient's dependencies (drug and alcohol). However, as noted above, only one comorbidity adjustment per comorbidity category will be paid under the IPF PPS. </P>
                    <P>
                        <E T="03">Comment:</E>
                         Several commenters requested clarification of specific ICD-9-CM codes they suspected were erroneous. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We agree with the commenters and acknowledge that we made the following typographical errors in the proposed rule: 
                    </P>
                    <P>• In Table 3 (68 FR 66931), in the Infectious Disease category, the correct range of codes is 07950 through 07959. </P>
                    <P>• In table 7 (68 FR 66941), the correct adjustment for Diabetes is 1.10 and the correct adjustment factor for Chronic Renal Failure is 1.14. </P>
                    <HD SOURCE="HD3">4. Patient Age </HD>
                    <P>We proposed a 13 percent payment adjustment for patients 65 years of age and over to reflect the additional costs associated with treating elderly patients. We received a wide range of comments about the proposed age adjustment. In general, the comments favored the creation of additional age groups and payment adjustments. </P>
                    <P>
                        <E T="03">Comment:</E>
                         Commenters requested clarification on how the proposed 13 percent differential between age groups was calculated. The commenters stated that the proposed adjustment factor is too low and does not reflect the current cost required to treat the elderly. 
                    </P>
                    <P>Several commenters recommended that CMS revise the age groupings to include a payment adjustment for patients under 14 years of age, under 40 years of age, 55 to 64 years of age, and 75 years of age and over. Other commenters suggested a payment adjustment for patients 65 years of age and over with increments added for each additional 5 years in age. </P>
                    <P>
                        <E T="03">Response:</E>
                         As indicated in the proposed rule (68 FR 66931), the 13 percent differential was calculated using the same cost regression that was used to estimate the payment adjustments for the other variables included in the proposed payment system. The dependent variable was the natural logarithm of average cost per day for each inpatient stay. The regression included a single variable for persons 65 years of age and over to estimate the relative cost per day of persons 65 years of age and over compared to persons less than 65 years of age. Since the cost variable was in logarithms, the age coefficient in the cost regression was then raised to the power of the base e to convert it to the relative payment factor, 1.13. 
                    </P>
                    <P>
                        In response to the public comments to create additional age payment adjustments (under 14 years of age and under 40 years of age, 55 to 64 years of age, and over 75 years of age), we updated our analysis of the impact of age on per diem cost by expanding the age variable (that is, the range of ages for payment adjustments). Since we have relatively few cases for persons under 40 years of age (and virtually no cases for persons under 14 years of age), we 
                        <PRTPAGE P="66947"/>
                        combined all persons under 40 years of age into a single category. Similarly, all persons over 80 years of age were placed in a single category. For patients in between 40 and 80 years of age, we categorized cases into 5-year intervals. As indicated in the proposed rule, the cost per day increases with increasing age. With the exception of the 40 through 44 age group, all the older age groups are more costly than the under 40 years of age group, the differences increase for each successive age group, the differences among the age groups increase for each successive age group, and the differences are statistically significant. 
                    </P>
                    <P>Based on these results, in this final rule we are expanding the relative adjustment factor for age from the single factor for patients 65 years of age and over to 8 adjustment factors beginning with age groupings 45 and under 50 years of age to patients 80 years of age and over. The magnitudes of these factors are shown in Table 6 below and in Addendum A. We are also adopting as final the same methodology we used in the proposed rule (that is, cost regression analysis) except we are using an updated and revised regression based on FY 2002 data and the age groupings described above (that is, 5 year intervals and 8 adjustment factors). </P>
                    <GPH SPAN="3" DEEP="137">
                        <GID>ER15NO04.446</GID>
                    </GPH>
                    <HD SOURCE="HD3">5. Variable Per Diem Adjustments </HD>
                    <P>Cost regressions indicate that the per diem cost declines as the length of stay increases. Therefore, we proposed adjustments to account for ancillary and certain administrative costs that occur disproportionately in the first days after admission to an IPF. As we explained in the proposed rule, we examined the per diem cost over a range of 1 to 14 days. According to the FY 1999 MedPAR data file, the per diem costs were highest on day 1 and declined for days 2 through 8 as follows. Per diem costs for days 9 and thereafter remained relatively constant. The proposed cost regression analysis was used to determine the proposed payment adjustment factors. Relative to a stay of 9 or more days, we proposed a variable per diem adjustment of 26 percent for day 1, a 12-percent adjustment for days 2 through 4, and a 5-percent adjustment for days 4 through 8. No variable per diem adjustments would be made after the 8th day. </P>
                    <P>We received multiple comments on the proposed variable per diem adjustments, primarily dealing with the amount of the proposed payment adjustments and the breakpoints for the adjustments. </P>
                    <P>
                        <E T="03">Comment:</E>
                         One commenter asked how CMS determined the cost per day for the different lengths of stay. Another commenter recommended more justification of the method used to control for length of stay. Specifically, this commenter asked whether CMS tested alternative breakpoints for the length of stay categories and whether CMS considered other approaches for estimating the relationship between per diem cost and length of stay. One commenter objected to the proposed length of stays blocks, in which days 2 through 4 and days 5 through 8 would be paid at the same rate rather than declining smoothly for each successive day. The commenter believes that the proposed approach creates incentives to terminate or unnecessarily extend the length of stay. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         As indicated in the proposed rule, the relationship between cost per day and length of stay was estimated within the same cost regression used to derive other payment adjustments. First, we defined variables for each stay's length of stay (from 1 to 14 days). The effects of the first 14 days on cost were measured relative to stays of more than 14 days. Based on the results of this regression, we considered payment breakpoints for each day up through 14 days. Based on the size and pattern of variation of the regression coefficients for the individual day coefficients (that is, the magnitude of decline), we decided to group the days into the categories presented in the proposed rule (that is, day 1, days 2 through 4, days 5 through 8, and days 9 and thereafter). We then re-estimated the cost regression including the first 3 of these groups and stays of more than 8 days as the reference group. 
                    </P>
                    <P>As a result of converting the regression coefficients to payment factors, we proposed to pay the first day of each stay 26 percent more than the Federal per diem base rate. Similarly, we proposed to pay days 2 through 4 of each stay 12 percent more than the Federal per diem base rate and days 5 through 8 about 5 percent more than the Federal per diem base rate. The Federal per diem base rate implicitly reflects the cost of stays with more than 8 days. </P>
                    <P>We used regression analysis to estimate the average differences in per diem cost among stays of different length. Regression analysis simultaneously controls for cost differences associated with the other variables (for example, age, DRG, and presence of specific comorbidities). The regression coefficients measure the relative average cost per day for stays of differing lengths compared to a reference group's length of stay. In the proposed rule, the variable per diem adjustment factors derived from the regression coefficients were applied to specific days within the stay. As indicated above, we proposed to pay all stays 26 percent more than the Federal per diem base rate for day 1, 12 percent more than the base payment amount for days 2 through 4, and 5 percent more than the base payment amount for days 5 through 8. </P>
                    <P>
                        To accurately measure the relative cost of specific days within the stay, we need estimates of the additional or marginal (not average) cost of those 
                        <PRTPAGE P="66948"/>
                        days. Using the relative average cost differences as if they were marginal cost differences will result in overpayment for the days with payment factors greater than 1.00. The reason for the overpayment is that, using a 4-day stay as an example, the average cost per day over the 4 days already contains the higher marginal costs of the preceding 3 days. In paying more than the 4-day average cost per day for days 1 through 3, we would be paying more than the total cost of the stay. 
                    </P>
                    <P>In reconsidering the variable per diem adjustments for this final rule, we re-evaluated the length of stay breakpoints in the regression and the method of applying the regression results for payment. Using the FY 2002 MedPAR data, we re-estimated the cost regression, expanding the number of length of stay categorical variables from 1 through 14 to 1 through 30 days in order to potentially allow payments to decline in smaller, more increments over a wider range of days. From the regression, we derived factors indicating the average cost per day, for example, a 1-day stay, a 2-day stay, and a 3-day stay, relative to a stay of more than 22 days. </P>
                    <P>Since the variable per diem adjustments are applied to all IPFs stays, the adjustments should reflect daily cost differences experienced by all types of IPFs, and not cost differences among different types of IPFs with different lengths of stay. Therefore, we also tested the sensitivity of the regression coefficients to the inclusion of the government-operated IPF stays, which tend to have longer lengths of stay than the other types of IPFs. For example, about one-third of all government-operated IPF stays are longer than 22 days, compared to only 10 to 13 percent of stays in for-profit or non-profit hospitals or in psychiatric units. We found that our coefficients varied little depending on whether cases from government-operated IPFs were included or excluded. </P>
                    <P>
                        CMS-funded research by RTI International
                        <E T="51">®</E>
                        , which was not available for the proposed rule, provides additional information about the variation in relative marginal costs by day of the stay. RTI International
                        <E T="51">®</E>
                         examined the variation in routine resource use across days within stays in its study of a sample of patients from 40 facilities. RTI International
                        <E T="51">®</E>
                         constructed a measure of a patient's routine cost for each of 7 days during which they were collecting data within a facility. 
                    </P>
                    <P>
                        As a result, RTI International
                        <E T="51">®</E>
                         data has a significant advantage compared to the MedPAR data that was available at the time of the proposed rule for examining cost variation by day-of-stay. Specifically, RTI International
                        <E T="51">®</E>
                         data enabled them to estimate a relationship between per diem cost and the day-of-stay that is consistent with the way we used the variable per diem adjustment factors for payment. In addition, since RTI International
                        <E T="51">®</E>
                         did not average daily routine costs over the entire length of stay, its estimates should provide a better approximation of the relationship of marginal cost than we were able to construct. RTI International
                        <E T="51">®</E>
                         did not collect information on ancillary usage by day-of-stay. In constructing its measure of daily total cost, RTI International
                        <E T="51">®</E>
                         allocated 1 day of average ancillary costs from the matching MedPAR stay record. RTI International
                        <E T="51">®</E>
                         used the same breakpoints that we used for the proposed rule. 
                    </P>
                    <P>
                        In the table below, we compare the revised CMS adjustment factors with the RTI International
                        <E T="51">®</E>
                         day-of-stay relative weights. Both sets of factors were scaled to set the day-9 (the median length of stay) factor equal to 1.00. The two series of factors are very similar, with the biggest differences occurring for days 2 to 4 and for day 19 and beyond. The differences for days 2 to 4 may be due to how the two methods handle ancillary costs, especially our exclusion of ED costs from the cost variable used in our regression analysis. The differences for day 19 and beyond probably are a result of the fact that RTI International
                        <E T="51">®</E>
                         only estimated specific day effects for the first 14 days. 
                    </P>
                    <P>Overall, the similarity of the adjustment factors gives us confidence that our variable per diem adjustment factors are reasonably accurate. The revised factors are also responsive to the comment that the variable per diem adjustments should decline more continuously than those presented in the proposed rule. Therefore, in this final rule we are using the updated variable per diem adjustment factors in adjusting per diem payments by day-of-stay. We note that the variable per diem adjustment are made in a budget-neutral manner. </P>
                    <GPH SPAN="3" DEEP="308">
                        <PRTPAGE P="66949"/>
                        <GID>ER15NO04.447</GID>
                    </GPH>
                    <P>
                        <E T="03">Comment:</E>
                         Several commenters recommended that CMS re-evaluate the decision to have no variable per diem adjustment paid after the 8th day. The commenters requested that we re-examine the analysis supporting the conclusion that “per diem costs for days 9 and thereafter remain relatively consistent with the median length of stay.” 
                    </P>
                    <P>A few commenters expressed concern that averages were used in all analyses except for the proposed variable per diem adjustments that were based on the median length of stay. The commenters believe use of the median creates distortions and requested that CMS analyze the impact if the variable per diem adjustments were based on the average length of stay. </P>
                    <P>
                        <E T="03">Response:</E>
                         We re-evaluated the decision to make no variable per diem adjustments to the Federal per diem base rate beyond the eighth day. We examined the per diem cost relationship for the first 30 days of the stay and found that beyond day 22, there was no consistent continuing pattern of decline. In addition, since the proportion of stays longer than 21 days is relatively small, there is relatively high statistical variability in the estimates of declining cost increases beyond day 22, which makes the estimates less reliable. As a result of that analysis, we found that the average per diem cost continued to decline until the twenty second day. Therefore, in this final rule we are extending the variable per diem adjustments through day 22. The adjustment for day 22 would be applied to any days after day 21. 
                    </P>
                    <P>We believe the commenter misunderstood the role of the median length of stay in the variable per diem adjustment factors. As indicated in the proposed rule, the median length of stay serves only as a point of reference for the variable per diem adjustment factors relative to the Federal per diem base rate (the day for which the factor equals the base amount). In addition, the actual magnitudes of the variable adjustment factors were not affected by using the median in this manner because the median had no impact on the cost regression from which the variable per diem adjustment factors are derived. The Federal per diem payment would be the same no matter which day of the stay (the median, the mean, or some other day) was used as the reference point. In this final rule, we are adopting as final the same methodology proposed to calculate the variable per diem adjustments. </P>
                    <P>
                        <E T="03">Comment:</E>
                         A few commenters expressed concern that the lack of variability in average daily charges results in understating the effect of the length of stay variable. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We disagree with the commenters. The RTI International
                        <E T="51">®</E>
                         research evaluated the variation of per diem cost by day of the stay using a measure of routine cost that varied according to the day of the stay. In addition, the comparison of RTI International
                        <E T="51">®</E>
                         results and our results did not support the commenters' concerns that the variable per diem adjustment factors are understated. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         Many commenters recommended increasing the per diem adjustment factor for day 1, or for the first several days of care. 
                    </P>
                    <P>One commenter recommended that in order to avoid the significant impact the proposed rule would have on high cost per discharge-short length of stay providers, the variable per diem adjustments for the first days of the stay should be weighted higher. The commenter recommended that CMS double the adjustments to 52 percent for day 1, 24 percent for days 2 through 4, and 10 percent for days 5 through 8. </P>
                    <P>
                        Other commenters recommended that days 2 and 3 receive the same adjustment factor as day 1. However, some commenters recommended that the per diem payment be uniform rather than variable throughout the patient's stay. They suggested that a higher per diem base payment amount for each day 
                        <PRTPAGE P="66950"/>
                        of stay would be preferable and more in line with the distribution of costs over an inpatient episode. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         These comments reflect a wide range of opinion about the appropriate range and magnitude of the variable per diem adjustment factors. We have updated and revised our variable per diem adjustment policy on the basis of our analysis of FY 2002 data and in response to public comments. In arriving at the final variable per diem adjustments, we have relied upon our empirical analysis, as previously described earlier in this section, to better approximate the additional costs of each successive day of the stay. We have also compared our results with the results of CMS-funded research by the RTI International
                        <E T="51">®</E>
                        . We believe that the outcome of the process we undertook to improve the variable per diem adjustment factors is a reasonably accurate, empirically-based set of adjustment factors. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         Several commenters expressed concern that the length of stay assumptions in the proposed rule did not take into consideration that certain interventions necessitate longer stays. A particular commenter indicated that medical safety standards for ECT dictate stays of more than 9 days. 
                    </P>
                    <P>One commenter stated that the elderly and younger chronically mentally ill adults represent two groups with longer than average lengths of stay. Another commenter stated that length of stay might be increased by the inclusion of trainees in a patient's care. </P>
                    <P>
                        <E T="03">Response:</E>
                         We are not sure that we understand these comments. As required by the BBRA, the IPF PPS is a per diem system. As a result, the IPF PPS recognizes differences in length of stay and will pay the Federal per diem base rate and applicable adjustments for each day of the inpatient stay. Therefore, the IPF PPS accounts for differences in length of stay regardless of cause (including providing ECT or other factors). 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         A few commenters recommended that CMS undertake a research inquiry into the added staffing costs for the first few days of a stay at an inpatient psychiatric unit or develop two per diems, one for routine patients and another for “clinically determined critical patients.” 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         The RTI International
                        <E T="51">®</E>
                         study addressed the issue raised by this comment because it examined the variation in routine cost by day of the stay. RTI International
                        <E T="51">®</E>
                         studied this relationship for all the patients in its sample, which included the full range of patients treated in IPFs. In addition, we are not sure how we could define “clinically determined critical” patients, especially considering the common practice of admitting to psychiatric facilities only those patients whose medical needs have either been resolved or are sufficiently controlled as to require limited attention for the period of the psychiatric admission. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         One commenter expressed concern that CMS would misinterpret increases in IPF admissions that result from the planned transition of inpatient psychiatric care from government-operated facilities to community-based resources such as private hospitals. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         Under the IPF PPS, both admissions referred to in the comment would be paid on a per diem basis, so that each facility (the government-operated facility and the private hospital) would be paid for the days of care it provides. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         One commenter recommended that CMS more accurately reflect the MedPAR data by using a variable Patient Day adjustment equal to the median value of 9 days, rather than limit the adjustments to days 1 through 8. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         By extending our analysis through 30 days, we more fully modeled the shape of the relationship between average per diem costs and length of stay and did not truncate the adjustments at either the median or the mean length of stay. As a result, the revised variable per diem adjustment factors presented in this final rule more accurately reflect the cost-day relationship than those we presented in the proposed rule. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         One commenter recommended that CMS provide more justification for the method used to control for length of stay. 
                    </P>
                    <P>A few commenters expressed concern that use of the median length of stay significantly understates the length of stay for an IPF that accepts chronic psychiatric patients (for example, a government-operated psychiatric hospital). The commenters believe that the proposed IPF PPS rewards acute psychiatric facilities for discharging patients quickly and provides an incentive for those facilities to discharge patients into government-operated IPFs. </P>
                    <P>
                        <E T="03">Response:</E>
                         We believe the commenter misunderstood the intent of the variable per diem adjustment policy, which is not to control for length of stay, but to better align the payment of each day of the say with its corresponding cost. Therefore, the facilities would have no incentive to either shorten or extend a patient's length of stay beyond what is clinically needed. 
                    </P>
                    <P>We agree with the commenters that certain types of IPFs have lengths of stay greater than the median length of stay. The variable per diem adjustment factors are intended to track the relative costs an IPF needs to spend on a case throughout the days of a stay. Thus, a facility with a length of stay greater than the median, or the mean for that matter, should be adequately reimbursed for the cost of care provided to a Medicare beneficiary. As explained above, we do not believe that the final IPF PPS provides an incentive for early discharge from one type of IPF to a government-operated facility. In addition, our use of the median length of stay has no effect on the actual payment amounts for each day of the stay. </P>
                    <HD SOURCE="HD3">6. Other Patient-Level Adjustments </HD>
                    <P>Although we proposed specific patient-level adjustments, we recognized that there were other variables not collected on the claim form. Therefore, we requested public comments on other patient-level adjustments for the IPF PPS. In response to our request for public comments, we received numerous comments recommending that we consider the following other types of adjustments: </P>
                    <HD SOURCE="HD3">a. Gender </HD>
                    <P>We invited public comments on the appropriateness of including a gender variable as a payment adjustment. </P>
                    <P>
                        <E T="03">Comment:</E>
                         Several commenters stated that elderly female patients represent 68 to 70 percent of the population they serve and recommended that CMS recognize the cost differential in treating female patients. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We analyzed the FY 2002 data and found that the cost regression continues to imply that female patients are approximately 2 percent more costly than male patients. However, as we found in the proposed regression analysis, adding an adjustment for gender increases the explanatory power of the patient model by less than one half of 1 percent, which means that the addition of gender does very little to improve explanatory power of the overall model. In addition, we are unable to determine the extent to which the interaction of psychiatric unit status with age and gender indicates higher direct costs of treating the elderly and women, as opposed to other reasons for the higher costs of psychiatric units. However, to the extent that gender is correlated with age and DRGs, facilities will be partially reimbursed for gender-related costs, since gender was not included as a variable in the regression. Therefore, we are not adopting a patient-level adjustment for gender. 
                        <PRTPAGE P="66951"/>
                    </P>
                    <HD SOURCE="HD3">b. Patients Admitted Through the Hospital's ED </HD>
                    <P>We received many comments recommending that we recognize the cost of ED services and provide a patient-level adjustment for patients who were admitted to a distinct part psychiatric unit through the hospital's ED. </P>
                    <P>
                        <E T="03">Comment:</E>
                         Many commenters recommended that CMS add a patient-level adjustment for patients who are admitted through the ED of the same hospital for inpatient psychiatric care. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         Our analysis indicated these cases were more costly on a per diem basis than cases without an ED admission. However, we are not including an adjustment for patients admitted through the ED. We are concerned about creating an incentive for psychiatric units in acute care hospitals with EDs to ensure that all psychiatric patients are admitted through the ED. However, we are providing a facility-level adjustment for psychiatric hospitals, or psychiatric units of acute care hospitals, with qualifying ED. Additional information regarding the analysis of ED costs is included in section VI.B.5.b. of this final rule. 
                    </P>
                    <HD SOURCE="HD3">c. Patients Who Receive Electroconvulsive Therapy (ECT) </HD>
                    <P>We received numerous comments recommending that we include ECT as a patient-level adjustment because furnishing ECT treatment adds significantly to the cost of these IPF stays. </P>
                    <P>
                        <E T="03">Comment:</E>
                         Several commenters recommended that CMS include ECT (procedure code 90870) under DRG 424 (Operating room procedure with principal diagnosis of mental illness) that has an adjustment factor of 1.22. One commenter suggested that DRG 430, “Psychosis” be disaggregated into two DRGs, “Psychosis with ECT,” incorporating the added costs for ECT treatment and “Psychosis without ECT.” 
                    </P>
                    <P>Other commenters recommended that CMS provide as an alternative, an add-on payment to the DRG for those patients who receive ECT treatments. </P>
                    <P>Many commenters recommended modifying the payment structure to include a separate payment adjustment for ECT, which should be higher than the payment adjustment for DRG 424. </P>
                    <P>
                        <E T="03">Response:</E>
                         After reviewing the public comments, we analyzed cases with ECT using the FY 2002 MedPAR data. We were able to identify ECT cases by the presence of procedure code 90870. Our analysis indicated that ECT cases comprised about 6 percent of all cases, and that almost 95 percent of ECT cases were treated in psychiatric units. Even among psychiatric units, ECT cases are concentrated among a relatively small number of facilities. 
                    </P>
                    <P>Overall, approximately 450 facilities had cases with ECT. Among these facilities, we estimate the mean number of ECT cases per facility to be approximately 25. In addition, approximately one-half of the IPFs providing ECT had no more than 15 cases in FY 2002. </P>
                    <P>Consistent with the comments we received about ECT, our analysis and review indicated that cases with ECT are substantially more costly than cases without ECT. On a per case basis, ECT cases are approximately twice as expensive as non-ECT cases ($16,287 vs. $7,684). Most of this difference is due to differences in length of stay (20.5 days for ECT cases vs. 11.6 days for non-ECT cases). The ancillary costs per case for ECT cases are $2,740 higher than those for non-ECT cases. </P>
                    <P>Based on this analysis, in this final rule we are providing an adjustment for each ECT treatment furnished during the IPF stay. In order to receive the payment adjustment, IPFs must indicate on their claims the revenue code and procedure code for ECT (Rev Code 901; procedure code 90870) and the number of units of ECT, that is, the number of ECT treatments the patient received during the IPF stay. Providing this data will ensure that facilities are appropriately reimbursed for the treatments they provided. </P>
                    <P>After careful review and analysis of IPF claims, we were unable to separate out the cost of a single ECT treatment. Therefore, we are using the pre-scaled and pre-adjusted median cost for procedure code 90870—developed for the hospital OPPS, based on hospital claims data. </P>
                    <P>
                        We used unadjusted hospital claims data under the OPPS, that is, the pre-scaled and pre-adjusted median hospital cost per treatment, to establish the ECT payment because we did not want the ECT payment under the IPF PPS to be affected by factors that are relevant to OPPS but not specifically applicable to IPFs. The median cost is then standardized and adjusted for budget neutrality. We will adjust the ECT rate for wage differences in the same manner that we adjust the per diem rate. The median cost for all hospital OPPS services are posted after publication of the hospital OPPS proposed and final rules at the following address: 
                        <E T="03">http://www.cms.hhs.gov/providers/hopps.</E>
                    </P>
                    <P>As explained above, we decided to pay the median cost for an ECT treatment, posted as part of the calendar year (CY) 2005 OPPS update, which is based on CY 2003 outpatient hospital claims. The amount is $311.88. Using the same OPPS CY 2003 claims that were used to calculate the aforementioned ECT median, we were able to calculate the average number of ECT treatments for a given patient to be approximately 9. A rate of $311.88 per ECT treatment multiplied by 9 is very close to the $2740 difference in ancillary costs observed for ECT and non-ECT cases. Accordingly, we believe that the payment adjustments for ECT will appropriately and adequately provide payment for ETC services provided to IPF patients. After applying the standardization factor, behavioral offset, stop-loss adjustment, and outlier adjustment (as described in section V.C. of this final rule), the adjusted ECT payment is $247.96. </P>
                    <P>We have established the ECT adjustment as a distinct payment under the PPS methodology, our preferred approach would be to include a patient level adjustment as a component of the model (for example, determined through the regression analyses) to account for the higher costs associated with ECT. We believe the approach will better control incentives towards over-utilization and be more consistent with the approach used for other patient level adjustments under the PPS. During the transition period we expect to collect more data on the number of ECT treatments per stay, and associated costs. We will utilize these data to evaluate alternative approaches for incorporating an adjustment for ECT in the payment system. We expect to complete this analysis during the first year of the transition and potentially propose changes at the time of the first annual update of the payment system. </P>
                    <P>ECT is an intensive procedure. Therefore, we are concerned that including a payment adjustment for ECT treatments in the final IPF PPS could result in a rise in the use of ECT treatment. We will monitor this area to ensure that the increased payments do not lead to changes in the frequency of utilization. </P>
                    <HD SOURCE="HD3">d. Patients Involuntarily Committed to the IPF </HD>
                    <P>We did not proposed to provide a payment adjustment for patients who are involuntarily committed to an IPF. However, we received multiple comments encouraging us to recognize the additional costs associated with these patients. </P>
                    <P>
                        <E T="03">Comment:</E>
                         Several commenters indicated that patients involuntarily committed to an IPF often require costly court proceedings before treatment can 
                        <PRTPAGE P="66952"/>
                        begin and that the hospital my incur cost for caring for these patients while awaiting the court decision. 
                    </P>
                    <P>Other commenters identified patient management issues, for example, more frequent one-on-one staff attention and more complex discharge planning. A few commenters indicated that involuntarily committed patients are often uncooperative and difficult to treat. One commenter reported a 27 percent longer length of stay for involuntarily committed patients. </P>
                    <P>
                        <E T="03">Response:</E>
                         One of the fields on the claim form indicates if patients were referred to the IPF by law enforcement or if the commitment were court ordered (FL 20, item 8, court/law enforcement). As a result, we were able to analyze the FY 2002 claims data to determine if the costs identified by the commenters are evident in the claims. The data did not indicate that patients involuntarily committed to the IPF are more costly on a per diem basis. We note that many of the costs associated with involuntary commitments (for example, legal fees, staff time to accompany the patient to court, and transportation costs) are part of the hospital's average routine per diem cost. 
                    </P>
                    <P>In addition, there are certain costs that are the responsibility of the court system or law enforcement, for example, where a court orders a 3-day psychiatric evaluation for a patient or where discharge is delayed pending court action. Thus, IPFs should be adequately reimbursed for patients involuntarily committed, even in the absence of a specific payment adjustment. </P>
                    <P>Therefore, at this time we are not providing an adjustment for involuntarily committed patients. </P>
                    <HD SOURCE="HD3">e. Administrative Necessary Days </HD>
                    <P>We received several comments recommending that we recognize the cost of administrative necessary days for continued inpatient care when discharge is delayed due to a lack of community resources. </P>
                    <P>
                        <E T="03">Comment:</E>
                         Commenters indicated that hospitals would be unable to discharge a patient without an appropriate discharge plan. The commenters requested that CMS provide reimbursement for this type of situation. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         Current hospital discharge planning requirements in § 482.43(a) and (b) require the discharge planning evaluation to include the likelihood of a patient needing post-hospitalization services and the availability of those services. Hospital personnel must complete the evaluation on a timely basis so that appropriate arrangements for post-hospital care are made before discharge, and to avoid unnecessary delays in discharge. 
                    </P>
                    <P>In addition, § 482.43(c)(4) requires that the hospital must reassess the patient's discharge plan if there are factors that may affect continuing care needs or the appropriateness of the discharge plan. </P>
                    <P>Moreover, § 412.27(c)(5) states, “the record of each patient who has been discharged must have a discharge summary that includes a recapitulation of the inpatient's hospitalization in the unit and recommendations from appropriate services concerning follow-up or aftercare as well as a brief summary of the patient's condition on discharge.” </P>
                    <P>Consequently, if an IPF determines that a patient needs post-hospitalization placement, then a statement to this effect is expected to be included in their discharge plan. Furthermore, if a patient cannot be safely discharged without this post-hospitalization placement and this placement is not available, then the patient has not met their discharge objectives and requires continued active treatment. </P>
                    <P>After careful review, we have decided not to provide additional payment for administrative necessary days for several reasons. Since claim data does not include coding or documentation for administrative data, we are unable to identify and discern the cost of these days. Therefore, we are unable to determine the extent to which the costs of administrative necessary days are included in the Federal per diem base payment amount. </P>
                    <P>Finally, since the IPF PPS is a per diem payment methodology, we are concerned about inadvertently creating an incentive to unnecessarily delay discharge in order to receive additional payment for administrative necessary days. </P>
                    <HD SOURCE="HD2">C. Facility-Level Adjustments </HD>
                    <P>In the proposed rule, we proposed adjustments for the IPF's wage area, rural location, and teaching status. </P>
                    <HD SOURCE="HD3">1. Wage Index </HD>
                    <P>Due to the variation in costs and because of the differences in geographic wage levels, we proposed that payment rates under the IPF PPS be adjusted by a geographic wage index. We proposed to use the unadjusted, pre-reclassified hospital wage index to account for geographic differences in labor costs. In the proposed rule, we proposed to use the inpatient acute care hospital wage data to compute the IPF wage since there is not an IPF-specific wage index available. We believe that IPFs generally compete in the same labor market as acute care hospitals since the inpatient acute care hospital wage data should be reflective of labor costs of IPFs. We believe this to be the best available data to use as proxy for an IPF specific wage index. We proposed to adjust the labor-related portion of the proposed Federal per diem base rate for area differences in wage levels by a factor reflecting the relative facility wage level in the geographic area of the IPF compared to the national average wage level for these hospitals. We believe that the actual location of the IPF as opposed to the location of affiliated providers is most appropriate for determining the wage adjustment because the data support the premise that the prevailing wages in the area in which the IPF is located influence the cost of a case. Thus, in the proposed rule and in this rule, we are using the inpatient acute care hospital wage data without regard to any approved geographic reclassification as specified in section 1886(d)(8) or 1886(d)(10) of the Act. Specifically, in this rule, we are using the FY 2005 hospital wage index (unadjusted, pre-reclassified) based on MSA definitions defined by OMB in 1993 (as opposed to the new MSA definitions that were used to define labor markets for the FY 2005 IPPS). Once we implement the IPF PPS, we will assess the implications of the new MSA definitions on IPFs. At the time of the proposed rule, the 2003 MSA definition had not been implemented for any medicare programs and consequently, were not proposed. We note that, after the publication of the IPF PPS proposed rule, new MSA definitions have been adopted for use in the IPPS. We, however, are not adopting those new definitions in this final rule. We expect that use of the new MSA (or labor market) definitions may have a significant impact on the wage index applied to IPFs and associated payments. Thus, before their use could be proposed, we would have to conduct a thorough analysis of their impact on the IPF PPS. Moreover, and most importantly, we believe it is appropriate to provide an opportunity for IPFs and other interested parties to comment on the use of the new definitions before proceeding with their possible application. We plan to publish in a proposed rule any changes that we consider for new labor market definitions, in order to provide the public with an opportunity to comment. </P>
                    <P>
                        <E T="03">Comment:</E>
                         Several commenters recommended that CMS apply the hospital wage index with geographic reclassifications in the same way that other hospital PPS adjust payments to reflect wage differences. Commenters 
                        <PRTPAGE P="66953"/>
                        believe that the reclassification process ensures that areas that are geographically close to an MSA may compete to employ a sufficient amount of skilled healthcare workers. Other commenters believe that the pre-reclassified wage index may result in a potential decrease in payment, especially for psychiatric units within hospitals that draw from the same workforce as acute care hospitals. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         The statute does not require geographic reclassification of other hospitals paid under TEFRA (for example, freestanding psychiatric hospitals) or other hospitals paid under different prospective payment systems. Geographic reclassifications are not recognized under the IRF or LTCH payment systems, and are not recognized under the final IPF PPS. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         A few commenters requested a modification to the portion of the payment that is adjusted by the wage index. The commenters stated that the proposed wage index should be applied to 72.8 percent of the Federal per diem base rate, as reflected in the proposed 1997-based excluded hospital with capital market basket. Generally, commenters in wage areas with a wage index above 1.0 indicated that the proposed labor portion of the payment was too low and commenters in wage areas with a proposed wage index less than 1.0 indicated that the labor portion was too high. 
                    </P>
                    <P>One commenter indicated that psychiatric care is more labor intensive than other modes of inpatient care, thus the commenter recommended that CMS research the costs of providing psychiatric care, and develop a labor adjustment that adequately compensates for the increased intensity of care for psychiatric patients. </P>
                    <P>
                        <E T="03">Response:</E>
                         In both the proposed rule and in this final rule, to account for wage differences, we first identified the proportion of labor and non-labor components of costs. We used the 1997-based excluded hospital market basket with capital to determine the labor-related share of cost. We calculated the labor-related share as the sum of the weights for those cost categories contained in the 1997-based excluded hospital with capital market basket that are influenced by local labor markets. These cost categories include wages and salaries, employee benefits, professional fees, labor-intensive services, and a share of capital-related expenses. 
                    </P>
                    <P>The labor-related share for the implementation period of the final IPF PPS (January 1, 2005 through June 30, 2006) is the sum of the relative shares which measure the relative importance of each labor-related cost category for this period. It also reflects the different rates of price change for these cost categories between the base year (FY 1997) and this period. 0 labor-related components of operating costs (wages and salaries, employee benefits, professional fees, and labor-intensive services) is 68.818 percent, as shown below in Table 8. Since capital cost also contains a significant component of labor-related cost, the labor-related share of total cost will be greater than the labor-related share of operating costs alone. The portion of capital cost that is influenced by local labor markets is estimated to be 46 percent. Because the capital accounts for 7.323 percent of the 1997-based excluded hospital with capital market basket for the period January 1, 2005 through June 30, 2006, the labor-related share of capital cost is 46 percent of 7.323 percent. The result, 3.369 percent, is then added to the 68.818 percent calculated for operating costs to determine the labor-related share of total cost. The resulting labor-related share that we are using in this IPF PPS rule is 72.247 percent. The table below shows that the labor-related share would have been 72.571 percent if we had not rebased the excluded hospital with capital market basket using more recent 1997 data rather than using 1992 data. As shown in Table 8, rebasing results in a lowering of the labor-related share by 0.324 percentage points. </P>
                    <P>The base methodology used to calculate the labor-related share for IPFs is the same as that used for calculating the labor-rated share for IPPS, SNFs, HHAs, LTCH, and IRFs PPS. The difference is that except for the IPPS, we use the relative importance for the effective period in developing this share, which changes annually. For IPPS, the labor share remains constant until the market basket is rebased. </P>
                    <P>CMS agrees with the commenter that it is important to have a market basket and labor share appropriate for use under the IPF PPS. We believe that using the excluded hospital with capital market basket accomplishes this goal. However, we indicated in the proposed rule that we plan to continue to study the feasibility of developing a market basket specific to IPF services. We hope that we may eventually be able to develop a market basket and labor-related share based primarily on IPF data (see 68 FR 66928). </P>
                    <GPH SPAN="3" DEEP="147">
                        <GID>ER15NO04.448</GID>
                    </GPH>
                    <P>
                        The labor-related relative share of total cost in this rule changed from that in the proposed rule for two reasons. First, the labor-related share of 72.247 in this rule comes from Global Insight's 2004: quarter 3 forecast, with historical data through 2004: quarter 2, while the proposed rule used data from the 2002: quarter 4 forecast, with historical data through 2002: quarter 3, to calculate the proposed labor share of 72.828. Second, in addition to using more historical data in a more recent forecast, there is a different implementation period in this final rule, meaning that different periods of data were used to calculate the labor-related relative importance in this rule. 
                        <PRTPAGE P="66954"/>
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         Several commenters requested that CMS establish a floor for the urban wage index so that an urban wage index would not fall below the wage index in a rural area in the same state. Another commenter requested that CMS apply the section of the MMA to the IPF PPS, which would limit an IPF's wage index to a minimum of 1. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We did not propose a wage index floor. We are unclear of what the commenter is referring to because there is no MMA provision that limits the hospital wage index to a minimum of 1.0. In order to be consistent with the wage area adjustments used in the PPS developed for other excluded hospitals, we did not apply a floor wage index under the IPF PPS. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         Many commenters suggested that CMS use more recent hospital wage data for the final IPF PPS. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We are also using the best available hospital wage index data in this final rule (that is, the wage data used to establish the FY 2005 IPPS wage index for the October 1, 2004). We will continue to use the best data available for future updates to the IPF PPS. 
                    </P>
                    <HD SOURCE="HD3">2. Rural Location </HD>
                    <P>We proposed a 16 percent payment adjustment for those IPFs located in a rural area. This adjustment was based on the proposed regression analysis, which indicated that the per diem cost of rural facilities was 16 percent higher than that of urban facilities after accounting for the influence of the other variables included in the regression. Many rural IPFs are small psychiatric units within small general acute care hospitals. In the proposed rule, we stated that small-scale facilities are more costly on a per diem basis because there are minimum levels of fixed costs that cannot be avoided, and they do not have the economies of size advantage. </P>
                    <P>We received several comments regarding the proposed rural adjustment. Most commenters supported the rural adjustment and encouraged us to recognize the higher cost incurred in rural settings. </P>
                    <P>
                        <E T="03">Comment:</E>
                         Commenters expressed concern that despite the 16 percent adjustment to the Federal per diem base rate for IPFs located in rural areas Medicare payment would decrease for rural psychiatric units. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         In implementing this rule, we updated our cost regression analysis using the most recent complete data available (that is, FY 2002 data). Based on the results of our regression analysis, we are now providing a payment adjustment for IPFs located in rural areas of 17 percent instead of the proposed 16 percent. The small change in the rural payment adjustment is largely the result of the adjustment we made to the cost data to account for the ED adjustment. A full description of the ED policy appears later in this section. 
                    </P>
                    <P>As is the case with implementing any prospective payment system, since the payment rates are not directly tied to the costs of each individual facility, relatively high cost facilities may experience reductions in Medicare payments. However, our analysis of the impact of this rule during the first year of implementation (see section VIII of this final rule) show that on average rural facilities are expected to have a payment to cost ratio of 1.00. This means that Medicare payments during the first year of the IPF PPS transition are expected to be the same as they would have been had the IPF PPS not been implemented and IPFs continued to be paid 100 percent. </P>
                    <P>
                        <E T="03">Comment:</E>
                         Several commenters specifically expressed concern that the multipliers used for urban and rural facilities are inappropriate and do not adequately adjust for higher per bed cost in smaller facilities. In addition, several commenters encouraged CMS to add a reasonable payment adjustment for urban psychiatric units. 
                    </P>
                    <P>Other commenters stated that if the proposed rules are adopted, hospitals may choose to close their psychiatric units. </P>
                    <P>
                        <E T="03">Response:</E>
                         We did not include an explicit payment adjustment for urban facilities in the proposed rule and we are not adopting one in this final rule. We are not including this type of adjustment factor since our adjustment for rural facilities is based on an explicit comparison of the relative per diem costs of rural and urban facilities after accounting for the effects of the other variables included in the regression as previously explained in the cost regression section of this final rule. The result of that comparison (as reflected in our cost regression) was that rural facilities are more costly than urban facilities, largely because rural facilities are smaller on average than urban facilities. In addition, because a variable reflecting facility size was not included in the cost regression, the rural payment adjustment factor may partially reflect the influence of size on per diem cost. 
                    </P>
                    <P>As previously stated, we have not included an explicit payment adjustment factor to account for the higher per diem costs of small facilities, because we think that to do so is counter to the basic principle of prospective payment systems that payment adjustments should be based on characteristics that are not under the control of the facility. Specifically in the case of psychiatric units where a facility can choose how much of its inpatient psychiatric care it wishes to include in its Medicare certified unit, we would be concerned that a facility could reduce the size of its Medicare-certified unit in order to increase Medicare payments. </P>
                    <P>We plan to monitor the impact of the IPF PPS on the financial status of psychiatric facilities. We are particularly concerned about potential effects of facility closures on beneficiaries' access to inpatient psychiatric care. As a result of this issue, we are adopting a stop-loss provision as part of the transition to assist all IPFs with revenue shortfalls during the transition period (see section V.C.3. of this final rule for a discussion of the stop-loss provision). </P>
                    <HD SOURCE="HD3">3. Teaching Adjustment </HD>
                    <P>We proposed to establish a facility level adjustment to the Federal per diem base rate for IPFs that are teaching institutions. In the past, we have made direct graduate medical education (GME) payments (for direct costs such as resident and faculty physician salaries, and other direct teaching costs) to teaching hospitals including those paid under the IPPS and those paid under the TEFRA rate of increase limits. However, we did not make separate indirect medical education (IME) payments to teaching hospitals paid under the TEFRA rate-of-increase limits because payments to these hospitals are based on the hospitals' reasonable costs. IME payments are authorized under the IPPS statute to be paid as an add-on to the IPPS per case payment, and there are no per case payments under the TEFRA system. In this final rule, we are establishing a facility-level adjustment for IPFs that are, or are part of, teaching institutions. The facility-level adjustment we are providing for teaching hospitals under the new IPF PPS parallels the IME payments paid under the IPPS. Both payments are add-on adjustments to the amount per case (there is now a per case payment to which the IPF teaching adjustment will be added) and both are based in part on the number of full-time equivalent (FTE) residents training at the facility. </P>
                    <P>
                        In the proposed rule, we proposed to calculate a teaching adjustment based on the IPF's “teaching variable,” which is one plus the ratio of the number of FTE residents training in the IPF divided by the IPF's average daily census (ADC). Based on our initial regression analysis, we proposed to raise the teaching variable to the .5215 power. We also requested suggestions from the public regarding how to estimate IPFs' indirect teaching costs 
                        <PRTPAGE P="66955"/>
                        and alternative methodologies to recognize the higher costs of teaching IPFs. However, we did not receive any suggestions on this issue. 
                    </P>
                    <P>Accordingly, we are adopting our proposed formula for calculating the adjustment in this final rule. Based on the final regression analysis using FY 2002 data, we are raising the teaching variable from .5215 power to the .5150 power. </P>
                    <P>We also indicated we were considering alternatives to limit the incentives for IPFs to add FTE residents for the purpose of increasing their teaching adjustment. We indicated that we were considering imposing a cap, similar to that established by sections 4621 and 4623 of the BBA for the IPPS, and noted that these caps already apply to teaching hospitals, including IPFs, for purposes of direct GME payments according to regulations at § 413.75 through § 413.83. </P>
                    <P>As indicated in the proposed rule (68 FR 66932), we were concerned about establishing an open-ended payment for the teaching adjustment because the BBA froze the number of residents that hospitals may count for both direct and indirect GME payments in order to reduce incentives for teaching institutions to add residents. We recognized that if we imposed no limits on the teaching adjustment under the IPF PPS, teaching programs in those facilities could grow and receive payments in a manner that is inconsistent with that in teaching hospitals paid under the IPPS. In addition, we were concerned that if a teaching hospital had a distinct part psychiatric unit and had a number of FTE residents above the amount recognized for reimbursement under the BBA limits, the hospital could potentially circumvent those limits by assigning residents to train in the IPF. For example, if a teaching hospital has 110 FTE residents of which only 100 are recognized for purposes of Medicare IME reimbursement under the BBA limits, the hospital could assign the excess 10 residents to its distinct part psychiatric unit where those FTE residents would be included for purposes of the teaching adjustment to the IPF PPS payments, which is similar in amount to IPPS IME payments. As a result, the hospital would be able to count all 110 FTE residents for purposes of calculating a teaching adjustment, in contradiction to the Congress' intent in establishing the BBA limits. </P>
                    <P>We considered imposing a cap that would operate in a substantially similar manner to the BBA limits on the number of FTE residents that may be counted for purposes of making IPPS IME payments. The BBA cap operates by limiting the number of allopathic and osteopathic FTE residents that Medicare will recognize for the purposes of calculating IPPS IME payments to no more than the number of FTE residents in a teaching hospital's most recent cost reporting period ending on or before December 31, 1996. In addition, the BBA placed a cap on the entire resident-to-bed ratio used to calculate the IPPS IME payment so that a hospital's ratio in its current cost reporting period could not exceed the ratio from its previous cost reporting period. </P>
                    <P>In response to public comments on the teaching adjustment, only one commenter agreed with the appropriateness of establishing a cap on the number of FTE residents that may be counted for purposes of the teaching adjustment under the IPF PPS. The majority of commenters was opposed to imposition of any resident cap and indicated that a cap would be arbitrary and burdensome. </P>
                    <P>After carefully reviewing the public comments, we have decided to adopt a cap on the number of FTE residents that may be counted under the IPF PPS for the teaching adjustment. We made this decision in order to—(1) exercise our statutory responsibility under the BBA to prevent any erosion of the resident caps established under the IPPS that could result from the perverse incentives created by the facility adjustment for teaching under the IPF PPS; and (2) avoid creating incentives to artificially expand residency training in IPFs, and ensure that the resident base used to determine payments is related to the care needs in IPF institutions. </P>
                    <P>In adopting the FTE resident cap for purposes of the IPF PPS teaching adjustment, we wish to emphasize that we are not limiting the number of residents teaching institutions can hire or train; we are limiting the number of residents that may be counted for purposes of calculating the IPF PPS teaching adjustment, and thus, the amount Medicare will pay for the teaching adjustment under the new IPF PPS. </P>
                    <P>The FTE resident cap we are establishing will work identically in freestanding teaching psychiatric hospitals and in distinct part psychiatric units with GME programs. In order to establish the cap on the number of residents used in calculating the IPF PPS teaching adjustment, the following policies will apply. </P>
                    <P>• Similar to the regulations for counting FTE residents under the IPPS as described in § 412.105(f), we will calculate the “base year” number of FTE residents that trained in the IPF based on the hospital's most recently filed cost report before November 15, 2004. Residents with less than full-time status and residents rotating through the psychiatric hospital or unit for less than a full year will be counted in proportion to the time they spend in their assignment with the IPF (for example, a resident on a full-time, 3-month rotation to the IPF will be counted as 0.25 FTEs for purposes of counting residents to calculate the ratio). Hospitals can file adjusted cost report data with their FIs until the cost report is settled if they believe the resident counts as submitted on that cost report are incorrect. For purposes of determining an IPF's teaching adjustment under the IPF PPS, the number of FTE residents in the numerator cannot exceed the number of FTE residents in the hospital's most recently filed cost report. </P>
                    <P>• The denominator used to calculate the teaching adjustment under the IPF PPS is the IPF's average daily census (ADC) from the current cost reporting period. As we indicated in the proposed rule, although a hospital's number of available beds is used in the denominator of the IPPS IME adjustment, the ADC is used in the denominator of the ratio used to compute the IME adjustment under the capital PPS as specified at § 412.322. We are using the ADC for the teaching adjustment under the IPF PPS rather than the number of beds because the ADC is more closely related to the IPF's patient load, and thus, its need for interns and residents. As we stated in the proposed rule, we also believe the ADC is easier to define precisely and less subject to manipulation. </P>
                    <P>Thus, under the IPF PPS, we are placing a cap on the number of FTE residents (that is, the numerator) used for purposes of computing the teaching adjustment, and not on the ADC (the denominator), or on the entire ratio. An IPF's FTE resident cap will ultimately be determined based on the final settlement of the hospital's cost report filed most recently before November 15, 2004. If a change is made to the base year cost report, the intermediary will reconcile any changes in IPF PPS teaching payments as appropriate. </P>
                    <P>If a psychiatric hospital or unit has fewer FTE residents in a given year than in the base year, payments in that year will be based on the lower number. This approach is consistent with the IME adjustment under the IPPS. The hospital will be free to add FTE residents and count them for purposes of calculating the teaching adjustment until it returns to its base year FTE resident count. </P>
                    <P>
                        In this final rule, we are adopting the policy currently applied under the BBA 
                        <PRTPAGE P="66956"/>
                        for IPPS teaching hospitals that start new teaching programs as specified in § 413.79 (1) for new teaching IPFS and for teaching IPFs that start new programs. We note that under § 412.105(f)(1)(vi) concerning IME payments under the IPPS, hospitals that have shared residency rotational relationships may elect to apply their respective IME resident caps on an aggregate basis via a Medicare GME affiliation agreement. Our intent is not to affect affiliation agreements and rotational arrangements for hospitals that have residents that train in more than one hospital. We are not implementing a provision concerning affiliation agreements specifically pertaining to the FTE caps used in the teaching adjustment under the IPF PPS at this time. This is an area we expect to closely monitor, and we will consider allowing IPFs to aggregate and adjust their FTE caps through affiliation agreements in the future. 
                    </P>
                    <P>We believe these policies fairly balance our responsibilities under the statute to assure appropriate enforcement of the BBA and the overall limits on payment adjustments for teaching hospitals with the greater precision that can be achieved by adjusting payments for teaching IPFs. We also believe that we have designed a cap that balances the need for limits with the unique conditions of teaching programs in freestanding psychiatric hospitals and in distinct part psychiatric units. We will, however, monitor the impact of these policies closely and consider changes in the future when appropriate. </P>
                    <P>
                        <E T="03">Comment:</E>
                         Several commenters indicated that a cap amounts to an absolute freeze on the number of residents that Medicare will recognize for payment purposes. In addition, the commenters stated that a cap allows only decreases and no increases in established resident counts at any time. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We acknowledge that the number of FTE residents will be frozen under the IPF PPS. As discussed above, we are adopting a cap on the number of FTE residents that may be counted under the IPF PPS teaching adjustment. This policy is to exercise our statutory responsibility under the BBA to prevent any erosion of the resident caps established under the IPPS that could result from the perverse incentives created by the facility adjustment for teaching hospitals under the IPF PPS. In addition, we wish to avoid creating incentives to artificially expand residency training in IPFs, and ensure that the resident base used to determine payments is related to the care needs in IPF institutions. Again, we will monitor the impact of these policies closely and consider changes in the future when appropriate. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         Several commenters were concerned that the administrative burden in reviewing resident counts back to 1996 cost reports would be excessive and recommended not imposing an FTE resident cap for the IPF PPS teaching adjustment for this reason. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         The resident cap under the IPPS is based on the hospital's 1996 cost report. However, the resident cap we are establishing under the IPF PPS relies on the number of residents training in the IPF for the most recently filed cost report before November 15, 2004. In addition, establishing the IPF PPS resident cap does not require the hospitals to submit information not currently included in their cost reports. As a result, we do not believe there is a significant burden associated with establishing the IPF PPS resident cap. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         Several commenters asked if the teaching adjustment would be limited to those hospitals with a dedicated psychiatric teaching program. In addition, the commenters asked if the adjustment would also apply to hospitals that schedule rotations to the psychiatric unit from a non-psychiatric teaching program. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         Under the IPPS, Medicare makes IME payments only for costs associated with residents in approved graduate medical education (GME) programs as defined in § 412.105(f)(1)(i) that are approved by one of the organizations listed in § 415.152, not residents in other types of teaching programs. Thus, IPFs that have residents in approved GME programs will receive the IME adjustment. The GME program could be a psychiatric teaching program or scheduled rotations to the IPF unit from a non-psychiatric teaching program. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         One commenter urged CMS to consider applying any cap on the number of interns and residents in a manner that is less sensitive to rapid declines in patient census. The commenter believes the use of the ratio of residents to ADC will negatively affect government-operated IPFs. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         Although we are unsure of the commenter's point, the commenter seems to be implying that the teaching adjustment would decline if there were a reduction in the IPF's ADC. However, a decrease in the ADC would result in an increase in the teaching adjustment. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         One commenter requested that CMS provide an example to show how the calculation of the teaching adjustment would be computed. The commenter requested that the example use a hypothetical resident count and ADC and the final teaching adjustment factor. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We were not able to present a single proportional factor that represents the payment adjustment for teaching as we did for most of the other payment variables (for example, age and rural location). The reason is because the teaching adjustment varies among teaching hospitals depending on the degree of their teaching intensity as measured by the ratio of interns and residents to the ADC. 
                    </P>
                    <P>The following example shows a step-by-step calculation of the teaching adjustment for 2 teaching hospitals. Hospital A has an interns and residents to ADC ratio of 0.10. Hospital B has an interns and residents to ADC ratio of 0.20. </P>
                    <P>
                        <E T="03">Step 1:</E>
                         Add 1.0 to the interns and residents to ADC ratio:
                    </P>
                    <FP SOURCE="FP-1">Hospital A: 1.0 + 0.1 = 1.1 </FP>
                    <FP SOURCE="FP-1">Hospital B: 1.0 + 0.2 = 1.2 </FP>
                    <P>
                        <E T="03">Step 2:</E>
                         Raise the factors in Step 1 to the power given by the regression coefficient for the teaching variable (.5150). 
                    </P>
                    <FP SOURCE="FP-1">Hospital A: 1.1 × exp (.5150) = 1.050 </FP>
                    <FP SOURCE="FP-1">Hospital B: 1.2 × exp (.5150) = 1.098 </FP>
                    <P>The Step 2 results indicate that Hospital A's payment will be 5.1 percent higher than the comparable payment for a non-teaching hospital and the Hospital B's payment will be 9.9 percent higher than the comparable payment for a non-teaching hospital. </P>
                    <P>
                        <E T="03">Step 3:</E>
                         Multiply the factors obtained in Step 2 by the appropriate per diem payment adjusted by all other relevant payment factors. For purpose of this example, the per diem payment is assumed to be $625 for both Hospital A and Hospital B. 
                    </P>
                    <FP SOURCE="FP-1">Hospital A: $625 × 1.050 = $656.25 </FP>
                    <FP SOURCE="FP-1">Hospital B: $625 × 1.098 = $686.25 </FP>
                    <P>The step 3 results indicate that Hospital A's per diem payment would be $656.25 compared to $686.25 for Hospital B. </P>
                    <P>
                        <E T="03">Comment:</E>
                         A commenter questioned why CMS used the ratio of interns and residents to the ADC, rather than the ratio of interns and residents to the number of beds. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         Using the ADC rather than the number of beds as the denominator of the teaching variable has two main advantages: Whereas there are many different and frequently imprecise ways of counting beds (licensed beds, available beds, staffed beds), the ADC is a single standard measure that hospitals know how to calculate. It is just the total number of patients days of care divided by 365, the number of days in the year. 
                        <PRTPAGE P="66957"/>
                    </P>
                    <P>Average daily census, which reflects the number of occupied beds in a year, is a readily available, more consistent measure than the number of beds because patient days are more accurately measured than are beds. Because it is directly measured by patient days, ADC is also less subject to understatement in an effort to increase the value of the teaching variable and in turn, teaching payments. </P>
                    <HD SOURCE="HD3">4. Other Facility-Level Adjustments </HD>
                    <P>In the proposed rule, we indicated that we considered facility-level adjustments for IPFs located in Alaska and Hawaii and an IPF's disproportionate share intensity. Other adjustment factors discussed in this section were requested in public comments. </P>
                    <HD SOURCE="HD3">a. Adjustment for Psychiatric Units </HD>
                    <P>In the proposed rule, we did not propose an adjustment for psychiatric units. We received a significant number of public comments expressing concern that the proposed IPF PPS is biased towards psychiatric hospitals and detrimental to psychiatric units. Therefore, the commenters requested that we provide an adjustment specifically for psychiatric units. We are not adopting an adjustment for psychiatric units in this final rule. </P>
                    <P>
                        <E T="03">Comment:</E>
                         Several commenters stated that the data analysis indicated that the average per diem cost in psychiatric units ($615) was 37 percent higher than the average per diem cost in psychiatric hospitals ($444). Although the proposed patient and facility adjustments account for 19 percent of the difference in average per diem costs, the commenters expressed concern that the proposed rule did not propose a specific adjustment for psychiatric units to account for the remaining 18 percent difference in average per diem costs. 
                    </P>
                    <P>Many commenters attribute the difference in average per diem cost to the types of patients admitted to psychiatric units and psychiatric hospitals. The commenters stated that patients admitted to psychiatric units generally present with multiple medical conditions in addition to severe or multiple psychiatric symptoms. In addition, EDs in acute care hospitals with psychiatric units serve as the portal for almost all psychiatric emergency patients, who usually are admitted to the psychiatric unit. As a result, psychiatric units have different patterns of care and staffing in order to treat patients with emergency psychiatric needs as well as comorbid medical conditions. </P>
                    <P>The commenters stated that freestanding psychiatric hospitals are not equipped or staffed to treat patients with complex comorbid medical conditions and generally do not admit patients who require treatment of chronic physical illnesses or who are not medically stable. As a result, freestanding psychiatric hospitals have lower average per diem costs than psychiatric units. </P>
                    <P>Many commenters recommended that we provide a Medicare-dependent IPF designation that would be applied to any IPF with at least an 80 percent Medicare share of admissions. An organization representing small, rural IPFs provided information describing rural psychiatric units and the patients generally treated in these units. The commenter indicated that rural psychiatric units usually have 12 or fewer beds and treat a high proportion (at least 80 percent of total patient days) of Medicare beneficiaries. The material furnished by the organization indicated that approximately 54 percent of these hospitals are located in areas not adjacent to a metropolitan area and 15 percent are in “completely rural” areas. </P>
                    <P>The organization indicated that these small rural Medicare-dependent units generally have average costs per day that are 27 percent higher than the national average due to the acuity of the patients they serve. In addition, an analysis conducted by the organization indicates an 11.9 percent negative impact between current TEFRA payments and estimated payments under the proposed IPF PPS. </P>
                    <P>Commenters also indicated that many of the psychiatric units are small, Medicare-dependent, and located in underserved rural and urban areas where they are the sole mental health provider. These commenters were concerned that inadequate Medicare payment would cause hospitals to close these units, resulting in diminished access to mental health services. The commenters stated that the proposed adjustments were insufficient and requested a specific adjustment for psychiatric units or, as an alternative, a temporary adjustment until we are able to refine the IPF PPS and account for more of the difference in average per diem cost. </P>
                    <P>
                        <E T="03">Response:</E>
                         As we discussed in the November 2003 proposed rule, we do not believe it is appropriate to pay an adjustment to all psychiatric units for all cases, regardless of the unit's cost, efficiency, or case-mix. 
                    </P>
                    <P>With respect to providing an adjustment for psychiatric units, as explained previously in this final rule, the payment model we are adopting for IPFs explains approximately 33 percent of the variation in per diem cost among IPFs. As a result, we believe the IPF PPS will generate payments that are reasonably related to the per diem cost in psychiatric units. In addition, IPFs located in rural areas will receive an adjustment to account for higher per diem costs. </P>
                    <P>Commenters stated that IPFs have many patients with longer stays or multiple co-morbidities. The IPF PPS provides a base payment amount and adjustments for each day of the stay and multiple co-morbidity categories as well as a variety of other adjustments, we believe IPF PPS payments to psychiatric units will adequate meet their costs. </P>
                    <P>In addition, we are providing a stop-loss provision during the 3-year transition period during which a stop-loss policy will be in place to ensure that small rural, Medicare-dependent, and urban psychiatric units get an IPF PPS payment amount that is no less than 70 percent of what they would have otherwise been paid under TEFRA had the IPF PPS not been implemented. This “safety net” will prevent an IPF from sustaining a significant financial “loss” by converting to the IPF PPS. Simultaneously, these providers will learn how to adjust their business structures efficiently under the IPF PPS framework. See section V.C. of this final rule. </P>
                    <HD SOURCE="HD3">b. Cost of Living Adjustment </HD>
                    <HD SOURCE="HD3">i. IPFs Located in Alaska and Hawaii </HD>
                    <P>As indicated in the proposed rule, we did not propose a cost-of-living adjustment (COLA) for IPFs located in Alaska and Hawaii. Based on the FY 1999 data, there were two psychiatric hospitals and no psychiatric units in Alaska and one psychiatric hospital and one psychiatric unit in Hawaii. Our analysis indicated that some IPFs in Alaska and Hawaii would “profit” from the proposed IPF PPS and other IPFs would experience a “loss.” Based on the limited number of cases in the analysis, we determined that the results were inconclusive and therefore we did not propose a COLA for IPFs located in Alaska and Hawaii. </P>
                    <P>
                        We received several comments requesting a COLA for IPFs located in Alaska and Hawaii. In response to the public comments, we analyzed the FY 2002 data. The FY 2002 data, unlike the FY 1999 data, demonstrated that IPFs in Alaska and Hawaii had costs disproportionately higher than IPFs across the nation. In the absence of a COLA, IPFs located in Alaska and Hawaii would receive payments under the IPF PPS that were far below their 
                        <PRTPAGE P="66958"/>
                        cost. Thus, the results of our analysis conclusively demonstrate that a COLA for IPFs located in Alaska and Hawaii would improve payment equity for these facilities. As a result of this analysis, we are providing a COLA adjustment in this final IPF PPS based on the higher costs found in Alaska and Hawaii IPFs. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         A few commenters recommended that CMS provide a facility-specific adjustment to the per diem payment amount to reflect the higher cost-of-living in Alaska. 
                    </P>
                    <P>One commenter recommended using the 25 percent Alaska COLA used under hospital IPPS for non-labor costs as a proxy adjustment for IPFs located in Alaska. The commenter stated that, despite the lack of IPF cases to study, CMS recognizes the need for a COLA adjustment for hospitals in Alaska under the hospital IPPS. The commenter indicated that MedPAC recently recommended that CMS provide an adjustment to the non-labor costs of skilled SNFs located in Alaska and Hawaii. </P>
                    <P>
                        <E T="03">Response:</E>
                         As indicated above, we analyzed the cases in the FY 2002 data and found that there are two IPFs in Alaska and four in Hawaii. Based on our analysis of the FY 2002 stays for these IPFs, we find that a COLA adjustment is warranted. However, the small number of cases from each IPF would make development of a facility-specific adjustment erroneous because, with few cases, a small number of extremely high-cost or low-cost cases could easily overstate or understate the IPF's per diem cost. In general, the COLA would account for the higher costs in the IPF and will eliminate the projected loss that IPFs in Alaska and Hawaii would experience absent the COLA. We will make a COLA adjustment for IPFs located in Alaska and Hawaii by multiplying the non-labor share of the Federal per diem base rate by the applicable COLA factor based on the county in which the IPF is located. The COLA factors were obtained from the U.S. Office of Personnel Management and used in other PPS system. For the convenience of the reader, Table 8 below lists the specific COLA for Alaska and Hawaii IPFs. 
                    </P>
                    <GPOTABLE COLS="1" OPTS="L0,tp0,p0,12/12,g1,t1,bl" CDEF="s200">
                        <TTITLE>  </TTITLE>
                        <BOXHD>
                            <CHED H="1">  </CHED>
                        </BOXHD>
                        <ROW>
                            <ENT I="21">
                                <E T="04">TABLE 9—COLA Factors for Alaska and Hawaii IPFS</E>
                            </ENT>
                        </ROW>
                    </GPOTABLE>
                    <GPH SPAN="3" DEEP="79">
                        <GID>ER15NO04.449</GID>
                    </GPH>
                    <HD SOURCE="HD3">ii. IPFs located in California </HD>
                    <P>Although we did not propose a cost-of-living adjustment for a specific State, we received a comment requesting that we provide an adjustment for California. We are not making a COLA to IPFs located in California as detailed below. </P>
                    <P>
                        <E T="03">Comment:</E>
                         One comment recommended that CMS establish a facility-specific adjustment for psychiatric units located in California to reflect the higher resource costs associated with mandatory staffing ratios. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         Although recently imposed State staffing ratios would not be evident in the FY 2002 data, we analyzed the FY 2002 MedPAR data to assess whether IPFs located in California have higher per diem cost than IPFs located in other States. We determined that after adjustment for facility mix, IPF per diem costs in California are slightly higher (1.6 percent). While we did not assess the variation for each State, we acknowledge that every State will have some variation from the average cost per day under the IPF PPS. We do not believe the slightly higher per diem cost in California warrants a special adjustment. There may be laws in other States that could create a cost difference greater or lower than California and it is not practical to account for all of the cost differences in every State resulting from State and local laws. 
                    </P>
                    <HD SOURCE="HD3">c. Disproportionate Share Intensity </HD>
                    <P>As indicated in the proposed rule, we did not propose an adjustment for disproportionate share hospital (DSH) status because the proposed regression analysis did not support an increase in payments. If we had proposed a payment adjustment for DSH facilities based on our empirical analysis, we would have proposed a reduction to the Federal per diem base rate paid to DSH facilities. Based on our analysis, we found a statistically significant negative relationship between per diem cost and DSH status. We did not believe that negative payment adjustment would be consistent with the intent of a DSH adjustment, which is intended to provide additional payments to providers to account for the costs of treating low-income patients. Therefore, we proposed no DSH adjustment. </P>
                    <P>We received numerous comments regarding the DSH adjustments. Most of the commenters disagreed with the proposed rule and stated that our reason for not providing a DSH adjustment was inadequate. A significant number of comments recommended that we re-examine the regression analysis and include a favorable DSH adjustment in the IPF PPS final rule. Based on the analysis discussed below, we are not providing a DSH adjustment in this final rule. </P>
                    <P>
                        <E T="03">Comment:</E>
                         Several commenters stated that hospitals providing large amounts of care to low-income individuals often serve as key access points for low-income Medicare beneficiaries and other low-income patients requiring psychiatric care. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         In the proposed rule, we indicated that we would continue to monitor whether we could find empirical evidence to indicate a relationship between disproportionate patient percentages and higher per diem costs to support the establishment of a DSH adjustments. We re-examined our regression analysis, as commenters requested, but did not find any relationship between DSH intensity and higher per diem costs. Our analysis of the FY 2002 data yielded the same results as our analysis of the FY 1999. Therefore in this final rule we are not making a DSH adjustment. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         One commenter stated that since CMS provided for a DSH adjustment in both the hospital IPPS and IRF PPS, IPFs should also receive this additional payment. 
                    </P>
                    <P>
                        Another commenter indicated that the reluctance to allow psychiatric hospitals to participate in DSH payments is 
                        <PRTPAGE P="66959"/>
                        related to the belief that the DSH hospitals are low cost providers. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         Consistent with the approach we have taken in the proposed rule and in this final rule, we believe that any IPF PPS DSH payment adjustment should be supported by data showing that DSH facilities experience higher per diem costs than other IPFs. Our data failed to demonstrate that the IPFs who serve a disproportionate number of low income patients have higher per diem costs. Therefore, we do not see a justification to make a DSH adjustment in the IPF PPS. Unlike IPFs, the IPPS and IRF PPS had data supporting the need for a DSH adjustment. IPPS and IRF PPS data showed that serving a disproportionate share of low income patients has a direct connection to higher facility costs. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         A commenter suggested that if government-operated hospitals bias the result, the analysis should be redone excluding those hospitals. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We believe the commenter misunderstood our statements in the proposed rule about the impact of government-operated hospitals in our analysis. Our intention was not that the government-operated hospitals might be responsible for the finding of a negative relationship between per diem cost and the DSH variable. Instead, we were emphasizing that many observers might think that the limitations of measuring DSH for government-operated hospitals (too low a value for their DSH variable) might explain why we found higher DSH intensity associated with lower cost. However, our finding was not attributable to the government-operated hospitals because we found the same negative relationship when we excluded them from the regression. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         Some commenters indicated that because Medicaid does not pay for services to certain individuals in an institution for mental diseases (IMD), low-income beneficiaries in psychiatric hospitals cannot be identified as Medicaid beneficiaries. In addition, the commenters believe that the Medicaid proportion will be biased downwards smaller than it should be. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         In the proposed rule and in this rule, the basis for the decision not to provide a DSH adjustment is our inability to find a correlation between available measures of low-income patient percentages and higher per diem costs. As previously indicated, potential measurement error in the Medicaid proportion did not explain the lack of a positive correlation between per diem cost and DSH status. We recognize that inpatients in institutions for mental diseases may still be eligible for Medicaid for purposes of the calculation of the DSH percentage (although there might be little incentive for facilities to establish a patient's Medicaid eligibility when there is no Medicaid payment available). The fact remains that, with currently available data, we found no basis for a DSH adjustment. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         Several commenters asked how section 402 of the MMA would impact payments under the IPF PPS. 
                    </P>
                    <P>One commenter recommended that CMS wait until after December 8, 2004, to develop the IPF DSH factors (when the MMA is implemented and CMS begins to furnish DSH data to all hospitals). The commenter indicated that they expect the data to be a viable source of information that could be used to establish an appropriate DSH adjustment factor for the IPF PPS. </P>
                    <P>
                        <E T="03">Response:</E>
                         Section 402 of the MMA has no effect on the IPF PPS as it only applies to DSH under the IPPS. The commenter is apparently referring to section 951 of the MMA, which requires that the Secretary arrange to furnish subsection (d) hospitals (those hospitals subject to the hospital IPPS) with the data necessary to compute the number of patient days used in computing the disproportionate patient percentage. We acknowledge that it is possible for this requirement to improve the accuracy of the disproportionate patient percentages for hospitals at some future point in time. However, we are making our decision not to include a DSH adjustment based on the best available data. If better data becomes available that indicates a need for a DSH adjustment, and an appropriate methodology for such an adjustment, the issue can be addressed in a future rulemaking. 
                    </P>
                    <HD SOURCE="HD3">d. IPFs With Full-Service Emergency Departments (EDs) </HD>
                    <P>We did not propose an adjustment for IPFs with a qualifying ED. However, we received many comments requesting a facility adjustment for hospitals that maintain an ED and provide crisis management services. Several commenters recommended that IPFs with an ED should receive a facility-level adjustment empirically determined through the regression model. One commenter recommended a 20 percent adjustment factor for IPFs in hospitals with an ED. </P>
                    <P>In this final rule, we are providing an adjustment to the Federal per diem base rate to account for the costs associated with maintaining a full-service ED. We conducted an analysis, as described below, to develop an appropriate payment adjustment to account for ED costs and to define the subset of IPFs that have, or are part of acute care hospitals that have, a full-service ED. </P>
                    <P>The overhead costs associated with maintaining an ED are included in each IPF's routine cost amount, but since routine costs are reported as a average, we are unable to determine the portion of the routine cost directly attributable to ED costs. As an alternative, we analyzed cases admitted through the ED using FY 2002 claims data. ED cases were identified by the presence of ED or ambulance charges on the MedPAR record. We found that about one-third of all cases were admitted through the ED, and that 98 percent of the cases were treated in psychiatric units. Among the psychiatric hospitals and units with at least one admission from an ED, the ED admissions comprise about 43 percent of all admissions. </P>
                    <P>In analyzing the relative cost of ED and other admissions, we limited the comparison to IPFs with ED admissions to avoid attributing cost differences to ED admissions that are due to other unrelated factors. On a per case basis, ED admissions are actually slightly less expensive than other admissions ($7,672 versus $8,036). Most of the difference results from the fact that ED stays are about one day shorter than other psychiatric stays (10.6 days versus 11.5 days). The ED costs average about $198 per case, and the mean difference in ancillary costs per case (which includes ED costs) is about $196. Thus, the ED costs effectively account for all of the difference in ancillary costs per case between the ED and other admissions. On average, admissions through the ED do not appear to require any more ancillary services than other admissions except for the ED costs themselves. </P>
                    <P>
                        Although this analysis indicated that patients admitted through the ED were more costly on a per diem basis than cases without an ED admission, we are not including an adjustment for patients admitted through the ED. As explained previously, we are concerned about creating an incentive for psychiatric units in acute care hospitals with EDs to inappropriately admit all psychiatric patients through the ED of the acute care hospital in which it is located in order to receive a patient-level ED adjustment. An ED adjustment at the patient level would be approximately $200. To the extent a psychiatric unit ensured that all of its patients were admitted for inpatient psychiatric care through the ED of the acute care hospital in which it is located, even though admission through the ED was unnecessary and inappropriate, Medicare would be substantially overpaying for these cases. 
                        <PRTPAGE P="66960"/>
                    </P>
                    <P>As an alternative, we have decided to provide a facility-level adjustment for IPFs, for both psychiatric hospitals and acute care hospitals with a distinct part psychiatric unit, that maintain a qualifying ED. We are providing the adjustment to psychiatric units in acute care hospitals because the costs of the ED are allocated to all hospital departments, including the psychiatric units. We intend that the adjustment only be provided to hospitals with EDs that are staffed and equipped to furnish a comprehensive array of emergency services and that meet the definition of a “dedicated emergency department” in § 489.24 and the definition of “provider-based entity” in § 413.65. We are defining a full-service ED in order to avoid providing an ED adjustment to an intake unit that is not comparable to a full-service ED with respect to the array of emergency services available or cost. </P>
                    <P>However, where a psychiatric unit would otherwise qualify for the ED adjustment, but an individual patient is discharged from that acute care hospital, we would not apply the ED adjustment. The reason we would not give an ED adjustment in this case is that the costs associated with maintaining the ED would have already been paid through the DRG payment paid to the acute care hospital. Thus, if we provided an ED adjustment in this case, the hospital would be paid twice for the overhead costs of the ED. </P>
                    <P>The ED adjustment will be incorporated into the variable per diem adjustment for the first day of each stay. That is, IPFs with qualifying EDs, will receive a higher variable per diem adjustment for the first day of each stay than will other IPFs. </P>
                    <P>Three steps were involved in the calculation of the ED adjustment factor. First, we estimated of the proportion by which the ED costs of a case would increase the cost of the first day of the stay. Using the IPFs with ED admissions in 2002, we divided their average ED cost per stay admitted through the ED ($198) by their average cost per day ($715), which equals 0.28. Second, we adjusted the factor estimated in step 1 to account for the fact that we will pay the higher first day adjustment for all cases in the qualifying IPFs, not just the cases admitted through the ED. Since on average, 44 percent of the cases in IPFs with ED admissions are admitted through the ED, we multiplied 0.28 by 0.44, which equals 0.12. Third, we added the adjusted factor calculated in the previous 2 steps to the variable per diem adjustment derived from the regression equation that we used to derive our other payment adjustment factors. The first day payment factor from this regression is 1.19. Adding the 0.12, we obtained a first day variable per diem adjustment for IPFs with a qualifying ED equal to 1.31. </P>
                    <HD SOURCE="HD2">D. Other Proposed Adjustments and Policy Changes </HD>
                    <HD SOURCE="HD3">1. Outlier Policy </HD>
                    <P>We proposed a 2 percent outlier policy to promote access to IPFs for those patients who require expensive care and to limit the financial risk of IPFs treating unusually costly cases. As explained in the proposed rule, we believe that it is appropriate to include an outlier policy in order to ensure that IPFs treating unusually costly cases do not incur substantial “losses” and promote access to care for patients requiring expensive care. Providing these additional payments to IPFs for costs that are beyond the IPF's control will also improve the accuracy of the payment system. Similar to the proposed rule, our payment simulations continue to support establishment of the outlier policy at 2 percent of total payments because it affords protection for vulnerable IPFs (and patients) while providing appropriate levels of payment for all other cases that are not outlier cases. The 2 percent target continues to provide an appropriate balance between patient access, IPF financial risk, and the payment rate reduction required for all cases to offset the cost of the policy. </P>
                    <P>We proposed to make outlier payments on a per case basis rather than on a per diem basis because it is the overall financial “gain” or “loss” of the case, and not of individual days, that determines an IPF's financial risk and, as a result, access for unusually costly cases. In addition, because patient level charges (from which costs are estimated) are typically aggregated for the entire IPF stay, they are not reported in a manner that would permit accurate accounting on a daily basis. </P>
                    <P>Thus, we proposed to make outlier payment for discharges in which estimated costs exceed an adjusted threshold amount ($4,200 multiplied by the IPF's facility adjustments, that is, wage area, rural location, teaching, and cost of living adjustment for IPFs located in Alaska and Hawaii) plus the total IPF adjusted payment amount for the stay. Where the case qualifies for an outlier payment, we proposed to pay 80 percent of the difference between the estimated IPF's cost for the case and the adjusted threshold amount for days 1 through 8 of the stay, and 60 percent of the difference for day 9 and thereafter. We established 80 percent and 60 percent to lost sharing ratios because we were concerned that a single ratio established at 80 percent (like other Medicare hospital prospective payment systems) might provide an incentive under the IPF per diem system to increase length of stay in order to receive additional payments. After establishing the ratios, we determined the threshold amount of $4,200 through payment simulations designed to compute a dollar loss beyond which payments are estimated to meet the 2 percent outlier spending target. In this final rule, we adopted this proposed outlier policy methodology, with an adjusted threshold amount of $5700. The revised amount is based on updated simulations using more recent data (from FY 2002) and the modified policy for the loss sharing ratios (see below). </P>
                    <P>In this final rule, we modified application of the loss-sharing provision of the outlier policy to pay 80 percent of the difference between the IPF's estimated cost for the case and the adjusted threshold amount for days 1 through 9 of the stay ( including median length of stay instead of days 1 through 8 up to the median length of stay) and 60 percent thereafter. As we explain above, we decided to reduce the 80 percent loss-sharing ratio by an additional 20 percent, resulting in a 60 percent loss sharing ratio for day 10 and thereafter. With this modification, we will pay 80 percent of the costs eligible for outlier payments for all cases whose length of stay is no greater than the median length of stay (9 days) of all Medicare inpatient psychiatric cases. </P>
                    <P>In the proposed rule, we proposed a number of policies to ensure the accuracy and integrity of our outlier payments. We are adopting these policies in this final rule, as decribed below. </P>
                    <P>Referring back to the payment calculation example in Section VI.B.2 of this final rule, the total estimated payment for the case is $7267.75. The adjusted threshold amount is calculated below: </P>
                    <P>
                        <E T="03">Step 1:</E>
                         Multiply threshold by labor share and the wage area.
                    </P>
                    <FP SOURCE="FP-1">$5700 × 0.72528 (labor share) × 0.7743 (area wage index) = $3201.03 </FP>
                    <P>
                        <E T="03">Step 2:</E>
                         Add this number to the non-labor share threshold amount.
                    </P>
                    <FP SOURCE="FP-1">$5700 × 0.27472 (non-labor share) = $1565.90 </FP>
                    <FP SOURCE="FP-1">$1565.90 + $3201.03 = $4766.93 </FP>
                    <P>
                        <E T="03">Step 3:</E>
                         Apply the other facility-level adjustments.
                    </P>
                    <FP SOURCE="FP-1">$4766.96 × 1.17 (rural adjustment) × 1.0 (teaching adjustment) = $5577.31 </FP>
                    <P>
                        <E T="03">Step 4:</E>
                         Calculate the adjusted threshold amount by adding the estimated payment amount to the amount above. 
                    </P>
                    <PRTPAGE P="66961"/>
                    <FP SOURCE="FP-1">$5577.31 + $7267.75 = $12,845.06 </FP>
                    <P>If estimated costs exceed the adjusted threshold amount ($12,845.06), then the case will qualify for an outlier payment. If the IPF in the example reports charges of $21,000 and they have a cost-to-charge ratio of 0.8, then the estimated cost of the case would be $16,800. The outlier amount is calculated below: </P>
                    <P>
                        <E T="03">Step 1:</E>
                         Calculate the difference between the estimated cost and the adjusted threshold amount. 
                    </P>
                    <FP SOURCE="FP-1">$16,800—$12.845.06 = $3954.94 </FP>
                    <P>
                        <E T="03">Step 2:</E>
                         Divide by the length of stay (in our example, 10 days). 
                    </P>
                    <FP SOURCE="FP-1">$3594.94 / 10 = $395.49 </FP>
                    <P>
                        <E T="03">Step 3:</E>
                         For days 1 through 9 of the stay, the IPF receives 80% of this difference.
                    </P>
                    <FP SOURCE="FP-1">$395.49 × 0.80 = $316.40 </FP>
                    <FP SOURCE="FP-1">$316.40 × 9 days = $2847.60 </FP>
                    <P>
                        <E T="03">Step 4:</E>
                         For days 10 and beyond, the IPF receives 60% of the difference.
                    </P>
                    <FP SOURCE="FP-1">395 × 0.60 = $237.30 (in the example, the patient stays for 10 days, so the IPF receives the above amount for day 10 only). </FP>
                    <P>Therefore, the IPF in the example would receive a total outlier payment of $3084.90.</P>
                    <FP SOURCE="FP-1">($2847.60 + $237.30). </FP>
                    <HD SOURCE="HD3">a. Statistical Accuracy of Cost-to-Charge Ratios </HD>
                    <P>We believe that there is a need to ensure that the cost-to-charge ratio used to compute an IPF's estimated costs should be subject to a statistical measure of accuracy. Removing aberrant data from the calculation of outlier payments will allow us to enhance the extent to which outlier payments are equitably distributed and continue to reduce incentives for IPFs to under serve patients who require more costly care. Further, using a statistical measure of accuracy to address aberrant cost-to-charge ratios would also allow us to be consistent with the outlier policy under the hospital inpatient prospective payment system. Therefore, we are making the following two proposals: </P>
                    <P>• We will calculate two national ceilings, one for IPFs located in rural areas and one for facilities located in urban areas. We will compute the ceiling by first calculating the national average and the standard deviation of the cost-to-charge ratios for both urban and rural IPFs. </P>
                    <P>To determine the rural and urban ceilings, we will multiply each of the standard deviations by 3 and add the result to the appropriate national cost-to-charge ratio average (either rural or urban). We believe that the method explained above results in statistically valid ceilings. If an IPF's cost-to-charge ratio is above the applicable ceiling, the ratio is considered to be statistically inaccurate. Therefore, we will assign the national (either rural or urban) median cost-to-charge ratio to the IPF. Due to the small number of IPFs compared to the number of acute care hospitals, we believe that statewide averages used in the hospital inpatient prospective payment system, would not be statistically valid in the IPF context. </P>
                    <P>In addition, the distribution of cost-to-charge ratios for IPFs is not normally distributed and there is no limit to the upper ceiling of the ratio. For these reasons, the average value tends to be overstated due to the higher values on the upper tail of the distribution of cost-to-charge ratios. Therefore, we will use the national median by urban and rural type as the substitution value when the facility's actual cost-to-charge ratio is outside the trim values. Cost-to-charge ratios above this ceiling are probably due to faulty data reporting or entry, and, therefore, should not be used to identify and make payments for outlier cases because these data are clearly erroneous and should not be relied upon. In addition, we will update and announce the ceiling and averages using this methodology every year. </P>
                    <P>• We will not apply the applicable national median cost-to-charge ratio when an IPF's cost-to-charge ratio falls below a floor. We are adopting this policy because we believe IPFs could arbitrarily increase their charges in order to maximize outlier payments. </P>
                    <P>Even though this arbitrary increase in charges should result in a lower cost-to-charge ratio in the future (due to the lag time in cost report settlement), if we propose a floor on cost-to-charge ratios, we will apply the applicable national median for the IPFs actual cost-to-charge ratio. Using the national median cost-to-charge ratio in place of the provider's actual cost-to-charge ratio would estimate the IPF's costs higher than they actually are and may allow the IPF to inappropriately qualify for outlier payments. </P>
                    <P>Accordingly, we will apply the IPF's actual cost-to-charge ratio to determine the cost of the case rather than creating and applying a floor. In such cases as described above, applying an IPF's actual cost-to-charge ratio to charges in the future to determine the cost of the case will result in more appropriate outlier payments. </P>
                    <P>Consistent with the policy change under the hospital inpatient prospective payment system, IPFs will receive their actual cost-to-charge ratios no matter how low their ratios fall. We are still assessing the procedural changes that would be necessary to implement this change. For this final rule, we are finalizing the above described policies. </P>
                    <HD SOURCE="HD3">b. Adjustment of IPF Outlier Payments </HD>
                    <P>As discussed in the hospital inpatient prospective payment system final rule for outliers, we have implemented changes to the IPPS outlier policy used to determine cost-to-charge ratios for acute care hospitals, because we became aware that payment vulnerabilities exist in the current outlier policy. Because we believe the IPF outlier payment methodology is likewise susceptible to the same payment vulnerabilities, we are adopting the following changes: </P>
                    <P>
                        • Include in § 412.424(c)(2)(v) a cross-reference to § 412.84(i) that was included in the final rule published in the 
                        <E T="04">Federal Register</E>
                         on June 9, 2003 (68 FR 34515). Through this cross-reference, FIs will use more recent data when determining an IPF's cost-to-charge ratio. Specifically, as provided in § 412.84(i), FIs will use either the most recent settled IPF cost report or the most recent tentatively settled IPF cost report, whichever is later to obtain the applicable IPF cost-to-charge ratio. In addition, as provided under § 412.84(i), any reconciliation of outlier payments will be based on a ratio of costs to charges computed from the relevant cost report and charge data determined at the time the cost report coinciding with the discharge is settled. 
                    </P>
                    <P>
                        Include in proposed § 412.424(c)(2)(v) a cross reference to § 412.84(m) (that was included in the final rule published in the 
                        <E T="04">Federal Register</E>
                         on June 9, 2003 (68 FR 34415) to revise the outlier policy under the hospital inpatient prospective payment system). Through this cross-reference, IPF outlier payments may be adjusted to account for the time value of money during the time period it was inappropriately held by the IPF as an “overpayment.” We also may adjust outlier payments for the time value of money for cases that are “underpaid” to the IPF. In these cases, the adjustment will result in additional payments to the IPF. Any adjustment will be based upon a widely available index to be established in advance by the Secretary, and will be applied from the midpoint of the cost reporting period to the date of reconciliation. 
                    </P>
                    <P>We received several comments on the proposed outlier policy. Most of the comments expressed support for the proposed outlier policy. </P>
                    <P>
                        <E T="03">Comment:</E>
                         Many commenters indicated that the outlier level is too low and that there should be a mechanism to appeal an outlier payment. The commenters 
                        <PRTPAGE P="66962"/>
                        recommended establishing the outlier policy at 5 percent of the total IPF PPS. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We are maintaining a 2 percent outlier policy in the final IPF PPS. The 2 percent outlier target percentage is lower than the target outlier percentage of other prospective payment systems that contain outlier polices, which range from 3 percent in the inpatient rehabilitation PPS to 8 percent in the LTCH PPS. The target outlier percentage in IPPS is about 5 percent. However, these other systems are per case or per episode payment systems in which Medicare's payment does not automatically account for the higher costs associated with longer lengths of stay. In a per diem system, such as the IPF PPS, there is less of a need for outlier payments because it automatically adjusts payments for length of stay. Therefore, we believe that 2 percent of total IPF PPS payment is appropriate. We estimate that approximately 5 percent of IPF cases would meet the fixed dollar loss threshold amount and qualify for an average outlier payment of $3,248. 
                    </P>
                    <P>If the provider is dissatisfied with the amount of payment, they can invoke existing appeal rights. </P>
                    <P>
                        <E T="03">Comment:</E>
                         Several commenters recommended modifying the outlier calculation so that the proposed risk sharing percentage of 60 percent for the ninth and subsequent days is increased to 80 percent. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We proposed to reduce the risk sharing percentage from 80 percent to 60 percent after the 8th day of the stay. The choice of the 8th day was based on the fact that a single variable per diem adjustment was proposed for days 5 through 8, and we thought it appropriate to make the change in the risk sharing percentage change coincide with the change in the variable per diem adjustment factor. After analyzing new data and based on public comments, we have revised the variable per diem adjustment factors so that they vary continuously over the first 22 days of the stay. As a result, there is no longer any reason to make the change in the risk sharing percentage coincide with the variable per diem adjustment factors. In this final rule, we are changing the risk sharing percentage from 80 percent to 60 percent after the 9th day of the stay. We chose to include the 9th day in the 80 percent risk sharing category because 9 days is the median length of stay. The median implies that one-half of the cases have a length of stay greater than 9 days, and the other half have a length of stay less than 9 days, which also can be interpreted as implying that the “typical” case has a length of stay of 9 days. We will pay the 80 percent risk sharing percentage for all cases whose length of stay is less than or equal to the length of stay of the typical case. We are reducing the risk sharing percentage for cases whose length of stay exceeds that of the typical case, because as we noted in the proposed rule (68 FR 66934), we are concerned that a single risk sharing percentage at 80 percent might provide an incentive to increase length of stay in order to received additional outlier payments. Reducing the amount Medicare shares in the loss of high cost cases provides an incentive for an IPF to contain costs once a case qualifies for outlier payments. The reduction from 80 percent to 60 percent is adequate to provide such an incentive, while maintaining a significant degree of risk sharing. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         Many commenters requested that CMS provide additional information to the sample calculation presented in the proposed rule. The commenters also recommended that CMS explain the circumstances under which an outlier would be paid (interim billing or at the time of discharge). 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         Since outlier payments will be made on a per-case basis, a determination as to whether a case qualifies for an outlier payment cannot be made until discharge. We are concerned about the potential for overpayments associated with IPF stays that may appear to qualify for outlier payments early in the stay, but do not meet the fixed dollar loss threshold once all costs and IPF PPS payments are considered. To avoid this situation, we proposed in § 412.432(d), that additional payments for outliers are not made on an interim basis. Rather, outlier payments are made based on the submission of a discharge bill. We are adopting this provision in this final rule. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         Several commenters recommended clarification on the methodology for determining the cost-to-charge ratio, a clear definition of the numerator and denominator in the ratio, identifying the applicable worksheet location for data on costs and charges, as well as the appeal or comments that might be available when the national cost-to-charge ratios are published. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We intend to follow similar procedures as outlined in the IPPS final rule published in the 
                        <E T="04">Federal Register</E>
                         on June 9, 2003 (68 FR 34498). IPF PPS outlier methodology requires the FI to calculate the provider's overall Medicare cost-to-charge ratio using the facility's latest settled cost report or tentatively settled cost report (whichever is from the later period), and associated data. Cost-to-charge ratios will be updated each time a subsequent cost report is settled or tentatively settled. 
                        <E T="03">Total Medicare charges</E>
                         will consist of the sum of inpatient routine charges and the sum of inpatient ancillary charges including capital. 
                        <E T="03">Total Medicare costs</E>
                         will consist of the sum of inpatient routine costs (net of private room differential and swing bed cost) plus the sum of ancillary costs plus capital-related pass-through cost only. Based on current Medicare cost reports and worksheet, specific FI instructions are described below. 
                    </P>
                    <P>For freestanding IPFs, Medicare charges will be obtained from Worksheet D-4, column 2, lines 25 through 30, plus line 103 from the cost report. For freestanding IPFS, total Medicare costs will be obtained from worksheet D-1, Part II, line 49 minus (Worksheet D, Part III, column 8, lines 25 through 30, plus Worksheet D, Part IV, column 7, line 101). Divide the Medicare costs by the Medicare charges to compute the cost-to-charge ratio. </P>
                    <P>For IPFs that are distinct part psychiatric units, total Medicare inpatient routine charges will be estimated by dividing Medicare routine costs on Worksheet D-1, Part II, line 41, by the result of Worksheet C, Part I, line 31, column 3 divided by line 31, column 6. Add this amount to Medicare ancillary charges on Worksheet D-4, column 2, line 103 to arrive at total Medicare charges. To calculate the total Medicare costs for distinct part units, data will be obtained from Worksheet D-1, Part II, line 49 minus (Worksheet D, part III, column 8, line 31 plus Worksheet D, Part IV, column 7, line 101). All references to Worksheet and specific line numbers should correspond with the subprovider identified as the IPF unit, that is the letter “S” is the third position of the Medicare provider number. Divide the total Medicare costs by the total Medicare charges to compute the cost-to-charge ratio. </P>
                    <P>If the provider is dissatisfied with the FI's cost-to-charge ratio determination, they can invoke their applicable appeal rights. </P>
                    <HD SOURCE="HD3">2. Interrupted Stays </HD>
                    <P>
                        In the proposed rule, we proposed an interrupted stay policy based on our concern that IPFs could maximize inappropriate Medicare payment by prematurely discharging patients after they receive the higher variable per diem adjustments and then readmitting the same patient. Under the proposed policy, if a patient is discharged from an IPF and returns to the same IPF before midnight on the fifth consecutive day following discharge, the case is 
                        <PRTPAGE P="66963"/>
                        considered to be continuous for applying the variable per diem adjustments and determining whether the case qualifies for outlier payments. Therefore, we would not apply the variable per diem adjustments for the second admission and would combine the costs of both admissions for the purpose of outlier payments. We proposed this policy in order to lower the incentive for a hospital to move patients among Medicare-covered sites in order to maximize Medicare payments. We received many public comments regarding the proposed interrupted stay policy. Most of the commenters requested that we delete the interrupted stay policy, provide an exception for discharges to an acute care hospital in order to receive medical or surgical services, for readmissions due to psychiatric decompensation, or shorten the duration of the interrupted stay policy. In this final rule, we are retaining the interrupted stay policy, but we are shortening the duration to 3 days. 
                    </P>
                    <P>Therefore, if a patient is discharged from an IPF and admitted to any IPF within 3 consecutive days of the discharge from the original IPF stay, the stay would be treated as continuous for purposes of the variable per diem adjustment and any applicable outlier payment. </P>
                    <P>For example a patient is discharged from an IPF on March 10 after an initial stay of 7 days and is admitted to another IPF on March 12 (before midnight of the 3rd consecutive day). The “readmission” is considered a continuation of the initial stay. Therefore day 1 of the readmission will be considered day 8 of the combined stay for purposes of the variable per diem stay and any applicable outlier payment. </P>
                    <P>
                        <E T="03">Comment:</E>
                         A few commenters stated that after a 5-day interruption, the patient would need a full workup similar to the admission process on the first day. One commenter stated that the proposed 5-day interrupted stay policy financially penalizes IPFs for ensuring that their patients receive necessary emergency medical care. 
                    </P>
                    <P>Most commenters requested that we shorten the duration of the interrupted stay policy. Other commenters stated that a 5-day interrupted stay policy would require IPFs to hold claims and not bill Medicare until after the fifth day of discharge and that a 5-day interrupted stay policy could cause IPFs to delay readmissions to avoid the policy. </P>
                    <P>Several commenters recommended that we reduce the duration of the interrupted stay policy to 3 days to coincide with the 72-hour rule for bundling of outpatient charges under IPPS. Other commenters suggested a 3-day interrupted stay policy in order to be consistent with the interrupted stay policy in the IRF prospective payment system. However, a few commenters suggested that we extend the interrupted stay policy to readmissions to the IPF within 15 or 30 days of the patients discharge that would prompt a readmission review by the hospital's Quality Improvement Organization. </P>
                    <P>
                        <E T="03">Response:</E>
                         In the proposed rule, we indicated that an absence from the IPF of less than 5 days would not necessitate repeating many of the admission-related services such as psychiatric evaluations and the patient's medical history. After receiving public comments we reanalyzed the duration of the interrupted stay policy. We now agree that after a 5-day absence from the IPF there are psychiatric and laboratory tests that would need to be repeated. As a result, we have revised the duration of the interrupted stay policy in this final rule from 5 days to 3 days. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         Several commenters did not believe an interrupted stay policy was necessary to avoid inappropriate transfers and readmissions to the IPF. One commenter stated that adequate safeguards already exist, such as the physician certification and recertification requirements, significant medical malpractice risk of premature discharge, periodic review of practice patterns by local licensing and national accreditation bodies, and FI audits. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         Despite the safeguards identified by the commenters, inappropriate transfers and readmissions of psychiatric patients continue to occur. For this reason, we continue to believe an interrupted stay policy is necessary to discourage inappropriate discharges and readmissions to IPFs. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         The majority of commenters requested that we provide an exception to the interrupted stay policy when a patient is discharged to an acute care hospital for medical care. The commenters maintain that the resources required to treat the patient at the time of readmission are of similar intensity to those required at the point of first admission. All assessments (including history and physical and psychiatric assessment) as well as the comprehensive treatment plan need to be reviewed and revised. In addition, the medical condition that required treatment must be addressed and incorporated into the ongoing treatment. One commenter suggested that discharges and subsequent readmissions to the IPF due to psychiatric decompensation should not be subject to the interrupted stay policy as well. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         Although we agree that some additional resources will be expended by IPFs when a patient is readmitted, we believe the resources required to reassess a patient upon readmission would be greatly reduced after a 3-day interrupted stay compared to the proposed 5-day interrupted stay policy. In addition, since almost three fourths of IPFs are distinct part psychiatric units in acute care hospitals, we remain concerned about hospitals inappropriately shifting patients between the psychiatric unit and the medical unit, thus receiving both the full DRG payment for the admission to the acute care hospital, and IPF payment for the admission to the excluded psychiatric unit. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         One commenter asked if the interrupted stay policy applies if a patient is discharged to receive acute care and is readmitted to a different IPF than the IPF that originally discharged and transferred the patient. The commenter indicated that the shuffling of psychiatric patients from hospital to hospital is an abusive practice that the interrupted stay policy should address. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We share the commenter's concern about the “shuffling” of psychiatric patients from hospital to hospital. We believe adopting an interrupted stay policy will address this concern from the viewpoint of the IPF PPS. 
                    </P>
                    <P>One example is when a patient is discharged from a psychiatric unit to receive acute care and discharged at the completion of the hospital IPPS stay, then transferred to a freestanding psychiatric hospital rather than returning to the psychiatric unit. Under the interrupted stay policy, if the readmission to the psychiatric hospital occurs within the 3-day interrupted stay timeframe, of the initial psychiatric unit stay, we would not pay the psychiatric hospital the variable per diem adjustments for the initial days of the original psychiatric unit stay otherwise applicable to the stay. The transferring hospital would send the psychiatric hospital the patient's medical record that will include information regarding the prior psychiatric stay in accordance with the hospital condition of participation for discharge planning (§ 482.43). </P>
                    <P>
                        As a result, we have revised § 412.424(d) to clarify that if a patient is discharged from an IPF and is readmitted to the same or another IPF before midnight on the third consecutive day following the discharge from the original IPF stay, the case is considered to be continuous for 
                        <PRTPAGE P="66964"/>
                        applying the variable per diem adjustments and determining whether the case qualifies for outlier payments. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         Several commenters asked if the interrupted stay policy would apply if a patient is transferred from a distinct part psychiatric unit to the hospital's medical unit and is readmitted to the IPF within the 5-day interrupted stay timeframe, but with a different principal diagnosis. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         In the situation described by the commenter, the interrupted stay policy would apply. A psychiatric patient whose illness is severe enough to require inpatient psychiatric treatment, should be receiving care for all of their psychiatric conditions. Therefore, if this psychiatric patient was discharged for acute medical care, and upon discharge from the acute medical hospital the patient still required inpatient psychiatric treatment, that treatment should be considered a continuation of the original stay. Thus, the principal diagnosis upon readmission is not relevant to the interrupted stay policy. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         One commenter asked if the interrupted stay policy would apply when a patient is discharged to a partial hospitalization program, decompensates while in that program, necessitating a readmission to the IPF within 5 days of the discharge from the IPF. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         Under this final rule, if a patient was in an IPF and was discharged to a partial hospitalization program but then required readmission to an IPF within the 3-day timeframe, the stay is considered an interrupted stay. The interrupted stay policy applies to all discharges and subsequent readmissions to an IPF within 3 consecutive days. 
                    </P>
                    <HD SOURCE="HD3">3. Stop-Loss Provision </HD>
                    <P>Many commenters who believed that they would be disadvantaged by implementation of the IPF PPS, requested that we provide additional payments through a risk sharing arrangement. We considered alternatives that would reduce financial risk to facilities expected to experience substantial reductions in Medicare payments during the period of transition to the IPF PPS. </P>
                    <P>Specifically, we considered stop-loss policies that would guarantee each facility, total IPF PPS payments no less than a minimum percent of its TEFRA payments, had the IPF PPS not been implemented. The two values for the minimum percent of TEFRA payments we examined were 70 percent and 80 percent. The 80 percent option was considered because 80 percent is a commonly used rate of risk-sharing in Medicare programs. We pay 80 percent of the estimated costs of outlier cases beyond the outlier threshold, and 80 percent is similarly used in other Medicare PPS's, as well as in many other insurance arrangements. The 70 percent option was assessed as an alternative, because it more narrowly targets stop-loss payments to facilities with greater financial risk. </P>
                    <P>Each of these policies was applied to the IPF PPS portion of Medicare payments during the transition. Hence, during year 1, three-quarters of the payment would be based on TEFRA and one-quarter on the IPF PPS. In year 2, one-half of the payment would be based on TEFRA and one-half on the IPF PPS. In year 3, one-quarter of the payment would be based on TEFRA and three-quarters on the IPF PPS. In year 4 of the IPF PPS, Medicare payments are based 100 percent on the IPF PPS. </P>
                    <P>The combined effects of the transition and the stop-loss policies would be to ensure that the total estimated IPF PPS payments would be no less than 92.5 or 95 percent in year 1, 85 or 90 percent in year 2, and 77.5 or 85 percent in year 3, depending upon whether the 70 percent or the 80 percent stop-loss option were implemented. Under the 70 percent policy, 75 percent of total payment would be TEFRA payments, and the 25 percent would be IPF PPS payments, which would be guaranteed to be at least 70 percent of the TEFRA payments. The resulting 92.5 percent of TEFRA payments is the sum of 75 percent and 25 percent times 70 percent (which equals 17.5 percent). </P>
                    <P>The 70 percent of TEFRA payment stop-loss policy would require a reduction in the Federal per diem and ECT base rates of 0.39 percent in order to make the stop-loss payments budget neutral. We estimate that about 10 percent of IPFs would receive stop-loss payments under the 70 percent policy. </P>
                    <P>The 80 percent of TEFRA stop-loss policy would require a reduction in the Federal per diem rate of almost 2 percent in order to make the stop-loss policy budget neutral. We estimate that almost 27 percent of all facilities would receive additional payments under the 80 percent stop-loss policy. </P>
                    <P>We also considered a risk-sharing policy modeled on the same principles as the case-level outlier policy, but applied at the facility level. Under this approach, we considered the case in which an IPF would have to incur a 12 percent loss in IPF PPS payments relative to TEFRA and then we would pay 80 percent of additional losses. This approach was estimated to require a reduction in the Federal per diem and ECT base rates of about 12 percent. </P>
                    <P>In order to target the stop-loss policy to the IPFs that may experience the greatest impact relative to current payments and to limit the size of the reductions to the Federal per diem and ECT base rates required to maintain budget neutrality, we are adopting the 70 percent stop-loss provision. We have added a new paragraph (d) to § 412.426 to include the 70 percent stop-loss provision as part of the 3-year transition to the IPF PPS. We will monitor expenditures under this policy to evaluate its effectiveness in targeting stop-loss payments to IPFs facing the greatest financial risk. </P>
                    <HD SOURCE="HD3">4. Physician Recertification Requirements </HD>
                    <P>In the proposed rule, we proposed to modify the timing of the first physician recertification after admission to the IPF. We proposed to revise § 424.14(d) to require that a physician recertify a patient's continued need for inpatient psychiatric care on the tenth day following admission to the IPF rather than the 18th day following admission to the IPF. </P>
                    <P>Also, we proposed to amend § 424.14 by adding a new paragraph (c)(3) to require that, in recertifying a patient's need for continued inpatient care, a physician must indicate that the patient continues to need, on a daily basis, inpatient psychiatric care (furnished directly by or requiring the supervision of IPF personnel) or other professional services that, as a practical matter, can be provided only on an inpatient basis. We received a few comments supporting the proposed change. However, most of the commenters did not support the proposed changes and indicated inconsistencies in the timeframes currently required for IPFs that warrant additional analysis. As a result, we are not including the proposed physician re-certification requirements in this final rule. We will continue to require that a physician recertify a patient's continued need for inpatient psychiatric care on the 18th day following admission to the IPF. </P>
                    <HD SOURCE="HD1">VII. Implementation of the IPF PPS </HD>
                    <HD SOURCE="HD2">A. Transition Period </HD>
                    <HD SOURCE="HD3">1. Existing Providers </HD>
                    <P>
                        We proposed a 3-year transition period during which IPFs would receive a blended payment of the Federal per diem payment amount and the facility-specific payment amount the IPF would receive under the TEFRA payment methodology. We proposed that the first year of the transition would be 15 months. Thus the first year of transition is for cost reporting periods beginning 
                        <PRTPAGE P="66965"/>
                        on or after April 1, 2004 and before July 1, 2005. The proposed total payment for this period would consist of 75 percent based on the TEFRA payment system and 25 percent based on the proposed IPF prospective payment amount. 
                    </P>
                    <P>We also proposed that for cost reporting periods beginning on or after July 1, 2005 and before July 1, 2006, the total payment would consist of 50 percent based on the TEFRA payment system, and 50 percent based on the proposed IPF prospective payment amount. In addition, we also proposed that for cost reporting periods beginning on or after July 1, 2006 and before July 1, 2007, the total payment would consist of 25 percent based on the TEFRA payment system and 75 percent based on the proposed IPF prospective payment amount. Thus, we proposed that payments to IPFs would be at 100 percent of the proposed IPF prospective payment amount for cost reporting periods beginning on or after July 1, 2007. </P>
                    <P>We proposed this transition period so existing IPFs would have time to adjust their cost structures and integrate the effects of changing to the IPF PPS payment system. We specified that we would not allow IPFs the option to be paid at 100 percent of the IPF PPS payment amount in the first year of the transition, but would require all IPFs to receive the blended IPF payments during the 3-year transition period. </P>
                    <P>However, new IPFs would be paid the full Federal per diem payment amount rather than a blended payment amount. This is because the transition period is intended to provide currently existing IPFs time to adjust to payment under the new system. A new IPF would not have received payment under TEFRA for delivery of IPF services before the effective date of the IPF PPS. Therefore, we believe new IPFs do not need a transition to adjust their operating or capital financing that IPFs that have been paid under the TEFRA payment methodology would need. </P>
                    <P>In the proposed rule (68 FR 66920), we defined new IPFs as those IPFs that, under current or previous ownership or both, have their first cost reporting period as an IPF beginning on or after April 1, 2004. In this final rule, we define a new provider as those IPFs that, under current or previous ownership or both, have their first cost reporting period as an IPF beginning on or after January 1, 2005 to coincide with the effective date of the final IPF PPS. </P>
                    <P>
                        <E T="03">Comment:</E>
                         The majority of commenters requested that we provide an option for IPFs to forego the transition and be paid at 100 percent of the IPF PPS payment amount in the first year of the transition. The commenters stated that other PPSs, specifically IRF PPS and LTCH PPS, included that option. 
                    </P>
                    <P>The commenters also stated that a mandatory transition period causes IPFs to continue to be paid under the outdated TEFRA payment system. The commenters requested that IPFs that are substantially underpaid under TEFRA or those that would be last to begin the transition to the IPF PPS because of the timing of their cost reporting year should be permitted to receive 100 percent of the Federal per diem payment amount. </P>
                    <P>One commenter stated that failure to provide for a 100 percent IPF PPS payment option disadvantages efficient providers. The commenter indicated IPFs that choose this option would strive to become more cost efficient more quickly. In addition, the blended payment methodology during the transition period could lead to payments that are less than current cost-based payments and would penalize IPFs that have a low TEFRA rate. Several commenters indicated that a 100 percent IPF PPS payment option would avoid the complications and financial burden of a blended payment process due to accounting difficulties caused by being paid under two payment systems. </P>
                    <P>One commenter indicated that the protection offered by the transition is short-lived and that psychiatric units suffering the greatest losses will experience significant financial hardship until the IPF PPS is refined to account for more of the variation in the per diem costs of psychiatric units and psychiatric hospitals. </P>
                    <P>Another commenter indicated that hospitals would be unable to offset Medicare “losses” under the IPF PPS with gains in other services. The commenter indicated that it would be very difficult for many of these hospitals to support “losses” in their psychiatric units for the long term and that some hospitals may decide to close their psychiatric units, which would result in diminished access for beneficiaries. </P>
                    <P>However, several commenters specifically requested that CMS retain the proposed 3-year transition period. The commenters stated that the IPF PPS could have unexpected financial consequences for IPFs and the full transition period is needed to enable IPFs to adapt to the new payment system. The commenters are concerned that allowing immediate implementation of the IPF PPS would dilute the Federal per diem base rate and exacerbate the redistributive effect of the new payment system. Several commenters indicated that the availability of new funding, a 100 percent of the Federal per diem payment amount option would result in further reductions to the Federal per diem base rate. As a result, these commenters would support a 100 percent option, but only if there is new funding available. </P>
                    <P>Other commenters requested that CMS phase-in the new IPF PPS more slowly, to allow corrections to any serious errors in the IPF PPS before full implementaion. Commenters recommended that CMS lengthen the transition to 5 or 6 years and perhaps for as long as 10 years to enable CMS to refine the IPF PPS before the full implementation. </P>
                    <P>
                        <E T="03">Response:</E>
                         We have retained the transition period in the final IPF PPS. We believe this approach strikes an appropriate balance between IPFs that are prepared immediately to move to full implementation of the IPF PPS and those IPFs that need time to make the changes before the full implementation of the new PPS. 
                    </P>
                    <P>Section 305(b)(10)(c) of BIPA allowed IRFs to elect to be paid 100 percent of the adjusted facility Federal prospective payment for each cost reporting period to which the blended payment methodology would other wise have been applied. In implementing LTCHs 5-year transition period of the PPS, one of the goals was to transition hospitals to full prospective payments as soon as appropriate. Due to the longer length of the transition period, under the LTCH PPS, we allowed LTCHs to elect payment based on 100 percent of the Federal rate at the start of any of its cost reporting periods during the 5-year transition period. Once the election to be paid 100 percent of the Federal per diem base rate was made, the LTCH was not able to revert to the transition blend. </P>
                    <P>The IPF statute does not mandate that IPFs be given the option to elect to be paid 100 percent of IPF PPS payment amount immediately Federal rate. The shorter timeframe of a 3-year transition period was to provide all IPFs adequate time to make the most prudent adjustments to their operations and capital financing to secure the maximum benefits of the new PPS. </P>
                    <P>
                        Absent the availability of additional funds, the reallocation of existing funds in budget neutral payment systems cause shifts in facility payments. The aim of having an IPF PPS payment amount that is a blend of an ever-decreasing TEFRA portion and ever increasing IPF PPS portion is to mitigate dramatic negative effects of converting too quickly to a new payment system. Every budget neutral payment system will impact different provider groups 
                        <PRTPAGE P="66966"/>
                        differently. Some providers believe that they will “gain” under the new IPF PPS while others believe they will do less well compared to the payments they have received under TEFRA. 
                    </P>
                    <P>To provide the impartial treatment to all IPFs, in the final IPF PPS, we have required all IPFs to participate in the 3-year transition period. Therefore, prolonging the transitional period to 5 or 10 years would not help providers who believe they have been disadvantaged under TEFRA as well as those who feel they are not being helped under IPF PPS for a an even longer period of time. </P>
                    <P>However, we share the commenter's concern about the ability of IPFs to adjust to the IPF PPS so that access to inpatient mental health care is maintained. Thus, we have tried to ensure continued access to mental health care by accounting for the complexity of patients with concurrent psychiatric and medical health conditions. We have created a PPS with numerous patient and facility level adjustments, an outlier policy, as well as a stop-loss policy that when used in combination with the transition period should ensure that an IPF PPS payment adequately reflects the costs of furnishing inpatient psychiatric care to Medicare beneficiaries. </P>
                    <HD SOURCE="HD3">2. New Providers </HD>
                    <P>We proposed a definition of a new IPF because new IPFs will not participate in the 3-year transition from cost-based reimbursement under TEFRA to the IPF PPS. The transition period is intended to provide existing IPFs time to adjust to payment under the IPF PPS. A new IPF would not have received payment under TEFRA for the delivery of IPF services before the effective date of the IPF PPS. Therefore, we do not believe that new IPFs require a transition period in order to make adjustments to their operating and capital financing, as will IPFs that have been paid under TEFRA, or need to otherwise integrate the effects of changing from one payment system to another payment system. </P>
                    <P>For purposes of applying the IPF PPS 3-year transition period, we proposed to define a new IPF as a provider of inpatient hospital psychiatric services that otherwise meets the qualifying criteria for IPFs, set forth in § 412.22, § 412.23, § 412.25, and § 412.27 under present or previous ownership (or both), and its first cost reporting period as an IPF begins on or after April 1, 2004, the effective date of the proposed IPF PPS. In this final rule, we are finalizing the definition, except we are replacing April 1, 2004 with January 1, 2005 in order to account for the revised effective date of the final IPF PPS. In other words, we are finalizing the definition of a new IPF as a provider of inpatient hospital psychiatric services that otherwise meets the qualifying criteria for IPFs, set forth in § 412.22, § 412.23, § 412.25, and § 412.27 under present or previous ownership (or both), and its first cost reporting period as an IPF begins on or after January 1, 2005. </P>
                    <HD SOURCE="HD3">B. Claims Processing </HD>
                    <P>We proposed to continue processing claims in a manner similar to the current claims processing system. Hospitals would continue to report diagnostic information on the claim form and the FIs would continue to enter clinical and demographic information in their claims processing systems for review by the Medicare Code Editor (MCE). </P>
                    <P>
                        <E T="03">Comment:</E>
                         We received a variety of comments from all-inclusive rate and nominal cost hospitals regarding specific billing issues. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We are issuing operational instructions to address the specific billing issues raised by the commenters. 
                    </P>
                    <HD SOURCE="HD3">C. Annual Update </HD>
                    <P>In the proposed rule, we indicated that section 124 of Public Law 106-113 does not specify an update strategy for the IPF PPS and is broadly written to give the Secretary discretion in proposing an update methodology. Therefore, we reviewed the update approach used in other hospital prospective payment systems (specifically, the IRF and LTCH PPS update methodologies). </P>
                    <P>As a result of this analysis, we proposed the following strategy for updating the IPF PPS: (1) use the FY 2000 bills and cost report data and the most current ICD-9-CM codes and DRGs when we issue the IPF prospective payment system final rule; (2) implement the system effective for cost reporting periods beginning on or after April 1, 2004; and (3) update the Federal per diem base rate on July 1, 2005, since a July 1 update coincides with more hospital cost reporting cycles and would be administratively easier to manage. As a result, the implementation period for the proposed IPF PPS was the 15-month period April 1, 2004 to June 30, 2005. </P>
                    <P>In this final rule, we calculated the final Federal per diem base rate to be budget neutral during the implementation period of the final IPF PPS. As in the proposed rule, for future updates, we will use a July 1 through June 30 annual update cycle. Similar to the proposed rule, we will not update the IPF PPS during the first year of implementation because we believe there would be an insufficient amount of time under the IPF PPS to generate data useful in updating the system. Thus, the implementation period for the final IPF PPS is the 18-month period January 1, 2005 through June 30, 2006. As a result, the first update to the IPF PPS will occur on July 1, 2006, and updated for each subsequent 12-month period thereafter. </P>
                    <P>
                        As we noted in the proposed rule, we believe it is important to delay updating the adjustment factors derived from the regression analysis until we have IPF PPS data that includes as much information as possible regarding the patient-level characteristics of the population that each IPF serves. For this reason, we do not intend to update the regression and recalculate the Federal per diem base rate until we have analyzed one complete year of data under the IPF PPS. Until that analysis is complete, we proposed to publish a notice in the 
                        <E T="04">Federal Register</E>
                         each spring to update the IPF PPS and identified the various elements of the IPF PPS that we would update. 
                    </P>
                    <P>In this final rule, we are adopting the proposed annual update with minor modifications to reflect the policies contained in this final rule. For example, we did not include an adjustment for ECT in the proposed rule and as a result, the proposed update strategy did not address how we would update that payment amount. </P>
                    <P>We will publish a notice in the spring of CY 2006 to update the IPF PPS effective July 1, 2006 and will publish a update notice for each 12-month period thereafter. In the notice, we will: </P>
                    <P>• Update the Federal per diem base rate using the excluded hospital with capital market basket increase in order to reflect the price of goods and services used by IPFs. </P>
                    <P>• Apply the best available hospital wage index with an adjustment factor to the Federal per diem base rate to ensure that aggregate payments to IPFs are not affected by an updated wage index. </P>
                    <P>• Update the fixed dollar loss threshold to maintain an outlier policy that is 2 percent of total estimated IPF PPS payments. </P>
                    <P>• Describe relevant ICD-9-CM coding and DRG classification changes discussed in the IPPS that would affect IPF PPS coding and payment. </P>
                    <P>• Update the payment amount for ECT based on the best available OPPS data. </P>
                    <P>
                        Finally, as we indicated in the proposed rule, we may propose an update methodology for the IPF PPS in the future. We anticipate that the update methodology would be based on the 
                        <PRTPAGE P="66967"/>
                        excluded hospital with capital market basket index along with other appropriate factors relevant to psychiatric service delivery such as productivity, intensity, new technology, and changes in practice patterns. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         Several commenters requested that we delay the proposed April 1, 2004 implementation date until October 1, 2004 in order to be consistent with the October 1 update cycle for the IPPS. The commenters believe that an October 1 update cycle for the IPF PPS would avoid confusion and coding errors that would occur because of the introduction of ICD-9-CM and DRG changes mid-cycle. In addition, the commenters believe adopting an update cycle consistent with the IPPS would facilitate cost efficiency by also allowing educational efforts for coding and DRG changes to occur once per year.
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         While we appreciate the commenter's concerns, it is important that CMS retain the flexibility to develop administratively feasible update schedules for the various prospective payment systems that must be updated annually. Therefore, we are retaining a July 1 through June 30 cycle for annual updating of the IPF PPS. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         A few commenters requested clarification regarding the timing of implementation since hospitals have different cost reporting year start dates.
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         IPFs will begin the first transition year of the IPF PPS at the beginning of their next cost reporting period after January 1, 2005. For example, if an IPF's cost reporting year begins on March 1, the IPF would begin to receive a blended payment amount consisting of 75 percent based on TEFRA payments and 25 percent based on IPF PPS payments for all discharges that occur after March 1, 2005.
                    </P>
                    <HD SOURCE="HD1">VIII. Future Refinements</HD>
                    <P>
                        In the proposed rule, we described research efforts by RTI International
                        <E T="51">®</E>
                         and the University of Michigan that were underway at the time the proposed rule was published. Section VI. of this final rule describes the outcome of the RTI International
                        <E T="51">®</E>
                         project to study modes of practice and patient characteristics to analyze the components of the routine cost category of the Medicare cost report.
                    </P>
                    <P>The University of Michigan project would assist us in developing a patient classification system based on a standard assessment tool, the Case Mix Assessment Tool (CMAT). We attached a draft of the assessment tool and explained that it had not been submitted to the Office of Management and Budget (OMB) for review in order to obtain approval to pilot test the draft assessment tool. We indicated that a public comment period would be available as part of the OMB review process. </P>
                    <P>We received multiple comments on the CMAT instrument. </P>
                    <P>Most of the comments received focused on the overall content of the instrument. There were several commenters that opposed the potential implements of the instrument. </P>
                    <P>
                        <E T="03">Comment:</E>
                         One commenter indicated that CMAT appeared to address the primary diagnostic needs of the mentally ill, but fell short on the collection of information on functional status. The commenters recommended that variables be added to CMAT instrument to collect information on social integration and the recreational use of time. The commenter also indicated that it was not clear how the functionality section would affect payment. Other commenters recommended that the instrument be revised to capture better information on patient conditions and resources needed to provide care. One commenter indicated that while the CMAT, as proposed, was an excellent tool for describing psychiatric signs and symptoms, it fails to assess active comorbid medical conditions. Another commenter recommended that the CMAT instrument be expanded to collect information on the use of seclusion and restraints. Another commenter also indicated that the CMAT should contain sections that specifically address the assessment reference date, common observational periods, and multiaxial assessments. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We are aware that the current draft CMAT instrument would not collect extensive information on patient conditions and comorbid conditions. However, if the instrument is pilot tested, and ultimately fielded for refinement purposes, we are planning to match the CMAT with CMS administrative files. This comparison will augment the collection capacity of the CMAT and provide detailed information of medical conditions. The draft CMAT instrument, which has not been proposed, is currently undergoing OMB review. Following this review, the instrument is to be pilot tested. The variables suggested in these comments (for example, seclusion and restraints, assessment dates, observational periods, and multi-axial assessments) are being evaluated for potential inclusion in the pilot test.
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         One commenter recommended that because the CMAT is controversial, any pilot test findings should be made available to the public.
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         The results of the pilot test will be made available to the public. We plan to test the feasibility of administration, reliability and validity of the instrument, and recommendations regarding potential modifications to the draft CMAT. A report from the pilot test will be available, and CMS will use this report and experience garnered from the pilot test to determine next steps for the instrument. We will then decide whether to propose the use of the CMAT instrument to assist us in developing a patient classification system.
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         Several commenters expressed support for development of a standardized instrument to collect patient level information to augment CMS administrative data. One commenter stated that the costs for an instrument would be outweighed by the benefits of creating a tool that collects information on patient conditions and necessary resources, so long as the tool is easy to use and complete.
                    </P>
                    <P>Another commenter was pleased with the development of the CMAT and indicated that only when information from the refined variables in CMAT are available would it be appropriate to implement the IPF PPS.</P>
                    <P>
                        <E T="03">Response:</E>
                         We will implement the IPF PPS before the CMAT is pilot tested because once the instrument has been pilot tested and the instrument reflects changes resulting from the testing, the instrument will have to be cleared by the Office of Management and Budget (OMB). We do not want to further delay implementation of the IPF PPS while the CMAT is tested and approved. However, a detailed OMB information collection package will be prepared and made available to the public.
                    </P>
                    <P>In addition, there are a number of steps that are necessary to insure that assessment instruments collect the most useful information. Pending the pilot test results and a national fielding of the CMAT instrument following the pilot test, and OMB clearance of a final instrument, we would potentially use these variables to propose future refinements to the IPF PPS.</P>
                    <P>
                        <E T="03">Comment:</E>
                         Many of the comments focused on the burden associated with completion of the CMAT instrument. Commenters stated that completion of the CMAT instrument for each discharged patient would require additional staff. The commenters recommended that CMS consider providing an adjustment to the Federal per diem base rate payment amount for the additional staff resources that would be required to complete the CMAT instrument.
                        <PRTPAGE P="66968"/>
                    </P>
                    <P>One commenter indicated that IPFs are already faced with funding and management challenges and should not be asked to allocate resources away from direct patient care to fulfill a reporting requirement.</P>
                    <P>
                        <E T="03">Response:</E>
                         The CMAT instrument and supporting materials is currently undergoing OMB review for potential fielding of the pilot test. One of the considerations of OMB review is to assess the potential burden on providers to complete the pilot test. One of the areas that will be assessed in administering the pilot test is the direct burden on the facilities to complete the instrument. CMS will assess the results of the pilot test to determine the feasibility of administering this instrument on a national basis, and the overall resources required to complete the instrument.
                    </P>
                    <P>If the pilot test is implemented, we have proposed approaches that could lessen the burden for administration, such as, automation of the instrument. In addition, we would allow the treatment team members providing patient care to complete the form, rather than to request that only nurses complete the form. CMS will monitor the experience in administering the form throughout the pilot test. Finally, the report on the pilot test will address the burden on staff of completing the CMAT instrument.</P>
                    <P>
                        <E T="03">Comment:</E>
                         One commenter indicated that the CMAT instrument, as currently drafted, would collect excessive and duplicative (to the medical record) information. Other commenters stressed that the instrument was time-consuming to complete and the potential use of the information proposed for collection was not clear. These commenters indicated that the relationship of the proposed data collection to case mix and reimbursement was not described.
                    </P>
                    <P>Some commenters referred to their experiences in implementing the assessment instruments currently in use for SNFs and IRFs, and indicated that the instruments used in those payment systems do not adequately collect information on the resources needed to provide patient care.</P>
                    <P>One commenter recommended that all research regarding the development of the CMAT instrument cease. Another commenter indicated that the tool, as currently drafted, requested superfluous data with too many gameable variables. Commenters also indicated that collection of the information contained on the CMAT instrument was not necessary for refinement purposes. Instead, they recommended expanding the variables that are collected as part of either the cost reports or the claims.</P>
                    <P>
                        <E T="03">Response:</E>
                         We are aware that some of the variables proposed to be pilot tested in the draft CMAT instrument (which we did not propose to use in the proposed IPF PPS) may appear to be duplicative of the medical record. The availability in the medical record of the potential variables to be collected by the CMAT instrument are expected to facilitate the completion of the instrument and reduce completion time.
                    </P>
                    <P>The number of steps to pilot test and implement an instrument on a national basis are many. When data is available on a national basis, we will be in a better position to test the predictability and usefulness of the variables and determine whether its use should be proposed as a refinement to the IPF PPS.</P>
                    <P>We are aware of the option of adding variables to the cost reports or claims. We have explored this option in developing other payment systems. Pending decisions on the implementation of the pilot test, we will explore either supplementing material from the CMAT or collecting stand alone variables using the cost reports or claims. In addition, we disagree with the commenters that suggest research for the development of the CMAT cease. Not only might continued development of the CMAT provide possible new useful information on patient resource needs and staffing utilization, it might ascertain whether our case mix is correct or need refinements. Furthermore, we believe the best way to ensure that our IPF PPS continues to be an adequate payment system is to continue research on all fronts so that we have the best available information to us when we must make policy decisions.</P>
                    <P>
                        <E T="03">Comment:</E>
                         Commenters raised concerns regarding the limitation of the draft CMAT instrument for collecting staffing information.
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We note that other CMS research studies are currently working towards providing information on staffing resources needed to provide patient care. We will review the findings from the studies and consider incorporating them in any proposed refinements to the IPF PPS.
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         A few commenters recommended that CMS engage in additional research to acquire a greater understanding of the payment dynamics between comorbidities and resource utilization before implementing the IPF PPS.
                    </P>
                    <P>Many commenters suggested that further analysis is needed to explain the difference in average per diem costs between psychiatric units and freestanding psychiatric hospitals. One commenter suggested an approach that would mirror a swing-bed methodology for patients needing both psychiatric and non-psychiatric inpatient services.</P>
                    <P>
                        <E T="03">Response:</E>
                         Additional research is planned that will address many outstanding questions regarding differences among IPFs, unit characteristics, patient characteristics, discharge and transfer criteria, and economic incentives.
                    </P>
                    <P>The current research agenda includes a project to assess the relationship between facilities that have scatter bed and organized DRG units and the IPF PPS. In addition, this research project will examine the role played by smaller psychiatric inpatient units and facilities, the continued use of partial hospitalizations and outpatient programs and their role in complementing and substituting for inpatient care. This project will further monitor the relationship between the IPF PPS, the OPPS, and IPPS payment systems over time.</P>
                    <P>
                        <E T="03">Comment:</E>
                         One commenter indicated that if there was any future research in support of the IPF PPS it should focus only on costs and payment, and build off existing facility and payment variables. The commenter did not support the creation of a new set of variables requiring additional data collection unless there was evidence that it would dramatically increase the predictability of the models. The commenter recommended research that focused on mode of practice and staffing patterns across different types of inpatient psychiatric facilities.
                    </P>
                    <P>Another commenter specifically questioned the need for the CMAT instrument in collecting new variables. The commenter also recommended that CMS consolidate all research efforts regarding payment for inpatient psychiatric services.</P>
                    <P>
                        <E T="03">Response:</E>
                         In general, the majority of the prospective payment systems focus on data that predict the cost and/or payment for the provision of services. While this is the current focus, it is our position that costs and payments may be influenced by a number of variables that are beyond those currently used for payment. We anticipate that in the future, quality and outcome measures may be useful in determining payments. In addition, in most of the prospective payment systems that rely on patient assessment data, additional variables are collected that may not be directly or significantly related, at that time, to the payment system, but could nonetheless be useful at some future time.
                    </P>
                    <P>
                        We believe that relying only on those variables that are currently perceived as directly or significantly influencing payment, may preclude potential 
                        <PRTPAGE P="66969"/>
                        refinements to the IPF PPS, limit research in the area, and prohibit the future inclusion of variables that could significantly predict payment, outcome, and quality. Therefore, we are reluctant to restrict further research and scientific excellence by building only on existing and available facility and payment variables.
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         For patient characteristics, a commenter recommended adding two statistical parameters to the RTI International
                        <E T="51">®</E>
                         study, length of the IPF stay and length of time since their last psychiatric hospitalization.
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We agree that it would be useful to investigate the potential relationship between the frequency of an individual's hospitalizations, their length of stay, and the per diem cost of their care. In addition, we believe that the issue is relevant as a topic for our monitoring and evaluation activities.
                    </P>
                    <HD SOURCE="HD1">IX. Comments Beyond the Scope of the Final Rule</HD>
                    <P>In response to the proposed rule, many commenters chose to raise issues that are beyond the scope of our proposals. In this final rule, we are not summarizing or responding to those comments in this document. However, we will review the comments and consider whether to take other actions, such as revising or clarifying CMS program operating instructions or procedures, based on the information or recommendations in the comments.</P>
                    <HD SOURCE="HD1">X. Provisions of the Final Rule</HD>
                    <P>We are making a number of revisions to the regulations in order to implement the IPF PPS. Specifically, we are making conforming changes in 42 CFR parts 412 and 413. We are establishing a new subpart N in part 412, “Prospective Payment System for Hospital Inpatient Services of Inpatient Psychiatric Facilities.” We have reorganized the regulations text to make it easier to follow.</P>
                    <P>This subpart implements section 124 of the BBRA, which requires the implementation of a per diem prospective payment system for IPFs. Subpart N sets forth the framework for the IPF PPS, including the methodology used for the development of the Federal per diem base payment amount and related rules. These revisions and others are discussed in detail below.</P>
                    <HD SOURCE="HD2">Section 412.1 Scope of Part</HD>
                    <P>We are revising the authority citation to include “Section 124 of Public Law 106-113” and “Section 405 of Public Law 108-173.”</P>
                    <P>We are revising § 412.1 by redesignating paragraphs (a)(2) and (a)(3) as paragraphs (a)(3) and (a)(4).</P>
                    <P>We are adding a new paragraph (a)(2) that specifies that this part implements section 124 of Public Law 106-113 by establishing a per diem based prospective payment system for inpatient operating and capital costs of hospital inpatient services furnished to Medicare beneficiaries by an inpatient psychiatric facility that meets the conditions of subpart N.</P>
                    <P>We are revising § 412.1 by redesignating paragraphs (b)(12) and (b)(13) as paragraphs (b)(13) and (b)(14).</P>
                    <P>We are revising newly redesignated paragraph (b)(13) by removing reference “paragraph (a)(3)” and adding the reference “paragraph (a)(4)” in its place.</P>
                    <P>We are revising newly redesignated paragraph (b)(14) by removing reference “paragraph (a)(2)” and adding the reference “paragraph (a)(3)” in its place.</P>
                    <P>We are adding a new paragraph (b)(12) that summarizes the content of the new subpart N and sets forth the general methodology for paying operating and capital costs for inpatient psychiatric facilities effective with cost reporting periods beginning on or after January 1, 2005.</P>
                    <HD SOURCE="HD2">Section 412.20 Hospital Services Subject to the Prospective Payment Systems</HD>
                    <P>We are amending § 412.20(a) by adding a reference to IPFs.</P>
                    <P>We are revising § 412.20 by redesignating paragraphs (b), (c), and (d), as paragraphs (c), (d), and (e).</P>
                    <P>We are adding a new paragraph (b) that indicates that effective for cost reporting periods beginning on or after January 1, 2005, covered inpatient hospital inpatient services furnished by an IPF as specified in § 412.404 of subpart N are paid under the IPF PPS.</P>
                    <HD SOURCE="HD2">Section 412.22 Excluded Hospitals and Hospital Units: General Rules</HD>
                    <P>We are amending § 412.22(b) by revising paragraph (b) to state that except for those hospitals specified in paragraph (c) of this section, and § 412.20(b), (c), and (d), all excluded hospitals (and excluded hospital units, as described in § 412.23 through § 412.29) are reimbursed under the cost reimbursement rules set forth in part 413 of this chapter, and are subject to the ceiling on the rate of hospital cost increases as specified in § 413.40.</P>
                    <HD SOURCE="HD2">Section 412.23 Excluded Hospitals: Classifications</HD>
                    <P>We are revising § 412.23 by redesignating paragraphs (a)(1) and (a)(2) as paragraphs (a)(2) and (a)(3).</P>
                    <P>We are adding a new paragraph (a)(1) that specifies the requirements a psychiatric hospital must meet in order to be excluded from reimbursement under the hospital IPPS as specified in § 412.1(a)(1) and to be paid under the IPF PPS as specified in § 412.1(a)(2).</P>
                    <P>We are revising paragraph (b) by removing the reference “§ 412.1(a)(2)” and adding the reference to “412.1(a)(3).”</P>
                    <P>We are revising paragraph (b)(9) by removing the reference to “§ 412.2(a)(2)” and adding the reference to “412.1(a)(3)” in its place.</P>
                    <P>We are revising paragraph (e) by removing the reference to “§ 412.1(a)(3)” and adding “§ 412.1(a)(4)” in its place.</P>
                    <HD SOURCE="HD2">Section 412.25 Excluded Hospital Units: Common Requirements</HD>
                    <P>We are amending § 412.25(a) by adding a reference to § 412.1(a)(2).</P>
                    <HD SOURCE="HD2">Section 412.27 Excluded Psychiatric Units: Additional Requirements</HD>
                    <P>We are amending the introductory text of § 412.27 by adding reference to § 412.1(a)(1) and (a)(2).</P>
                    <P>We are amending § 412.27(a) by removing the words the “Third Edition,” and adding in its place, “Fourth Edition, Text Revision.”</P>
                    <HD SOURCE="HD2">Section 412.429 Excluded Rehabilitation Units: Additional Requirements</HD>
                    <P>We are revising the introductory text by removing the reference “§ 412.1(a)(2)” and adding “§ 412.1(a)(3)” in its place.</P>
                    <HD SOURCE="HD2">Section 412.116 Method of Payment</HD>
                    <P>We are revising § 412.116 by redesignating paragraphs (a)(3) and (a)(4) as paragraphs (a)(4) and (a)(5).</P>
                    <P>We are adding a new paragraph (a)(3) that specifies the cost-reporting period to which the IPF PPS applies and how payments for inpatient psychiatric services are made to a qualified IPF.</P>
                    <HD SOURCE="HD2">Section 412.130 Exclusion of New Rehabilitation Units and Expansion of Units Already Excluded</HD>
                    <HD SOURCE="HD2">Subpart N—Prospective Payment System for Hospital Inpatient Services of Inpatient Psychiatric Facilities</HD>
                    <P>We are revising paragraph (a)(1) and paragraph (a)(2) by removing reference to “§ 412.1(a)(2)” and adding reference “§ 412.1(a)(3)” in its place.</P>
                    <P>
                        We are adding a new subpart N as follows:
                        <PRTPAGE P="66970"/>
                    </P>
                    <HD SOURCE="HD2">Section 412.400 Basis and Scope of Subpart</HD>
                    <P>We are adding a new § 412.400. In § 412.400(a), we provide the requirements for the implementation of a PPS for IPFs.</P>
                    <P>In § 412.400(b), we specify that this subpart sets forth the framework for the IPF PPS, including the methodology used for the development of payment rates and associated adjustments, the application of a transition period, and related rules for IPFs for cost reporting periods beginning on or after January 1, 2005.</P>
                    <HD SOURCE="HD2">Section 412.402 Definitions</HD>
                    <P>In § 412.402, we are defining the following terms for purposes of this new subpart:</P>
                    <FP SOURCE="FP-1">
                        • 
                        <E T="03">Comorbidity</E>
                    </FP>
                    <FP SOURCE="FP-1">
                        • 
                        <E T="03">Federal per diem base rate</E>
                    </FP>
                    <FP SOURCE="FP-1">
                        • 
                        <E T="03">Federal per diem payment amount</E>
                    </FP>
                    <FP SOURCE="FP-1">
                        • 
                        <E T="03">Federal per diem</E>
                    </FP>
                    <FP SOURCE="FP-1">
                        • 
                        <E T="03">Fixed dollar loss threshold</E>
                    </FP>
                    <FP SOURCE="FP-1">
                        • 
                        <E T="03">Inpatient psychiatric facilities</E>
                    </FP>
                    <FP SOURCE="FP-1">
                        • 
                        <E T="03">Interrupted stay</E>
                    </FP>
                    <FP SOURCE="FP-1">
                        • 
                        <E T="03">Outlier payment</E>
                    </FP>
                    <FP SOURCE="FP-1">
                        • 
                        <E T="03">Principal diagnosis</E>
                    </FP>
                    <FP SOURCE="FP-1">
                        • 
                        <E T="03">Rural area</E>
                    </FP>
                    <FP SOURCE="FP-1">
                        • 
                        <E T="03">Urban area</E>
                    </FP>
                    <HD SOURCE="HD2">Section 412.404 Conditions for Payment Under the Prospective Payment System for Hospital Inpatient Services of Psychiatric Facilities</HD>
                    <P>In § 412.404(a), we specify that IPFs must meet the following general requirements to receive payment under the IPF PPS: </P>
                    <P>• The IPF must meet the conditions as specified in this subpart. </P>
                    <P>• If the IPF fails to comply fully with the provisions of this part, then CMS may, as appropriate— </P>
                    <P>++ Withhold (in full or in part) or reduce payment to the IPF until the facility provides adequate assurances of compliance; or </P>
                    <P>++ Classify the IPF as a hospital subject to the IPPS. </P>
                    <P>In paragraph (b), we specify that, subject to the special payment provisions of § 412.22(c), an IPF must meet the general criteria set forth in § 412.22 for exclusion from the hospital IPPS as specified in § 412.1(a)(1). Additionally, a psychiatric hospital must meet the criteria set forth in § 412.23(a), § 482.60, § 482.61, and § 482.62 and psychiatric units must meet the criteria set forth in § 412.25 and § 412.27. </P>
                    <P>In paragraph (c), we specify the prohibited and permitted charges that may be imposed on Medicare beneficiaries. </P>
                    <P>In paragraph (c)(1), we specify that except as permitted in paragraph (c)(2), an IPF may not charge the beneficiary for any services for which payment is made by Medicare, except as permitted in paragraph (c)(2), even if the IPFs costs are greater than the amount the facility is paid under the IPF PPS. </P>
                    <P>In paragraph (c)(2), we specify that an IPF receiving payment for a covered stay may charge the Medicare beneficiary or other person for only the applicable deductible and coinsurance amounts under § 409.82, § 409.83, and § 409.87. </P>
                    <P>In paragraph (d), we specify the following provisions for furnishing IPF services directly or under arrangement: </P>
                    <P>Applicable payments made under the IPF PPS are considered payment in full for all inpatient hospital services (as defined in § 409.10(a)). In addition, we specify the following— </P>
                    <P>• Inpatient hospital services do not include physician, physician assistant, nurse practitioner, clinical nurse specialist, certified nurse midwives, qualified psychologist, and certified registered nurse anesthetist services. </P>
                    <P>• Payment is not made to a provider or supplier other than the IPF, except for services provided by a physician, physician assistant, nurse practitioner, clinical nurse specialist, certified nurse midwives, qualified psychologist, and certified registered nurse anesthetist. </P>
                    <P>• The IPF must furnish all necessary covered services to the Medicare beneficiary directly or under arrangement (as defined in § 409.3). </P>
                    <P>In paragraph (e), we specify that IPFs must meet the recordkeeping and cost reporting requirements of § 412.27(c), § 413.20, and § 413.24. </P>
                    <HD SOURCE="HD2">Section 412.422 Basis of Payment </HD>
                    <P>In § 412.422(a), we specify that under the IPF PPS, IPFs will receive a predetermined per diem amount, adjusted for patient characteristics and facility characteristics, for inpatient hospital services furnished to Medicare Part A fee-for-service beneficiaries. In addition, we specify that during the transition period, payment is based on a blend of the Federal per diem payment amount and the facility-specific payment rate as specified in § 412.426. </P>
                    <P>In § 412.422(b), we specify that payments made under the IPF PPS represent payment in full for inpatient operating and capital-related costs associated with furnishing Medicare covered service in an IPF, but not for the cost of an approved medical education program described in § 413.85 and § 413.86 and for bad debts of Medicare beneficiaries as specified in § 413.80. </P>
                    <HD SOURCE="HD2">Section 412.424 Methodology for Calculating the Federal Per Diem Payment Amount </HD>
                    <P>In § 412.424, we specify the methodology for calculating the Federal per diem base rate for IPFs. </P>
                    <P>In paragraph (a), we specify the data sources used to calculate the Federal per diem base rate. </P>
                    <P>In paragraph (b), we specify that we determine the average inpatient operating, ancillary, and capital related per diem cost for which payment is made to IPF as described in paragraph (a)(1). </P>
                    <P>In paragraph (c), we specify that the methodology used for determining the Federal per diem base rate for cost reporting periods beginning on or after January 5, 2005 through June 30, 2006 includes the following:</P>
                    <FP SOURCE="FP-1">• The updated average per diem amount </FP>
                    <FP SOURCE="FP-1">• The budget-neutrality adjustment factor </FP>
                    <FP SOURCE="FP-1">• Outlier payments </FP>
                    <FP SOURCE="FP-1">• Standardization </FP>
                    <FP SOURCE="FP-1">• Computation of the Federal per diem base rate</FP>
                    <P>In paragraph (d), we specify that the Federal per diem payment amount for IPFs is the product of the Federal per diem base rate, the facility-level adjustments applicable to the IPF and the patient-level adjustments applicable to the case as described below: </P>
                    <FP SOURCE="FP-1">• Facility-level adjustments include: </FP>
                    <FP SOURCE="FP-1">++ Adjustment for wages </FP>
                    <FP SOURCE="FP-1">++ Rural location </FP>
                    <FP SOURCE="FP-1">++ Teaching adjustments </FP>
                    <FP SOURCE="FP-1">++ Cost of living adjustments for IPFs in Alaska and Hawaii </FP>
                    <FP SOURCE="FP-1">++ IPFs with qualifying emergency departments </FP>
                    <FP SOURCE="FP-1">• Patient-level adjustments include: </FP>
                    <FP SOURCE="FP-1">++ Age </FP>
                    <FP SOURCE="FP-1">++ Diagnosis-related group assignment </FP>
                    <FP SOURCE="FP-1">++ Principal diagnosis </FP>
                    <FP SOURCE="FP-1">++ Comorbodities </FP>
                    <FP SOURCE="FP-1">++ Variable per diem adjustments </FP>
                    <FP SOURCE="FP-1">• Other payment adjustments include: </FP>
                    <FP SOURCE="FP-1">++ Outlier payments </FP>
                    <FP SOURCE="FP-1">++ Stop-loss payments </FP>
                    <FP SOURCE="FP-1">++ Special payment provision for interrupted stay </FP>
                    <FP SOURCE="FP-1">++ Patients who receive ECT treatments </FP>
                    <FP SOURCE="FP-1">++ Adjustment for high-cost outlier cases </FP>
                    <P>In paragraph (d), we specify the special payment provisions for interrupted stays. </P>
                    <HD SOURCE="HD2">Section 412.426 Transition Period </HD>
                    <P>
                        In § 412.426(a), we specify the duration of the transition period to the IPF PPS. In addition, we specify that IPFs receive a payment that is a blend of the Federal per diem payment 
                        <PRTPAGE P="66971"/>
                        amount and the facility-specific payment amount the IPF would receive under the TEFRA payment methodology. 
                    </P>
                    <P>In paragraph (b), we specify how the facility-specific payment amount is calculated. </P>
                    <P>In paragraph (c), we specify that a new IPF, that is, a facility that under present or previous ownership, or both, has its first cost reporting period as an IPF beginning on or after January 1, 2005, is paid based on 100 percent of the full Federal per diem payment. </P>
                    <HD SOURCE="HD2">Section 412.428 Publication of Updated to the IPF PPS </HD>
                    <P>
                        In § 412.428, we specify how we plan to publish information each year in the 
                        <E T="04">Federal Register</E>
                         to update the IPF PPS. 
                    </P>
                    <HD SOURCE="HD2">Section 412.432 Method of Payment Under the IPF PPS </HD>
                    <P>In § 412.432, we specify the following method of payment used under the IPF PPS:</P>
                    <FP SOURCE="FP-1">• General rules for receiving payment </FP>
                    <FP SOURCE="FP-1">• Periodic interim payments including— </FP>
                    <FP SOURCE="FP-1">++ Criteria for receiving periodic interim payments </FP>
                    <FP SOURCE="FP-1">++ Frequency of payments </FP>
                    <FP SOURCE="FP-1">++ Termination of periodic interim payments </FP>
                    <FP SOURCE="FP-1">• Interim payment for Medicare bad debts and for costs of an approved education program and other costs paid outside the PPS </FP>
                    <FP SOURCE="FP-1">• Outlier payments </FP>
                    <FP SOURCE="FP-1">• Accelerated payments including— </FP>
                    <FP SOURCE="FP-1">++ General rule for requesting accelerated payments </FP>
                    <FP SOURCE="FP-1">++ Approval of accelerated payments </FP>
                    <FP SOURCE="FP-1">++ Amount of the accelerated payment </FP>
                    <FP SOURCE="FP-1">++ Recovery of the accelerated payment </FP>
                    <HD SOURCE="HD2">Section 413.1 Introduction </HD>
                    <P>We are revising the authority citation to include “Section 124 of Public Law 106-113.” </P>
                    <P>We are amending § 413.1(d)(2)(ii) by removing the words “psychiatric hospitals (as well as separate psychiatric units (distinct parts) of short-term general hospitals).” </P>
                    <P>We are revising § 413.1 by redesignating paragraphs (d)(2)(iv), (d)(2)(v), (d)(2)(vi), and (d)(2)(vii) as paragraphs (d)(2)(vi), (d)(2)(vii), (d)(2)(viii), and (d)(2)(ix). </P>
                    <P>We are adding a new paragraph (iv) to specify that for cost reporting periods beginning before January 1, 2005, payment to psychiatric hospitals (as well as separate psychiatric units of short-term general hospitals) that are excluded under subpart B of part 412 of this chapter from the PPS is on a reasonable cost basis, subject to the provisions of § 413.40. </P>
                    <P>We are adding a new paragraph (v) to specify that for cost reporting periods beginning on or after January 1, 2005, payment to psychiatric hospitals that meet the conditions of § 412.404 of this chapter is made under the PPS as described in subpart N of part 412. </P>
                    <HD SOURCE="HD2">Section 413.40 Ceiling on the Rate of Increase in Hospital Costs </HD>
                    <P>Section 413.40(a)(2)(i) specifies the types of facilities to which the ceiling on the rate of increase in hospital inpatient costs is not applicable. </P>
                    <P>We are revising § 413.40(a)(2)(i) by redesignating paragraphs (a)(2)(i)(C) and (a)(2)(i)(D) as paragraphs (a)(2)(i)(D) and (a)(2)(i)(E). </P>
                    <P>We are adding a new paragraph (a)(2)(i)(C) to § 413.40 to clarify that § 413.40 is not applicable to psychiatric hospitals and psychiatric units under subpart N of part 412 of this chapter for cost reporting periods beginning on or after January 1, 2005. </P>
                    <P>We are republishing paragraph (a)(2)(ii). </P>
                    <P>We are revising paragraph (a)(2)(ii)(B) to include reference to psychiatric hospitals and psychiatric units as specified in § 412.22, § 412.23, § 412.25, § 412.27, § 412.29, and § 412.30 of this chapter. </P>
                    <P>We are revising paragraph (a)(2)(iii) by redesignating paragraphs (a)(2)(iii) and (a)(2)(iv) as paragraphs (a)(2)(iv) and (a)(2)(v). </P>
                    <P>We are revising paragraph (a)(2)(ii)(C) by removing reference to “paragraph (a)(2)(iv)” and adding the reference to “paragraph (a)(2)(v)” in its place. </P>
                    <P>We are adding a new paragraph (a)(2)(iii) to specify psychiatric facilities are excluded from the prospective payment system as specified in § 412.1(a)(1) and paid under § 412.1(a)(2) for cost reporting periods beginning on or after January 1, 2005. </P>
                    <HD SOURCE="HD2">Section 413.64 Payment to Providers: Special Rules </HD>
                    <P>We are amending § 413.64(h)(2)(i) to add a reference to hospitals paid under the IPF PPS. </P>
                    <HD SOURCE="HD2">Section 413.70 Payment for Services of a CAH </HD>
                    <P>We are revising paragraph (e) to specify that for cost reporting periods beginning before January 1, 2005, payment is made on a reasonable cost basis, subject to the provisions of § 413.40. For cost reporting periods beginning on or after January 1, 2005, payment is based on prospectively determined rates under subpart N § 412.400 through § 412.432) of part 412 of this subchapter. </P>
                    <HD SOURCE="HD1">XI. Collection of Information Requirements </HD>
                    <P>These regulations do not impose any new information collection requirements. The burden of the requirements in § 412.404(e), reporting and recordkeeping requirements, are captured in the burden for the cross-referenced § 412.27(c), § 413.20, and § 413.24 under OMB approval numbers 0938-0301, 0938-0050, 0938-0358, and 0938-0600. </P>
                    <HD SOURCE="HD1">XII. Regulatory Impact Analysis </HD>
                    <HD SOURCE="HD2">A. Overall Impact </HD>
                    <P>We have examined the impact of this final rule as required by Executive Order 12866 (September 1993, Regulatory Planning and Review), the Regulatory Flexibility Act (RFA) (September 19, 1980, Pub. L. 96-354), section 1102(b) of the Act, the Unfunded Mandates Reform Act of 1995 (UMRA) (Pub. L. 104-4), and Executive Order 13132). </P>
                    <P>Executive Order 12866 (as amended by Executive Order 13258, which merely reassigns responsibility of duties) directs agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). A regulatory impact analysis (RIA) must be prepared for major rules with economically significant effects ($100 million or more in any 1 year). </P>
                    <P>
                        Based on analysis of the aggregate dollar impacts for each of the different facility types, we have determined that the re-distributive impact of the IPF PPS among facility types is $96 million in the first year the system is fully implemented. In addition, our analysis showed that an estimated payment “reduction” of almost $48 million would occur for psychiatric units and an estimated payment “increase” of $18 million would occur for for-profit hospitals, $27 million for government-operated hospitals, and slightly more than $3 million for non-profit hospitals. Although this final rule does not meet the $100 million threshold established by Executive Order 12866 in its first year of implementation, we have determined that this final rule is a major rule within the meaning of Executive Order 12866 in its first year of implementation, because the re-distributive effects are estimated to be close to constituting a shift of $100 million in the first year of implementation. In addition, although we have not estimated the distributional 
                        <PRTPAGE P="66972"/>
                        impact of this rule in subsequent years, because of the trends in medical expenditure discussed below, we believe it is likely that the rule would have distributional impacts greater than $100 million in subsequent years, relative to TEFRA payments. In addition, because the IPF PPS must be budget neutral in accordance with section 124(a)(1) of Public Law 106-113, we estimate that there will be no budgetary impact for the Medicare program as discussed later in this analysis. 
                    </P>
                    <P>The RFA requires agencies to analyze options for regulatory relief of small businesses. For purposes of the RFA, small entities include small businesses, nonprofit organizations, and small government jurisdictions. Most hospitals and most other providers and suppliers are small entities, either by nonprofit status or by having revenues of $29 million or less in any 1 year. Medicare fiscal intermediaries are not considered to be small entities. Individuals and States are not included in the definition of a small entity. </P>
                    <P>HHS considers that a substantial number of entities are affected if the rule impacts more than 5 percent of the total number of small entities as it does in this rule. We included all freestanding psychiatric hospitals (79 are non-profit hospitals) in the analysis since their total revenues do not exceed the $29 million threshold. We also included psychiatric units of small hospitals, that is, fewer than 100 beds. We did not include psychiatric units within larger hospitals in the analysis because we believe this final rule would not significantly impact total revenues of the entire hospital that supports the unit. We have provided the following RFA analysis in section B, to emphasize that although the final rule would impact a substantial number of IPFs that were identified as small entities, we do not believe it would have a significant economic impact. Based on the analysis of the 1063 psychiatric facilities that were classified as small entities by the definitions described above, we estimate the combined impact of the IPF PPS will be a 5-percent increase in payments relative to their payments under TEFRA. We have prepared the following analysis to describe the impact of the final rule in order to provide a factual basis for our conclusions regarding small business impact. </P>
                    <P>In addition, section 1102(b) of the Act requires us to prepare a regulatory impact analysis if a rule may have a significant impact on the operations of a substantial number of small rural hospitals. This analysis must conform to the provisions of section 604 of the RFA. For purposes of section 1102(b) of the Act, we define a small rural hospital as a hospital that is located outside of an MSA and has fewer than 100 beds. We have determined that this final rule would have a substantial impact on hospitals classified as located in rural areas. As discussed earlier in this preamble, we are providing a payment adjustment of 17 percent for IPFs located in rural areas. In addition, we are establishing a 3-year transition to the new system to allow IPFs an opportunity to adjust to the new system. Therefore, the impacts shown in Table 10 below reflect the adjustments that are designed to minimize or eliminate any potentially significant negative impact that the IPF PPS may otherwise have on small rural IPFs. </P>
                    <P>Section 202 of the UMRA also requires that agencies assess anticipated costs and benefits before issuing any final rule that may result in expenditures in any 1 year by State, local, or tribal governments, in the aggregate, or by the private sector, of $110 million or more. This final rule does not mandate any requirements for State, local, or tribal governments nor would it result in expenditures by the private sector of $110 million or more in any 1 year. </P>
                    <P>Executive Order 13132 establishes certain requirements that an agency must meet when it promulgates a final rule that imposes substantial direct requirement costs on State and local governments, preempts State law, or otherwise has Federalism implications. </P>
                    <P>We have examined this final rule under the criteria set forth in Executive Order 13132 and have determined that the final rule will not have any negative impact on the rights, roles, and responsibilities of State, local, or tribal governments or preempt State law. </P>
                    <HD SOURCE="HD2">B. Anticipated Effects </HD>
                    <P>Below, we discuss the impact of this final rule on the Federal Medicare budget and on IPFs. </P>
                    <HD SOURCE="HD3">1. Budgetary Impact </HD>
                    <P>Section 124(a)(1) of Public Law 106-113 requires us to set the payment rates contained in this final rule to ensure that total payments under the IPF PPS are projected to equal the amount that would have been paid if the IPF PPS had not been implemented. As a result of this analysis, which is discussed in section V.B.2.b. of this final rule, we are establishing a budget-neutrality adjustment to the Federal per diem base rate. Thus, there will be no budgetary impact to the Medicare program by implementation of the IPF PPS. </P>
                    <HD SOURCE="HD3">2. Impacts on Providers </HD>
                    <P>To understand the impact of the IPF PPS on providers, it is necessary to compare estimated payments that would be made under the current TEFRA payment methodology (current payments) to estimated payments under the IPF PPS. The IPFs were grouped into the categories listed below based on characteristics provided in the Online Survey and Certification and Reporting (OSCAR) file and the 2002 cost report data from HCRIS: </P>
                    <FP SOURCE="FP-1">• Facility Type </FP>
                    <FP SOURCE="FP-1">• Location </FP>
                    <FP SOURCE="FP-1">• Teaching Status Adjustment </FP>
                    <FP SOURCE="FP-1">• Census Region </FP>
                    <FP SOURCE="FP-1">• Size </FP>
                    <P>To estimate the impacts among the various categories of IPFs, we had to compare estimated future payments that would have been made under the TEFRA payment methodology to estimated payments under the IPF PPS. We estimated the impacts using the same set of providers (1,806 IPFs) that was used for the regression analysis to calculate the budget-neutral Federal per diem base rate, and to determine the appropriateness of various adjustments to the Federal per diem base rate. A detailed explanation of the methods we used to simulate TEFRA payments and estimate payments under the IPF PPS is provided in section V. of this final rule. </P>
                    <P>The impacts reflect the estimated “losses” or “gains” among the various classifications of IPF providers for the first year of the IPF PPS. Prospective payments were based on the budget-neutral Federal per diem base rate of $572 adjusted by the IPFs' estimated patient-level, facility-level adjustments, and simulated outlier amounts. This simulated PPS payment was compared to the IPF's payments based on its cost from the cost report inflated to the midpoint of the implementation period (January 1, 2005 through June 30, 2006) and subject to the updated per discharge target amount. Table 10 below illustrates the aggregate impact of the IPF PPS on various classifications of IPFs. The first column identifies the type of IPF, the second column indicates the number of IPFs for each type of IPF, and the third column indicates the ratio of IPF PPS payments to the current TEFRA payments in the first period of the transition. </P>
                    <BILCOD>BILLING CODE 4120-03-P</BILCOD>
                    <GPH SPAN="3" DEEP="640">
                        <PRTPAGE P="66973"/>
                        <GID>ER15NO04.450</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="91">
                        <PRTPAGE P="66974"/>
                        <GID>ER15NO04.451</GID>
                    </GPH>
                    <BILCOD>BILLING CODE 4120-03-C</BILCOD>
                    <HD SOURCE="HD3">3. Results </HD>
                    <P>We measured the impact of the IPF PPS by comparing estimated payments under the IPF PPS relative to current TEFRA payments. This was computed as a ratio of IPF PPS payment to current TEFRA payment for each classification of IPF. We have prepared the following summary of the impact of the IPF PPS set forth in this final rule. </P>
                    <HD SOURCE="HD3">a. Facility type </HD>
                    <P>We grouped the IPFs into the following four categories: (1) Psychiatric units; (2) government-operated hospitals; (3) for-profit hospitals; and (4) non-profit hospitals. Roughly 77 percent of all IPFs are psychiatric units. The impact analysis in Table 10 indicates that under the IPF PPS, freestanding psychiatric hospitals receive an estimated “increase” relative to the current payment. Psychiatric units have an estimated IPF PPS payment to current TEFRA payment ratio of 0.98, the government-operated hospitals have an estimated IPF PPS payment to current TEFRA payment ratio of 1.13, and the non-profit and for-profit hospitals have an estimated IPF PPS payment to current TEFRA payment ratio of 1.02 and 1.05, respectively. </P>
                    <HD SOURCE="HD3">b. Location </HD>
                    <P>Approximately 24 percent of all IPFs are located in rural areas. The impact analysis in Table 10 indicates that under the IPF PPS, the estimated IPF PPS payment to current TEFRA payment ratio is approximately 1.00 for rural and urban IPFs. When we group all of the IPFs by facility type within urban and rural locations, the impact analysis indicates that the estimated IPF PPS payment to current TEFRA payment ratios would be between approximately 0.98 and 1.05 for all IPFs except government-operated hospitals. Under the IPF PPS, the payment ratios for rural and urban government-operated hospitals are estimated to be 1.14 and 1.12, respectively. </P>
                    <HD SOURCE="HD3">c. Teaching Status Adjustment </HD>
                    <P>Using the ratio of interns and residents to the average daily census for each facility as a measure of the magnitude of the teaching status, we grouped facilities into the following four major categories: (1) Non teaching; (2) less than 0.10 (it is not a percent) ratio of interns and residents to average daily census; (3) 0.10 to 0.30 ratio of interns and residents to average daily census; and (4) more than 0.30 ratio of interns and residents to average daily census. Facilities with a teaching ratio greater than 0.10, have payment ratios less than 1.00. </P>
                    <HD SOURCE="HD3">d. Census Region </HD>
                    <P>Under the IPF PPS, IPFs in the Mid-Atlantic region receive a payment ratio of approximately 1.03 when compared to IPFs in other regions that receive payment ratios between approximately 0.98 and 1.01. Specifically, the New England States, the West North Central States, and the Mountain States receive payment ratios of 1.00. The South Atlantic States, East North Central States, and the Pacific States, receive payments ratios of approximately 0.99. The East South Central States have a payment ratio of 1.01, and the West South Central States have a ratio of 0.98. </P>
                    <HD SOURCE="HD3">e. Size </HD>
                    <P>We grouped the IPFs into 5 categories for each group of psychiatric facilities based on bed size: (1) Under 12 beds; (2) 12 to 25 beds; (3) 25 to 50 beds; (4) 50 to 75 beds; and (5) over 75 beds. Under the IPF PPS, the majority of IPFs' bed sizes were categories in which the payment ratio would be greater than 0.98. Under the IPF PPS, large IPFs with over 75 beds receive the highest payment ratio (1.10 for psychiatric hospitals and 1.01 for psychiatric units), while psychiatric units with less than 10 beds receive the lowest payment ratio of 0.96. </P>
                    <HD SOURCE="HD3">4. Effect on the Medicare Program </HD>
                    <P>Based on actuarial projections resulting from our experience with other prospective payment systems, we estimate that Medicare spending (total Medicare program payments) for IPF services over the next 5 years would be as follows: </P>
                    <GPH SPAN="3" DEEP="156">
                        <GID>ER15NO04.452</GID>
                    </GPH>
                    <PRTPAGE P="66975"/>
                    <FP>These estimates are based on the current estimate of increases in the number of proposed excluded hospitals with capital market basket as follows: </FP>
                    <P>• 3.4 percent for FY 2005; </P>
                    <P>• 3.0 percent for FY 2006; </P>
                    <P>• 2.8 percent for FY 2007; </P>
                    <FP SOURCE="FP-1">• 2.7 percent for FY 2008; </FP>
                    <FP SOURCE="FP-1">• 3.0 percent for FY 2009; and </FP>
                    <FP SOURCE="FP-1">• 3.0 percent for FY 2010. </FP>
                    <P>We estimate that there would be a change in fee-for-service Medicare beneficiary enrollment as follows: </P>
                    <FP SOURCE="FP-1">• 0.5 percent in FY 2005; </FP>
                    <FP SOURCE="FP-1">• -7.3 percent in FY 2006; </FP>
                    <FP SOURCE="FP-1">• -4.7 percent in FY 2007; </FP>
                    <FP SOURCE="FP-1">• -0.2 percent in FY 2008; </FP>
                    <FP SOURCE="FP-1">• -0.1 percent in FY 2009; and </FP>
                    <FP SOURCE="FP-1">• 1.4 percent in FY 2010. </FP>
                    <P>Consistent with the statutory requirement for budget neutrality in the initial implementation period, we intend for estimated aggregate payments under the IPF PPS to equal the estimated aggregate payments that would be made if the IPF PPS were not implemented. Our methodology for estimating payments for purposes of the budget-neutrality calculations uses the best available data. </P>
                    <P>After the IPF PPS is implemented, we will evaluate the accuracy of the assumptions used to compute the budget-neutrality calculation. We intend to analyze claims and cost report data from the first year of the IPF PPS to determine whether the factors used to develop the Federal per diem base rate are not significantly different from the actual results experienced in that year. We are planning to compare payments under the final IPF PPS (which relies on an estimate of cost-based TEFRA payments using historical data from a base year and assumptions that trend the data to the initial implementation period) to estimated cost-based TEFRA payments based on actual data from the first year of the IPF PPS. The percent difference (either positive or negative) would be applied prospectively to the established prospective payment rates to ensure the rates accurately reflect the payment levels intended by the statute. We intend to perform this analysis within the first 5 years of the implementation of the IPF PPS. </P>
                    <P>Section 124 of Public Law 106-113 provides the Secretary broad authority in developing the IPF PPS, including the authority for appropriate adjustments. In accordance with this authority, as stated above, we may make a one-time prospective adjustment to the Federal per diem base rate in an effort to ensure that the best historical data available forms the foundation of the prospective payment rates in future years. </P>
                    <HD SOURCE="HD3">5. Effect on Beneficiaries </HD>
                    <P>Under the IPF PPS, IPFs will receive payment based on the average resources consumed by patients for each day. We do not expect changes in the quality of care or access to services for Medicare beneficiaries under the IPF PPS. In fact, we believe that access to IPF services would be enhanced due to the patient and facility level adjustment factors, all of which are intended to adequately reimburse IPFs for expensive cases. Finally, the stop-loss policy is intended to assist IPFs during the transition. In addition, we expect that paying prospectively for IPF services will enhance the efficiency of the Medicare program. </P>
                    <HD SOURCE="HD3">6. Computer Hardware and Software </HD>
                    <P>We do not anticipate that IPFs will incur additional systems operating costs in order to effectively participate in the IPF PPS. We believe that IPFs possess the computer hardware capability to handle the billing requirements under the IPF PPS. Our belief is based on indications that approximately 99 percent of hospital inpatient claims are submitted electronically. In addition, we are not adopting significant changes in claims processing (see section IV. C. of this final rule). </P>
                    <HD SOURCE="HD2">C. Alternatives Considered </HD>
                    <P>We considered the following alternatives in developing the IPF PPS: One option we considered incorporated not only the patient-level and facility-level variables described previously, but also a site-of-service distinction. Under this approach, psychiatric units would have received a higher per diem payment, all other factors being equal, based on the assumption that psychiatric units on average treat a more complex and costly case-mix. A psychiatric unit adjustment to the otherwise applicable per diem payment rate would reflect the absence of a more sophisticated patient classification system specifically linked to resource use. Our analysis of the FY 2002 cost report and billing data used to develop the final IPF PPS reveals that an adjustment would have increased the otherwise applicable per diem payment to psychiatric units by approximately 33 percent. The average 2002 IPF per diem costs was $615 for psychiatric units, $534 for non-profit hospitals, $448 for proprietary providers, and $378 for governmental-operated facilities. While some of the higher than average per diem cost in psychiatric units may be due to a greater medical and surgical acuity among patients treated in psychiatric units, part of the difference is likely attributable to economy of scale inefficiencies associated with operating small units, including higher overhead expenses, and generally lower occupancy rates. A psychiatric unit site-of-service distinction in payment rates would represent a proxy adjuster in lieu of a more sophisticated patient classification system. </P>
                    <P>We considered alternative policies in order to reduce financial risk to facilities in the event that they experience substantial reductions in Medicare payments during the period of transition to the IPF PPS. As discussed previously in this final rule, we have adopted a provision that would guarantee each facility an average payment per case under the IPF PPS that is estimated to be no less than a minimum proportion of its average payment per case under TEFRA. We analyzed the impact on losses if we were to make a payment adjustment to ensure that the minimum IPF PPS per case payment to an IPF is at least 70 percent of its TEFRA payment. </P>
                    <P>The stop-loss adjustment will be applied to the IPF PPS portion of Medicare payments during the transition. For example, during year 1 of the 3-year transition period, three-quarters of the payment is based on TEFRA, and one-quarter of the payment is based on the Federal rate. We would apply the stop-loss adjustment to the portion of the IPF's payments during the transition based on the Federal rate. We estimate that the combined effects of the transition and the stop-loss policies will ensure that per case payments relative to pre-IPF PPS TEFRA per case payments are no less than 92.5 percent in year 1, 85 percent in year 2, and 77.5 percent in year 3. We estimate that about 10 percent of IPFs will receive additional payments under the stop-loss policy. </P>
                    <P>The 70 percent of TEFRA stop-loss policy would require a reduction in the per diem rate to make the stop-loss policy budget neutral. As a result, we made a reduction to the Federal per diem base rate of 0.4 percent in order to maintain budget neutrality. </P>
                    <P>In accordance with the provisions of Executive Order 12866, this rule was reviewed by OMB. </P>
                    <LSTSUB>
                        <HD SOURCE="HED">List of Subjects </HD>
                        <CFR>42 CFR Part 412 </CFR>
                        <P>
                            Administrative practice and procedure, Health facilities, Medicare, Puerto Rico, Reporting and recordkeeping requirements.
                            <PRTPAGE P="66976"/>
                        </P>
                        <CFR>42 CFR Part 413 </CFR>
                        <P>Health facilities, Kidney diseases, Medicare, Puerto Rico, Reporting and recordkeeping requirements.</P>
                    </LSTSUB>
                    <REGTEXT TITLE="42" PART="412">
                        <AMDPAR>For the reasons set forth in the preamble, the Centers for Medicare &amp; Medicaid Services amends 42 CFR chapter IV as follows: </AMDPAR>
                        <PART>
                            <HD SOURCE="HED">PART 412—PROSPECTIVE PAYMENT SYSTEMS FOR INPATIENT PSYCHIATRIC SERVICES </HD>
                        </PART>
                        <AMDPAR>1. The authority citation for part 412 is revised to read as follows: </AMDPAR>
                        <AUTH>
                            <HD SOURCE="HED">Authority:</HD>
                            <P>Secs. 1102 and 1871 of the Social Security Act (42 U.S.C. 1302 and 1395hh), Sec. 124 of Pub. L. 106-113, 113 Stat. 1515, and Sec. 405 of Pub. L. of 108-173, 117 Stat. 2266, 42 U.S.C. 1305, 1395. </P>
                        </AUTH>
                    </REGTEXT>
                    <REGTEXT TITLE="42" PART="412">
                        <SUBPART>
                            <HD SOURCE="HED">Subpart A—General Provisions </HD>
                        </SUBPART>
                        <AMDPAR>2. Section 412.1 is amended as follows: </AMDPAR>
                        <AMDPAR>a. Redesignating paragraphs (a)(2) and (a)(3) as paragraphs (a)(3) and (a)(4). </AMDPAR>
                        <AMDPAR>b. Adding a new paragraph (a)(2). </AMDPAR>
                        <AMDPAR>c. Redesignating paragraphs (b)(12) and (b)(13) as paragraphs (b)(13) and (b)(14). </AMDPAR>
                        <AMDPAR>d. Adding a new paragraph (b)(12). </AMDPAR>
                        <AMDPAR>e. Amending newly redesignated paragraph (b)(13) by removing the reference “paragraph (a)(3)” and adding the reference “paragraph (a)(4)” in its place. </AMDPAR>
                        <AMDPAR>f. Amending newly redesignted paragraph (b)(14) by removing the reference “paragraph (a)(2)” and adding the reference “paragraph (a)(3)” in its place. </AMDPAR>
                        <P>The additions read as follows:</P>
                        <SECTION>
                            <SECTNO>§ 412.1 </SECTNO>
                            <SUBJECT>Scope of part. </SUBJECT>
                            <P>(a) * * * </P>
                            <P>(2) This part implements section 124 of Public Law 106-113 by establishing a per diem prospective payment system for the inpatient operating and capital costs of hospital inpatient services furnished to Medicare beneficiaries by a psychiatric facility that meets the conditions of subpart N of this part. </P>
                            <STARS/>
                            <P>(b) * * * </P>
                            <P>(12) Subpart N describes the prospective payment system specified in paragraph (a)(2) of this section for inpatient psychiatric facilities and sets forth the general methodology for paying the operating and capital-related costs of inpatient hospital services furnished by inpatient psychiatric facilities effective with cost reporting periods beginning on or after January 1, 2005. </P>
                            <STARS/>
                        </SECTION>
                    </REGTEXT>
                    <REGTEXT TITLE="42" PART="412">
                        <SUBPART>
                            <HD SOURCE="HED">Subpart B—Hospital Services Subject to and Excluded From the Prospective Payment Systems for Inpatient Operating Costs and Inpatient Capital Related Costs </HD>
                        </SUBPART>
                        <AMDPAR>3. Section 412.20 is amended as follows: </AMDPAR>
                        <AMDPAR>a. Revising paragraph (a). </AMDPAR>
                        <AMDPAR>b. Redesignating paragraphs (b), (c), and (d) as paragraphs (c), (d), and (e). </AMDPAR>
                        <AMDPAR>c. Adding a new paragraph (b). </AMDPAR>
                        <P>The revision and addition read as follows:</P>
                        <SECTION>
                            <SECTNO>§ 412.20 </SECTNO>
                            <SUBJECT>Hospital services subject to the prospective payment systems. </SUBJECT>
                            <P>(a) Except for services described in paragraphs (b), (c), (d), and (e) of this section, all covered hospital inpatient services furnished to beneficiaries during the subject cost reporting periods are paid under the prospective payment system as specified in § 412.1(a)(1). </P>
                            <P>(b) Effective for cost reporting periods beginning on or after January 1, 2005, covered inpatient hospital services furnished to Medicare beneficiaries by a inpatient psychiatric facility that meets the conditions of § 412.404 are paid under the prospective payment system described in subpart N of this part. </P>
                            <STARS/>
                        </SECTION>
                    </REGTEXT>
                    <REGTEXT TITLE="42" PART="412">
                        <AMDPAR>4. Section 412.22 is amended by revising paragraph (b). </AMDPAR>
                        <SECTION>
                            <SECTNO>§ 412.22 </SECTNO>
                            <SUBJECT>Excluded hospitals and hospital units: General rules. </SUBJECT>
                            <STARS/>
                            <P>
                                (b) 
                                <E T="03">Cost reimbursement</E>
                                . Except for those hospitals specified in paragraph (c) of this section, and § 412.20(b), (c), and (d), all excluded hospitals (and excluded hospital units, as described in § 412.23 through § 412.29) are reimbursed under the cost reimbursement rules set forth in part 413 of this chapter, and are subject to the ceiling on the rate of hospital cost increases as specified in § 413.40 of this chapter. 
                            </P>
                            <STARS/>
                        </SECTION>
                    </REGTEXT>
                    <REGTEXT TITLE="42" PART="412">
                        <AMDPAR>5. Section 412.23 is amended as follows: </AMDPAR>
                        <AMDPAR>a. Republishing paragraph (a) introductory text. </AMDPAR>
                        <AMDPAR>b. Redesignating paragraphs (a)(1) and (a)(2) as paragraphs (a)(2) and (a)(3). </AMDPAR>
                        <AMDPAR>c. Adding a new paragraph (a)(1). </AMDPAR>
                        <AMDPAR>d. Amending the introductory text to paragraph (b) by removing the reference “§ 412.1(a)(2)” and adding the reference to “§ 412.1(a)(3)” in its place. </AMDPAR>
                        <AMDPAR>e. Amending paragraph (b)(9) by removing the reference to “§ 412.2(a)(2)” and adding the reference to “§ 412.1(a)(3)” in its place. </AMDPAR>
                        <AMDPAR>f. Revising the introductory text to paragraph (e). </AMDPAR>
                        <P>The republication and addition read a follows:</P>
                        <SECTION>
                            <SECTNO>§ 412.23 </SECTNO>
                            <SUBJECT>Excluded hospitals: Classifications. </SUBJECT>
                            <STARS/>
                            <P>
                                (a) 
                                <E T="03">Psychiatric hospitals</E>
                                . A psychiatric hospital must—
                            </P>
                            <P>(1) Meet the following requirements to be excluded from the prospective payment system as specified in § 412.1(a)(1) and to be paid under the prospective payment system as specified in § 412.1(a)(2) and in subpart N of this part; </P>
                            <STARS/>
                            <P>
                                (e) 
                                <E T="03">Long-term care hospitals</E>
                                . A long-term care hospital must meet the requirements of paragraph (e)(1) and (e)(2) of this section and, when applicable, the additional requirement of § 412.22(e), to be excluded from the prospective payment system specified in § 412.1(a)(1) and to be paid under the prospective payment system specified in § 412.1(a)(4) and in Subpart O of this part. 
                            </P>
                            <STARS/>
                        </SECTION>
                    </REGTEXT>
                    <REGTEXT TITLE="42" PART="412">
                        <AMDPAR>6. Section 412.25 is amended by revising the paragraph (a) introductory text to read as follows: </AMDPAR>
                        <SECTION>
                            <SECTNO>§ 412.25 </SECTNO>
                            <SUBJECT>Excluded hospital units: Common requirements. </SUBJECT>
                            <P>
                                (a) 
                                <E T="03">Basis for exclusion</E>
                                . In order to be excluded from the prospective payment systems as specified in § 412.1(a)(1) and to be paid under the prospective payment system as specified in 412.1(a)(2), a psychiatric unit must meet the following requirements. 
                            </P>
                            <STARS/>
                        </SECTION>
                    </REGTEXT>
                    <REGTEXT TITLE="42" PART="412">
                        <AMDPAR>7. Section 412.27 is amended as follows: </AMDPAR>
                        <AMDPAR>a. Revising the introductory text. </AMDPAR>
                        <AMDPAR>b. Amending paragraph (a) by removing the words “Third Edition”, and adding in its place, “Fourth Edition, Text Revision”. </AMDPAR>
                        <P>The revision reads as follows:</P>
                        <SECTION>
                            <SECTNO>§ 412.27 </SECTNO>
                            <SUBJECT>Excluded psychiatric units: Additional requirements. </SUBJECT>
                            <P>In order to be excluded from the prospective payment system as specified in § 412.1(a)(1), and paid under the prospective payment system as specified in § 412.1(a)(2), a psychiatric unit must meet the following requirements: </P>
                            <STARS/>
                        </SECTION>
                    </REGTEXT>
                    <REGTEXT TITLE="42" PART="412">
                        <SECTION>
                            <SECTNO>§ 412.29 </SECTNO>
                            <SUBJECT>[Amended] </SUBJECT>
                        </SECTION>
                        <AMDPAR>8. In § 412.29, the introductory text is amended by removing the reference “§ 412.1(a)(2)” and adding the reference “§ 412.1(a)(3)” in its place. </AMDPAR>
                        <AMDPAR>
                            9. Section 412.116 is amended as follows: 
                            <PRTPAGE P="66977"/>
                        </AMDPAR>
                        <AMDPAR>a. Redesignating paragraphs (a)(3) and (a)(4) as paragraphs (a)(4) and (a)(5). </AMDPAR>
                        <AMDPAR>b. Adding a new paragraph (a)(3). </AMDPAR>
                        <P>The addition reads as follows:</P>
                        <SECTION>
                            <SECTNO>§ 412.116 </SECTNO>
                            <SUBJECT>Method of payment. </SUBJECT>
                            <P>(a) * * * </P>
                            <P>(3) For cost reporting periods beginning on or after January 1, 2005, payments for inpatient hospital services furnished by an inpatient psychiatric facility that meets the conditions of § 412.404 are made as described in § 412.432. </P>
                            <STARS/>
                        </SECTION>
                    </REGTEXT>
                    <REGTEXT TITLE="42" PART="412">
                        <SECTION>
                            <SECTNO>§ 412.130 </SECTNO>
                            <SUBJECT>[Amended] </SUBJECT>
                        </SECTION>
                        <AMDPAR>10. In § 412.130, paragraphs (a)(1) and (a)(2) are amended by removing the reference “§ 412.1(a)(2)” and adding the reference “§ 412.1(a)(3)” in its place. </AMDPAR>
                        <AMDPAR>11. A new subpart N is added to read as follows: </AMDPAR>
                        <SUBPART>
                            <HD SOURCE="HED">Subpart N—Prospective Payment System for Hospital Inpatient Services of Inpatient Psychiatric Facilities </HD>
                        </SUBPART>
                        <CONTENTS>
                            <SECHD>Sec. </SECHD>
                            <SECTNO>412.400 </SECTNO>
                            <SUBJECT>Basis and scope of subpart. </SUBJECT>
                            <SECTNO>412.402 </SECTNO>
                            <SUBJECT>Definitions. </SUBJECT>
                            <SECTNO>412.404 </SECTNO>
                            <SUBJECT>Conditions for payment under the prospective payment system for inpatient hospital services of psychiatric facilities. </SUBJECT>
                            <SECTNO>412.422 </SECTNO>
                            <SUBJECT>Basis of payment. </SUBJECT>
                            <SECTNO>412.424 </SECTNO>
                            <SUBJECT>Methodology for calculating the Federal per diem payment amount. </SUBJECT>
                            <SECTNO>412.426 </SECTNO>
                            <SUBJECT>Transition period. </SUBJECT>
                            <SECTNO>412.428 </SECTNO>
                            <SUBJECT>Publication of Updates to the inpatient psychiatric facility prospective payment system. </SUBJECT>
                            <SECTNO>412.432 </SECTNO>
                            <SUBJECT>Method of payment under the inpatient psychiatric facility prospective payment system. </SUBJECT>
                        </CONTENTS>
                        <SUBPART>
                            <HD SOURCE="HED">Subpart N—Prospective Payment System for Inpatient Hospital Services of Inpatient Psychiatric Facilities </HD>
                            <SECTION>
                                <SECTNO>§ 412.400 </SECTNO>
                                <SUBJECT>Basis and scope of subpart. </SUBJECT>
                                <P>
                                    (a) 
                                    <E T="03">Basis</E>
                                    . This subpart implements section 124 of Public Law 106-113, which provides for the implementation of a per diem-based prospective payment system for inpatient hospital services of inpatient psychiatric facilities. 
                                </P>
                                <P>
                                    (b) 
                                    <E T="03">Scope</E>
                                    . This subpart sets forth the framework for the prospective payment system for the inpatient hospital services of inpatient psychiatric facilities, including the methodology used for the development of the Federal per diem rate, payment adjustments, implementation issues, and related rules. Under this system, for cost reporting periods beginning on or after January 1, 2005, payment for the operating and capital-related costs of inpatient hospital services furnished by inpatient psychiatric facilities to Medicare Part A fee-for-service beneficiaries is made on the basis of prospectively determined payment amount applied on a per diem basis. 
                                </P>
                            </SECTION>
                            <SECTION>
                                <SECTNO>§ 412.402 </SECTNO>
                                <SUBJECT>Definitions. </SUBJECT>
                                <P>As used in this subpart—</P>
                                <P>
                                    <E T="03">Comorbidity</E>
                                     means all specific patient conditions that are secondary to the patient's primary diagnosis and that coexist at the time of admission, develop subsequently, or that affect the treatment received or the length of stay or both. Diagnoses that relate to an earlier episode of care that have no bearing on the current hospital stay are excluded. 
                                </P>
                                <P>
                                    <E T="03">Federal per diem base rate</E>
                                     means the payment based on the average routine operating, ancillary, and capital-related cost of 1 day of hospital inpatient services in an inpatient psychiatric facility. 
                                </P>
                                <P>
                                    <E T="03">Federal per diem payment amount</E>
                                     means the Federal per diem base rate with all applicable adjustments. 
                                </P>
                                <P>
                                    <E T="03">Fixed dollar loss threshold</E>
                                     means a dollar amount by which the costs of a case exceed payment in order to qualify for an outlier payment. 
                                </P>
                                <P>
                                    <E T="03">Inpatient psychiatric facilities</E>
                                     means hospitals that meet the requirements as specified in § 412.22, § 412.23(a), § 482.60, § 482.61, and § 482.62, and units that meet the requirements as specified in § 412.22, § 412.25, and § 412.27. 
                                </P>
                                <P>
                                    <E T="03">Interrupted stay</E>
                                     means a Medicare inpatient is discharged from an inpatient psychiatric facility and is admitted to any inpatient psychiatric facility within 3 consecutive calendar days following discharge. The 3 consecutive calendar days begins with the day of discharge from the inpatient psychiatric facility and ends on midnight of the third day. 
                                </P>
                                <P>
                                    <E T="03">Outlier payment</E>
                                     means an additional payment beyond the Federal per diem payment amount for cases with unusually high costs. 
                                </P>
                                <P>
                                    <E T="03">Principal diagnosis</E>
                                     means the condition established after study to be chiefly responsible for occasioning the admission of the patient to the inpatient psychiatric facility also referred to as primary diagnosis. Principal diagnosis is also referred to as primary diagnosis. 
                                </P>
                                <P>
                                    <E T="03">Qualifying emergency department</E>
                                     means an emergency department that is staffed and equipped to furnish a comprehensive array of emergency services and meting the definitions of a dedicated emergency department as specified in § 489.24(b). 
                                </P>
                                <P>
                                    <E T="03">Rural area</E>
                                     means any area outside an urban area. 
                                </P>
                                <P>
                                    <E T="03">Urban area</E>
                                     means an area as defined in § 412.62(f)(1)(ii). 
                                </P>
                            </SECTION>
                            <SECTION>
                                <SECTNO>§ 412.404 </SECTNO>
                                <SUBJECT>Conditions for payment under the prospective payment system for inpatient hospital services of psychiatric facilities. </SUBJECT>
                                <P>
                                    (a) 
                                    <E T="03">General requirements</E>
                                    . (1) Effective for cost reporting periods beginning on or after January 1, 2005, an inpatient psychiatric facility must meet the conditions of this section to receive payment under the prospective payment system described in this subpart for inpatient hospital services furnished in to Medicare Part A fee-for-service beneficiaries. 
                                </P>
                                <P>(2) If an inpatient psychiatric facility fails to comply fully with these conditions, CMS may, as appropriate—</P>
                                <P>(i) Withhold (in full or in part) or reduce Medicare payment to the inpatient psychiatric facility until the facility provides adequate assurances of compliance; or </P>
                                <P>(ii) Classify the inpatient psychiatric facility as an inpatient hospital that is subject to the conditions of subpart C of this part and is paid under the prospective payment system as specified in § 412.1(a)(1). </P>
                                <P>
                                    (b) 
                                    <E T="03">Inpatient psychiatric facilities subject to the prospective payment system</E>
                                    . Subject to the special payment provisions of § 412.22(c), an inpatient psychiatric facility must meet the general criteria set forth in § 412.22. In order to be excluded from the hospital inpatient prospective payment system as specified in § 412.1(a)(1), a psychiatric hospital must meet the criteria set forth in § 412.23(a), § 482.60, § 482.61, and § 482.62 and psychiatric units must meet the criteria set forth in § 412.25 and § 412.27. 
                                </P>
                                <P>
                                    (c) 
                                    <E T="03">Limitations on charges to beneficiaries</E>
                                    —(1) 
                                    <E T="03">Prohibited charges</E>
                                    . Except as permitted in paragraph (c)(2) of this section, an inpatient psychiatric facility may not charge a beneficiary for any services for which payment is made by Medicare, even if the facility's cost of furnishing services to that beneficiary are greater than the amount the facility is paid under the prospective payment system. 
                                </P>
                                <P>
                                    (2) 
                                    <E T="03">Permitted charges</E>
                                    . An inpatient psychiatric facility receiving payment under this subpart for a covered hospital stay (that is, a stay that included at least one covered day) may charge the Medicare beneficiary or other person only the applicable deductible and coinsurance amounts under § 409.82, § 409.83, and § 409.87 of this chapter and for items or services as specified under § 489.20(a) of this chapter. 
                                </P>
                                <P>
                                    (d) 
                                    <E T="03">Furnishing of inpatient hospital services directly or under arrangement</E>
                                    . 
                                    <PRTPAGE P="66978"/>
                                    (1) Subject to the provisions of § 412.422, the applicable payments made under this subpart are payment in full for all inpatient hospital services, as specified in § 409.10 of this chapter. Hospital inpatient services do not include the following: 
                                </P>
                                <P>(i) Physicians' services that meet the requirements of § 415.102(a) of this chapter for payment on a fee schedule basis. </P>
                                <P>(ii) Physician assistant services, as specified in section 1861(s)(2)(K)(i) of the Act. </P>
                                <P>(iii) Nurse practitioners and clinical nurse specialist services, as specified in section 1861(s)(2)(K)(ii) of the Act. </P>
                                <P>(iv) Certified nurse midwife services, as specified in section 1861(gg) of the Act. </P>
                                <P>(v) Qualified psychologist services, as specified in section 1861(ii) of the Act. </P>
                                <P>(vi) Services of a certified registered nurse anesthetist, as specified in section 1861(bb) of the Act and defined in § 410.69 of this subchapter. </P>
                                <P>(2) CMS does not pay providers or suppliers other than inpatient psychiatric facilities for services furnished to a Medicare beneficiary who is an inpatient of the inpatient psychiatric facility, except for services described in paragraphs (d)(1)(i) through (d)(1)(vi) of this section </P>
                                <P>(3) The inpatient psychiatric facility must furnish all necessary covered services to a Medicare beneficiary who is an inpatient of the inpatient psychiatric facility, either directly or under arrangements (as specified in § 409.3 of this chapter). </P>
                                <P>
                                    (e) 
                                    <E T="03">Reporting and recordkeeping requirements</E>
                                    . All inpatient psychiatric facilities participating in the prospective payment system under this subpart must meet the recordkeeping and cost reporting requirements as specified in § 412.27(c), § 413.20, § 413.24, and § 482.61 of this chapter. 
                                </P>
                            </SECTION>
                            <SECTION>
                                <SECTNO>§ 412.422 </SECTNO>
                                <SUBJECT>Basis of payment. </SUBJECT>
                                <P>
                                    (a) 
                                    <E T="03">Method of Payment</E>
                                    . (1) Under the inpatient psychiatric facility prospective payment system, inpatient psychiatric facilities receive a predetermined Federal per diem base rate for inpatient hospital services furnished to Medicare Part A fee-for-service beneficiaries. 
                                </P>
                                <P>(2) The Federal per diem payment amount is based on the Federal per diem base rate plus applicable adjustments as specified in § 412.424. </P>
                                <P>(3) During the transition period, payment is based on a blend of the Federal per diem payment amount as specified in § 412.424, and the facility-specific payment rate as specified in § 412.426. </P>
                                <P>
                                    (b) 
                                    <E T="03">Payment in full.</E>
                                     (1) The payment made under this subpart represents payment in full (subject to applicable deductibles and coinsurance as specified in subpart G of part 409 of this chapter) for inpatient operating and capital-related costs associated with furnishing Medicare covered services in an inpatient psychiatric facility, but not the cost of an approved medical education program as specified in § 413.79 through § 413.75 of this chapter. 
                                </P>
                                <P>(2) In addition to the Federal per diem payment amounts, inpatient psychiatric facilities receive payment for bad debts of Medicare beneficiaries, as specified in § 413.80 of this chapter. </P>
                            </SECTION>
                            <SECTION>
                                <SECTNO>§ 412.424 </SECTNO>
                                <SUBJECT>Methodology for calculating the Federal per diem payment amount. </SUBJECT>
                                <P>
                                    (a) 
                                    <E T="03">Data sources.</E>
                                     (1) To calculate the Federal per diem base rate (as specified in paragraph (b) of this section for inpatient psychiatric facilities, as specified in paragraph (b) of this section, CMS uses the following data sources: 
                                </P>
                                <P>(2) The best Medicare data available to estimate the average inpatient operating and capital-related costs per day made as specified in part 413 of this chapter. </P>
                                <P>(i) Patient and facility cost report data capturing routine and ancillary costs. </P>
                                <P>(ii) An appropriate wage index to adjust for wage differences. </P>
                                <P>(iii) An increase factor to adjust for the most recent estimate of increases in the prices of an appropriate market basket of goods and services provided by inpatient psychiatric facilities. </P>
                                <P>
                                    (b) 
                                    <E T="03">Determining the average per diem cost of inpatient psychiatric facilities for FY 2002.</E>
                                     CMS determines the average inpatient operating, ancillary, and capital-related per diem cost for which payment is made to each inpatient psychiatric facility, using the available data described in paragraph (a) of this section. 
                                </P>
                                <P>
                                    (c) 
                                    <E T="03">Determining the Federal per diem base rate for cost reporting periods beginning on or after January 1, 2005 through June 30, 2006.</E>
                                     (1) 
                                    <E T="03">General.</E>
                                     Payment under the inpatient psychiatric facility prospective payment system is based on a standardized per diem payment referred to as the Federal per diem base rate. The Federal per diem base rate is the unadjusted cost for 1 day of inpatient hospital services in an inpatient psychiatric facility in a base year as described in paragraph (b) of this section. The unadjusted cost per day is adjusted in accordance with paragraphs (c)(2) through (c)(5) of this section. 
                                </P>
                                <P>
                                    (2) 
                                    <E T="03">Update of the average per diem cost.</E>
                                     CMS applies the increase factor described in paragraph (a)(2)(iii) of this section to the updated average per diem cost to the midpoint of the January 1, 2005 through June 30, 2006, under the update methodology described in section 1886(b)(3)(B)(ii) of the Act. 
                                </P>
                                <P>
                                    (3) 
                                    <E T="03">Budget neutrality.</E>
                                     (i) CMS adjusts the updated average per diem cost so that the aggregate payments in the first 18 months (for January 1, 2005 through June 30, 2006) under the inpatient psychiatric facility prospective payment system are estimated to equal the amount that would have been made to the inpatient psychiatric facilities under part 413 of this chapter if the inpatient psychiatric facility prospective payment system described in this subpart were not implemented. 
                                </P>
                                <P>(ii) CMS evaluates the accuracy of the budget-neutrality adjustment within the first 5 years after implementation of the inpatient psychiatric facility prospective payment system. CMS may make a one-time prospective adjustment to the Federal per diem base rate to account for significant differences between the historical data on cost-based TEFRA payments (the basis of the budget-neutrality adjustment at the time of implementation) and estimates of TEFRA payments based on actual data from the first year of the prospective payment system. </P>
                                <P>
                                    (4) 
                                    <E T="03">Outlier payments.</E>
                                     CMS determines a reduction factor equal to the estimated proportion of outlier payments described in paragraph (d)(3)(i) of this section. 
                                </P>
                                <P>
                                    (5) 
                                    <E T="03">Standardization.</E>
                                     CMS determines a reduction factor to reflect estimated increases in the Federal per diem base rate as defined in § 412.402 resulting from the facility-level and patient-level adjustments described in paragraph (d) of this section. 
                                </P>
                                <P>
                                    (6) 
                                    <E T="03">Computation of the Federal per diem base rate.</E>
                                     The Federal per diem base rate is computed as follows: 
                                </P>
                                <P>(i) For cost reporting periods beginning on or after January 1, 2005 and on or before June 30, 2006, the Federal per diem base rate is computed in accordance with paragraph (c) of this section. </P>
                                <P>(ii) For inpatient psychiatric facilities beginning on or after July 1, 2006, the Federal per diem base rate will be the Federal per diem base rate for the previous year, updated by an increase factor described in paragraph (a)(2)(iii) of this section. </P>
                                <P>
                                    (d) Determining the Federal per diem payment amount. The Federal per diem payment amount is the product of the Federal per diem base rate established under paragraph (c) of this section, the facility-level adjustments applicable to the inpatient psychiatric facility, and the patient-level adjustments applicable to the case. 
                                    <PRTPAGE P="66979"/>
                                </P>
                                <P>
                                    (1) 
                                    <E T="03">Facility-level adjustments.</E>
                                     (i) 
                                    <E T="03">Adjustment for wages.</E>
                                     CMS adjusts the labor portion of the Federal per diem base rate to account for geographic differences in the area wage levels using an appropriate wage index. The application of the wage index is made on the basis of the location of the inpatient psychiatric facility in an urban or rural area as defined in § 412.402. 
                                </P>
                                <P>
                                    (ii) 
                                    <E T="03">Rural location.</E>
                                     CMS adjusts the Federal per diem base rate for inpatient psychiatric facilities located in a rural area as defined in § 412.402. 
                                </P>
                                <P>
                                    (iii) 
                                    <E T="03">Teaching adjustment.</E>
                                     CMS adjusts the Federal per diem base rate by a factor to account for indirect medical education costs. 
                                </P>
                                <P>(A) An inpatient psychiatric facility's teaching adjustment is based on the ratio of the number of residents training in the inpatient psychiatric facility divided by the facility's average daily census. </P>
                                <P>(B) The number of full-time equivalent residents used in calculating the teaching adjustment cannot exceed the number of full-time equivalent residents in a base year. </P>
                                <P>(1) The base year is the inpatient psychiatric facility's most recently filed cost report filed with its fiscal intermediary before November 15, 2004. Residents with less than full-time status and residents rotating through the inpatient psychiatric facility for less than a full year will be counted in proportion to the time they spend in the inpatient psychiatric facility. </P>
                                <P>
                                    (
                                    <E T="03">2</E>
                                    ) The teaching status adjustment for new inpatient psychiatric facilities as defined in § 412.426 is made in accordance with § 413.79(e)(1)(i) and (ii). 
                                </P>
                                <P>(C) If an inpatient psychiatric facility has fewer full-time equivalent residents than in its base year payment of the teaching adjustment will be based on the actual number of full-time equivalent residents. The inpatient psychiatric facility may add residents in subsequent years up to its resident cap established under section (1)(iii)(B) of this paragraph. </P>
                                <P>
                                    (iv) 
                                    <E T="03">Inpatient psychiatric facilities located in Alaska and Hawaii.</E>
                                     CMS adjusts the non-labor portion of the Federal per diem base rate to reflect the higher cost of living of inpatient psychiatric facilities located in Alaska and Hawaii. 
                                </P>
                                <P>
                                    (v) 
                                    <E T="03">Adjustment for IPF with qualifying emergency departments.</E>
                                     (A) CMS adjusts the Federal per diem base rate to account for the costs associated with maintaining a qualifying emergency department. A qualifying emergency department is staffed and equipped to furnish a comprehensive array of emergency services and meets the requirements of § 489.24(b) and § 413.65. 
                                </P>
                                <P>(B) Where the inpatient psychiatric facility is part of an acute care hospital that has a qualifying emergency department as described in paragraph (d)(1)(v)(A) of this section and an individual patient is discharged to the inpatient psychiatric facility from that acute care hospital, CMS would not apply the emergency adjustment. </P>
                                <P>
                                    (2) 
                                    <E T="03">Patient-level adjustments.</E>
                                     (i) 
                                    <E T="03">Age.</E>
                                     CMS adjusts the Federal per diem base rate to account for patient age based on age groupings specified by CMS. 
                                </P>
                                <P>
                                    (ii) 
                                    <E T="03">Diagnosis-related group assignment.</E>
                                     The inpatient psychiatric facility must identify a principal diagnosis as specified in § 412.27(a) for each patient. CMS adjusts the Federal per diem base rate by a factor to account for the CMS inpatient psychiatric facility prospective payment system recognized diagnosis-related group assignment associated with each patient's principal diagnosis. 
                                </P>
                                <P>
                                    (iii) 
                                    <E T="03">Principal diagnosis.</E>
                                     The inpatient psychiatric facility must identify a principal psychiatric diagnosis as specified in § 412.27(a) for each patient. CMS adjusts the Federal per diem base rate by a factor to account for the diagnosis-related group assignment associated with the principal diagnosis, as specified by CMS. 
                                </P>
                                <P>
                                    (iv) 
                                    <E T="03">Comorbidities.</E>
                                     CMS adjusts the Federal per diem base rate by a factor to account for certain comorbidities as specified by CMS. 
                                </P>
                                <P>
                                    (v) 
                                    <E T="03">Variable per diem adjustments.</E>
                                     CMS adjusts the Federal per diem base rate by factors as specified by CMS to account for the cost of each day of inpatient psychiatric care relative to the cost of the median length of stay. 
                                </P>
                                <P>
                                    (3) 
                                    <E T="03">Other adjustments.</E>
                                     (i) 
                                    <E T="03">Outlier payments.</E>
                                     CMS provides an additional payment if an inpatient psychiatric facility's estimated total cost for a case exceeds a fixed dollar loss threshold as defined in § 412.402 plus the Federal per diem payment amount for the case. 
                                </P>
                                <P>(A) The fixed dollar loss threshold is adjusted for the inpatient psychiatric facility's adjustments for wage area, teaching, rural location, and cost of living adjustment for facilities located in Alaska and Hawaii.</P>
                                <P>(B) The outlier payment equals 80 percent of the difference between the IPF's estimated cost for the case and the adjusted threshold amount for days 1 through 9, and 60 percent for day 10 and thereafter. </P>
                                <P>(C) For discharges occurring in cost reporting periods beginning on or after January 1, 2005, outlier payments are subject to the adjustments specified at § 412.84(i) and § 412.84(m) of this part, except that national urban and rural median cost-to-charge ratios would be used instead of statewide average cost-to-charge ratios. </P>
                                <P>
                                    (ii) 
                                    <E T="03">Stop-loss payments.</E>
                                     CMS will provide additional payments during the transition period, specified in § 412.426(a)(1) through (3), to an inpatient psychiatric facility to ensure that aggregate payments under the prospective payment system are at least 70 percent of the amount the inpatient psychiatric facility would have received under reasonable cost reimbursement had the prospective payment system not been implemented. 
                                </P>
                                <P>
                                    (iii) 
                                    <E T="03">Special payment provision for interrupted stays.</E>
                                     If a patient is discharged from an inpatient psychiatric facility and is admitted to the same or another inpatient psychiatric facility within 3 consecutive calendar days following the discharge, the case is considered to be continuous for the purposes listed below. The 3 consecutive calendar days begins with the day of discharge from the inpatient psychiatric facility and ends on midnight of day 3. 
                                </P>
                                <P>(A) Determining the appropriate variable per diem adjustment, as specified in paragraph (d)(2)(v) of this section, applicable to the case. </P>
                                <P>(B) Determining whether the total cost for a case meets the criteria for outlier payments, as specified in paragraph (d)(3)(i)(C) of this section. </P>
                                <P>(iv) Payment for electroconvulsive therapy treatments. CMS provides an additional payment to reflect the cost of electroconvulsive therapy treatments received by a patient during an inpatient psychiatric facility stay in a manner specified by CMS. </P>
                                <P>
                                    (v) 
                                    <E T="03">Adjustment for high-cost cases.</E>
                                     CMS provides for an additional payment if the estimated total cost for a case exceeds a fixed dollar loss threshold plus the total per diem payment amount for the case. 
                                </P>
                                <P>(A) The fixed dollar loss threshold is adjusted for area wage levels, teaching status, and rural location. </P>
                                <P>(B) The additional payment equals 80 percent of the difference between the estimated cost of the case and the Federal per diem payment amount for days 1 through 9, and 60 percent for days 10 and beyond. </P>
                                <P>
                                    (C) Effective for discharges occurring in cost reporting periods beginning on or after January 1, 2005, additional payments made under this section would be subject to the adjustments at § 412.84(i) and § 412.84(m) of this part, except that the national urban and rural median cost-to-charge ratios would be 
                                    <PRTPAGE P="66980"/>
                                    used instead of statewide averages, and at § 412.84(m) of this part. 
                                </P>
                            </SECTION>
                            <SECTION>
                                <SECTNO>§ 412.426 </SECTNO>
                                <SUBJECT>Transition period. </SUBJECT>
                                <P>
                                    (a) 
                                    <E T="03">Duration of transition period and composition of the blended transition payment.</E>
                                     Except as provided in paragraph (c) of this section, for cost reporting periods beginning on or after January 1, 2005 through June 30, 2008, an inpatient psychiatric facility receives a payment comprised of a blend of the estimated Federal per diem payment amount, as specified in § 412.424(c) and a facility-specific payment as specified under paragraph (b). 
                                </P>
                                <P>(1) For cost reporting periods beginning on or after January 1, 2005 and on or before June 30, 2006, payment is based on 75 percent of the facility-specific payment and 25 percent is based on the Federal per diem payment amount. </P>
                                <P>(2) For cost reporting periods beginning on or after July 1, 2006 and on or before June 30, 2007, payment is based on 50 percent of the facility-specific payment and 50 percent is based on the Federal per diem payment amount. </P>
                                <P>(3) For cost reporting periods beginning on or after July 1, 2007 and on or before June 30, 2008, payment is based on 25 percent of the facility-specific payment and 75 percent is based on the Federal per diem payment amount. </P>
                                <P>(4) For cost reporting periods beginning on or after July 1, 2008, payment is based entirely on the Federal per diem payment amount. </P>
                                <P>
                                    (b) 
                                    <E T="03">Calculation of the facility-specific payment.</E>
                                     The facility-specific payment is equal to the estimated payment for each cost reporting period in the transition period that would have been made without regard to this subpart. The facility's Medicare fiscal intermediary calculates the facility-specific payment for inpatient operating costs and capital costs in accordance with part 413 of this chapter. 
                                </P>
                                <P>
                                    (c) 
                                    <E T="03">Treatment of new inpatient psychiatric facilities.</E>
                                     New inpatient psychiatric facilities, are facilities that under present or previous ownership or both have their first cost reporting period as an IPF beginning on or after January 1, 2005. New IPFs are paid based on 100 percent of the Federal per diem payment amount. 
                                </P>
                            </SECTION>
                            <SECTION>
                                <SECTNO>§ 412.428 </SECTNO>
                                <SUBJECT>Publication of Updates to the inpatient psychiatric facility prospective payment system. </SUBJECT>
                                <P>
                                    CMS will publish annually in the 
                                    <E T="04">Federal Register</E>
                                     information pertaining to updates to the inpatient psychiatric facility prospective payment system. This information includes: 
                                </P>
                                <P>(a) A description of the methodology and data used to calculate the updated Federal per diem base payment amount. </P>
                                <P>(b) The rate of increase factor as described in 412.424(a)(2)(iii), which is based on the excluded hospital with capital market basket under the update methodology of 1886(b)(3)(B)(ii) of the Act for each year. </P>
                                <P>(c) The best available hospital wage index and information regarding whether an adjustment to the Federal per diem base rate is needed to maintain budget neutrality. </P>
                                <P>(d) Updates to the fixed dollar loss threshold in order to maintain the appropriate outlier percentage. </P>
                                <P>(e) Describe the ICD-9-CM coding changes and DRG classification changes discussed in the annual update to the hospital inpatient prospective payment system regulations. </P>
                                <P>(f) Update the electroconvulsive therapy adjustment by a factor specified by CMS. </P>
                            </SECTION>
                            <SECTION>
                                <SECTNO>§ 412.432 </SECTNO>
                                <SUBJECT>Method of payment under the inpatient psychiatric facility prospective payment system. </SUBJECT>
                                <P>
                                    (a) 
                                    <E T="03">General rule.</E>
                                     Subject to the exceptions in paragraphs (b) and (c) of this section, an inpatient psychiatric facility receives payment under this subpart for inpatient operating cost and capital-related costs for each inpatient stay following submission of a bill. 
                                </P>
                                <P>
                                    (b) 
                                    <E T="03">Periodic interim payments (PIP).</E>
                                     (1) Criteria for receiving PIP. 
                                </P>
                                <P>(i) An inpatient psychiatric facility receiving payment under this subpart may receive PIP for Part A services under the PIP method subject to the provisions of § 413.64(h) of this chapter. </P>
                                <P>(ii) To be approved for PIP, the inpatient psychiatric facility must meet the qualifying requirements in § 413.64(h)(3) of this chapter. </P>
                                <P>(iii) A hospital that is receiving periodic interim payments also receives payment under this subpart for applicable services furnished by its excluded psychiatric unit. </P>
                                <P>(iv) As provided in § 413.64(h)(5) of this chapter, intermediary approval is conditioned upon the intermediary's best judgment as to whether payment can be made under the PIP method without undue risk of resulting in an overpayment to the provider. </P>
                                <P>
                                    (2) 
                                    <E T="03">Frequency of payment.</E>
                                     For facilities approved for PIP, the intermediary estimates the annual inpatient psychiatric facility's Federal per diem prospective payments, net of estimated beneficiary deductibles and coinsurance, and makes biweekly payments equal to 
                                    <FR>1/26</FR>
                                     of the total estimated amount of payment for the year. If the inpatient psychiatric facility has payment experience under the prospective payment system, the intermediary estimates PIP based on that payment experience, adjusted for projected changes supported by substantiated information for the current year. Each payment is made 2 weeks after the end of a biweekly period of service as specified in § 413.64(h)(6) of this chapter. The interim payments are reviewed at least twice during the reporting period and adjusted if necessary. Fewer reviews may be necessary if an inpatient psychiatric facility receives interim payments for less than a full reporting period. These payments are subject to final settlement. 
                                </P>
                                <P>
                                    (3) 
                                    <E T="03">Termination of PIP.</E>
                                     (i) 
                                    <E T="03">Request by the inpatient psychiatric facility.</E>
                                     Subject to the provisions of paragraph (b)(1)(iii) of this section, an inpatient psychiatric facility receiving PIP may convert to receiving prospective payments on a non-PIP basis at any time. 
                                </P>
                                <P>
                                    (ii) 
                                    <E T="03">Removal by the intermediary.</E>
                                     An intermediary terminates PIP if the inpatient psychiatric facility no longer meets the requirements of § 413.64(h) of this chapter. 
                                </P>
                                <P>
                                    (c) 
                                    <E T="03">Interim payments for Medicare bad debts and for costs of an approved education program and other costs paid outside the prospective payment system.</E>
                                     For Medicare bad debts and for costs of an approved education program and other costs paid outside the prospective payment system, the intermediary determines the interim payments by estimating the reimbursable amount for the year based on the previous year's experience, adjusted for projected changes supported by substantiated information for the current year, and makes biweekly payments equal to 1/26 of the total estimated amount. Each payment is made 2 weeks after the end of the biweekly period of service as specified in § 413.64(h)(6) of this chapter. The interim payments are reviewed at least twice during the reporting period and adjusted if necessary. Fewer reviews may be necessary if an inpatient psychiatric facility receives interim payments for less than a full reporting period. These payments are subject to final cost settlement. 
                                </P>
                                <P>
                                    (d) 
                                    <E T="03">Outlier payments.</E>
                                     Additional payments for outliers are not made on an interim basis. Outlier payments are made based on the submission of a discharge bill and represents final payment subject to the cost report settlement specified in § 412.84(i) and § 412.84(m). 
                                </P>
                                <P>
                                    (e) 
                                    <E T="03">Accelerated payments.</E>
                                     (1) 
                                    <E T="03">General rule.</E>
                                     Upon request, an accelerated payment may be made to an inpatient psychiatric facility that is receiving 
                                    <PRTPAGE P="66981"/>
                                    payment under this subpart and is not receiving PIP under paragraph (b) of this section if the inpatient psychiatric facility is experiencing financial difficulties because of the following: 
                                </P>
                                <P>(i) There is a delay by the intermediary in making payment to the inpatient psychiatric facility. </P>
                                <P>(ii) Due to an exceptional situation, there is a temporary delay in the inpatient psychiatric facility's preparation and submittal of bills to the intermediary beyond the normal billing cycle. </P>
                                <P>
                                    (2) 
                                    <E T="03">Approval of accelerated payment.</E>
                                     An inpatient psychiatric facility's request for an accelerated payment must be approved by the intermediary and CMS. 
                                </P>
                                <P>
                                    (3) 
                                    <E T="03">Amount of accelerated payment.</E>
                                     The amount of the accelerated payment is computed as a percent of the net payment for unbilled or unpaid covered services. 
                                </P>
                                <P>
                                    (4) 
                                    <E T="03">Recovery of accelerated payment.</E>
                                     Recovery of the accelerated payment is made by recoupment as inpatient psychiatric facility bills are processed or by direct payment by the inpatient psychiatric facility. 
                                </P>
                            </SECTION>
                        </SUBPART>
                    </REGTEXT>
                    <REGTEXT TITLE="42" PART="413">
                        <PART>
                            <HD SOURCE="HED">PART 413—PRINCIPLES OF REASONABLE COST REIMBURSEMENT; PAYMENT FOR END-STAGE RENAL DISEASE SERVICES; PROSPECTIVELY DETERMINED PAYMENT FOR SKILLED NURSING FACILITIES </HD>
                        </PART>
                        <AMDPAR>1. The authority citation for part 413 is revised to read as follows: </AMDPAR>
                        <AUTH>
                            <HD SOURCE="HED">Authority:</HD>
                            <P>Secs. 1102, 1812(d), 1814(b), 1815, 1833(a), (i), and (n), 1861 (v), 1871, 1881, 1883, and 1886 of the Social Security Act (42 U.S.C. 1302, 1395d(d), 1395f(b), 1395g, 1395l(a), (i), and (n), 1395x(v), 1395hh, 1395rr, 1395tt, and 1395ww) Sec 124 of Pub. L. 106-113, 113 Stat. 1515. </P>
                        </AUTH>
                    </REGTEXT>
                    <REGTEXT TITLE="42" PART="413">
                        <AMDPAR>2. Section 413.1 is amended as follows: </AMDPAR>
                        <AMDPAR>a. Revising paragraph (d)(2)(ii). </AMDPAR>
                        <AMDPAR>b. Redesignating paragraphs (d)(2)(iv), (d)(2)(v), (d)(2)(vi), and (d)(2)(vii) as paragraphs (d)(2)(vi), (d)(2)(vii), (d)(2)(viii), and (d)(2)(ix). </AMDPAR>
                        <AMDPAR>(c) Adding new paragraphs (d)(2)(iv) and (d)(2)(v). </AMDPAR>
                        <P>The revision and additions read as follows:</P>
                        <SECTION>
                            <SECTNO>§ 413.1 </SECTNO>
                            <SUBJECT>Introduction. </SUBJECT>
                            <STARS/>
                            <P>(d) * * * </P>
                            <P>(2) * * * </P>
                            <P>(ii) Payment to children's hospitals that are excluded from the prospective payment systems under subpart B of part 412 of this chapter, and hospitals outside the 50 States and the District of Columbia is on a reasonable cost basis, subject to the provisions of § 413.40. </P>
                            <STARS/>
                            <P>(iv) For cost reporting periods beginning before January 1, 2005, payment to psychiatric hospitals (as well as separate psychiatric units (distinct parts) of short-term general hospitals) that are excluded under subpart B of part 412 of this chapter from the prospective payment system is on a reasonable cost basis, subject to the provisions of § 413.40. </P>
                            <P>(v) For cost reporting periods beginning on or after January 1, 2005, payment to inpatient psychiatric facilities that meet the conditions of § 412.404 of this chapter, is made under the prospective payment system described in subpart N of part 412 of this chapter. </P>
                            <STARS/>
                        </SECTION>
                    </REGTEXT>
                    <REGTEXT TITLE="42" PART="413">
                        <AMDPAR>3. Section 413.40 is amended as follows: </AMDPAR>
                        <AMDPAR>a. Redesignating paragraphs (a)(2)(i)(C) and (a)(2)(i)(D) as paragraphs (a)(2)(i)(D) and (a)(2)(i)(E). </AMDPAR>
                        <AMDPAR>b. Adding a new paragraph (a)(2)(i)(C). </AMDPAR>
                        <AMDPAR>c. Republishing paragraph (a)(2)(ii) introductory text. </AMDPAR>
                        <AMDPAR>d. Revising paragraph (a)(2)(ii)(B). </AMDPAR>
                        <AMDPAR>e. Amending paragraph (a)(2)(ii)(C) by removing reference to “paragraph (a)(2)(iv)” and adding the reference “paragraph (a)(2)(v)” in its place. </AMDPAR>
                        <AMDPAR>f. Redesignating paragraphs (a)(2)(iii) and (a)(2)(iv) as paragraphs (a)(2)(iv) and (a)(2)(v). </AMDPAR>
                        <AMDPAR>g. Adding a new paragraph (a)(2)(iii). </AMDPAR>
                        <P>The revision and additions read as follows: </P>
                        <SECTION>
                            <SECTNO>§ 413.40 </SECTNO>
                            <SUBJECT>Ceiling on the rate of increase in hospital inpatient costs. </SUBJECT>
                            <P>(a) * * * </P>
                            <P>(2) * * * </P>
                            <P>(i) * * * </P>
                            <P>(C) Psychiatric hospitals and psychiatric units that are paid under the prospective payment system for inpatient psychiatric facilities described in subpart N of part 412 of this chapter for cost reporting periods beginning on or after January 1, 2005. </P>
                            <STARS/>
                            <P>(ii) For cost reporting periods beginning on or after October 1, 1983, this section applies to—</P>
                            <STARS/>
                            <P>(B) Psychiatric and rehabilitation units excluded from the prospective payment systems, as specified in § 412.1(a)(1) of this chapter and in accordance with § 412.25 through § 412.30 of this chapter, except as limited by paragraphs (a)(2)(iii) and (a)(2)(iv) of this section with respect to psychiatric and rehabilitation hospitals and psychiatric and rehabilitation units as specified in § 412.22, § 412.23, § 412.25, § 412.27, § 412.29 and § 412.30 of this chapter. </P>
                            <STARS/>
                            <P>(iii) For cost reporting periods beginning on or after October 1, 1983 and before January 1, 2005 this section applies to psychiatric hospitals and psychiatric units that are excluded from the prospective payment systems as specified in § 412.1(a)(1) of this chapter and paid under the prospective payment system as specified in § 412.1(a)(2) of this chapter. </P>
                            <STARS/>
                        </SECTION>
                    </REGTEXT>
                    <REGTEXT TITLE="42" PART="413">
                        <AMDPAR>4. Section 413.64 is amended by revising paragraph (h)(2)(i) to read as follows: </AMDPAR>
                        <SECTION>
                            <SECTNO>§ 413.64 </SECTNO>
                            <SUBJECT>Payment to providers: Specific rules. </SUBJECT>
                            <STARS/>
                            <P>(h) * * * </P>
                            <P>(2) * * * </P>
                            <P>(i) Part A inpatient services furnished in hospitals that are excluded from the prospective payment systems, as specified in § 412.1(a)(1) of this chapter under subpart B of part 412 of this subchapter, or are paid under the prospective payment systems described in subpart N, O, and P of part 412 of this chapter. </P>
                            <STARS/>
                        </SECTION>
                    </REGTEXT>
                    <REGTEXT TITLE="42" PART="413">
                        <AMDPAR>5. Section 413.70 is amended by revising paragraph (e) to read as follows: </AMDPAR>
                        <SECTION>
                            <SECTNO>§ 413.70 </SECTNO>
                            <SUBJECT>Payment for services of a CAH. </SUBJECT>
                            <STARS/>
                            <P>
                                (e) 
                                <E T="03">Payment for service of distinct part psychiatric and rehabilitation units of CAHS.</E>
                                 Payment for inpatient services of distinct part psychiatric units of CAHs— 
                            </P>
                            <P>(1) For cost reporting periods beginning before January 1, 2005, payment is made on a reasonable cost basis, subject to the provisions of § 413.40. </P>
                            <P>(2) For cost reporting periods beginning on or after January 1, 2005, payment is made in accordance with regulations governing inpatient psychiatric facilities at subpart N (§ 412.400 through § 412.432) of Part 412 of this subchapter. </P>
                            <P>(3) Payment for inpatient services of distinct part rehabilitation units of CAHs is made in accordance with regulations governing the inpatient rehabilitation facilities prospective payment system at Subpart P (§ 412.600 through § 412.632) of Part 412 of this subchapter. </P>
                            <EXTRACT>
                                <FP>(Catalog of Federal Domestic Assistance Program No. 93.778, Medical Assistance Program) </FP>
                                <PRTPAGE P="66982"/>
                                <FP>(Catalog of Federal Domestic Assistance Program No. 93.773, Medicare—Hospital Insurance; and Program No. 93.774, Medicare—Supplementary Medical Insurance Program) </FP>
                            </EXTRACT>
                        </SECTION>
                        <SIG>
                            <DATED>Dated: October 26, 2004. </DATED>
                            <NAME>Mark B. McClellan, </NAME>
                            <TITLE>Administrator, Centers for Medicare &amp; Medicaid Services. </TITLE>
                            <APPR>Approved: November 2, 2004. </APPR>
                            <NAME>Tommy G. Thompson, </NAME>
                            <TITLE>Secretary. </TITLE>
                        </SIG>
                        <NOTE>
                            <HD SOURCE="HED">Note:</HD>
                            <P>The following Addenda will not appear in the Code of Federal Regulations </P>
                        </NOTE>
                        <HD SOURCE="HD1">Addendum A—Psychiatric Prospective Payment Adjustment Rate and Adjustment Factors </HD>
                        <BILCOD>BILLING CODE 4120-01-P</BILCOD>
                        <GPH SPAN="3" DEEP="535">
                            <GID>ER15NO04.453</GID>
                        </GPH>
                        <GPH SPAN="3" DEEP="596">
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                            <GID>ER15NO04.454</GID>
                        </GPH>
                        <GPH SPAN="3" DEEP="221">
                            <PRTPAGE P="66984"/>
                            <GID>ER15NO04.455</GID>
                        </GPH>
                        <GPH SPAN="3" DEEP="589">
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                            <GID>ER15NO04.456</GID>
                        </GPH>
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                        </GPH>
                        <GPH SPAN="3" DEEP="589">
                            <PRTPAGE P="66987"/>
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                        </GPH>
                        <GPH SPAN="3" DEEP="590">
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                        </GPH>
                        <GPH SPAN="3" DEEP="576">
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                        </GPH>
                        <GPH SPAN="3" DEEP="600">
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                        </GPH>
                        <GPH SPAN="3" DEEP="612">
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                        </GPH>
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                        </GPH>
                        <GPH SPAN="3" DEEP="616">
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                        </GPH>
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                        </GPH>
                        <GPH SPAN="3" DEEP="360">
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                        </GPH>
                        <GPH SPAN="3" DEEP="597">
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                        </GPH>
                        <GPH SPAN="3" DEEP="616">
                            <PRTPAGE P="67013"/>
                            <GID>ER15NO04.484</GID>
                        </GPH>
                        <GPH SPAN="3" DEEP="611">
                            <PRTPAGE P="67014"/>
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                        </GPH>
                        <GPH SPAN="3" DEEP="345">
                            <PRTPAGE P="67015"/>
                            <GID>ER15NO04.486</GID>
                        </GPH>
                    </REGTEXT>
                </SUPLINF>
                <FRDOC>[FR Doc. 04-24787 Filed 11-2-04; 4:47 pm] </FRDOC>
                <BILCOD>BILLING CODE 4120-03-C</BILCOD>
            </RULE>
        </RULES>
    </NEWPART>
    <VOL>69</VOL>
    <NO>219</NO>
    <DATE>Monday, November 15, 2004</DATE>
    <UNITNAME>Rules and Regulations</UNITNAME>
    <NEWPART>
        <PTITLE>
            <PRTPAGE P="67017"/>
            <PARTNO>Part VI</PARTNO>
            <AGENCY TYPE="P">Social Security Administration</AGENCY>
            <CFR>20 CFR Part 404</CFR>
            <TITLE>Revised Medical Criteria for Evaluating Hematological Disorders and Malignant Neoplastic Diseases; Final Rule and Proposed Rule</TITLE>
        </PTITLE>
        <RULES>
            <RULE>
                <PREAMB>
                    <PRTPAGE P="67018"/>
                    <AGENCY TYPE="S">SOCIAL SECURITY ADMINISTRATION </AGENCY>
                    <CFR>20 CFR Part 404 </CFR>
                    <DEPDOC>[Regulations No. 4] </DEPDOC>
                    <RIN>RIN 0960-AD67 </RIN>
                    <SUBJECT>Revised Medical Criteria for Evaluating Malignant Neoplastic Diseases </SUBJECT>
                    <AGY>
                        <HD SOURCE="HED">AGENCY:</HD>
                        <P>Social Security Administration. </P>
                    </AGY>
                    <ACT>
                        <HD SOURCE="HED">ACTION:</HD>
                        <P>Final rules. </P>
                    </ACT>
                    <SUM>
                        <HD SOURCE="HED">SUMMARY:</HD>
                        <P>We are revising the criteria in the Listing of Impairments (the listings) that we use to evaluate claims involving malignant neoplastic diseases. We apply these criteria when you claim benefits based on disability under title II and title XVI of the Social Security Act (the Act). The revisions reflect advances in medical knowledge, treatment, and methods of evaluating malignant neoplastic diseases. </P>
                    </SUM>
                    <EFFDATE>
                        <HD SOURCE="HED">DATES:</HD>
                        <P>These rules are effective December 15, 2004. </P>
                    </EFFDATE>
                    <HD SOURCE="HD1">Electronic Version </HD>
                    <P>
                        The electronic file of this document is available on the date of publication in the 
                        <E T="04">Federal Register</E>
                         at 
                        <E T="03">http://www.gpoaccess.gov/fr/index.html.</E>
                         It is also available on the Internet site for SSA (
                        <E T="03">i.e.</E>
                        , Social Security Online): 
                        <E T="03">http://policy.ssa.gov/pnpublic.nsf/LawsRegs.</E>
                    </P>
                    <FURINF>
                        <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                        <P>
                            Martin Sussman, Regulations Officer, Office of Regulations, Social Security Administration, 100 Altmeyer Building, 6401 Security Boulevard, Baltimore, Maryland 21235-6401, (410) 965-1767 or TTY (410) 966-5609. For information on eligibility or filing for benefits, call our national toll-free number, 1-800-772-1213 or TTY 1-800-325-0778, or visit our Internet Web site, Social Security Online, at 
                            <E T="03">http://www.socialsecurity.gov/.</E>
                        </P>
                    </FURINF>
                </PREAMB>
                <SUPLINF>
                    <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                    <P>
                        We are revising and making final the rules we proposed for evaluating malignant neoplastic diseases in the Notice of Proposed Rulemaking (NPRM) published in the 
                        <E T="04">Federal Register</E>
                         on November 27, 2001 (66 FR 59306). In that NPRM, we proposed revisions to both the listings for hematological disorders and the listings for malignant neoplastic diseases. We proposed to make revisions to the listings for these two body systems in order to update their medical criteria and to provide more information about how we evaluate disorders in these body systems. We initially provided a 60-day comment period that ended on January 28, 2002. Subsequently, on April 18, 2002, we reopened the comment period for an additional 60 days, until June 17, 2002 (67 FR 19138). For the reasons explained below, we have decided to publish only revisions to the malignant neoplastic diseases body system in this final rule. We are publishing separately, in today's edition of the 
                        <E T="04">Federal Register</E>
                        , a notice withdrawing the proposed rules that would have revised the hematological disorders listings. We plan to publish a new NPRM for the hematological disorders listings at a later date. 
                    </P>
                    <P>We provide a summary of the provisions of the final rules below, with an explanation of the changes we have made from the text in the NPRM. We then provide summaries of the public comments and our reasons for adopting or not adopting the recommendations in those comments in the section “Public Comments.” The final rule language follows the public comments section. </P>
                    <HD SOURCE="HD1">What Programs Do These Final Regulations Affect? </HD>
                    <P>These final regulations affect disability determinations and decisions that we make under title II and title XVI of the Act. In addition, to the extent that Medicare entitlement and Medicaid eligibility are based on whether you qualify for disability benefits under title II and title XVI, these final regulations also affect the Medicare and Medicaid programs. </P>
                    <HD SOURCE="HD1">Who Can Get Disability Benefits? </HD>
                    <P>Under title II of the Act, we provide for the payment of disability benefits if you are disabled and belong to one of the following three groups: </P>
                    <P>• Workers insured under the Act. </P>
                    <P>• Children of insured workers. </P>
                    <P>
                        • Widows, widowers, and surviving divorced spouses (
                        <E T="03">see</E>
                         § 404.336) of insured workers. 
                    </P>
                    <P>Under title XVI of the Act, we provide for Supplemental Security Income (SSI) payments on the basis of disability if you are disabled and have limited income and resources. </P>
                    <HD SOURCE="HD1">How Do We Define Disability? </HD>
                    <P>Under both the title II and title XVI programs, disability must be the result of any medically determinable physical or mental impairment or combination of impairments that is expected to result in death or which has lasted or can be expected to last for a continuous period of at least 12 months. Our definitions of disability are shown in the following table: </P>
                    <GPOTABLE COLS="3" OPTS="L2,tp0,i1" CDEF="s50,r50,r100">
                        <TTITLE>  </TTITLE>
                        <BOXHD>
                            <CHED H="1" O="L">If you file a claim under * * * </CHED>
                            <CHED H="1" O="L">And you are * * * </CHED>
                            <CHED H="1" O="L">Disability means you have a medically determinable impairment(s) as described above and that results in * * * </CHED>
                        </BOXHD>
                        <ROW>
                            <ENT I="01">title II</ENT>
                            <ENT>an adult or a child</ENT>
                            <ENT>the inability to do any substantial gainful activity (SGA). </ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">title XVI</ENT>
                            <ENT>an individual age 18 or older</ENT>
                            <ENT>the inability to do any SGA. </ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">title XVI</ENT>
                            <ENT>an individual under age 18</ENT>
                            <ENT>marked and severe functional limitations. </ENT>
                        </ROW>
                    </GPOTABLE>
                    <HD SOURCE="HD1">How Do We Decide Whether You Are Disabled? </HD>
                    <P>If you are seeking benefits under title II of the Act, or if you are an adult seeking benefits under title XVI of the Act, we use a five-step “sequential evaluation process” to decide whether you are disabled. We describe this five-step process in our regulations at §§ 404.1520 and 416.920. We follow the five steps in order and stop as soon as we can make a determination or decision. The steps are: </P>
                    <P>1. Are you working and is the work you are doing substantial gainful activity? If you are working and the work you are doing is substantial gainful activity, we will find that you are not disabled, regardless of your medical condition or your age, education, and work experience. If you are not, we will go on to step 2. </P>
                    <P>2. Do you have a “severe” impairment? If you do not have an impairment or combination of impairments that significantly limits your physical or mental ability to do basic work activities, we will find that you are not disabled. If you do, we will go on to step 3. </P>
                    <P>3. Do you have an impairment(s) that meets or medically equals the severity of an impairment in the listings? If you do, and the impairment(s) meets the duration requirement, we will find that you are disabled. If you do not, we will go on to step 4. </P>
                    <P>4. Do you have the residual functional capacity to do your past relevant work? If you do, we will find that you are not disabled. If you do not, we will go on to step 5. </P>
                    <P>
                        5. Does your impairment(s) prevent you from doing any other work that exists in significant numbers in the 
                        <PRTPAGE P="67019"/>
                        national economy, considering your residual functional capacity, age, education, and work experience? If it does, and it meets the duration requirement, we will find that you are disabled. If it does not, we will find that you are not disabled. 
                    </P>
                    <P>
                        We use a different sequential evaluation process for children who apply for payments based on disability under title XVI of the Act. We describe that sequential evaluation process in § 416.924 of our regulations. If you are already receiving benefits, we also use a different sequential evaluation process when we decide whether your disability continues. 
                        <E T="03">See</E>
                         §§ 404.1594, 416.924, 416.994, and 416.994a of our regulations. However, all of these processes include steps at which we consider whether your impairment meets or medically equals one of our listings. 
                    </P>
                    <HD SOURCE="HD1">What Are the Listings? </HD>
                    <P>The listings are examples of impairments that we consider severe enough to prevent you as an adult from doing any gainful activity. If you are a child seeking SSI benefits based on disability, the listings describe impairments that we consider severe enough to result in marked and severe functional limitations. Although the listings are contained only in appendix 1 to subpart P of part 404 of our regulations we incorporate them by reference in the SSI program in § 416.925 of our regulations, and apply them to claims under both title II and title XVI of the Act. </P>
                    <HD SOURCE="HD1">How Do We Use the Listings? </HD>
                    <P>The listings are in two parts. There are listings for adults (part A) and for children (part B). If you are an individual age 18 or over, we apply the listings in part A when we assess your claim, and we do not use the listings in part B. </P>
                    <P>
                        If you are an individual under age 18, we first use the criteria in part B of the listings. If the listings in part B do not apply, and the specific disease process(es) has a similar effect on adults and children, we then use the criteria in part A. (
                        <E T="03">See</E>
                         §§ 404.1525 and 416.925.) 
                    </P>
                    <P>
                        If your impairment(s) does not meet any listing, we will also consider whether it medically equals any listing; that is, whether it is as medically severe as an impairment in the listings. (
                        <E T="03">See</E>
                         §§ 404.1526 and 416.926.) 
                    </P>
                    <HD SOURCE="HD1">What if You Do Not Have an Impairment(s) That Meets or Medically Equals a Listing? </HD>
                    <P>We use the listings only to decide that individuals are disabled or that they are still disabled. We will not deny your claim because your impairment(s) does not meet or medically equal a listing. If you are not doing work that is substantial gainful activity, and you have a severe impairment(s) that does not meet or medically equal any listing, we may still find you disabled based on other rules in the “sequential evaluation process” described above. Likewise, we will not decide that your disability has ended only because your impairment(s) does not meet or medically equal a listing. </P>
                    <P>
                        Also, when we conduct reviews to determine whether your disability continues, we will not find that your disability has ended because we have changed a listing. Our regulations explain that, when we change our listings, we continue to use our prior listings when we review your case, if you had qualified for disability benefits or SSI payments based on our determination or decision that your impairment(s) met or medically equaled a listing. In these cases, we determine whether you have experienced medical improvement, and if so, whether the medical improvement is related to the ability to work. If your condition(s) has medically improved so that you no longer meet or medically equal the prior listing, we evaluate your case further to determine whether you are currently disabled. We may find that you are currently disabled, depending on the full circumstances of your case. 
                        <E T="03">See</E>
                         §§ 404.1594(c)(3)(i) and 416.994(b)(2)(iv)(A). If you are a child who is eligible for SSI payments, we follow a similar rule when we decide whether you have experienced medical improvement in your condition(s). 
                        <E T="03">See</E>
                         § 416.994a(b)(2). 
                    </P>
                    <HD SOURCE="HD1">Why Are We Revising the Listings for Malignant Neoplastic Diseases? </HD>
                    <P>
                        We are revising these listings to update our medical criteria for evaluating malignant neoplastic diseases and to provide more information about how we evaluate such diseases. On April 24, 2002, we published final rules in the 
                        <E T="04">Federal Register</E>
                         (67 FR 20018) that included technical revisions to some of the listings for malignant neoplastic diseases. Prior to this, we last published final rules making comprehensive revisions to the listings for malignant neoplastic diseases in the 
                        <E T="04">Federal Register</E>
                         on December 6, 1985 (50 FR 50068). Because we have not comprehensively revised the listings for this body system since 1985, we believe that we need to update the rules. 
                    </P>
                    <HD SOURCE="HD1">What Do We Mean by “Final Rules” and “Prior Rules”? </HD>
                    <P>Even though these rules will not go into effect until 30 days after publication of this notice, for clarity, we refer to the changes we are making here as the “final rules” and to the rules that will be changed by these final rules as the “prior rules.” </P>
                    <HD SOURCE="HD1">When Will We Start To Use These Final Rules? </HD>
                    <P>We will start to use these final rules on their effective date. We will continue to use our prior rules until the effective date of these final rules. When the final rules become effective, we will apply them to new applications filed on or after the effective date of these rules and to claims pending before us, as we describe below. </P>
                    <P>As is our usual practice when we make changes to our regulations, we will apply these final rules on or after their effective date when we make a determination or decision, including those claims in which we make a determination or decision after remand to us from a Federal court. With respect to claims in which we have made a final decision, and that are pending judicial review in Federal court, we expect that the court's review of the Commissioner's final decision would be made in accordance with the rules in effect at the time of the administrative law judge's (ALJ) decision, if the ALJ's decision is the final decision of the Commissioner. If the court determines that the Commissioner's final decision is not supported by substantial evidence, or contains an error of law, we would expect that the court would reverse the final decision, and remand the case for further administrative proceedings pursuant to the fourth sentence of section 205(g) of the Act, except in those few instances in which the court determines that it is appropriate to reverse the final decision and award benefits without remanding the case for further administrative proceedings. In those cases decided by a court after the effective date of the rules, where the court reverses the Commissioner's final decision and remands the case for further administrative proceedings, on remand, we will apply the provisions of these final rules to the entire period at issue in the claim. </P>
                    <HD SOURCE="HD1">How Long Will These Final Rules Be Effective? </HD>
                    <P>
                        These rules will no longer be effective 5 years after the date on which they become effective, unless we extend them or revise and issue them again. 
                        <PRTPAGE P="67020"/>
                    </P>
                    <HD SOURCE="HD1">Why Are We Not Publishing Final Rules for Evaluating Hematological Disorders in This Notice? </HD>
                    <P>The public comments we received on the NPRM raised significant issues about the proposed listings for some of the hematological disorders, and we have not finished resolving these issues. The public comments did not raise similar issues with respect to the listings for malignant neoplastic diseases. Therefore, we are issuing these final regulations to implement changes to the listings for malignant neoplastic diseases, and we summarize and respond here only to the significant public comments that we received about the proposed changes regarding those diseases. </P>
                    <P>
                        As noted above, we are publishing separately in today's edition of the 
                        <E T="04">Federal Register</E>
                         a notice withdrawing the proposed rules for the hematological disorders listings. We plan to issue a new NPRM for the hematological disorders listings at a later date. 
                    </P>
                    <HD SOURCE="HD1">What General Changes Are We Making That Affect Both the Adult and Childhood Listings for Malignant Neoplastic Diseases? </HD>
                    <P>To present the listings in a more logical order, and make them easier to use, we are: </P>
                    <P>• Redesignating the listings in part A and part B. To the extent possible, the listings in part B correspond with listings addressing the same or similar impairments in part A. </P>
                    <P>• Placing all listings for malignant neoplastic diseases in this body system, with the exception of certain ones associated with human immunodeficiency virus (HIV) infection. To do this, we are moving the criteria for acute leukemia, chronic leukemia, myeloma, and malignant brain tumors, prior listings 7.11, 7.12, 7.16, 11.05, 107.11, and 111.05, to final listings 13.06, 13.07, 13.13, 113.06 and 113.13, respectively. We are also moving the guidance for evaluating macroglobulinemia or heavy chain disease, prior listing 7.14, to 13.00K3 of the introductory text because the prior listing for this disorder was a reference listing. As noted below, we are eliminating reference listings and providing guidance in the introductory text. </P>
                    <P>• Removing reference listings from this body system. Reference listings are listings that are met by satisfying the criteria of another listing. For example, prior listing 7.16B, for myeloma with evidence of renal impairment, was a reference listing that requires evaluation under listing 6.02, for impairment of renal function. Instead of using reference listings, we are providing guidance in the introductory text stating that these impairments should be evaluated under the criteria for the affected body system. Where appropriate, we also provide references to specific listings. For example, in 13.00K3 we indicate that macroglobulinemia or heavy chain disease should be evaluated under the criteria of 7.02, 7.06, or 7.08, or under the criteria of any other affected body system. </P>
                    <HD SOURCE="HD1">How Are We Changing the Introductory Text to the Listings for Evaluating Malignant Neoplastic Diseases in Adults? </HD>
                    <HD SOURCE="HD2">13.00 Malignant Neoplastic Diseases </HD>
                    <P>We are expanding and reorganizing the introductory text to these listings to provide additional guidance and reflect the new listings. The following is a detailed explanation of this material. </P>
                    <HD SOURCE="HD2">13.00A—What Impairments Do These Listings Cover? </HD>
                    <P>In this section, we explain that we use these listings to evaluate all malignant neoplasms, except certain neoplasms associated with human immunodeficiency virus (HIV) infection. We use the criteria in listing 14.08E to evaluate carcinoma of the cervix, Kaposi's sarcoma, lymphoma, and squamous cell carcinoma of the anus if you also have HIV infection. </P>
                    <HD SOURCE="HD2">13.00B—What Do We Consider When We Evaluate Malignant Neoplastic Diseases Under These Listings? </HD>
                    <P>This section corresponds to prior 13.00A, “Introduction.” For clarity, we are using the phrase “origin of the malignancy” instead of the prior language, “the site of the lesion, the histogenesis of the tumor” to describe one of the factors we consider when we evaluate malignant neoplastic diseases. We also changed the phrase “apparent adequacy and response to therapy” in the prior section to “[r]esponse to antineoplastic therapy” to eliminate any misunderstanding concerning who can make judgments about the appropriateness of the treatment regimen. “Apparent adequacy” was intended to mean effectiveness of the therapy. Judgments about its appropriateness must be left entirely to the treating source. We added the word “antineoplastic” to be consistent with the language in the listing criteria. We also specifically identify the types of antineoplastic therapy referred to in the listings. </P>
                    <HD SOURCE="HD2">13.00C—How Do We Apply the Listings? </HD>
                    <P>In this section, we explain that we apply the criteria in a specific listing to a malignancy originating from that specific site. </P>
                    <P>In this section of the NPRM (66 FR at 59321), we stated that metastatic carcinoma to the brain or spinal cord was an exception to the guidance above. We received a public comment questioning this exception. In response to this comment, we determined that this exception was unnecessary and have removed it. We will evaluate metastatic carcinoma to the brain or spinal cord under the site of origin for the primary tumor or, if this is unknown, under final listing 13.27. </P>
                    <HD SOURCE="HD2">13.00D—What Evidence Do We Need? </HD>
                    <P>We are expanding the guidance in prior 13.00B, “Documentation,” by: </P>
                    <P>• Explaining that when the primary site cannot be identified, we will use evidence documenting the site(s) of metastasis to evaluate the impairment under listing 13.27. </P>
                    <P>• Clarifying that we consider biopsies and needle aspirations to be “operative procedures.” </P>
                    <P>• Using the more general term “pathology report” instead of “the report of the gross and microscopic examination of the surgical specimen.” We made this change to recognize that a report of the gross examination is not always required and to recognize that a microscopic examination of appropriate body fluids may be used as an alternative to the gross and microscopic examination of the surgical specimen. </P>
                    <HD SOURCE="HD2">13.00E—When Do We Need Longitudinal Evidence? </HD>
                    <P>We are incorporating and expanding the guidance in the fourth paragraph of prior 13.00C, “Evaluation.” We explain when we need longitudinal evidence, and the time period such evidence should cover. We also explain when we may need to defer adjudication. </P>
                    <HD SOURCE="HD2">13.00F—How Do We Evaluate Impairments That Do Not Meet One of the Malignant Neoplastic Diseases Listings? </HD>
                    <P>
                        This paragraph corresponds to the first sentence in the second paragraph of prior 13.00D, “Effects of Therapy.” We state our basic adjudicative principle that, if your impairment(s) does not meet or medically equal the requirements of a listing, we will continue the sequential evaluation process to determine whether you are disabled. 
                        <PRTPAGE P="67021"/>
                    </P>
                    <HD SOURCE="HD2">13.00G—How Do We Consider the Effects of Therapy? </HD>
                    <P>We are reorganizing the guidance in prior 13.00D, “Effects of Therapy.” In final 13.00G2a, we are adding “extent of surgery” and “schedule and fields of radiation therapy” to the list of the elements of therapy for which we will request a description noted in the second paragraph of prior 13.00D. In final 13.00G2b, we are adding “neurological complications” and “cardiovascular complications” to the list of examples of complications or adverse effects for which we will request a description. We are also clarifying that we will not delay adjudication to determine whether the therapy has achieved its intended effect if we can make a fully favorable determination or decision based on the evidence in the case record. </P>
                    <HD SOURCE="HD2">13.00H—How Long Do We Consider Your Impairment To Be Disabling? </HD>
                    <P>We are incorporating and expanding the guidance contained in the third paragraph of prior 7.00E, “Acute leukemia,” and the fifth paragraph of prior 13.00C, “Evaluation.” In some of the listings, we specify that we consider an impairment to be disabling until a particular point in time; for example, at least 18 months from the date of diagnosis. If you have an impairment(s) that meets or equals a listing in this body system that does not contain such a specification, we provide that we will consider the impairment(s) to be disabling until at least 3 years after onset of complete remission. We also explain what we do when the appropriate time period has passed. </P>
                    <P>For those listings in which we specify that the impairment is considered disabling until a particular point in time, such as listing 13.28, the beginning date specified is not related to the onset date. We can establish an earlier onset date if the evidence in your case record supports the earlier onset date, as we explain in final 13.00J. </P>
                    <HD SOURCE="HD2">13.00I—What Do These Terms in the Listings Mean? </HD>
                    <P>We are revising the first two paragraphs and the first sentence of the third paragraph of prior 13.00C, “Evaluation,” and providing additional definitions. The prior section contained an adjudicative definition of “distant metastases” and “metastases beyond the regional lymph nodes.” We are not retaining this definition because our use of these terms in the final listings is consistent with current clinical practice. We are also adding definitions in order to differentiate between the terms “inoperable” and “unresectable.” </P>
                    <HD SOURCE="HD2">13.00J—Can We Establish the Existence of a Disabling Impairment Prior to the Date of the Evidence That Shows the Malignancy Satisfies the Criteria of a Listing?</HD>
                    <P>This section corresponds to prior 13.00E, “Onset.” We are making no substantive changes. </P>
                    <HD SOURCE="HD2">13.00K—How Do We Evaluate Specific Malignant Neoplastic Diseases? </HD>
                    <P>We are incorporating and clarifying prior 7.00E, “Acute leukemia,” and the last sentence of the third paragraph in prior 13.00C, “Evaluation,” and providing guidance for evaluating additional malignant neoplastic disorders. The following is a detailed discussion of the information provided. </P>
                    <HD SOURCE="HD3">13.00K1—Lymphoma </HD>
                    <P>In paragraphs K1a and K1b of this section, we discuss the evaluation of low grade or indolent (non-aggressive) lymphomas. We explain that we may defer adjudication of these cases for an appropriate period after the initiation of therapy to determine whether the therapy will achieve its intended effect. We do not specify a particular time for this deferral because it will vary from case to case. We also explain that changes in therapy based solely on patient or physician preference are not indicative of a failure to stabilize the disease. We also explain how the disease should be evaluated when stability has been achieved. </P>
                    <P>Final paragraphs 13.00K1a and 13.00K1b reflect nonsubstantive editorial corrections made to the corresponding proposed paragraphs in the NPRM (66 FR at 59322). Proposed paragraph K1a referred to indolent lymphoma. We added a reference to low grade lymphoma to final paragraph K1a to be consistent with the listing language. We also added a reference to low grade or indolent lymphoma in final paragraph K1b for clarity. </P>
                    <P>We have not retained the last sentence of the third paragraph of prior 13.00C, “Evaluation.” This sentence stated, “In the evaluation of lymphomas, the tissue type and site of involvement are not necessarily indicators of the degree of impairment.” We do not believe this guidance provided useful information for applying the criteria in final listing 13.05. </P>
                    <P>In paragraph K1c, we provide that Hodgkin's disease that recurs more than 12 months after completing initial antineoplastic therapy will be evaluated as a new disease rather than as a recurrence. </P>
                    <HD SOURCE="HD3">13.00K2—Leukemia </HD>
                    <P>In paragraph K2a, we expand the guidance in the first paragraph of prior 7.00E, “Acute leukemia,” to indicate sources of additional diagnostic information. We clarify that recurrent disease must be documented by peripheral blood, bone marrow, or cerebrospinal fluid examination. We also clarify that the initial and follow-up pathology reports should be included. </P>
                    <P>In paragraph K2b, we provide guidance on documenting chronic myelogenous leukemia (CML). We have not included in this paragraph the guidance in the second paragraph of prior 7.00E, which provided that the acute phase of CML should be considered under the requirements for acute leukemia. Instead, we have provided a separate listing for the acute phase (more appropriately called the accelerated or blast phase) of CML, final listing 13.06B1, that uses the same criteria as the listing for acute leukemia (final listing 13.06A). </P>
                    <P>In paragraph K2c, we provide guidance for documenting and evaluating chronic lymphocytic leukemia (CLL). Consistent with our effort to eliminate reference listings, this guidance incorporates the cross-references from prior listing 7.12 that are appropriate for evaluating CLL. </P>
                    <P>In paragraph K2d, we explain that, in cases of chronic leukemia (either myelogenous or lymphocytic), an elevated white cell count, in itself, is not ordinarily a factor in determining the severity of the impairment.</P>
                    <HD SOURCE="HD3">13.00K3—Macroglobulinemia or Heavy Chain Disease</HD>
                    <P>This section replaces prior listing 7.14, which was a reference listing. We are making no substantive changes in how we evaluate these disorders.</P>
                    <HD SOURCE="HD3">13.00K4—Bilateral Primary Breast Cancer</HD>
                    <P>
                        We are clarifying the statement in prior listing 13.09D, “bilateral breast carcinoma, synchronous or metachronous is 
                        <E T="03">usually</E>
                         primary in each breast” (emphasis added) by removing the suggestion that there are exceptions to this rule. 
                        <E T="03">See</E>
                         the discussion of final listing 13.10B, below.
                    </P>
                    <HD SOURCE="HD3">13.00K5—Carcinoma-in-situ</HD>
                    <P>
                        In this section, we explain that this type of carcinoma usually responds to treatment and is not included when we use the term “carcinoma” in these listings.
                        <PRTPAGE P="67022"/>
                    </P>
                    <HD SOURCE="HD3">13.00K6—Brain Tumors</HD>
                    <P>In this section, we explain that malignant tumors are evaluated under final listing 13.13, while benign tumors continue to be evaluated under listing 11.05. We also explain that we evaluate any complications of malignant brain tumors, such as resultant neurological or psychological impairments, under the criteria for the affected body system.</P>
                    <HD SOURCE="HD3">13.00L—How Do We Evaluate Malignant Neoplastic Diseases Treated by Bone Marrow or Stem Cell Transplantation?</HD>
                    <P>In paragraphs L1 and L2, we discuss how long we consider you disabled if you have leukemia, lymphoma, or multiple myeloma and you undergo bone marrow or stem cell transplantation.</P>
                    <P>In paragraph L3, we provide that any other malignant neoplastic diseases treated with bone marrow or stem cell transplantation must be evaluated under final listing 13.28, regardless of whether there is another listing that addresses that impairment. We explain that under final listing 13.28, the length of time we will consider you disabled will depend on whether you undergo allogeneic or autologous transplantation. We also define “allogeneic” and “autologous” in paragraphs L3a and L3b.</P>
                    <P>In paragraph L4, we discuss some of the factors we consider when we evaluate any residual impairment(s) that results from transplantation.</P>
                    <HD SOURCE="HD1">How Are We Changing the Listings for Evaluating Malignant Neoplastic Diseases in Adults?</HD>
                    <HD SOURCE="HD2">13.01—Category of Impairments, Malignant Neoplastic Diseases</HD>
                    <P>We are removing prior listing 13.15, “Abdomen,” because disorders covered by this listing can be evaluated under other final listings. Prior listings 13.15A, “Generalized carcinomatosis,” and 13.15C, “Ascites with demonstrated malignant cells,” represent malignancies that have spread to the abdomen from another site. We will evaluate these conditions under final listing 13.27, “Primary site unknown after appropriate search for primary.” We will evaluate “Retroperitoneal cellular sarcoma not controlled by prescribed therapy,” the impairment in prior listing 13.15B, under final listing 13.04, “Soft tissue sarcoma.”</P>
                    <P>In the final listings, we:</P>
                    <P>• Take into account medical advances in the detection, treatment, control, and cure of malignant neoplastic diseases.</P>
                    <P>• Recognize that in some situations the effects of therapy for these disorders can be disabling.</P>
                    <P>• Provide for the evaluation of residual impairments.</P>
                    <P>The following is a detailed explanation of the final listings.</P>
                    <HD SOURCE="HD2">Listing 13.02—Soft Tissue Tumors of the Head and Neck (Except Salivary Glands—13.06—and Thyroid Gland—13.07)</HD>
                    <P>This listing corresponds to prior listing 13.02, “Head and neck.” We are revising the listing heading to ensure that only tumors of the soft tissue of the head and neck are considered under this listing. This change allows us to delete the last two exceptions in the prior heading (orbit or temporal fossa), as these are not soft tissue tumors. In response to a comment, we are also removing prior listing 13.02E, “Epidermoid carcinoma occurring in the pyriform sinus or posterior third of the tongue,” as these conditions can be evaluated under other sections of the final listing. We had proposed to evaluate epidermoid carcinoma occurring in the pyriform sinus under proposed listing 13.02E. We explain our reasons for this change in more detail in the public comments section of this preamble.</P>
                    <P>Final listing 13.02A is substantively the same as prior listing 13.02A. We are updating the terminology to reflect the definitions used in the final listings.</P>
                    <P>In final listing 13.02B, which corresponds to prior listing 13.02B, we are replacing “[n]ot controlled by prescribed therapy” with “[p]ersistent disease following initial multimodal antineoplastic therapy” to clarify our intent. </P>
                    <P>Final listing 13.02C corresponds to prior listing 13.02C. We are replacing “after radical surgery or irradiation” with “following initial antineoplastic therapy” to recognize that other therapeutic modalities may be used. We are also excluding local vocal cord recurrences, because these recurrences have a good response to therapy. </P>
                    <P>Final listing 13.02D corresponds to prior listing 13.02D. We are making no substantive change. </P>
                    <P>Final listing 13.02E corresponds to proposed listing 13.02F in the NPRM. As we have already noted, we removed prior and proposed listing 13.02E in response to a comment. Therefore, we are redesignating proposed listing 13.02F as final listing 13.02E. It recognizes the length and debilitating effects of multimodal treatment for soft tissue tumors of the head and neck. </P>
                    <HD SOURCE="HD2">Listing 13.03—Skin </HD>
                    <P>We are combining prior listing 13.03, “Sarcoma of skin,” and prior listing 13.05, “Malignant melanoma,” so that all malignancies originating in the skin are evaluated under this listing. Accordingly, we are revising the heading by removing the reference to sarcoma. </P>
                    <P>Final listing 13.03A corresponds to prior listing 13.03A, “Angiosarcoma with metastases to regional lymph nodes or beyond.” We are expanding the provision to include all skin sarcomas and carcinomas because other skin malignancies of the severity described would also be disabling. </P>
                    <P>Final listing 13.03B corresponds to prior listing 13.05. We clarify that an additional primary melanoma at a different site is not considered recurrent disease. We are also adding a criterion for palpable nodal metastases. Prior listing 13.05B addressed only metastases to the regional lymph nodes or beyond, and not palpable nodal metastases. </P>
                    <P>We are moving prior listing 13.03B, “Mycosis fungoides” (a type of lymphoma), to final listing 13.05, “Lymphoma,” so that all lymphomas will be evaluated under the same listing. </P>
                    <HD SOURCE="HD2">Listing 13.04—Soft Tissue Sarcoma </HD>
                    <P>We are updating the heading of prior listing 13.04, “Sarcoma of soft parts,” to recognize that “soft tissue” is a more common term than “soft parts.” We are adding a criterion for regional or distant metastases, final listing 13.04A, to be consistent with the criteria for other malignant neoplastic diseases and to recognize the grave prognosis for these conditions. In final listing 13.04B, we define the prior criterion “not controlled by prescribed therapy” similarly to the way we defined it in other listings, such as final listing 13.02B. </P>
                    <HD SOURCE="HD2">Listing 13.05—Lymphoma (Including Mycosis Fungoides, But Excluding T-cell Lymphoblastic Lymphoma—13.06) </HD>
                    <P>This listing corresponds to prior listing 13.06. We are changing the heading from “Lymph nodes” to “Lymphoma” to more accurately reflect the disease. We also provide a cross-reference to the explanatory paragraphs in 13.00K1 and 13.00K2c. This listing also replaces prior listing 7.13, “Lymphomas.” </P>
                    <P>
                        We evaluated both Hodgkin's disease and non-Hodgkin's lymphoma under prior listing 13.06A. We are separating and clarifying the criteria for each of these diseases. Final listing 13.05A provides criteria for evaluating non-Hodgkin's lymphoma; final listing 13.05B provides criteria for Hodgkin's disease. For each of these disorders, we clarify the prior criteria by replacing the phrase “progressive disease not 
                        <PRTPAGE P="67023"/>
                        controlled by prescribed therapy” in the prior listing with clearer language. 
                    </P>
                    <P>In the final rules, we are making a minor editorial revision to proposed listing 13.05A2 for clarity. We amended the proposed listing by adding the words “at least” between “from” and “the” in the last sentence to clarify that the individual can be found disabled prior to the date specified in the listing. </P>
                    <P>In final listing 13.05C, we provide that a lymphoma treated by bone marrow or stem cell transplantation is considered disabling until at least 12 months from the date of transplantation. After this period, we will evaluate any residual impairment(s) under the criteria for the affected body system. </P>
                    <P>We are removing prior listing 13.06B, “Metastatic carcinoma in a lymph node (except for epidermoid carcinoma in a lymph node in the neck) where the primary site is not determined after adequate search.” We will evaluate this impairment under final listing 13.27, “Primary site unknown after appropriate search for primary.” We are also removing prior listing 13.06C. We will evaluate epidermoid carcinoma in a lymph node in the neck under final listing 13.02, “Soft tissue tumors of the head and neck.” </P>
                    <HD SOURCE="HD2">Listing 13.06—Leukemia </HD>
                    <P>This final listing replaces prior listing 7.11, “Acute leukemia,” and prior listing 7.12, “Chronic leukemia.” </P>
                    <P>Final listing 13.06A replaces prior listing 7.11. We provide that acute leukemia (including T-cell lymphoblastic lymphoma) will be considered disabling until at least 24 months from the date of diagnosis or relapse, or at least 12 months from the date of bone marrow or stem cell transplantation, whichever is later. After the appropriate period, we will evaluate any residual impairment(s) under the criteria for the affected body system. </P>
                    <P>
                        Under the prior listing, we considered acute leukemia disabling for 2
                        <FR>1/2</FR>
                         years from the time of the initial diagnosis. We are shortening this period to 2 years because of improvement in the treatment of this disorder. However, as with other final listings, and unlike the prior listing, we permit a longer period when the facts warrant it. We also recognize that a relapse of acute leukemia is as significant as the initial diagnosis. 
                    </P>
                    <P>The criterion for bone marrow or stem cell transplantation in cases of acute leukemia is similar to the transplantation criteria for other diseases. Unlike those diseases, however, we will not reevaluate cases of acute leukemia 12 months after transplantation if that date is earlier than 24 months after onset or relapse. We provide this option for this disease because of the disease course and the high rate of infection and other complications that occur when this disease is treated with bone marrow or stem cell transplantation. </P>
                    <P>Final listing 13.06B, “Chronic myelogenous leukemia,” replaces prior listing 7.12. The prior listing was a reference listing. Rather than replace the entire listing with guidance in the preface, we are providing separate evaluation criteria for CML. Consistent with our guidance in the second paragraph of prior 7.00E, the listing for the accelerated or blast phase of CML is the same as final listing 13.06A. </P>
                    <P>We are retaining references to the listings that are appropriate for evaluating chronic lymphocytic leukemia in 13.00K2c. </P>
                    <HD SOURCE="HD2">Listing 13.07—Multiple Myeloma (Confirmed by Appropriate Serum or Urine Protein Electrophoresis and Bone Marrow Findings) </HD>
                    <P>This listing replaces prior listing 7.16. In this listing, we remove the specific findings in prior listings 7.16A-D and substitute the criterion “[f]ailure to respond or progressive disease following initial antineoplastic therapy.” Our intent is to clarify that this listing includes all listing-level manifestations of this disease. We also clarify that we consider multiple myeloma treated with bone marrow or stem cell transplantation to be disabling until at least 12 months from the date of transplantation. After that time, we will evaluate any residual impairment(s) under the criteria for the affected body system. </P>
                    <HD SOURCE="HD2">Listing 13.08—Salivary Glands </HD>
                    <P>This listing redesignates prior listing 13.07. There are no substantive changes. </P>
                    <HD SOURCE="HD2">Listing 13.09—Thyroid Gland </HD>
                    <P>In the NPRM, we proposed to amend current listing 13.08, for malignancies of the thyroid gland, by: </P>
                    <P>• Redesignating the current listing as proposed listing 13.09. </P>
                    <P>• Adding a separate criterion for anaplastic (undifferentiated) carcinoma in proposed listing 13.09A. </P>
                    <P>• Redesignating the criterion in current listing 13.08, “carcinoma with metastases beyond the regional lymph nodes, not controlled by prescribed therapy,” as proposed listing 13.09B. </P>
                    <P>• Replacing the term “not controlled by prescribed therapy” used in current listing 13.08 with “progressive despite radioactive iodine therapy” to clarify our intent. </P>
                    <P>
                        On April 24, 2002, we published final rules in the 
                        <E T="04">Federal Register</E>
                         (67 FR 20018, 20026) that made technical revisions to the listings. Those rules added the criterion for anaplastic (undifferentiated) carcinoma and redesignated the criterion in prior listing 13.08 as final listing 13.08B. 
                    </P>
                    <P>In these final rules, we are redesignating prior listing 13.08 as final listing 13.09, and are clarifying the language as indicated in the fourth bullet above. </P>
                    <HD SOURCE="HD2">Listing 13.10—Breast </HD>
                    <P>This listing corresponds to prior listing 13.09. In final listing 13.10A, we are amending the criterion in prior listing 13.09B, “Inflammatory carcinoma,” by adding other types of locally advanced carcinoma. </P>
                    <P>In final listing 13.10B, “Carcinoma with distant metastases,” we are revising prior listing 13.09D by removing the parenthetical statement “bilateral breast carcinoma, synchronous or metachronous, is usually primary in each breast.” Instead, we provide guidance about evaluating bilateral breast cancer in final 13.00K4. As indicated in our discussion of that section, we are clarifying this guidance by removing the suggestion that there are exceptions to this rule. </P>
                    <P>In final listing 13.10C, which replaces prior listing 13.09C, we are replacing the term “controlled by prescribed therapy” used in the prior listing with “that remits with antineoplastic therapy” to clarify our intent. </P>
                    <P>We are removing prior listing 13.09A, “inoperable carcinoma,” to avoid confusion about what this term means for this malignancy. We can evaluate cases in which breast cancer is inoperable under other criteria in final listing 13.10. We are also removing prior listing 13.09E, “Sarcoma with metastases anywhere.” We will evaluate this impairment under final listing 13.04, “Soft tissue sarcoma.” </P>
                    <HD SOURCE="HD2">Listing 13.11—Skeletal System </HD>
                    <P>
                        This listing replaces prior listing 13.10. We are expanding the listing to include tumors of the mandible that were evaluated under prior listing 13.11. In final listings 13.11A, 13.11B, and 13.11C, we revise prior listing 13.10A to clarify when these tumors are of listing-level severity. In final listing 13.11D, we provide that we consider all other malignant tumors originating in bone with multimodal antineoplastic therapy to be disabling for 12 months from the date of diagnosis. Consistent with the changes we have made for other listings, any residual impairment(s) will be evaluated under 
                        <PRTPAGE P="67024"/>
                        the criteria for the affected body system after that period. With this criterion, we recognize the length and debilitating effects of multimodal treatment for these tumors. 
                    </P>
                    <HD SOURCE="HD2">Listing 13.12—Maxilla, Orbit, or Temporal Fossa </HD>
                    <P>This listing corresponds to prior listing 13.11. As noted above, we evaluate tumors of the mandible under final listing 13.11. Final listings 13.12A and 13.12B reorganize the criteria in prior listings 13.11A and 13.11B by moving the criterion for carcinoma with regional or distant metastases (part of prior listing 13.11B) to final listing 13.12A. We did this so that all tumors of the maxilla, orbit, or temporal fossa with regional or distant metastases would be covered in the same listing. The final listings do not make any substantive changes. </P>
                    <P>In the NPRM, we inadvertently changed the word “temporal” in the heading of current listing 13.11 to “infratemporal” in the heading of proposed listing 13.12 (66 FR at 59323). We are correcting the heading in these final rules. Additionally, although we moved the criterion for carcinoma with regional or distant metastases to proposed listing 13.12A, we failed to remove the criterion from proposed listing 13.12B. We are removing the criterion from final listing 13.12B in response to a public comment indicating that retaining the criterion in listing 13.12B was redundant. </P>
                    <P>In final listing 13.12C, we consolidate the disease sites in prior listings 13.11C, 13.11D, 13.11E, and 13.11F. </P>
                    <HD SOURCE="HD2">Listing 13.13—Nervous System </HD>
                    <P>This listing incorporates the criteria for malignant brain tumors from listing 11.05, “Brain tumors,” in the neurological body system, and replaces prior listing 13.12, “Brain or spinal cord.” We are expanding the listings to include tumors of the spinal cord, spinal nerve roots, and the peripheral nervous system. We are also including tumors of the central nervous system that are not specifically named. </P>
                    <P>Under final listing 13.13A, we evaluate central nervous system malignant neoplasms; that is, those affecting the brain or spinal cord. In final listing 13.13A1, we list and revise the criteria for the impairments named in prior listing 11.05A. We are revising the reference to medulloblastoma to include other primitive neuroectodermal tumors (PNETs) and to require documented metastases for this type of tumor. Advances in treatment have significantly improved the overall prognosis of this disease, so that, in the absence of metastases, many individuals do well. We can evaluate medulloblastomas or other PNETs that have not metastasized, as well as the malignant brain tumors listed in prior listing 11.05B, under final listing 13.13A2. </P>
                    <P>We are also adding diffuse intrinsic brain stem gliomas in final listing 13.13A1. We are requiring that the impairment be “diffuse” and “intrinsic” because progress in medical diagnostic tools has now allowed for effective treatment of individuals with localized brain stem tumors. </P>
                    <P>In the NPRM, the criteria in proposed listing 13.13A were preceded by the phrase, “Central nervous system neoplasms (brain and spinal cord), including * * *.” In final listing 13.13A, we are changing the word “including” to the phrase “as described in 1 or 2” to be consistent with other listings. </P>
                    <P>In final listing 13.13B, we provide criteria for evaluating malignant tumors of peripheral nerves and spinal roots. </P>
                    <P>In the NPRM, we had proposed a listing, listing 13.13C, to correspond to prior listing 13.12A for metastatic carcinoma to brain or spinal cord. In response to a public comment, we have determined that this listing is unnecessary. These malignancies will be evaluated under the criteria for the site of origin, or under listing 13.27 if the primary site is unknown. Therefore, we are removing prior listing 13.12A and proposed listing 13.13C. We are also removing prior listing 13.12B, which was a reference listing. </P>
                    <HD SOURCE="HD2">Listing 13.14—Lungs </HD>
                    <P>This listing corresponds to prior listing 13.13. In final listing 13.14A, we consolidate prior listings 13.13A, 13.13B, 13.13D, and 13.13E. This change is consistent with current medical terminology, which no longer distinguishes between the types of non-small-cell carcinoma. </P>
                    <P>In the NPRM, proposed listing 13.14A covered metastatic disease to or beyond the mediastinal or subcarinal lymph nodes. A public comment pointed out that this criterion would exclude cases of non-small-cell carcinomas with metastases to the hilar lymph nodes that had been included under prior listing 13.13E. The comment also indicated that, even when the involved hilar nodes are excised, the prognosis for this disease is unfavorable. In response to this comment, we have revised final listing 13.14A to include metastases to the hilar nodes. </P>
                    <P>We are redesignating prior listing 13.13C as final listing 13.14B. We are making no substantive changes. </P>
                    <HD SOURCE="HD2">Listing 13.15—Pleura or Mediastinum </HD>
                    <P>This listing corresponds to prior listing 13.14. Final listing 13.15A is the same as prior listing 13.14A. In final listing 13.15B, which corresponds to prior listing 13.14C, we provide new language that clarifies the phrase “not controlled by prescribed therapy” used in the prior listing. </P>
                    <P>In the NPRM, the criterion in proposed listing 13.15B1 was “Metastatic.” In final listing 13.15B1, we revise this criterion to “With metastases to or beyond the regional lymph nodes” to be consistent with the other listings in these rules. </P>
                    <P>We are removing prior listing 13.14B, “Malignant tumors, metastatic to pleura.” We will evaluate this malignancy under final listing 13.27, “Primary site unknown.” </P>
                    <HD SOURCE="HD2">Listing 13.16—Esophagus or Stomach </HD>
                    <P>This listing corresponds to prior listing 13.16. Final listing 13.16A is the same as prior listing 13.16A. In final listing 13.16B, we consolidate prior listings 13.16B through 13.16E to clarify that all of those criteria relate to carcinoma or sarcoma of the stomach. We also provide new language to clarify the phrase “not controlled by prescribed therapy” used in prior listing 13.16C. </P>
                    <HD SOURCE="HD2">Listing 13.17—Small Intestine </HD>
                    <P>This listing corresponds to prior listing 13.17. In final listing 13.17A, we expand the criterion in prior listing 13.17B, for recurrent malignancies, to indicate that inoperable and unresectable malignancies are also of listing-level severity. We also provide new language to clarify the phrase “not controlled by prescribed therapy” used in prior listing 13.17C. Final listing 13.17B corresponds to prior listing 13.17A, and is substantively unchanged. </P>
                    <HD SOURCE="HD2">Listing 13.18—Large Intestine (From Ileocecal Valve to and Including Anal Canal)</HD>
                    <P>
                        This listing corresponds to prior listing 13.18. We are removing the phrase “carcinoma or sarcoma” from the heading of this listing because sarcomas of the large intestine are extremely rare. In final listing 13.18A, we consolidate prior listings 13.18A and 13.18C and clarify that these criteria apply to adenocarcinoma. In final listing 13.18B, we provide that squamous cell carcinoma of the anus will not be found to meet the listing unless it is recurrent after surgery. Advances in treatment have made chemotherapy and radiation the treatment of choice for this disorder. However, good results can be achieved through surgery if the preferred treatment is not effective. Final listing 
                        <PRTPAGE P="67025"/>
                        13.18C is the same as prior listing 13.18B. 
                    </P>
                    <HD SOURCE="HD2">Listing 13.19—Liver or Gallbladder </HD>
                    <P>This listing corresponds to prior listing 13.19. We are clarifying that the listing applies only to malignancies that originate in the liver, gallbladder, or bile ducts. We evaluate metastases to the liver from other sites under the criteria for the site of origin, or under the criteria of final listing 13.27 when the primary site is unknown. </P>
                    <HD SOURCE="HD2">Listing 13.20—Pancreas </HD>
                    <P>This listing corresponds to prior listing 13.20. We are not making any substantive changes, other than adding “inoperable” conditions to the second listing criterion. We are making this change to reflect the revised definitions used in these listings. </P>
                    <HD SOURCE="HD2">Listing 13.21—Kidneys, Adrenal Glands, or Ureters </HD>
                    <P>This listing corresponds to prior listing 13.21. In final listing 13.21A, we expand the criteria of unresectable tumors in prior listing 13.21A to include inoperable and recurrent tumors. Final listing 13.21B consolidates prior listings 13.21B and 13.21C. We are eliminating the modifier “hematogenous” used in prior listing 13.21B because metastases by lymphatic spread or by direct extension carry the same poor prognosis. </P>
                    <HD SOURCE="HD2">Listing 13.22—Urinary Bladder </HD>
                    <P>This listing corresponds to prior listing 13.22. We are removing prior listing 13.22E, which provided for the evaluation of renal impairment following total cystectomy under the criteria in listing 6.02, because it was a reference listing. </P>
                    <HD SOURCE="HD2">Listing 13.23—Cancers of the Female Genital Tract </HD>
                    <P>In this listing, we incorporate and revise prior listings 13.25, “Uterus,” 13.26, “Ovaries,” 13.28, “Uterine (Fallopian) tubes,” and 13.30, “Vulva.” </P>
                    <P>In final listings 13.23A, “Uterus (corpus),” and 13.23B “Uterine cervix,” we replace the prior criteria in listings 13.25B, “Recurrent after total hysterectomy,” and 13.25C, “Total pelvic exenteration,” with “Persistent or recurrent following initial antineoplastic therapy.” With this revision, we recognize changes in treatment for these disorders. In final listing 13.23C, “Vulva,” we provide criteria in addition to the criteria for distant metastases used in the prior listing. </P>
                    <P>We are making several changes in final listing 13.23D, “Fallopian tubes.” In final listing 13.23D1, “ Extending to the serosa or beyond,” we replace the criteria in prior listings 13.28A, “Unresectable,” and 13.28B, “Metastases to regional lymph nodes.” Tumors extending to the serosa are considered to be unresectable for the purposes of this listing; tumors extending beyond the serosa equate to tumors that have metastasized to the regional lymph nodes. In final listing 13.23D2, we are also adding criteria to evaluate fallopian tube tumors when the initial antineoplastic therapy has not achieved the desired effect. </P>
                    <P>In final listing 13.23E, “Ovaries,” we separate germ-cell and non-germ-cell tumors. In final listing 13.23E1, which provides the criteria for evaluating non-germ-cell tumors, we expand the criteria in prior listing 13.26 to reflect advances in diagnostic techniques and treatment. We provide criteria for evaluating germ-cell tumors in final listing 13.23E2. </P>
                    <HD SOURCE="HD2">Listing 13.24—Prostate Gland </HD>
                    <P>In this listing, which corresponds to prior listing 13.23, we provide new language to clarify the phrase “not controlled by prescribed therapy” used in the prior listing. </P>
                    <HD SOURCE="HD2">Listing 13.25—Testicles </HD>
                    <P>
                        This listing corresponds to prior listing 13.24. We are removing prior listing 13.24A, for choriocarcinoma because the literature we consulted does not separate choriocarcinoma from other forms of nonseminomatous germ-cell tumors with regard to staging or treatment. (
                        <E T="03">See</E>
                         67 FR 19138 for a list of the literature we consulted.) 
                    </P>
                    <HD SOURCE="HD2">Listing 13.26—Penis </HD>
                    <P>This listing corresponds to prior listing 13.29. We have clarified the listing to explicitly include metastases to or beyond the regional lymph nodes. </P>
                    <HD SOURCE="HD2">Listing 13.27—Primary Site Unknown After Appropriate Search for Primary </HD>
                    <P>We are providing a listing for the occasional case in which metastases have been appropriately verified but the site of the primary malignancy cannot be determined. The final listing specifically excludes solitary squamous cell carcinoma in the neck, as this type of metastasis is often amenable to treatment. </P>
                    <HD SOURCE="HD2">Listing 13.28—Malignant Neoplastic Diseases Treated by Bone Marrow or Stem Cell Transplantation </HD>
                    <P>As we have already noted in our discussion of final 13.00L above, final listing 13.28 is a listing for bone marrow or stem cell transplantation in any malignant neoplastic disease other than acute leukemia, CML, lymphoma, or multiple myeloma, which we evaluate under final listings 13.05, 13.06 and 13.07. In final listing 13.28A, we provide that allogeneic transplantation is disabling until at least 12 months from the date of transplantation. In final listing 13.28B, we provide that autologous transplantation is disabling until at least 12 months from the date of the first treatment under the treatment plan that includes transplantation. We use an earlier date to begin the 12-month period for autologous transplantation because the recovery period after this type of transplantation is generally shorter than for allogeneic transplantation. In both cases, we will evaluate any residual impairment(s) after the applicable period under the criteria for the affected body system. </P>
                    <HD SOURCE="HD1">How Are We Changing the Introductory Text to the Listings for Evaluating Malignant Neoplastic Diseases in Children? </HD>
                    <HD SOURCE="HD2">113.00 Malignant Neoplastic Diseases </HD>
                    <P>Except for minor changes to refer to children, we are repeating much of the introductory text in 13.00 in the introductory text in 113.00. This is because the same basic rules for establishing and evaluating the existence and severity of malignant neoplastic diseases in adults also apply to children. Because we have already described these provisions under the explanation of 13.00, the following discussions describe only those provisions that are unique to the childhood rules or that require further explanation. </P>
                    <HD SOURCE="HD2">113.00B—What Do We Consider When We Evaluate Malignant Neoplastic Diseases Under These Listings? </HD>
                    <P>In this section, which is the same as final 13.00B, we replace the guidance in prior 113.00A1. </P>
                    <HD SOURCE="HD2">113.00D—What Evidence Do We Need? </HD>
                    <P>
                        In this section, we replace and expand prior 113.00B. This section is substantively the same as final 13.00D. We are not including a childhood listing to correspond to final listing 13.27, primary site unknown after appropriate search for primary, because the inability to determine the primary site is an extremely rare occurrence in childhood malignancies. Instead, we indicate that, in these rare situations, we will use final listing 13.27. 
                        <PRTPAGE P="67026"/>
                    </P>
                    <HD SOURCE="HD2">113.00E—When Do We Need Longitudinal Evidence? </HD>
                    <P>This section is similar to final 13.00E. We are adding a general description of most malignant childhood tumors. </P>
                    <HD SOURCE="HD2">113.00F—How Do We Evaluate Impairments That Do Not Meet One of the Malignant Neoplastic Diseases Listings? </HD>
                    <P>In this section, we repeat the guidance in final 13.00F, but use the definition of disability for children who claim SSI payments. </P>
                    <HD SOURCE="HD2">113.00G—How Do We Consider the Effects of Therapy? </HD>
                    <P>This section replaces prior 113.00A2 and the last paragraph of prior 113.00A. We repeat the guidance in final 13.00G but use the definition of disability for children who claim SSI payments. </P>
                    <HD SOURCE="HD2">113.00H—How Long Do We Consider Your Impairment To Be Disabling? </HD>
                    <P>This section corresponds to final 13.00H. It also replaces prior 113.00D, “Duration of disability,” which referred to the specific time periods that we included in prior listings 113.02 and 113.03. Although we do not cite specific listings, we indicate that some listings specify that the impairment should be considered disabling until a particular point in time. In final 113.00H2, we state that, when the listing does not contain such a specification, we will consider an impairment that meets or medically equals the listings in this body system to be disabling until at least 3 years after onset of complete remission. We added this section to ensure consistency between the adult and childhood rules. </P>
                    <HD SOURCE="HD2">113.00I—What Do These Terms in the Listings Mean? </HD>
                    <P>This section corresponds to final 13.00I. As we explain below, we are retaining our listings for malignant solid tumors. Because of this, there are no listings in part B of these final rules that include the terms “inoperable” and “unresectable.” Therefore, in these final rules, we revised proposed 113.00I to remove the definitions of those terms. </P>
                    <HD SOURCE="HD2">113.00K—How Do We Evaluate Specific Malignant Neoplastic Diseases? </HD>
                    <P>In this section, we incorporate the discussion in prior 107.00C, “Acute leukemia,” and provide guidance for other childhood malignancies. Except for minor changes to refer to children, final 113.00K4, “Brain Tumors,” is the same as final 13.00K6. The following is a discussion of the other malignant neoplastic diseases addressed in this section. </P>
                    <HD SOURCE="HD3">113.00K1—Lymphoma</HD>
                    <P>In this section, we indicate that final listing 113.05 should not be used for evaluating low grade or indolent lymphomas because they are rare in children. We will evaluate these lymphomas under final listing 13.05. We also indicate that many children with lymphoma are treated according to a long-term protocol that can result in significant adverse medical, social, and emotional consequences. We provide a reference to final 113.00G to evaluate those consequences. </P>
                    <HD SOURCE="HD3">113.00K2—Leukemia </HD>
                    <P>In final 113.00K2c, we provide a description of juvenile CML (JCML) and explain that we will evaluate it under final listing 113.06A. </P>
                    <P>Final 113.00K2d is similar to final 13.00K2d. We did not include a discussion about chronic lymphocytic leukemia, as in final 13.00K2c, because the disorder is extremely rare in children. </P>
                    <HD SOURCE="HD3">113.00K3—Malignant Solid Tumors </HD>
                    <P>In this section, we incorporate the guidance in prior 113.00C, “Malignant solid tumors.” We have revised the reference to the listing for brain tumors because that listing is now in this body system. As we have added a listing for the thyroid gland, we no longer need guidance in the introductory text explaining how thyroid tumors should be evaluated. </P>
                    <HD SOURCE="HD3">113.00K5—Retinoblastoma </HD>
                    <P>In this section, we state that treatment for bilateral retinoblastoma usually results in a visual impairment and that we will evaluate any resulting visual impairment under listing 102.02. </P>
                    <HD SOURCE="HD2">113.00L—How Do We Evaluate Malignant Neoplastic Diseases Treated by Bone Marrow or Stem Cell Transplantation? </HD>
                    <P>In this section, we provide the same guidance as in final 13.00L1, 13.00L2, and 13.00L4. We have added JCML to the heading of 13.00L1 to reflect that JCML is included in final listing 113.06A. We do not refer to multiple myeloma in final 113.00L2 because this impairment is not included in the final childhood listings. Multiple myeloma is extremely rare in children. </P>
                    <P>In the NPRM, we had also proposed a section in part B, similar to final 13.00L3, that contained guidance on how to evaluate bone marrow or stem cell transplantation for other disorders in children. That section, proposed 113.00L3, indicated that malignant neoplastic diseases treated with bone marrow or stem cell transplantation should be evaluated under proposed listing 113.28. Proposed listing 113.28 was one of several listings that we proposed as a replacement for prior listing 113.03, “Malignant solid tumors.” As we explain in the public comments section of this preamble, we have decided not to change our prior criteria for malignant solid tumors in these final rules. Therefore, we do not need the guidance we included in proposed section 113.00L3, and we are not including it in these final rules. As we indicate in response to a public comment on bone marrow or stem cell transplantation in chidren, final listing 13.28 can be used in those few cases in which the end of the 2-year period provided by final listing 113.03 is earlier than the end of the period that the impairment would be considered disabling based on the bone marrow or stem cell transplantation. </P>
                    <HD SOURCE="HD1">How Are We Changing the Listings for Evaluating Malignant Neoplastic Diseases in Children? </HD>
                    <HD SOURCE="HD2">113.01 Category of Impairments, Malignant Neoplastic Diseases </HD>
                    <P>We are redesignating the childhood listings to maintain consistency with the adult rules for those malignancies that are addressed in both the adult and childhood rules. Because of this, the numbers of the final childhood listings are not consecutive. </P>
                    <HD SOURCE="HD2">Listing 113.03—Malignant Solid Tumors </HD>
                    <P>This listing corresponds to prior listing 113.03, “Malignant Solid Tumors.” We are making minor editorial changes to make the language consistent with that used in other listings and to indicate that, after the appropriate time period has passed, any residual impairment should be evaluated under criteria for the affected body system. </P>
                    <P>
                        In the NPRM, we proposed removing prior listing 113.03 and providing separate listings for specific types of malignant solid tumors and a listing for malignant neoplastic diseases treated by bone marrow or stem cell transplantation. In response to a comment, we have decided to retain prior listing 113.03 as we further consider how to include solid tumors in children in our listings. Because we are retaining prior listing 113.03 in these final rules, we are not incorporating the proposed listings that would have replaced it: Proposed listing 113.04, “Soft Tissue Sarcoma (including Ewing's Sarcoma, Primitive Neuroectodermal Tumors (PNETs)”; proposed listing 113.11, “Osteogenic Sarcoma”; proposed listing 113.13A2, 
                        <PRTPAGE P="67027"/>
                        for any central nervous system neoplasm progressive or recurrent following initial antineoplastic therapy; proposed listing 113.13B, for peripheral nerve or spinal root neoplasm; proposed listing 113.21B, for Wilms' tumor persistent or recurrent following initial Antineoplastic therapy; proposed listing 113.25, “Testicles—Tumor With Metastatic Disease Progressive of Recurrent Following Initial Chemotherapy”; proposed listing 113.26, “Germ Cell Tumors—Gonadal or Extragonadal”; and proposed listing 113.28, “Malignant Neoplastic Diseases Treated by Bone Marrow or Stem Cell Transplantation.” 
                    </P>
                    <HD SOURCE="HD2">Listing 113.05—Lymphoma (Excluding T-cell Lymphoblastic Lymphoma—113.06) </HD>
                    <P>This listing corresponds to prior listing 113.02, “Lymphoreticular malignant neoplasms.” We are revising the listing to make it more consistent with final listing 13.05. </P>
                    <P>Final listing 113.05A replaces the criteria for non-Hodgkin's lymphoma in prior listing 113.02B. Currently, there are several treatment regimens for this disease, and they vary in the amount of time needed to complete them. Many are of sufficiently short duration that the impairment may be disabling for less than 12 months. Due to these advances in treatment, it is no longer appropriate to assume that the impairment will meet the statutory duration requirement. Instead, we will find the impairment disabling under this listing when it is persistent or recurrent following initial antineoplastic therapy. We also clarify that non-Hodgkins lymphoma includes Burkitt's and anaplastic large cell. </P>
                    <P>Final listing 113.05B replaces the criteria for Hodgkin's disease in prior listing 113.02A. With the final criterion, we clarify what we meant by “progressive disease not controlled by prescribed therapy” in the prior listing. </P>
                    <P>In final listing 113.05C, we add a criterion for bone marrow or stem cell transplantation. </P>
                    <HD SOURCE="HD2">Listing 113.06—Leukemia </HD>
                    <P>This listing replaces prior listing 107.11, “Acute leukemia.” In final listing 113.06A, for “acute leukemia,” we also include T-cell lymphoblastic lymphoma and JCML. JCML is an aggressive leukemia that responds poorly to therapy and is, therefore, more appropriately evaluated like an acute leukemia. The criteria in this listing are the same as in final listing 13.06A, and are explained in the discussion of that listing. </P>
                    <P>In final listing 113.06B, which is the same as final listing 13.06B, we added criteria for evaluating CML other than JCML. </P>
                    <HD SOURCE="HD2">Listing 113.09—Thyroid Gland </HD>
                    <P>This listing is the same as final listing 13.09 and incorporates the guidance contained in prior 113.00C. The listing criteria define when the malignancy is not controlled by prescribed therapy. </P>
                    <HD SOURCE="HD2">Listing 113.12—Retinoblastoma </HD>
                    <P>This final listing revises prior listing 113.05. We are removing prior listing 113.05A, for bilateral involvement, because with advances in treatment this malignancy is often treated successfully. As we indicate in final 113.00K4, we will evaluate the resulting visual impairment under listing 102.02. If treatment is not successful, we will evaluate the impairment under the other criteria in the final listing. </P>
                    <P>Final listing 113.12A corresponds to prior listing 113.05C. We are making no substantive changes. </P>
                    <P>Final listing 113.12B corresponds to prior listing 113.05D. We are revising the criteria to recognize that persistence after treatment, as well as recurrence, indicates a poor prognosis. </P>
                    <P>Final listing 113.12C corresponds to prior listing 113.05B. We are revising the description to make it clear that any metastatic disease is included under the listing. </P>
                    <HD SOURCE="HD2">Listing 113.13—Brain Tumors </HD>
                    <P>This listing revises the criteria for malignant brain tumors in prior listing 111.05, “Brain tumors.” We use the same criteria for evaluating brain tumors in children as in final listing 13.13A1. </P>
                    <P>In the NPRM, we proposed to expand the criteria in this listing to address other tumors of the nervous system. As explained above, we have decided to retain our prior criteria for evaluating malignant solid tumors, and these additional criteria are not needed. Because we are not including the additional criteria, we have revised the heading of this listing to reflect the types of tumors evaluated under it. </P>
                    <HD SOURCE="HD2">Listing 113.21—Neuroblastoma </HD>
                    <P>Final listing 113.21A corresponds to prior listing 113.04, “Neuroblastoma.” We have made minor editorial revisions to be consistent with other listings. </P>
                    <P>In the NPRM, we proposed changing the criteria for neuroblastoma. As explained above, we have decided to retain our prior criteria for malignant solid tumors as we further consider how to include solid tumors in children in our listings. Similarly, we have decided to retain our prior criteria for neuroblastoma. </P>
                    <P>We also proposed to expand the criteria in this listing to address Wilms' tumors. Because we are retaining our prior criteria for malignant solid tumors, this additional criterion is not needed. Therefore, we have revised the heading of this listing to reflect the types of tumors evaluated under it. </P>
                    <HD SOURCE="HD1">What Other Revisions Are We Making? </HD>
                    <P>Consistent with the changes explained above, we are also: </P>
                    <P>• Changing the name of 7.00 and 107.00 from Hemic and Lymphatic System to Hematological Disorders. We are making this change because we are moving the lymphatic impairments now contained in these body systems to 13.00 and 113.00. </P>
                    <P>• Revising the heading of listing 7.17 to remove the reference to hematologic malignancies. We are making this change because we are moving the listings for hematological malignancies to 13.00 and 113.00. </P>
                    <P>• Revising 11.00B to indicate that malignant brain tumors should be evaluated under the criteria in listing 13.13. </P>
                    <P>• Adding 111.00E to provide the same guidance as final 11.00B. </P>
                    <P>• Revising prior listings 11.05 and 111.05 by removing the criteria for malignant brain tumors. In the NPRM, proposed listing 11.05 indicated that benign brain tumors would be evaluated under 11.02, 11.03, 11.04A or B, or 12.02. Proposed listing 111.05 indicated that these tumors would be evaluated under the criteria for the resulting neurological impairment. As we reviewed these criteria, we realized that these listings should be the same. We also realized that they should allow for the evaluation of all complications of benign brain tumors. Therefore, we have replaced the reference to 12.02 with “the criteria of the affected body system” and revised final listing 111.05 for consistency between the adult and childhood listings. </P>
                    <P>
                        • Making nonsubstantive editorial changes throughout these rules to reflect the technical changes that were implemented by the final regulation we published in the 
                        <E T="04">Federal Register</E>
                         on April 24, 2002, (67 FR 20018), to correct typographical errors and omissions, to make the language clearer, and to be consistent with other rules. 
                    </P>
                    <HD SOURCE="HD1">Public Comments </HD>
                    <P>
                        In the NPRM we published in the 
                        <E T="04">Federal Register</E>
                         on November 27, 2001 (66 FR 59306), we provided the public with a 60-day comment period that ended on January 28, 2002. Due to some significant issues raised by commenters, we provided an additional 60-day 
                        <PRTPAGE P="67028"/>
                        public comment period by publishing a notice in the 
                        <E T="04">Federal Register</E>
                         on April 18, 2002 (67 FR 19138). The additional comment period ended on June 17, 2002. 
                    </P>
                    <P>In response to the two notices, we received comments from 61 commenters, 16 of whom addressed the proposed criteria for malignant neoplastic diseases. These 16 commenters included medical organizations, legal services organizations, State agencies that make disability determinations for us, and individuals. Many of the commenters raised more than one issue. We carefully considered all of the comments. </P>
                    <P>A number of the comments were quite long and detailed, requiring us to condense, summarize, or paraphrase them. We have tried to accurately present all views of the commenters and have tried to respond to all of the significant issues raised by the commenters. We provide our reasons for adopting or not adopting the comments in our responses below. </P>
                    <HD SOURCE="HD1">General Comments </HD>
                    <HD SOURCE="HD2">Extend the Comment Period and Provide the Medical and Scientific Justification for the Proposed Listings. </HD>
                    <P>
                        <E T="03">Comment:</E>
                         During the initial comment period, several commenters asked us to extend the 60-day comment period due to the length and complexity of the proposed rules. Commenters also asked us to provide the medical and scientific justification for these changes. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         As we reviewed the initial comments, we realized that significant issues were being raised, and we determined that it would be appropriate to reopen the comment period in order to get additional input on those and other issues. Therefore, on April 18, 2002, we published a notice in the 
                        <E T="04">Federal Register</E>
                         (67 FR 19138) reopening the comment period and providing an additional 60-day period within which to comment. The additional comment period ended on June 17, 2002. The notice that reopened the comment period included references to the medical and scientific sources we consulted when developing the NPRM, and invited comment on those references as well. 
                    </P>
                    <HD SOURCE="HD1">The Proposed Listings are More Restrictive Than the Prior Listings</HD>
                    <P>
                        <E T="03">Comment:</E>
                         Some commenters believed that these criteria reflect a trend toward an increased level of severity in the listings. One commenter noted that, although good arguments may be made for these changes, the criteria in the childhood listings for non-Hodgkin's lymphoma, chronic granulocytic leukemia, thyroid carcinoma, medulloblastoma, Wilms' tumor, testicular cancer, and germ-cell tumors were more restrictive. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         As we reviewed our proposed listings to respond to the public comments, we realized that we need to consider further how to address childhood malignant solid tumors in our listings. In the interim, we are retaining our prior criteria that provide that malignant solid tumors, other than brain tumors or thyroid tumors, are disabling for 2 years from the date of initial diagnosis or from the date of recurrence of active disease. We are also retaining our prior criteria for neuroblastoma. 
                    </P>
                    <HD SOURCE="HD1">Impact of the Changes </HD>
                    <P>
                        <E T="03">Comment:</E>
                         Two commenters stated that the proposed rules would result in a considerable reduction in the number of individuals eligible for disability benefits and requested that we provide an estimate of the impact of these changes. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         Based on our assessment of these rules, we do not believe that a considerable number of individuals will be adversely affected by the changes we are making in these final rules. We believe that these final rules appropriately reflect advances in medical knowledge, treatment, and methods for evaluating malignant neoplastic diseases. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         One commenter expressed concern that these rules would result in fewer claims being allowed at step 3 of the sequential evaluation process, and that a functional assessment would be required in more cases. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         Based on our assessment of these rules, we do not believe that fewer claims will be allowed at step 3 of the sequential evaluation process. 
                    </P>
                    <HD SOURCE="HD1">The Proposed Listings May Result in Delays </HD>
                    <P>
                        <E T="03">Comment:</E>
                         Several commenters expressed concern that it will take longer to evaluate some malignancies because the proposed listings for these malignancies require that the treatment has not been effective. Some of these commenters believed that evaluation of these malignancies would need to be delayed until treatment was completed. One commenter thought that we would not evaluate cases at other steps in the sequential evaluation process while we were waiting to determine the effectiveness of the treatment. One commenter thought that deferring adjudication in these cases would result in more informed decisions and prevent us from denying some cases in error. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         While we agree that these final rules may delay the adjudication of some cases, we do not believe the number of affected cases will be significantly more than under the prior rules. The prior listings for most of these malignancies also included a requirement that the impairments not be controlled by prescribed therapy. To make this determination under the prior rules, we also had to allow sufficient time to determine whether the impairments would be controlled. 
                    </P>
                    <P>When we can determine whether treatment will be effective before the treatment regimen is completed, we will make the decision about whether the malignancy is of listing-level severity at that point. Additionally, as we state in final 13.00E3 and 113.00E3, we will not defer adjudication to determine whether the therapy will achieve its intended effect if we can make a fully favorable determination or decision based on the length and effects of therapy, or the residuals of the malignancy or therapy. </P>
                    <HD SOURCE="HD1">Focus on the Individual's Particular Situation </HD>
                    <P>
                        <E T="03">Comment:</E>
                         One commenter stressed the importance of focusing on an individual's particular situation, especially when he or she has significant limitations past the listed disability time period. The commenter stated that cancer patients typically incur short-term impairments resulting from toxicities associated with chemotherapy and other treatment, and from the disease itself. The commenter also noted that impairments from treatment, such as cardiotoxicity and infertility, can manifest several years later, and that a tumor may cause disability to a patient for a period of time far surpassing that which has been allocated by the proposed regulations for certain malignant neoplastic diseases. The commenter believed that it is essential that the new regulations maintain sufficient flexibility to adequately adjust disability time periods based on the individualized nature of cancer and patient responses to treatment of the disease. 
                    </P>
                    <P>Another commenter believed that the proposed rules did not adequately address problems with fatigue, energy levels and ability to sustain work for normal periods of time. The commenter also requested that we consider the lack of immunity to infection from which many individuals with cancer suffer. </P>
                    <P>
                        <E T="03">Response:</E>
                         We believe these final regulations do allow sufficient flexibility to adjust the period of time the individual is considered disabled and stress the importance of considering residual impairment(s) or symptoms 
                        <PRTPAGE P="67029"/>
                        caused by the disease or the treatment. However, the severity of any residual impairment(s) or symptom can vary greatly, and must be evaluated on an individualized, case-by-case basis. If a severe residual impairment(s) does not meet or medically equal any listing, we will evaluate the impact of the impairment(s), as well as the impact of any symptoms caused by the disease or the treatment, at later steps in the sequential evaluation process. 
                    </P>
                    <HD SOURCE="HD1">The Listings Need Timely Review </HD>
                    <P>
                        <E T="03">Comment:</E>
                         Two commenters stated that these listings will need timely review in the future to keep up with advances in treatment and to ensure that they reflect current medical knowledge. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We agree that the listings should continue to reflect the latest medical knowledge and advances in treatment. We intend to monitor these listings and to update the criteria for any impairment contained in these listings as the need arises. For this reason, we are indicating that these rules will be in effect for 5 years after they become effective, unless we extend them or revise and issue them again. 
                    </P>
                    <HD SOURCE="HD1">Comments on the Introductory Text </HD>
                    <HD SOURCE="HD2">Provide Additional Definitions </HD>
                    <P>
                        <E T="03">Comment:</E>
                         Two commenters asked us to include definitions of “regional lymph nodes” and “distant metastases” in the introductory text. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         As we indicated in our explanation of 13.00I, our intent is to use these terms as they are used in current clinical practice. In clinical practice, these terms are defined in relation to the site of the primary malignancy. To define these terms in our listings, we would need a separate definition for each primary site specified in the listings. Our adjudicative experience has shown that the medical evidence usually indicates whether the malignancy has spread to the regional lymph nodes or beyond. Therefore, we do not believe it is practicable or necessary to add these definitions to the introductory text. Instead, we will rely on the description of the malignancy contained in the medical records. 
                    </P>
                    <HD SOURCE="HD3">Documenting Complete Remission </HD>
                    <P>
                        <E T="03">Comment:</E>
                         One commenter requested that we add a discussion of the documentation required to establish a “complete remission.” 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We partially adopted this comment by revising final 13.00H2 and 113.00H2 to clarify that “complete remission” occurs when the original tumor and any metastases are no longer evident. However, we did not add a discussion about the documentation we require to establish a complete remission. The treating source will determine the methods of evaluating complete remission for the particular malignancy for each individual patient. We will usually rely on the documentation provided by the treating source. 
                    </P>
                    <HD SOURCE="HD3">13.00 K2c—Chronic Lymphocytic Leukemia </HD>
                    <P>
                        <E T="03">Comment:</E>
                         One commenter noted that chronic lymphocytic leukemia (CLL) is mentioned only in the introductory text and believed that this is a potential source of confusion. The commenter requested that CLL be added to the heading of proposed listing 13.05, Lymphoma, and included in the criteria in proposed listings 13.05A1 and 13.05A2, which address non-Hodgkin's lymphoma. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We partially adopted the comment. The complications of CLL are diverse and, because of this, it is not always appropriate to evaluate CLL using the criteria for lymphoma. By maintaining the references in the introductory text, we provide the flexibility needed to evaluate this disorder. We have, however, included a reference to 13.00K2c in the heading of final listing 13.05 as a reminder that CLL may be evaluated under this listing when appropriate. 
                    </P>
                    <HD SOURCE="HD1">Evaluation of Hodgkin's Disease That Recurs More Than 1 Year After Completion of Therapy </HD>
                    <P>
                        <E T="03">Comment:</E>
                         One commenter disagreed with our proposed rule in 13.00K1c to consider Hodgkin's disease that recurs more than 12 months after the completion of initial antineoplastic therapy as new disease under the listings, rather than a recurrence. The commenter indicated that oncologists would consider such patients as having relapsed, rather than as having developed a new disease. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We agree that, for treatment purposes, Hodgkin's disease that recurs more than 12 months after the completion of therapy should not be considered as new disease. However, Hodgkin's disease frequently remits within 12 months of the initiation of treatment, and the period of remission is often longer than 12 months. In these instances, the impairment would not satisfy the statutory duration requirement. If the disease then recurs, we have to consider it as a new disease for purposes of determining whether the duration requirement will be met. Additionally, secondary treatment for a recurrence after 12 months can result in complete remission or cure. 
                    </P>
                    <HD SOURCE="HD1">Comments on the Listing Criteria </HD>
                    <HD SOURCE="HD2">Add Additional Criteria </HD>
                    <P>
                        <E T="03">Comment:</E>
                         Several commenters suggested that we add specific additional malignancies to the listings. One commenter expressed concern that malignancies that are not contained in the listings because they are rare or because they are often amenable to treatment will not be properly evaluated. The commenter indicated that there are no instructions as to how to adjudicate the cases of individuals who do not respond well to treatment, and believed that there was no guidance for evaluating any cases on a case-by-case basis. The commenter also believed it is not acceptable to rely on the sequential evaluation process, since that process is often difficult to enforce and apply uniformly to people of all age groups. The commenter said this is especially true for children. The commenter suggested that these regulations include a full listing of any malignancy that is of listing-level severity. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We have not added the specific malignancies suggested by the commenters. In some instances, we believe the malignancies are already included in the final rules. For example, one commenter suggested we add nasopharyngeal cancer. This malignancy will be evaluated under final listing 13.02, for soft tissue tumors of the head and neck. Another commenter suggested we add an adult listing for germ-cell tumors. These malignancies will be evaluated under the criteria in listing 13.15B or listing 13.23E2, depending on the site of the malignancy. 
                    </P>
                    <P>In other instances, such as prostate cancer with bone metastases or earlier stages of multiple myeloma, we believe that there are effective therapies that, even considering their length and effects, generally do not result in an impairment of listing-level severity. In these situations, we believe that the impairment should not be considered to be of listing-level severity until it is demonstrated that therapy is not effective. </P>
                    <P>
                        We did not add the other suggested additions, such as granulocytic sarcoma, because these malignancies are rare. As noted in sections 13.00F and 113.00F of these rules, the listings contain examples of impairments that we consider severe enough to prevent an adult from doing any gainful activity, or that cause marked and severe functional limitations in a child. The listings are 
                        <PRTPAGE P="67030"/>
                        not intended to be all-inclusive. The purpose of the listings—to allow us to readily identify individuals with common impairments of listing-level severity—would be defeated if we tried to identify every malignancy that could be of listing-level severity. 
                    </P>
                    <P>However, we believe that our regulations do provide adequate guidance about how to evaluate malignancies that do not respond to treatment or that are unlisted. Many of these final listings address situations in which treatment is not successful. For example, final listing 13.02B addresses the situation in which the malignancy is persistent following initial multimodal antineoplastic treatment and final listing 13.09B addresses the situation in which the malignancy is progressive despite radioactive iodine therapy. We also have other rules that discuss how to evaluate impairments that are not listed. These other rules are not included in this notice, as we are not making any changes to them. We believe that malignancies that are not listed can be properly and uniformly evaluated under these other rules. </P>
                    <P>Also, and as we have already noted, as we reviewed our proposed listings to respond to the last comment, we realized that we need to consider further how to include childhood malignant solid tumors in our listings. In the interim, we have decided to retain our prior criteria for these impairments. </P>
                    <P>
                        <E T="03">Comment:</E>
                         One commenter recommended that all cases of lymphoma should be determined to be of listing-level severity and that cases not covered by the proposed rules should be allowed with a short reexamination diary. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We have not included criteria for additional lymphoma cases. It would not be appropriate to include lymphomas that do not satisfy the criteria in these final rules because we cannot presume that these impairments will meet the statutory duration requirement. Other lymphomas may respond more readily to therapy. 
                    </P>
                    <HD SOURCE="HD2">Use Staging Systems </HD>
                    <P>
                        <E T="03">Comment:</E>
                         Two commenters suggested we incorporate accepted classifications and staging in the listings. One indicated we should use clinical classifications and stagings that are tied to ongoing tumor registries that are matched with survival rates. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         As in the NPRM, these final rules incorporate staging criteria where appropriate. In these instances, we list the criteria for the stage rather than refer to the stage number. For example, the criteria in final listing 13.10A, for locally advanced breast carcinoma, correspond to stage IIIB. 
                    </P>
                    <P>We decided not to include staging numbers for two reasons. The first is that there are different staging classifications and these different classifications are not necessarily consistent. The second is that staging classifications change. If we used the staging number as the criterion, these rules may no longer be appropriate if a change in staging classifications is made. </P>
                    <HD SOURCE="HD2">Listings With Time Limits </HD>
                    <P>
                        <E T="03">Comment:</E>
                         Several commenters noted that several of the proposed listings included language about time limits after which the adjudicator was advised to evaluate any residual impairment(s) under the relevant body system, but that these listings did not refer to the medical improvement review standard in §§ 404.1594, 416.994, and 416.994a. They believed that failure to apply the medical improvement review standard at the end of the specified period would be contrary to the statute. One of these commenters believed that a time limit should, at most, result in a date for reviewing the individual's continuing eligibility for disability benefits. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         As in the prior listings and in a number of listings in other body systems, some of the listings in these final rules contain time limits in their criteria to explain the period for which we will presume that the individuals are disabled based on the nature of their impairments, the duration and effects of therapy, and the expected course of the impairments. After the therapy is completed and the relevant time period has passed, we can no longer presume that these individuals are disabled. When we review these claims to determine if these individuals continue to be disabled, we will apply the appropriate medical improvement review standard set forth in our regulations in §§ 404.1594, 416.994, or 416.994a. 
                    </P>
                    <HD SOURCE="HD2">Final Listing 13.02 </HD>
                    <P>
                        <E T="03">Comment:</E>
                         One commenter noted that we replaced the phrase “not controlled by prescribed therapy” in prior listing 13.02B with “[p]ersistent disease following initial multimodal antineoplastic therapy” in proposed listing 13.02B. The commenter expressed concern that this criterion would exclude patients who are treated with radiation alone (uni-modal therapy), have persistent disease, and who cannot undergo surgery because of the medical condition or because the tumor remains unresectable. The commenter indicated the prognosis for these individuals seems to fit the intent of the listing. The commenter recommended we use the phrase “therapy for curative intent” instead of “initial multimodal antineoplastic therapy.” 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We did not adopt the comment because individuals described in the comment have impairments that meet final listing 13.02A. That listing describes individuals who have tumors that are inoperable or unresectable. The definitions of the terms “inoperable” and “unresectable” in final 13.00I1 and 13.00I2 include the individuals described by the commenter. 
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         One commenter noted the criterion for epidermoid carcinoma occurring in the pyriform sinus in proposed listing 13.02E and questioned why this site was singled out. The commenter indicated this impairment would be covered under the criteria for soft tissue tumors with multimodal therapy in proposed listing 13.02F. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We agree with the commenter and have deleted the criterion for epidermoid carcinoma occurring in the pyriform sinus in final listing 13.02. Due to this deletion, we redesignated proposed listing 13.02F, for soft tissue tumors of the head and neck treated with multimodal therapy, as final listing 13.02E. 
                    </P>
                    <HD SOURCE="HD2">Final Listing 13.05 </HD>
                    <P>
                        <E T="03">Comment:</E>
                         One commenter believed that the language in proposed listing 13.05A2, for low-grade or indolent lymphoma requiring initiation of more than 1 antineoplastic treatment regimen within a consecutive 12-month period, was confusing. The commenter indicated that we should specify that concurrent treatments would not apply and that the treatments must occur on separate occasions. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         The listing refers to a treatment regimen that may consist of more than one modality of treatment. The modalities used in the treatment regimen may be administered concurrently or sequentially, depending on the regimen. Regardless of the way the modalities are administered, they are still considered to be one treatment regimen. Therefore, we have not adopted the commenter's suggested changes. 
                    </P>
                    <P>
                        However, in reviewing the proposed listing in response to this comment, we realized that some clarification of the introductory text to the listings was needed. The heading of final listing 13.05 cross-refers to 13.00K1 in the introductory text. However, proposed 13.00K1a discussed only “indolent” lymphoma, and did not refer to “low grade” lymphoma even though the 
                        <PRTPAGE P="67031"/>
                        listing refers to both. This was an oversight. To be consistent with the listing criteria, we have amended final 13.00K1a to refer to both low grade and indolent lymphomas. 
                    </P>
                    <HD SOURCE="HD2">Final Listing 13.10 </HD>
                    <P>
                        <E T="03">Comment:</E>
                         One commenter noted the criterion for breast cancer in proposed listing 13.10C, for recurrent carcinoma, except local recurrence that remits with antineoplastic therapy. The commenter believed that this criterion should be interpreted to mean a recurrence that remits with therapy subsequent to initial treatment and that adjudicators would therefore be looking at two separate events. The commenter asked whether this interpretation was correct. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         The commenter's interpretation is correct. Breast carcinoma that had previously remitted with initial antineoplastic treatment, that has now recurred locally, and that remits with the antineoplastic therapy given for the recurrence does not represent an impairment of listing-level severity. An example is breast cancer that initially remits following a lumpectomy and radiation, but later recurs at the site of the incision, and is successfully treated with mastectomy. 
                    </P>
                    <HD SOURCE="HD2">Final Listing 13.12 </HD>
                    <P>
                        <E T="03">Comment:</E>
                         One commenter noted that the phrase “or with regional or distant metastases” in proposed listing 13.12B was unnecessary as regional and distant metastases are covered in proposed listing 13.12A. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We agree with the commenter and have removed the phrase from final listing 13.12B. 
                    </P>
                    <HD SOURCE="HD2">Final Listing 13.13 </HD>
                    <P>
                        <E T="03">Comment:</E>
                         One commenter questioned why we retained the listing for metastatic carcinoma to the brain (proposed listings 13.13C and 113.13C) when all other listings refer to the site of origin of the tumor. The commenter asked if these listings apply to cases of testicular cancer with brain metastases. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         In response to this comment, we did not incorporate proposed listings 13.13C and 113.13C, for metastatic carcinoma to brain or spinal cord, in the final rules so that the final listings will refer to the site of origin of the tumor. We also revised the introductory text (13.00C and 113.00C) to reflect this change. 
                    </P>
                    <HD SOURCE="HD2">Final Listing 13.14 </HD>
                    <P>
                        <E T="03">Comment:</E>
                         One commenter disagreed with the proposed deletion of the listing for non-squamous non-small-cell carcinoma with metastases to the hilar lymph nodes (prior listing 13.13E). The commenter indicated that there have not been significant treatment advances for this malignancy, nor has there been a significant improvement in prognosis. The commenter stated that excising the involved hilar nodes has not altered the unfavorable prognosis for this malignancy. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We agree with the commenter and have revised listing 13.14A to include the hilar nodes. 
                    </P>
                    <HD SOURCE="HD2">Final Listing 13.25 </HD>
                    <P>
                        <E T="03">Comment:</E>
                         One commenter objected to the deletion of prior listing 13.24A, for choriocarcinoma. The commenter indicated that choriocarcinoma is a particularly aggressive testicular cancer with frequent distant metastases and should not be evaluated in the same manner as other forms of testicular cancer. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         The literature we consulted did not separate choriocarcinoma from other forms of testicular nonseminomatous germ-cell tumors with regard to staging or treatment. Therefore, we did not adopt the comment. 
                    </P>
                    <HD SOURCE="HD2">Final Listing 113.10 </HD>
                    <P>
                        <E T="03">Comment:</E>
                         One commenter questioned the proposed deletion of the criterion for bilateral retinoblastoma (prior listing 113.05A). The commenter indicated that most children with this disease are blind in one eye and have decreased vision in the other eye, resulting in significant visual impairments. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We recognize that the current treatment of this disease results in significant visual impairments. While we have not retained this criterion in final listing 113.10, we have added guidance to the introductory text, final 113.00K5, providing that we will evaluate any resulting visual impairment(s) under the criteria in listing 102.02. 
                    </P>
                    <HD SOURCE="HD2">Final Listing 113.21 </HD>
                    <P>
                        <E T="03">Comment:</E>
                         One commenter noted that prior listing 113.04, for neuroblastoma, included a criterion for recurrent disease which was not included in proposed listing 113.21A. The commenter asked if we intended to delete this criterion, as the deletion was not addressed in the explanation of the proposed listing. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We did not intend to delete this criterion, and it is included in these rules as final listing 113.21C. 
                    </P>
                    <HD SOURCE="HD2">Final Listings 113.25 and 113.26 </HD>
                    <P>
                        <E T="03">Comment:</E>
                         Two commenters noted that testicular germ-cell tumors could be evaluated under either proposed listing 113.25, for testicular malignancies, or proposed listing 113.26, for germ-cell tumors. The commenters suggested that we evaluate testicular germ-cell tumors under the listing for testicular malignancies and exclude them from the listing for germ-cell tumors. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We did not adopt the comments because we decided to retain our prior criteria for malignant solid tumors in children. Under these final rules, malignant neoplasms that would have been evaluated under the proposed listings 113.25 and 113.26 will be considered to be disabling for 2 years from the date of initial diagnosis or the date of recurrence of active disease. 
                    </P>
                    <HD SOURCE="HD2">Final Listing 113.28 </HD>
                    <P>
                        <E T="03">Comment:</E>
                         One commenter believed that a 12-month listing criterion is too short for children who have malignant neoplastic diseases treated by allogeneic bone marrow or stem cell transplantation. The commenter believed we should consider the increased risk of acute or chronic graft vs. host disease and infection in pediatric patients. 
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         As already noted, we decided to retain our prior criteria for malignant solid tumors in children. Therefore, we are not including the proposed listing that was the subject of this comment in these final rules. 
                    </P>
                    <P>
                        Under these final rules, criteria for evaluating bone marrow or stem cell transplants in cases of leukemia or lymphoma are included in the listings for those disorders, final listings 113.05 and 113.06. Under final listing 113.03, malignant solid tumors in children will be considered disabling for 2 years from the date of initial diagnosis or the date of recurrence of active disease regardless of whether a bone marrow or stem cell transplant has been performed. The adult listing for bone marrow or stem cell transplantation, final listing 13.28, can be used to evaluate those few cases in which the end of the 2-year period is earlier than the end of the period that the impairment would be considered disabling based on the bone marrow or stem cell transplantation. Final listing 13.28A, for malignant neoplastic diseases treated by allogeneic bone marrow or stem cell transplantation, provides that the individual will be considered to be under a disability until “at least” 12 months from the date of transplantation. Use of the phrase “at least” provides us with the flexibility to set a longer time frame when appropriate. 
                        <PRTPAGE P="67032"/>
                    </P>
                    <HD SOURCE="HD1">Regulatory Procedures </HD>
                    <HD SOURCE="HD2">Executive Order 12866 </HD>
                    <P>We have consulted with the Office of Management and Budget (OMB) and determined that these final rules meet the criteria for a significant regulatory action under Executive Order 12866, as amended by Executive Order 13258. Thus, they were subject to OMB review. </P>
                    <HD SOURCE="HD2">Regulatory Flexibility Act </HD>
                    <P>We certify that these final rules do not have a significant economic impact on a substantial number of small entities because they affect only individuals. Thus, a regulatory flexibility analysis as provided in the Regulatory Flexibility Act, as amended, is not required. </P>
                    <HD SOURCE="HD2">Paperwork Reduction Act </HD>
                    <P>
                        These final rules contain reporting requirements at 13.00B, 13.00D, 13.00E, 13.00G, 13.00K, 113.00B, 113.00D, 113.00E, 113.00G, and 113.00K of the final rules. An Information Collection Request has been submitted to OMB. While these rules will be effective 30 days from publication, these burdens will not be effective until approved by OMB. We will publish a notice in the 
                        <E T="04">Federal Register</E>
                         upon OMB's approval of the information collection requirements. 
                    </P>
                    <LSTSUB>
                        <HD SOURCE="HED">List of Subjects in 20 CFR Part 404 </HD>
                        <P>Administrative practice and procedure, Death benefits, Blind, Disability benefits, Old-Age, Survivors, and Disability Insurance, Reporting and recordkeeping requirements, Social Security.</P>
                    </LSTSUB>
                    <SIG>
                        <FP>(Catalog of Federal Domestic Assistance Program Nos. 96.001, Social Security-Disability Insurance; 96.002, Social Security-Retirement Insurance; 96.004, Social Security-Survivors insurance; and 96.006, Supplemental Security Income) </FP>
                        <DATED>Dated: July 19, 2004. </DATED>
                        <NAME>Jo Anne B. Barnhart, </NAME>
                        <TITLE>Commissioner of Social Security. </TITLE>
                    </SIG>
                    <REGTEXT TITLE="20" PART="404">
                        <AMDPAR>For the reasons set forth in the preamble, subpart P of part 404 of chapter III of title 20 of the Code of Federal Regulations is amended as set forth below: </AMDPAR>
                        <PART>
                            <HD SOURCE="HED">PART 404—FEDERAL OLD-AGE, SURVIVORS AND DISABILITY INSURANCE (1950-    ) </HD>
                        </PART>
                        <AMDPAR>1. The authority citation for subpart P of part 404 continues to read as follows: </AMDPAR>
                        <AUTH>
                            <HD SOURCE="HED">Authority:</HD>
                            <P>Secs. 202, 205(a), (b), and (d)-(h), 216(i), 221(a) and (i), 222(c), 223, 225, and 702(a)(5) of the Social Security Act (42 U.S.C. 402, 405(a), (b), and (d)-(h), 416(i), 421(a) and (i), 422(c), 423, 425, and 902(a)(5)); sec. 211(b), Pub. L. 104-193, 110 Stat. 2105, 2189. </P>
                        </AUTH>
                    </REGTEXT>
                    <REGTEXT TITLE="20" PART="404">
                        <HD SOURCE="HD1">Appendix 1 to Subpart P of Part 404—[Amended] </HD>
                        <AMDPAR>2. Appendix 1 to subpart P of part 404 is amended as follows: </AMDPAR>
                        <AMDPAR>a. Item 8 of the introductory text before part A of appendix 1 is amended by revising the body system name. </AMDPAR>
                        <AMDPAR>b. Item 14 of the introductory text before part A of appendix 1 is amended by revising the body system name and expiration date. </AMDPAR>
                        <AMDPAR>c. The Table of Contents for part A of appendix 1 is amended by revising the body system names for sections 7.00 and 13.00. </AMDPAR>
                        <AMDPAR>d. The body system name of section 7.00 of part A of appendix 1 is revised and paragraph E of the introductory text of section 7.00, Hematological Disorders, is removed.</AMDPAR>
                        <AMDPAR>e. Listings 7.11, 7.12, 7.13, 7.14, and 7.16 of part A of appendix 1 are removed.</AMDPAR>
                        <AMDPAR>f. Listing 7.17 of part A of appendix 1 is revised.</AMDPAR>
                        <AMDPAR>g. Paragraph B of the introductory text of section 11.00, Neurological, of part A of appendix 1 is revised.</AMDPAR>
                        <AMDPAR>h. Listing 11.05 of part A of appendix 1 is revised.</AMDPAR>
                        <AMDPAR>i. Section 13.00 of part A of appendix 1 is revised.</AMDPAR>
                        <AMDPAR>j. The Table of Contents for part B of appendix 1 is amended by revising the body system names for sections 107.00 and 113.00.</AMDPAR>
                        <AMDPAR>k. The body system name of section 107.00 of part B of appendix 1 is revised and paragraph C of the introductory text of section 107.00, Hematological Disorders, is removed.</AMDPAR>
                        <AMDPAR>l. Listing 107.11 of part B of appendix 1 is removed.</AMDPAR>
                        <AMDPAR>m. Paragraph E is added to the introductory text of section 111.00, Neurological, of part B of appendix 1.</AMDPAR>
                        <AMDPAR>n. Listing 111.05 of part B of appendix 1 is revised.</AMDPAR>
                        <AMDPAR>o. Section 113.00 of part B of appendix 1 is revised.</AMDPAR>
                        <P>The revised text is set forth as follows:</P>
                        <APPENDIX>
                            <HD SOURCE="HED">Appendix 1 to Subpart P of Part 404—Listing of Impairments</HD>
                            <STARS/>
                            <P>8. Hematological Disorders (7.00 and 107.00): July 1, 2005.</P>
                            <STARS/>
                            <P>14. Malignant Neoplastic Diseases (13.00 and 113.00): December 15, 2009.</P>
                            <STARS/>
                            <HD SOURCE="HD2">Part A</HD>
                            <STARS/>
                            <P>7.00 Hematological Disorders</P>
                            <STARS/>
                            <P>13.00 Malignant Neoplastic Diseases</P>
                            <STARS/>
                            <P>7.00 HEMATOLOGICAL DISORDERS</P>
                            <STARS/>
                            <P>E. [removed]</P>
                            <STARS/>
                            <P>7.11 [removed]</P>
                            <P>7.12 [removed]</P>
                            <P>7.13 [removed]</P>
                            <P>7.14 [removed]</P>
                            <STARS/>
                            <P>7.16 [removed]</P>
                            <P>
                                7.17 
                                <E T="03">Aplastic anemias</E>
                                 with bone marrow or stem cell transplantation. Consider under a disability for 12 months following transplantation; thereafter, evaluate according to the primary characteristics of the residual impairment.
                            </P>
                            <STARS/>
                            <P>11.00 NEUROLOGICAL</P>
                            <STARS/>
                            <P>
                                B. 
                                <E T="03">Brain tumors.</E>
                                 We evaluate malignant brain tumors under the criteria in 13.13. For benign brain tumors, we determine the severity and duration of the impairment on the basis of symptoms, signs, and laboratory findings (11.05).
                            </P>
                            <STARS/>
                            <P>
                                11.05 
                                <E T="03">Benign brain tumors.</E>
                                 Evaluate under 11.02, 11.03, 11.04, or the criteria of the affected body system.
                            </P>
                            <STARS/>
                            <P>13.00 MALIGNANT NEOPLASTIC DISEASES </P>
                            <P>
                                A. 
                                <E T="03">What impairments do these listings cover?</E>
                                 We use these listings to evaluate all malignant neoplasms except certain neoplasms associated with human immunodeficiency virus (HIV) infection. We use the criteria in 14.08E to evaluate carcinoma of the cervix, Kaposi's sarcoma, lymphoma, and squamous cell carcinoma of the anus if you also have HIV infection. 
                            </P>
                            <P>
                                B. 
                                <E T="03">What do we consider when we evaluate malignant neoplastic diseases under these listings?</E>
                                 We consider factors such as the: 
                            </P>
                            <P>1. Origin of the malignancy. </P>
                            <P>2. Extent of involvement. </P>
                            <P>3. Duration, frequency, and response to antineoplastic therapy. Antineoplastic therapy means surgery, irradiation, chemotherapy, hormones, immunotherapy, or bone marrow or stem cell transplantation. When we refer to surgery as an antineoplastic treatment, we mean surgical excision for treatment, not for diagnostic purposes. </P>
                            <P>4. Effects of any post-therapeutic residuals. </P>
                            <P>
                                C. 
                                <E T="03">How do we apply these listings?</E>
                                 We apply the criteria in a specific listing to a malignancy originating from that specific site. 
                            </P>
                            <P>
                                D. 
                                <E T="03">What evidence do we need?</E>
                            </P>
                            <P>1. We need medical evidence that specifies the type, extent, and site of the primary, recurrent, or metastatic lesion. When the primary site cannot be identified, we will use evidence documenting the site(s) of metastasis to evaluate the impairment under 13.27. </P>
                            <P>2. For operative procedures, including a biopsy or a needle aspiration, we generally need a copy of both the: </P>
                            <P>a. Operative note. </P>
                            <P>b. Pathology report. </P>
                            <P>
                                3. When we cannot get these documents, we will accept the summary of 
                                <PRTPAGE P="67033"/>
                                hospitalization(s) or other medical reports. This evidence should include details of the findings at surgery and, whenever appropriate, the pathological findings. 
                            </P>
                            <P>
                                4. In some situations we may also need evidence about recurrence, persistence, or progression of the malignancy, the response to therapy, and any significant residuals. (
                                <E T="03">See</E>
                                 13.00G.) 
                            </P>
                            <P>
                                E. 
                                <E T="03">When do we need longitudinal evidence?</E>
                            </P>
                            <P>
                                1. 
                                <E T="03">Tumors with distant metastases.</E>
                                 We generally do not need longitudinal evidence for tumors that have metastasized beyond the regional lymph nodes because these tumors usually meet the requirements of a listing. Exceptions are for tumors with distant metastases that are expected to respond to antineoplastic therapy. For these exceptions, we usually need a longitudinal record of 3 months after therapy starts to determine whether the intended effect of therapy has been achieved and is likely to persist. 
                            </P>
                            <P>
                                2. 
                                <E T="03">Other malignancies.</E>
                                 When there are no distant metastases, many of the listings require that we consider your response to initial antineoplastic therapy; that is, the initial planned treatment regimen. This therapy may consist of a single modality or a combination of modalities (multimodal) given in close proximity as a unified whole, and is usually planned before any treatment(s) is initiated. Examples of multimodal therapy include: 
                            </P>
                            <P>a. Surgery followed by chemotherapy or radiation. </P>
                            <P>b. Chemotherapy followed by surgery. </P>
                            <P>c. Chemotherapy and concurrent radiation. </P>
                            <P>
                                3. 
                                <E T="03">Types of treatment.</E>
                                 Whenever the initial planned therapy is a single modality, enough time must pass to allow a determination about whether the therapy will achieve its intended effect. If the treatment fails, the failure will often happen within 6 months after the treatment starts, and there will often be a change in the treatment regimen. Whenever the initial planned therapy is multimodal, a determination about the effectiveness of the therapy usually cannot be made until the effects of all the planned modalities can be determined. In some cases, we may need to defer adjudication until the effectiveness of therapy can be assessed. However, we do not need to defer adjudication to determine whether the therapy will achieve its intended effect if we can make a fully favorable determination or decision based on the length and effects of therapy, or the residuals of the malignancy or therapy (
                                <E T="03">see</E>
                                 13.00G). 
                            </P>
                            <P>
                                F. 
                                <E T="03">How do we evaluate impairments that do not meet one of the malignant neoplastic diseases listings?</E>
                            </P>
                            <P>1. These listings are only examples of malignant neoplastic diseases that we consider severe enough to prevent you from doing any gainful activity. If your severe impairment(s) does not meet the criteria of any of these listings, we must also consider whether you have an impairment(s) that meets the criteria of a listing in another body system. </P>
                            <P>
                                2. If you have a severe medically determinable impairment(s) that does not meet a listing, we will determine whether your impairment(s) medically equals a listing. (
                                <E T="03">See</E>
                                 §§ 404.1526 and 416.926.) If your impairment(s) does not meet or medically equal a listing, you may or may not have the residual functional capacity to engage in substantial gainful activity. In that situation, we proceed to the fourth, and, if necessary, the fifth steps of the sequential evaluation process in §§ 404.1520 and 416.920. If you are an adult, we use the rules in §§ 404.1594 and 416.994, as appropriate, when we decide whether you continue to be disabled. 
                            </P>
                            <P>
                                G. 
                                <E T="03">How do we consider the effects of therapy?</E>
                            </P>
                            <P>
                                1. 
                                <E T="03">How we consider the effects of therapy under the listings.</E>
                                 In many cases, malignancies meet listing criteria only if the therapy does not achieve the intended effect: the malignancy persists, progresses, or recurs despite treatment. However, as explained in the following paragraphs, we will not delay adjudication if we can make a fully favorable determination or decision based on the evidence in the case record. 
                            </P>
                            <P>
                                2. 
                                <E T="03">Effects can vary widely.</E>
                            </P>
                            <P>a. Because the therapy and its toxicity may vary widely, we consider each case on an individual basis. We will request a specific description of the therapy, including these items: </P>
                            <P>i. Drugs given. </P>
                            <P>ii. Dosage. </P>
                            <P>iii. Frequency of drug administration. </P>
                            <P>iv. Plans for continued drug administration. </P>
                            <P>v. Extent of surgery. </P>
                            <P>vi. Schedule and fields of radiation therapy. </P>
                            <P>b. We will also request a description of the complications or adverse effects of therapy, such as the following: </P>
                            <P>i. Continuing gastrointestinal symptoms. </P>
                            <P>ii. Persistent weakness. </P>
                            <P>iii. Neurological complications. </P>
                            <P>iv. Cardiovascular complications. </P>
                            <P>v. Reactive mental disorders. </P>
                            <P>
                                3. 
                                <E T="03">Effects of therapy may change.</E>
                                 Because the severity of the adverse effects of antineoplastic therapy may change during treatment, enough time must pass to allow us to evaluate the therapy's effect. The residual effects of treatment are temporary in most instances. But on occasion, the effects may be disabling for a consecutive period of at least 12 months. 
                            </P>
                            <P>
                                4. 
                                <E T="03">When the initial antineoplastic therapy is effective.</E>
                                 We evaluate any post-therapeutic residual impairment(s) not included in these listings under the criteria for the affected body system. We must consider any complications of therapy. When the residual impairment(s) does not meet or medically equal a listing, we must consider its effect on your ability to do substantial gainful activity. 
                            </P>
                            <P>
                                H. 
                                <E T="03">How long do we consider your impairment to be disabling?</E>
                            </P>
                            <P>1. In some listings, we specify that we will consider your impairment to be disabling until a particular point in time (for example, at least 18 months from the date of diagnosis). We may consider your impairment to be disabling beyond this point when the medical and other evidence justifies it. </P>
                            <P>2. When a listing does not contain such a specification, we will consider an impairment(s) that meets or medically equals a listing in this body system to be disabling until at least 3 years after onset of complete remission. When the impairment(s) has been in complete remission for at least 3 years, that is, the original tumor and any metastases have not been evident for at least 3 years, the impairment(s) will no longer meet or medically equal the criteria of a listing in this body system. </P>
                            <P>3. Following the appropriate period, we will consider any residuals, including residuals of the malignancy or therapy (see 13.00G), in determining whether you are disabled. </P>
                            <P>
                                I. 
                                <E T="03">What do these terms in the listings mean?</E>
                            </P>
                            <P>
                                1. 
                                <E T="03">Inoperable:</E>
                                 Surgery is thought to be of no therapeutic value or the surgery cannot be performed. Examples of when surgery cannot be performed include a tumor that is too large or that invades crucial structures, or an intolerance of anesthesia or surgery due to other medical conditions. This term does not include situations in which the tumor could have been surgically removed but another method of treatment was chosen; for example, an attempt at organ preservation. The determination whether a tumor is inoperable usually occurs before attempts to shrink the tumor with chemotherapy or radiation. 
                            </P>
                            <P>
                                2. 
                                <E T="03">Unresectable:</E>
                                 The operation was performed, but the malignant tumor was not removed. This term includes situations in which a tumor is incompletely resected or the surgical margins are positive. 
                            </P>
                            <P>
                                3. 
                                <E T="03">Persistent:</E>
                                 Failure to achieve a complete remission. 
                            </P>
                            <P>
                                4. 
                                <E T="03">Progressive:</E>
                                 The malignancy became more extensive after treatment. 
                            </P>
                            <P>
                                5. 
                                <E T="03">Recurrent, relapse:</E>
                                 A malignancy that had been in complete remission or entirely removed by surgery has returned. 
                            </P>
                            <P>
                                J. 
                                <E T="03">Can we establish the existence of a disabling impairment prior to the date of the evidence that shows the malignancy satisfies the criteria of a listing?</E>
                                 Yes. We will consider factors such as: 
                            </P>
                            <P>1. The type of malignancy and its location. </P>
                            <P>2. The extent of involvement when the malignancy was first demonstrated. </P>
                            <P>3. Your symptoms. </P>
                            <P>
                                K. 
                                <E T="03">How do we evaluate specific malignant neoplastic diseases?</E>
                            </P>
                            <P>
                                1. 
                                <E T="03">Lymphoma.</E>
                            </P>
                            <P>
                                a. Many low grade or indolent (non-aggressive) lymphomas are controlled by well-tolerated treatment modalities, although they may produce intermittent symptoms and signs. Therefore, we may defer adjudication of these cases for an appropriate period after initiation of therapy to determine whether the therapy will achieve its intended effect. (
                                <E T="03">See</E>
                                 13.00E3.) For a low grade or indolent lymphoma, the intended effect of therapy is usually stability of the disease process. When stability has been achieved, we will assess severity on the basis of the extent of involvement of other organ systems and residuals from therapy. 
                            </P>
                            <P>
                                b. A change in therapy for low grade or indolent lymphomas is usually an indicator that the therapy is not achieving its intended effect. However, it does not indicate this if the change is based on your (or your physician's) choice rather than a failure to achieve stability. If the therapy is changed 
                                <PRTPAGE P="67034"/>
                                due solely to choice, the requirements of listing 13.05A2a are not met. 
                            </P>
                            <P>c. We consider Hodgkin's disease that recurs more than 12 months after completing initial antineoplastic therapy to be a new disease rather than a recurrence. </P>
                            <P>
                                2. 
                                <E T="03">Leukemia.</E>
                            </P>
                            <P>
                                a. 
                                <E T="03">Acute leukemia.</E>
                                 The initial diagnosis of acute leukemia, including the accelerated or blast phase of chronic myelogenous (granulocytic) leukemia, is based upon definitive bone marrow examination. Additional diagnostic information is based on chromosomal analysis, cytochemical and surface marker studies on the abnormal cells, or other methods consistent with the prevailing state of medical knowledge and clinical practice. Recurrent disease must be documented by peripheral blood, bone marrow, or cerebrospinal fluid examination. The initial and follow-up pathology reports should be included. 
                            </P>
                            <P>
                                b. 
                                <E T="03">Chronic myelogenous leukemia (CML).</E>
                                 The diagnosis of CML should be based upon documented granulocytosis, including immature forms such as differentiated or undifferentiated myelocytes and myeloblasts, and a chromosomal analysis that demonstrates the Philadelphia chromosome. In the absence of a chromosomal analysis, or if the Philadelphia chromosome is not present, the diagnosis may be made by other methods consistent with the prevailing state of medical knowledge and clinical practice. 
                            </P>
                            <P>
                                c. 
                                <E T="03">Chronic lymphocytic leukemia.</E>
                            </P>
                            <P>
                                i. The diagnosis of chronic lymphocytic leukemia (CLL) must be documented by evidence of a chronic lymphocytosis of at least 10,000/mm 
                                <SU>3</SU>
                                 for 3 months or longer, or other acceptable diagnostic techniques consistent with the prevailing state of medical knowledge and clinical practice. 
                            </P>
                            <P>ii. We evaluate the complications and residual impairment(s) from CLL under the appropriate listings, such as 13.05A2, 7.02, and 7.15. </P>
                            <P>
                                d. 
                                <E T="03">Elevated white cell count.</E>
                                 In cases of chronic leukemia (either myelogenous or lymphocytic), an elevated white cell count, in itself, is not ordinarily a factor in determining the severity of the impairment. 
                            </P>
                            <P>
                                3. 
                                <E T="03">Macroglobulinemia or heavy chain disease.</E>
                                 The diagnosis of these diseases must be confirmed by protein electrophoresis or immunoelectrophoresis. We evaluate the resulting impairment(s) under the criteria of 7.02, 7.06, 7.08, or any other affected body system. 
                            </P>
                            <P>
                                4. 
                                <E T="03">Bilateral primary breast cancer.</E>
                                 We evaluate bilateral primary breast cancer (synchronous or metachronous) under 13.10A, which covers local primary disease, and not as a primary disease that has metastasized. 
                            </P>
                            <P>
                                5. 
                                <E T="03">Carcinoma-in-situ.</E>
                                 Carcinoma-in-situ, or preinvasive carcinoma, usually responds to treatment. When we use the term “carcinoma” in these listings, it does not include carcinoma-in-situ. 
                            </P>
                            <P>
                                6. 
                                <E T="03">Brain tumors.</E>
                                 We use the criteria in 13.13 to evaluate malignant brain tumors. We will evaluate any complications of malignant brain tumors, such as resultant neurological or psychological impairments, under the criteria for the affected body system. We evaluate benign brain tumors under 11.05. 
                            </P>
                            <P>
                                L. 
                                <E T="03">How do we evaluate malignant neoplastic diseases treated by bone marrow or stem cell transplantation?</E>
                                 Bone marrow or stem cell transplantation is performed for a variety of malignant neoplastic diseases. 
                            </P>
                            <P>
                                1. 
                                <E T="03">Acute leukemia (including T-cell lymphoblastic lymphoma) or accelerated or blast phase of CML.</E>
                                 If you undergo bone marrow or stem cell transplantation for any of these disorders, we will consider you to be disabled until at least 24 months from the date of diagnosis or relapse, or at least 12 months from the date of transplantation, whichever is later. 
                            </P>
                            <P>
                                2. 
                                <E T="03">Lymphoma, multiple myeloma, or chronic phase of CML.</E>
                                 If you undergo bone marrow or stem cell transplantation for any of these disorders, we will consider you to be disabled until at least 12 months from the date of transplantation. 
                            </P>
                            <P>
                                3. 
                                <E T="03">Other malignancies.</E>
                                 We will evaluate any other malignant neoplastic disease treated with bone marrow or stem cell transplantation under 13.28, regardless of whether there is another listing that addresses that impairment. The length of time we will consider you to be disabled depends on whether you undergo allogeneic or autologous transplantation. 
                            </P>
                            <P>
                                a. 
                                <E T="03">Allogeneic bone marrow or stem cell transplantation.</E>
                                 If you undergo allogeneic transplantation (transplantation from an unrelated donor or a related donor other than an identical twin), we will consider you to be disabled until at least 12 months from the date of transplantation. 
                            </P>
                            <P>
                                b. 
                                <E T="03">Autologous bone marrow or stem cell transplantation.</E>
                                 If you undergo autologous transplantation (transplantation of your own cells or cells from your identical twin (syngeneic transplantation)), we will consider you to be disabled until at least 12 months from the date of the first treatment under the treatment plan that includes transplantation. The first treatment usually refers to the initial therapy given to prepare you for transplantation. 
                            </P>
                            <P>
                                4. 
                                <E T="03">Evaluating disability after the appropriate time period has elapsed.</E>
                                 We consider any residual impairment(s), such as complications arising from: 
                            </P>
                            <P>a. Graft-versus-host (GVH) disease. </P>
                            <P>b. Immunosuppressant therapy, such as frequent infections. </P>
                            <P>c. Significant deterioration of other organ systems. </P>
                            <HD SOURCE="HD3">13.01 Category of Impairments, Malignant Neoplastic Diseases </HD>
                            <P>
                                13.02 
                                <E T="03">Soft tissue tumors of the head and neck (except salivary glands—13.06—and thyroid gland—13.07).</E>
                            </P>
                            <P>A. Inoperable or unresectable. </P>
                            <FP>OR </FP>
                            <P>B. Persistent disease following initial multimodal antineoplastic therapy. </P>
                            <FP>OR </FP>
                            <P>C. Recurrent disease following initial antineoplastic therapy, except local vocal cord recurrence. </P>
                            <FP>OR </FP>
                            <P>D. With metastases beyond the regional lymph nodes. </P>
                            <FP>OR </FP>
                            <P>E. Soft tissue tumors of the head and neck not addressed in A-D, with multimodal antineoplastic therapy. Consider under a disability until at least 18 months from the date of diagnosis. Thereafter, evaluate any residual impairment(s) under the criteria for the affected body system. </P>
                            <P>
                                13.03 
                                <E T="03">Skin.</E>
                            </P>
                            <P>A. Sarcoma or carcinoma with metastases to or beyond the regional lymph nodes. </P>
                            <FP>OR </FP>
                            <P>B. Melanoma, with either 1 or 2: </P>
                            <P>1. Recurrent after wide excision (except an additional primary melanoma at a different site, which is not considered to be recurrent disease). </P>
                            <P>2. Palpable nodal metastases or metastases to adjacent skin (satellite lesions) or elsewhere. </P>
                            <P>
                                13.04 
                                <E T="03">Soft tissue sarcoma.</E>
                            </P>
                            <P>A. With regional or distant metastases. </P>
                            <FP>OR </FP>
                            <P>B. Persistent or recurrent following initial antineoplastic therapy. </P>
                            <P>
                                13.05 
                                <E T="03">Lymphoma (including mycosis fungoides, but excluding T-cell lymphoblastic lymphoma—13.06).</E>
                                 (
                                <E T="03">See</E>
                                 13.00K1 and 13.00K2c.) 
                            </P>
                            <P>A. Non-Hodgkin's lymphoma, as described in 1 or 2: </P>
                            <P>1. Intermediate or high-grade lymphoma persistent or recurrent following initial antineoplastic therapy. </P>
                            <P>2. Low-grade or indolent lymphoma requiring initiation of more than one antineoplastic treatment regimen within a consecutive 12-month period. Consider under a disability from at least the date of initiation of the treatment regimen that failed within 12 months. </P>
                            <FP>OR </FP>
                            <P>B. Hodgkin's disease with failure to achieve clinically complete remission, or recurrent disease within 12 months of completing initial antineoplastic therapy. </P>
                            <FP>OR </FP>
                            <P>C. With bone marrow or stem cell transplantation. Consider under a disability until at least 12 months from the date of transplantation. Thereafter, evaluate any residual impairment(s) under the criteria for the affected body system. </P>
                            <P>
                                13.06 
                                <E T="03">Leukemia.</E>
                                 (
                                <E T="03">See</E>
                                 13.00K2.) 
                            </P>
                            <P>A. Acute leukemia (including T-cell lymphoblastic lymphoma). Consider under a disability until at least 24 months from the date of diagnosis or relapse, or at least 12 months from the date of bone marrow or stem cell transplantation, whichever is later. Thereafter, evaluate any residual impairment(s) under the criteria for the affected body system. </P>
                            <FP>OR </FP>
                            <P>B. Chronic myelogenous leukemia, as described in 1 or 2: </P>
                            <P>1. Accelerated or blast phase. Consider under a disability until at least 24 months from the date of diagnosis or relapse, or at least 12 months from the date of bone marrow or stem cell transplantation, whichever is later. Thereafter, evaluate any residual impairment(s) under the criteria for the affected body system. </P>
                            <P>
                                2. Chronic phase, as described in a or b: 
                                <PRTPAGE P="67035"/>
                            </P>
                            <P>a. Consider under a disability until at least 12 months from the date of bone marrow or stem cell transplantation. Thereafter, evaluate any residual impairment(s) under the criteria for the affected body system. </P>
                            <P>b. Progressive disease following initial antineoplastic therapy. </P>
                            <P>
                                13.07 
                                <E T="03">Multiple myeloma (confirmed by appropriate serum or urine protein electrophoresis and bone marrow findings).</E>
                            </P>
                            <P>A. Failure to respond or progressive disease following initial antineoplastic therapy. </P>
                            <FP>OR </FP>
                            <P>B. With bone marrow or stem cell transplantation. Consider under a disability until at least 12 months from the date of transplantation. Thereafter, evaluate any residual impairment(s) under the criteria for the affected body system. </P>
                            <P>
                                13.08 
                                <E T="03">Salivary glands</E>
                                —carcinoma or sarcoma with metastases beyond the regional lymph nodes. 
                            </P>
                            <P>
                                13.09 
                                <E T="03">Thyroid gland.</E>
                            </P>
                            <P>A. Anaplastic (undifferentiated) carcinoma. </P>
                            <FP>OR </FP>
                            <P>B. Carcinoma with metastases beyond the regional lymph nodes progressive despite radioactive iodine therapy. </P>
                            <P>
                                13.10 
                                <E T="03">Breast (except sarcoma—13.04).</E>
                                 (
                                <E T="03">See</E>
                                 13.00K4.) 
                            </P>
                            <P>A. Locally advanced carcinoma (inflammatory carcinoma, tumor of any size with direct extension to the chest wall or skin, tumor of any size with metastases to the ipsilateral internal mammary nodes). </P>
                            <FP>OR </FP>
                            <P>B. Carcinoma with distant metastases. </P>
                            <FP>OR </FP>
                            <P>C. Recurrent carcinoma, except local recurrence that remits with antineoplastic therapy. </P>
                            <P>
                                13.11 
                                <E T="03">Skeletal system</E>
                                —carcinoma or sarcoma. 
                            </P>
                            <P>A. Inoperable or unresectable. </P>
                            <FP>OR </FP>
                            <P>B. Recurrent tumor (except local recurrence) after initial antineoplastic therapy. </P>
                            <FP>OR </FP>
                            <P>C. With distant metastases. </P>
                            <FP>OR </FP>
                            <P>D. All other tumors originating in bone with multimodal antineoplastic therapy. Consider under a disability for 12 months from the date of diagnosis. Thereafter, evaluate any residual impairment(s) under the criteria for the affected body system. </P>
                            <P>
                                13.12 
                                <E T="03">Maxilla, orbit, or temporal fossa.</E>
                            </P>
                            <P>A. Sarcoma or carcinoma of any type with regional or distant metastases. </P>
                            <FP>OR </FP>
                            <P>B. Carcinoma of the antrum with extension into the orbit or ethmoid or sphenoid sinus. </P>
                            <FP>OR </FP>
                            <P>C. Tumors with extension to the base of the skull, orbit, meninges, or sinuses. </P>
                            <P>
                                13.13 
                                <E T="03">Nervous system.</E>
                                 (
                                <E T="03">See</E>
                                 13.00K6.) 
                            </P>
                            <P>A. Central nervous system neoplasms (brain and spinal cord), as described in 1 or 2: </P>
                            <P>1. Highly malignant tumors, such as Grades III and IV astrocytomas, glioblastoma multiforme, ependymoblastoma, medulloblastoma or other primitive neuroectodermal tumors (PNETs) with documented metastases, diffuse intrinsic brain stem gliomas, or primary sarcomas. </P>
                            <P>2. Any central nervous system neoplasm progressive or recurrent following initial antineoplastic therapy. </P>
                            <FP>OR </FP>
                            <P>B. Peripheral nerve or spinal root neoplasm, as described in 1 or 2: </P>
                            <P>1. Metastatic. </P>
                            <P>2. Progressive or recurrent following initial antineoplastic therapy. </P>
                            <P>
                                13.14 
                                <E T="03">Lungs</E>
                                . 
                            </P>
                            <P>A. Non-small-cell carcinoma—inoperable, unresectable, recurrent, or metastatic disease to or beyond the hilar nodes. </P>
                            <FP>OR</FP>
                            <P>B. Small-cell (oat cell) carcinoma. </P>
                            <P>
                                13.15 
                                <E T="03">Pleura or mediastinum</E>
                                . 
                            </P>
                            <P>A. Malignant mesothelioma of pleura.</P>
                            <FP>OR</FP>
                            <P>B. Tumors of the mediastinum, as described in 1 or 2: </P>
                            <P>1. With metastases to or beyond the regional lymph nodes. </P>
                            <P>2. Persistent or recurrent following initial antineoplastic therapy. </P>
                            <P>
                                13.16 
                                <E T="03">Esophagus or stomach</E>
                                . 
                            </P>
                            <P>A. Carcinoma or sarcoma of the esophagus.</P>
                            <P>OR</P>
                            <P>B. Carcinoma or sarcoma of the stomach, as described in 1 or 2:</P>
                            <P>1. Inoperable, unresectable, extending to surrounding structures, or recurrent. </P>
                            <P>2. With metastases to or beyond the regional lymph nodes. </P>
                            <P>
                                13.17 
                                <E T="03">Small intestine</E>
                                —carcinoma, sarcoma, or carcinoid. 
                            </P>
                            <P>A. Inoperable, unresectable, or recurrent.</P>
                            <FP>OR</FP>
                            <P>B. With metastases beyond the regional lymph nodes. </P>
                            <P>
                                13.18 
                                <E T="03">Large intestine (from ileocecal valve to and including anal canal)</E>
                                . 
                            </P>
                            <P>A. Adenocarcinoma that is inoperable, unresectable, or recurrent. </P>
                            <FP>OR</FP>
                            <P>B. Squamous cell carcinoma of the anus, recurrent after surgery.</P>
                            <FP>OR</FP>
                            <P>C. With metastases beyond the regional lymph nodes. </P>
                            <P>
                                13.19 
                                <E T="03">Liver or gallbladder</E>
                                —tumors of the liver, gallbladder, or bile ducts. 
                            </P>
                            <P>
                                13.20 
                                <E T="03">Pancreas.</E>
                            </P>
                            <P>A. Carcinoma (except islet cell carcinoma). </P>
                            <FP>OR</FP>
                            <P>B. Islet cell carcinoma that is inoperable or unresectable and physiologically active. </P>
                            <P>
                                13.21 
                                <E T="03">Kidneys, adrenal glands, or ureters</E>
                                —carcinoma. 
                            </P>
                            <P>A. Inoperable, unresectable, or recurrent.</P>
                            <FP>OR </FP>
                            <P>B. With metastases to or beyond the regional lymph nodes. </P>
                            <P>
                                13.22 
                                <E T="03">Urinary bladder</E>
                                —carcinoma. 
                            </P>
                            <P>A. With infiltration beyond the bladder wall.</P>
                            <FP>OR </FP>
                            <P>B. Recurrent after total cystectomy.</P>
                            <FP>OR </FP>
                            <P>C. Inoperable or unresectable.</P>
                            <FP>OR </FP>
                            <P>D. With metastases to or beyond the regional lymph nodes. </P>
                            <P>
                                13.23 
                                <E T="03">Cancers of the female genital tract</E>
                                —carcinoma or sarcoma. 
                            </P>
                            <P>A. Uterus (corpus), as described in 1, 2, or 3: </P>
                            <P>1. Invading adjoining organs. </P>
                            <P>2. With metastases to or beyond the regional lymph nodes. </P>
                            <P>3. Persistent or recurrent following initial antineoplastic therapy. </P>
                            <FP>OR </FP>
                            <P>B. Uterine cervix, as described in 1 or 2:</P>
                            <P>1. Extending to the pelvic wall, lower portion of the vagina, or adjacent or distant organs. </P>
                            <P>2. Persistent or recurrent following initial antineoplastic therapy. </P>
                            <FP>OR </FP>
                            <P>C. Vulva, as described in 1, 2, or 3:</P>
                            <P>1. Invading adjoining organs. </P>
                            <P>2. With metastases to or beyond the regional lymph nodes. </P>
                            <P>3. Persistent or recurrent following initial antineoplastic therapy. </P>
                            <FP>OR </FP>
                            <P>D. Fallopian tubes, as described in 1 or 2: </P>
                            <P>1. Extending to the serosa or beyond. </P>
                            <P>2. Persistent or recurrent following initial antineoplastic therapy. </P>
                            <FP>OR </FP>
                            <P>E. Ovaries, as described in 1 or 2:</P>
                            <P>1. All tumors except germ-cell tumors, with at least one of the following: </P>
                            <P>a. Tumor extension beyond the pelvis; for example, tumor implants on peritoneal, omental, or bowel surfaces. </P>
                            <P>b. Metastases to or beyond the regional lymph nodes. </P>
                            <P>c. Ruptured ovarian capsule, tumor on the serosal surface of the ovary, ascites with malignant cells, or positive peritoneal washings. </P>
                            <P>d. Recurrent following initial antineoplastic therapy. </P>
                            <P>2. Germ-cell tumors—progressive or recurrent following initial antineoplastic therapy. </P>
                            <P>
                                13.24 
                                <E T="03">Prostate gland</E>
                                —carcinoma. 
                            </P>
                            <P>A. Progressive or recurrent despite initial hormonal intervention.</P>
                            <FP>OR </FP>
                            <P>B. With visceral metastases. </P>
                            <P>
                                13.25 
                                <E T="03">Testicles</E>
                                —tumor with metastatic disease progressive or recurrent following initial chemotherapy. 
                            </P>
                            <P>
                                13.26 
                                <E T="03">Penis</E>
                                —carcinoma with metastases to or beyond the regional lymph nodes. 
                            </P>
                            <P>
                                13.27 
                                <E T="03">Primary site unknown after appropriate search for primary</E>
                                —metastatic carcinoma or sarcoma, except for solitary squamous cell carcinoma in the neck. 
                            </P>
                            <P>
                                13.28 
                                <E T="03">Malignant neoplastic diseases treated by bone marrow or stem cell transplantation.</E>
                                 (
                                <E T="03">See</E>
                                 13.00L.) 
                            </P>
                            <P>A. Allogeneic transplantation. Consider under a disability until at least 12 months from the date of transplantation. Thereafter, evaluate any residual impairment(s) under the criteria for the affected body system. </P>
                            <PRTPAGE P="67036"/>
                            <FP>OR </FP>
                            <P>B. Autologous transplantation. Consider under a disability until at least 12 months from the date of the first treatment under the treatment plan that includes transplantation. Thereafter, evaluate any residual impairment(s) under the criteria for the affected body system. </P>
                            <STARS/>
                            <HD SOURCE="HD2">Part B </HD>
                            <STARS/>
                            <P>107.00 Hematological Disorders </P>
                            <STARS/>
                            <P>113.00 Malignant Neoplastic Diseases </P>
                            <STARS/>
                            <P>107.00 HEMATOLOGICAL DISORDERS </P>
                            <STARS/>
                            <P>C. [removed] </P>
                            <STARS/>
                            <P>107.11 [removed] </P>
                            <STARS/>
                            <P>111.00 NEUROLOGICAL </P>
                            <STARS/>
                            <P>
                                E. 
                                <E T="03">Brain tumors.</E>
                                 We evaluate malignant brain tumors under the criteria in 113.13. For benign brain tumors, we determine the severity and duration of the impairment on the basis of symptoms, signs, and laboratory findings (111.05). 
                            </P>
                            <STARS/>
                            <P>
                                111.05 
                                <E T="03">Benign brain tumors.</E>
                                 Evaluate under 111.02, 111.03, 111.06, 111.09 or the criteria of the affected body system. 
                            </P>
                            <STARS/>
                            <P>113.00 MALIGNANT NEOPLASTIC DISEASES </P>
                            <P>
                                A. 
                                <E T="03">What impairments do these listings cover?</E>
                                 We use these listings to evaluate all malignant neoplasms except certain neoplasms associated with human immunodeficiency virus (HIV) infection. We use the criteria in 114.08E to evaluate carcinoma of the cervix, Kaposi's sarcoma, lymphoma, and squamous cell carcinoma of the anus if you also have HIV infection. 
                            </P>
                            <P>
                                B. 
                                <E T="03">What do we consider when we evaluate malignant neoplastic diseases under these listings?</E>
                                 We consider factors such as the: 
                            </P>
                            <P>1. Origin of the malignancy. </P>
                            <P>2. Extent of involvement. </P>
                            <P>3. Duration, frequency, and response to antineoplastic therapy. Antineoplastic therapy means surgery, irradiation, chemotherapy, hormones, immunotherapy, or bone marrow or stem cell transplantation. When we refer to surgery as an antineoplastic treatment, we mean surgical excision for treatment, not for diagnostic purposes. </P>
                            <P>4. Effects of any post-therapeutic residuals. </P>
                            <P>
                                C. 
                                <E T="03">How do we apply these listings?</E>
                                 We apply the criteria in a specific listing to a malignancy originating from that specific site. 
                            </P>
                            <P>
                                D. 
                                <E T="03">What evidence do we need?</E>
                            </P>
                            <P>1. We need medical evidence that specifies the type, extent, and site of the primary, recurrent, or metastatic lesion. In the rare situation in which the primary site cannot be identified, we will use evidence documenting the site(s) of metastasis to evaluate the impairment under 13.27 in part A. </P>
                            <P>2. For operative procedures, including a biopsy or a needle aspiration, we generally need a copy of both the: </P>
                            <P>a. Operative note. </P>
                            <P>b. Pathology report. </P>
                            <P>3. When we cannot get these documents, we will accept the summary of hospitalization(s) or other medical reports. This evidence should include details of the findings at surgery and, whenever appropriate, the pathological findings. </P>
                            <P>
                                4. In some situations we may also need evidence about recurrence, persistence, or progression of the malignancy, the response to therapy, and any significant residuals. (
                                <E T="03">See</E>
                                 113.00G.) 
                            </P>
                            <P>
                                E. 
                                <E T="03">When do we need longitudinal evidence?</E>
                            </P>
                            <P>
                                1. 
                                <E T="03">Tumors with distant metastases.</E>
                                 Most malignant tumors of childhood consist of a local lesion with metastases to regional lymph nodes and, less often, distant metastases. We generally do not need longitudinal evidence for tumors that have metastasized beyond the regional lymph nodes because these tumors usually meet the requirements of a listing. Exceptions are for tumors with distant metastases that are expected to respond to antineoplastic therapy. For these exceptions, we usually need a longitudinal record of 3 months after therapy starts to determine whether the intended effect of therapy has been achieved and is likely to persist. 
                            </P>
                            <P>
                                2. 
                                <E T="03">Other malignancies.</E>
                                 When there are no distant metastases, many of the listings require that we consider your response to initial antineoplastic therapy; that is, the initial planned treatment regimen. This therapy may consist of a single modality or a combination of modalities (multimodal) given in close proximity as a unified whole, and is usually planned before any treatment(s) is initiated. Examples of multimodal therapy include: 
                            </P>
                            <P>a. Surgery followed by chemotherapy or radiation. </P>
                            <P>b. Chemotherapy followed by surgery. </P>
                            <P>c. Chemotherapy and concurrent radiation. </P>
                            <P>
                                3. 
                                <E T="03">Types of treatment.</E>
                                 Whenever the initial planned therapy is a single modality, enough time must pass to allow a determination about whether the therapy will achieve its intended effect. If the treatment fails, the failure will often happen within 6 months after treatment starts, and there will often be a change in the treatment regimen. Whenever the initial planned therapy is multimodal, a determination about the effectiveness of the therapy usually cannot be made until the effects of all the planned modalities can be determined. In some cases, we may need to defer adjudication until the effectiveness of therapy can be assessed. However, we do not need to defer adjudication to determine whether the therapy will achieve its intended effect if we can make a fully favorable determination or decision based on the length and effects of therapy, or the residuals of the malignancy or therapy (
                                <E T="03">see</E>
                                 113.00G). 
                            </P>
                            <P>
                                F. 
                                <E T="03">How do we evaluate impairments that do not meet one of the malignant neoplastic diseases listings?</E>
                            </P>
                            <P>1. These listings are only examples of malignant neoplastic diseases that we consider severe enough to result in marked and severe functional limitations. If your impairment(s) does not meet the criteria of any of these listings, we must also consider whether you have an impairment(s) that meets the criteria of a listing in another body system. </P>
                            <P>
                                2. If you have a severe medically determinable impairment(s) that does not meet a listing, we will determine whether your impairment(s) medically equals a listing. (
                                <E T="03">See</E>
                                 §§ 404.1526 and 416.926.) If it does not, we will also consider whether you have an impairment(s) that functionally equals the listings. (
                                <E T="03">See</E>
                                 § 416.926a.) We use the rules in § 416.994a when we decide whether you continue to be disabled. 
                            </P>
                            <P>
                                G. 
                                <E T="03">How do we consider the effects of therapy?</E>
                            </P>
                            <P>
                                1. 
                                <E T="03">How we consider the effects of therapy under the listings.</E>
                                 In many cases, malignancies meet listing criteria only if the therapy does not achieve the intended effect: the malignancy persists, progresses, or recurs despite treatment. However, as explained in the following paragraphs, we will not delay adjudication if we can make a fully favorable determination or decision based on the evidence in the case record. 
                            </P>
                            <P>
                                2. 
                                <E T="03">Effects can vary widely.</E>
                            </P>
                            <P>a. Because the therapy and its toxicity may vary widely, we consider each case on an individual basis. We will request a specific description of the therapy, including these items: </P>
                            <P>i. Drugs given. </P>
                            <P>ii. Dosage. </P>
                            <P>iii. Frequency of drug administration. </P>
                            <P>iv. Plans for continued drug administration. </P>
                            <P>v. Extent of surgery. </P>
                            <P>vi. Schedule and fields of radiation therapy. </P>
                            <P>b. We will also request a description of the complications or adverse effects of therapy, such as the following: </P>
                            <P>i. Continuing gastrointestinal symptoms. </P>
                            <P>ii. Persistent weakness. </P>
                            <P>iii. Neurological complications. </P>
                            <P>iv. Cardiovascular complications. </P>
                            <P>v. Reactive mental disorders. </P>
                            <P>
                                3. 
                                <E T="03">Effects of therapy may change.</E>
                                 Because the severity of the adverse effects of antineoplastic therapy may change during treatment, enough time must pass to allow us to evaluate the therapy's effect. The residual effects of treatment are temporary in most instances. But on occasion, the effects may be disabling for a consecutive period of at least 12 months. 
                            </P>
                            <P>
                                4. 
                                <E T="03">When the initial antineoplastic therapy is effective.</E>
                                 We evaluate any post-therapeutic residual impairment(s) not included in these listings under the criteria for the affected body system. We must consider any complications of therapy. When the residual impairment(s) does not meet a listed impairment, we must consider whether it medically equals a listing, or, as appropriate, functionally equals the listings. 
                            </P>
                            <P>
                                H. 
                                <E T="03">How long do we consider your impairment to be disabling?</E>
                            </P>
                            <P>
                                1. In some listings, we specify that we will consider your impairment to be disabling until a particular point in time (for example, at least 12 months from the date of diagnosis). We may consider your impairment to be disabling beyond this point 
                                <PRTPAGE P="67037"/>
                                when the medical and other evidence justifies it. 
                            </P>
                            <P>2. When a listing does not contain such a specification, we will consider an impairment(s) that meets or medically equals a listing in this body system to be disabling until at least 3 years after onset of complete remission. When the impairment(s) has been in complete remission for at least 3 years, that is, the original tumor and any metastases have not been evident for at least 3 years, the impairment(s) will no longer meet or equal the criteria of a listing in this body system. </P>
                            <P>
                                3. Following the appropriate period, we will consider any residuals, including residuals of the malignancy or therapy (
                                <E T="03">see</E>
                                 113.00G), in determining whether you are disabled. 
                            </P>
                            <P>
                                I. 
                                <E T="03">What do these terms in the listings mean?</E>
                            </P>
                            <P>
                                1. 
                                <E T="03">Persistent:</E>
                                 Failure to achieve a complete remission. 
                            </P>
                            <P>
                                2. 
                                <E T="03">Progressive:</E>
                                 The malignancy became more extensive after treatment. 
                            </P>
                            <P>
                                3. 
                                <E T="03">Recurrent, relapse:</E>
                                 A malignancy that had been in complete remission or entirely removed by surgery has returned. 
                            </P>
                            <P>
                                J. 
                                <E T="03">Can we establish the existence of a disabling impairment prior to the date of the evidence that shows the malignancy satisfies the criteria of a listing?</E>
                                 Yes. We will consider factors such as: 
                            </P>
                            <P>1. The type of malignancy and its location. </P>
                            <P>2. The extent of involvement when the malignancy was first demonstrated. </P>
                            <P>3. Your symptoms. </P>
                            <P>
                                K. 
                                <E T="03">How do we evaluate specific malignant neoplastic diseases?</E>
                            </P>
                            <P>
                                1. 
                                <E T="03">Lymphoma.</E>
                            </P>
                            <P>a. Listing 113.05 provides criteria for evaluating intermediate or high grade lymphomas that have not responded to antineoplastic therapy. Low grade or indolent lymphomas are rare in children. We will evaluate low grade or indolent lymphomas under 13.05 in part A. </P>
                            <P>b. We consider Hodgkin's disease that recurs more than 12 months after completing initial antineoplastic therapy to be a new disease rather than a recurrence. </P>
                            <P>
                                c. Many children with lymphoma are treated according to a long-term protocol that can result in significant adverse medical, social, and emotional consequences. (
                                <E T="03">See</E>
                                 113.00G.) 
                            </P>
                            <P>
                                2. 
                                <E T="03">Leukemia.</E>
                            </P>
                            <P>
                                a. 
                                <E T="03">Acute leukemia.</E>
                                 The initial diagnosis of acute leukemia, including the accelerated or blast phase of chronic myelogenous (granulocytic) leukemia, is based upon definitive bone marrow examination. Additional diagnostic information is based on chromosomal analysis, cytochemical and surface marker studies on the abnormal cells, or other methods consistent with the prevailing state of medical knowledge and clinical practice. Recurrent disease must be documented by peripheral blood, bone marrow, or cerebrospinal fluid examination. The initial and follow-up pathology reports should be included. 
                            </P>
                            <P>
                                b. 
                                <E T="03">Chronic myelogenous leukemia (CML).</E>
                                 The diagnosis of CML should be based upon documented granulocytosis, including immature forms such as differentiated or undifferentiated myelocytes and myeloblasts, and a chromosomal analysis that demonstrates the Philadelphia chromosome. In the absence of a chromosomal analysis, or if the Philadelphia chromosome is not present, the diagnosis may be made by other methods consistent with the prevailing state of medical knowledge and clinical practice. 
                            </P>
                            <P>
                                c. 
                                <E T="03">Juvenile chronic myelogenous leukemia (JCML).</E>
                                 JCML is a rare, Philadelphia-chromosome-negative childhood leukemia that is aggressive and clinically similar to acute myelogenous leukemia. We evaluate JCML under 113.06A. 
                            </P>
                            <P>
                                d. 
                                <E T="03">Elevated white cell count.</E>
                                 In cases of chronic leukemia, an elevated white cell count, in itself, is not ordinarily a factor in determining the severity of the impairment. 
                            </P>
                            <P>
                                3. 
                                <E T="03">Malignant solid tumors.</E>
                                 The tumors we consider under 113.03 include the histiocytosis syndromes except for solitary eosinophilic granuloma. Therefore, we will not evaluate brain tumors (
                                <E T="03">see</E>
                                 113.13) or thyroid tumors (
                                <E T="03">see</E>
                                 113.09) under this listing. 
                            </P>
                            <P>
                                4. 
                                <E T="03">Brain tumors.</E>
                                 We use the criteria in 113.13 to evaluate malignant brain tumors. We will evaluate any complications of malignant brain tumors, such as resultant neurological or psychological impairments, under the criteria for the affected body system. We evaluate benign brain tumors under 111.05. 
                            </P>
                            <P>
                                5. 
                                <E T="03">Retinoblastoma.</E>
                                 The treatment for bilateral retinoblastoma usually results in a visual impairment. We will evaluate any resulting visual impairment under 102.02. 
                            </P>
                            <P>
                                L. 
                                <E T="03">How do we evaluate malignant neoplastic diseases treated by bone marrow or stem cell transplantation?</E>
                                 Bone marrow or stem cell transplantation is performed for a variety of malignant neoplastic diseases. 
                            </P>
                            <P>
                                1. 
                                <E T="03">Acute leukemia (including T-cell lymphoblastic lymphoma and JCML) or accelerated or blast phase of CML.</E>
                                 If you undergo bone marrow or stem cell transplantation for any of these disorders, we will consider you to be disabled until at least 24 months from the date of diagnosis or relapse, or at least 12 months from the date of transplantation, whichever is later. 
                            </P>
                            <P>
                                2. 
                                <E T="03">Lymphoma or chronic phase of CML.</E>
                                 If you undergo bone marrow or stem cell transplantation for any of these disorders, we will consider you to be disabled until at least 12 months from the date of transplantation. 
                            </P>
                            <P>
                                3. 
                                <E T="03">Evaluating disability after the appropriate time period has elapsed.</E>
                                 We consider any residual impairment(s), such as complications arising from: 
                            </P>
                            <P>a. Graft-versus-host (GVH) disease. </P>
                            <P>b. Immunosuppressant therapy, such as frequent infections. </P>
                            <P>c. Significant deterioration of other organ systems. </P>
                            <HD SOURCE="HD3">113.01 Category of Impairments, Malignant Neoplastic Diseases </HD>
                            <P>
                                113.03 
                                <E T="03">Malignant solid tumors.</E>
                                 Consider under a disability: 
                            </P>
                            <P>A. For 2 years from the date of initial diagnosis. Thereafter, evaluate any residual impairment(s) under the criteria for the affected body system. </P>
                            <FP>OR </FP>
                            <P>B. For 2 years from the date of recurrence of active disease. Thereafter, evaluate any residual impairment(s) under the criteria for the affected body system. </P>
                            <P>
                                113.05 
                                <E T="03">Lymphoma (excluding T-cell lymphoblastic lymphoma—113.06).</E>
                                 (
                                <E T="03">See</E>
                                 113.00K1.) 
                            </P>
                            <P>A. Non-Hodgkins lymphoma, including Burkitt's and anaplastic large cell. Persistent or recurrent following initial antineoplastic therapy. </P>
                            <FP>OR </FP>
                            <P>B. Hodgkin's disease with failure to achieve clinically complete remission, or recurrent disease within 12 months of completing initial antineoplastic therapy. </P>
                            <FP>OR </FP>
                            <P>C. With bone marrow or stem cell transplantation. Consider under a disability until at least 12 months from the date of transplantation. Thereafter, evaluate any residual impairment(s) under the criteria of the affected body system. </P>
                            <P>
                                113.06 
                                <E T="03">Leukemia.</E>
                                 (
                                <E T="03">See</E>
                                 113.00K2.) 
                            </P>
                            <P>A. Acute leukemia (including T-cell lymphoblastic lymphoma and juvenile chronic myelogenous leukemia (JCML)). Consider under a disability until at least 24 months from the date of diagnosis or relapse, or at least 12 months from the date of bone marrow or stem cell transplantation, whichever is later. Thereafter, evaluate any residual impairment(s) under the criteria for the affected body system. </P>
                            <FP>OR </FP>
                            <P>B. Chronic myelogenous leukemia (except JCML), as described in 1 or 2: </P>
                            <P>1. Accelerated or blast phase. Consider under a disability until at least 24 months from the date of diagnosis or relapse, or at least 12 months from the date of bone marrow or stem cell transplantation, whichever is later. Thereafter, evaluate any residual impairment(s) under the criteria for the affected body system. </P>
                            <P>2. Chronic phase, as described in a or b: </P>
                            <P>a. Consider under a disability until at least 12 months from the date of bone marrow or stem cell transplantation. Thereafter, evaluate any residual impairment(s) under the criteria for the affected body system. </P>
                            <P>b. Progressive disease following initial antineoplastic therapy. </P>
                            <P>
                                113.09 
                                <E T="03">Thyroid gland.</E>
                            </P>
                            <P>A. Anaplastic (undifferentiated) carcinoma. </P>
                            <FP>OR </FP>
                            <P>B. Carcinoma with metastases beyond the regional lymph nodes progressive despite radioactive iodine therapy. </P>
                            <P>
                                113.12 
                                <E T="03">Retinoblastoma.</E>
                            </P>
                            <P>A. With extension beyond the orbit. </P>
                            <FP>OR </FP>
                            <P>B. Persistent or recurrent following initial antineoplastic therapy. </P>
                            <FP>OR </FP>
                            <P>C. With regional or distant metastases. </P>
                            <P>
                                113.13 
                                <E T="03">Brain tumors.</E>
                                 (
                                <E T="03">See</E>
                                 113.00K4.) Highly malignant tumors, such as Grades III and IV astrocytomas, glioblastoma multiforme, ependymoblastoma, medulloblastoma or other primitive neuroectodermal tumors (PNETs) with documented metastases, diffuse intrinsic brain stem gliomas, or primary sarcomas. 
                            </P>
                            <P>
                                113.21 
                                <E T="03">Neuroblastoma.</E>
                            </P>
                            <P>A. With extension across the midline. </P>
                            <PRTPAGE P="67038"/>
                            <FP>OR </FP>
                            <P>B. With distant metastases. </P>
                            <FP>OR </FP>
                            <P>C. Recurrent. </P>
                            <FP>OR </FP>
                            <P>D. With onset at age 1 year or older. </P>
                            <STARS/>
                        </APPENDIX>
                    </REGTEXT>
                </SUPLINF>
                <FRDOC>[FR Doc. 04-24897 Filed 11-12-04; 8:45 am] </FRDOC>
                <BILCOD>BILLING CODE 4191-02-P</BILCOD>
            </RULE>
        </RULES>
    </NEWPART>
    <VOL>69</VOL>
    <NO>219</NO>
    <DATE>Monday, November 15, 2004</DATE>
    <UNITNAME>Proposed Rules</UNITNAME>
    <NEWPART>
        <PRORULES>
            <PRORULE>
                <PREAMB>
                    <PRTPAGE P="67039"/>
                    <AGENCY TYPE="S">SOCIAL SECURITY ADMINISTRATION </AGENCY>
                    <CFR>20 CFR Part 404 </CFR>
                    <SUBJECT>Revised Medical Criteria for Evaluating Hematological Disorders and Malignant Neoplastic Diseases </SUBJECT>
                    <AGY>
                        <HD SOURCE="HED">AGENCY:</HD>
                        <P>Social Security Administration. </P>
                    </AGY>
                    <ACT>
                        <HD SOURCE="HED">ACTION:</HD>
                        <P>Proposed rule; partial withdrawal. </P>
                    </ACT>
                    <SUM>
                        <HD SOURCE="HED">SUMMARY:</HD>
                        <P>
                            We are withdrawing the rules we proposed for evaluating hematological disorders that were included in the Notice of Proposed Rulemaking (NPRM) published in the 
                            <E T="04">Federal Register</E>
                             on November 27, 2001 (66 FR 59306). In that NPRM, we proposed revisions to both the listings for hematological disorders and the listings for malignant neoplastic diseases. The public comments we received on the NPRM raised significant issues about the proposed listings for some of the hematological disorders, and we have decided to withdraw the proposed rules for hematological disorders while we obtain additional input to resolve these issues. We plan to publish a new NPRM for the hematological disorders listings at a later date. We are publishing separately in today's edition of the 
                            <E T="04">Federal Register</E>
                             final rules for evaluating malignant neoplastic diseases. 
                        </P>
                    </SUM>
                    <FURINF>
                        <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                        <P>
                            Martin Sussman, Regulations Officer, Office of Regulations, Social Security Administration, 100 Altmeyer Building, 6401 Security Boulevard, Baltimore, Maryland 21235-6401, (410) 965-1767 or TTY (410) 966-5609. For information on eligibility or filing for benefits, call our national toll-free number, 1-800-772-1213 or TTY 1-800-325-0778, or visit our Internet Web site, 
                            <E T="03">Social Security Online</E>
                            , at 
                            <E T="03">http://www.socialsecurity.gov/</E>
                            . 
                        </P>
                        <SIG>
                            <DATED>Dated: July 19, 2004. </DATED>
                            <NAME>Jo Anne B. Barnhart, </NAME>
                            <TITLE>Commissioner of Social Security. </TITLE>
                        </SIG>
                    </FURINF>
                </PREAMB>
                <FRDOC>[FR Doc. 04-24898 Filed 11-12-04; 8:45 am] </FRDOC>
                <BILCOD>BILLING CODE 4191-02-P</BILCOD>
            </PRORULE>
        </PRORULES>
    </NEWPART>
</FEDREG>
